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The Assignm consists of a WORKSHEET to fill based on reading 2 chapters from a book about the THEORIES applied. I have an article teh WRKSHEET is based on, BUT YOU NEED TO GO THROUGH the 2 chapters of the book to read &familiarize with the Theories in Public health Programs and find the one that applies to the article. ONLY then the WORKSHEET can easily be filled up. There is also a “Rubric Detail for you to see how the Prof. grades this worksheet. I also have a 15 Qs Quizz, along with the WORKSHEET which is also attached. Quizz is also based on the book. I have the book and I will give the book to the person I will work with. Simple as that: go through the 2 chapters in the book, all Quizz Answers are there and all the theories that can be applied to my artcle are there.
MD4 Assignment 1 INSTRCUTIONS
MD4Assignment 1: Intervention Development Article Review
The published literature is rich with examples of health promotion programs that have utilized the principles of effective program implementation covered in this course. The Intervention Development Article Review Worksheet will allow you to critically examine the assignment of these concepts in real-world settings.
To prepare for the Article Review, read Chapters 7 and 8 of the textbook and review the articles listed in the Learning Resources for this module. Reflect on the ways that theories of health behavior were used to develop health promotion interventions.
To complete the Intervention Development Article Review Worksheet, select one of the articles provided, analyze the use of behavioral health theories, and complete the Intervention Development Article Review Worksheet based on the information you obtained from the article. For this assignment do not select the McLeroy, et al. (1988) article.
Support your work with specific citations from this module’s Learning Resources and additional scholarly sources as appropriate. Refer to the Essential Guide to APA Style for Walden Students to ensure that your in-text citations and reference list are correct.
Intervention Development Article Review Worksheet
APA citation for article selected:
1. Identify the health behavior theory used in this article.
2. Identify the level of intervention targeted by the intervention (individual, interpersonal, community).
3. Identify the intervention strategy used in this article and provide your assessment of its appropriateness.
4. Summarize how the theory was used in the development of the intervention activities.
5. Provide your assessment of why this theory would or would not be a good fit for the program you are proposing for your Health Promotion Program Proposal.
© 2014 Laureate Education, Inc.
Page 1 of 1
Rubric Detail
Select Grid View or List View to change the rubric’s layout.
Content
Name:
USW1_PUBH_6475_Module_4_Article_Review_Worksheet_Rubric
- Grid View
- List View
| Fully Met | Partially Met/Good | Partially Met/Fair | Not Met |
|---|---|---|---|
|
Points: Points Range: The level of intervention used in the article is correctly Feedback: |
Points: Points Range: A level of intervention is Feedback: |
Points: Points Range: A level of intervention is Feedback: |
Points: Points Range: No level of intervention Feedback: |
|
Points: Points Range: Provided a thorough Feedback: |
Points: Points Range: An intervention strategy is identified Feedback: |
Points: Points Range: An intervention strategy is identified Feedback: |
Points: Points Range: No intervention Feedback: |
|
Points: Points Range: Provided an assessment of the appropriatenes Feedback: |
Points: Points Range: Provided an assessment Feedback: |
Points: Points Range: Did not provide an Feedback: |
Points: Points Range: Did not provide an Feedback: |
|
Points: Points Range: Provided a thorough Feedback: |
Points: Points Range: Provided a summary of Feedback: |
Points: Points Range: Provided a partial summary of the way the theory was used to develop the intervention Feedback: |
Points: Points Range: Did not summarize how Feedback: |
|
Points: Points Range: Provided an assessment of the whether or Feedback: |
Points: Points Range: Provided an assessment Feedback: |
Points: Points Range: Did not provide an Feedback: |
Points: Points Range: Did not provide an Feedback: |
|
Points: Points Range: Feedback: |
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Points: Points Range: Feedback: |
Show Descriptions
Show Feedback
Correctly
Identified
the level of
intervention
used in the
article–
Levels of Achievement:
Fully Met
16 (18.82%) – 16 (18.82%)
The level of intervention used in the article is correctly
identified
Partially Met/Good
10 (11.76%) – 15 (17.65%)
A level of intervention is
identified
And,
The level identified was
appropriate for the type
of intervention described
in the article
But,
The level of intervention
identified is not the level
used in the article
Partially Met/Fair
1 (1.18%) – 9 (10.59%)
A level of intervention is
identified
But,
The level identified is not
appropriate for the type of
intervention described in the
article
And,
The level of intervention
identified is not the level
used in the article
Not Met
0 (0%) – 0 (0%)
No level of intervention
is identified
Feedback:
Correctly
determined
intervention
strategy–
Levels of Achievement:
Fully Met
15 (17.65%) – 15 (17.65%)
Provided a thorough
summary of the way the theory was used to
develop the intervention
Partially Met/Good
10 (11.76%) – 14 (16.47%)
An intervention strategy is identified
And,
The strategy identified
was appropriate for the type of intervention described in the article
But,
The strategy identified is
not the strategy used in the article
Partially Met/Fair
1 (1.18%) – 9 (10.59%)
An intervention strategy is identified
But,
The strategy identified is not
appropriate for the type of intervention described in the article
And,
The strategy identified is not
the strategy used in the article
Not Met
0 (0%) – 0 (0%)
No intervention
strategy is identified
Feedback:
Provided an
assessment
of whether
the
intervention
strategy was
appropriate–
Levels of Achievement:
Fully Met
15 (17.65%) – 15 (17.65%)
Provided an assessment of the appropriatenes
s of the intervention
strategy
And,
Provided sufficient detail to support the
assessment
Partially Met/Good
10 (11.76%) – 14 (16.47%)
Provided an assessment
of the appropriateness of the intervention strategy
But,
Did not provide sufficient detail to support the assessment
Partially Met/Fair
1 (1.18%) – 9 (10.59%)
Did not provide an
assessment of the
intervention strategy
But,
Did indicate whether or not the strategy was appropriate
Not Met
0 (0%) – 0 (0%)
Did not provide an
assessment of the
intervention strategy
And,
Did not indicate
whether the strategy
was appropriate
Feedback:
Summarized
how the
theory was
used to
develop the
intervention–
Levels of Achievement:
Fully Met
16 (18.82%) – 16 (18.82%)
Provided a thorough
summary of the way the theory was used to
develop the intervention
Partially Met/Good
10 (11.76%) – 15 (17.65%)
Provided a summary of
the way the theory was
used to develop the
intervention
But,
Some detail was missing
Partially Met/Fair
1 (1.18%) – 9 (10.59%)
Provided a partial summary of the way the theory was used to develop the intervention
But,
Significant detail was
missing
Not Met
0 (0%) – 0 (0%)
Did not summarize how
the theory was used to
develop the intervention
Feedback:
Provided an
assessment
of why the
theory
would or
would not be
a good fit for
the
proposed
program–
Levels of Achievement:
Fully Met
16 (18.82%) – 16 (18.82%)
Provided an assessment of the whether or
not the theory would be appropriate
And,
Provided sufficient detail to support the
assessment
Partially Met/Good
10 (11.76%) – 15 (17.65%)
Provided an assessment
of the theory
But,
Did not provide sufficient
detail to support the
assessment
Partially Met/Fair
1 (1.18%) – 9 (10.59%)
Did not provide an
assessment of the theory
But,
Did indicate whether or not the strategy was appropriate
Not Met
0 (0%) – 0 (0%)
Did not provide an
assessment of the
theory
And,
Did not indicate
whether the strategy
was appropriate
Feedback:
Correct APA citation provided–
Levels of Achievement:
Fully Met
0 (0%) – 3 (3.53%)
Partially Met/Good
0 (0%) – 3 (3.53%)
Partially Met/Fair
0 (0%) – 3 (3.53%)
Not Met
0 (0%) – 3 (3.53%)
Feedback:
Correctly identified the primary health behavior theory used to develop the intervention–
Levels of Achievement:
Fully Met
0 (0%) – 4 (4.71%)
Partially Met/Good
0 (0%) – 4 (4.71%)
Partially Met/Fair
0 (0%) – 4 (4.71%)
Not Met
0 (0%) – 4 (4.71%)
Feedback:
Name: USW1_PUBH_6475_Module_4_Article_Review_Worksheet_Rubric
STUDY PROTOCOL Open Access
Values and options in cancer care (VOICE): study
design and rationale for a patient-centered
communication and decision-making intervention
for physicians, patients with advanced cancer,
and their caregivers
Michael Hoerger1,2,3,10*, Ronald M Epstein1,2,3,4, Paul C Winters4, Kevin Fiscella3,4, Paul R Duberstein1,2,
Robert Gramling1,4, Phyllis N Butow5, Supriya G Mohile3, Paul R Kaesberg6, Wan Tang7, Sandy Plumb4,
Adam Walczak5, Anthony L Back8, Daniel Tancredi9, Alison Venuti4, Camille Cipri9, Gisela Escalera9, Carol Ferro4,
Don Gaudion4, Beth Hoh4, Blair Leatherwood9, Linda Lewis9, Mark Robinson9, Peter Sullivan4
and Richard L Kravitz6,9
Abstract
Background: Communication about prognosis and treatment choices is essential for informed decision making in
advanced cancer. This article describes an investigation designed to facilitate communication and decision making
among oncologists, patients with advanced cancer, and their caregivers.
Methods/design: The Values and Options in Cancer Care (VOICE) Study is a National Cancer Institute sponsored
randomized controlled trial conducted in the Rochester/Buffalo, NY and Sacramento, CA regions. A total of 40
oncologists, approximately 400 patients with advanced cancer, and their family/friend caregivers (one per patient, when
available) are expected to enroll in the study. Drawing upon ecological theory, the intervention uses a two-pronged
approach: oncologists complete a multifaceted tailored educational intervention involving standardized patient
instructors (SPIs), and patients and caregivers complete a coaching intervention to facilitate prioritizing and discussing
questions and concerns. Follow-up data will be collected approximately quarterly for up to three years.
Discussion: The intervention is hypothesized to enhance patient-centered communication, quality of care, and patient
outcomes. Analyses will examine the effects of the intervention on key elements of physician-patient-caregiver
communication (primary outcomes), the physician-patient relationship, shared understanding of prognosis, patient
well-being, and health service utilization (secondary outcomes).
Trial registration: Clinical Trials Identifier: NCT01485627
Keywords: Patient-centered care, Decision making, End-of-life care, Communication, Caregivers, Cancer, Palliative care,
Quality of life, Utilization, Physician-patient relations
* Correspondence: michael_hoerger@urmc.rochester.edu
1Rochester Healthcare Decision-Making Group, University of Rochester
Medical Center, Rochester, New York, USA
2Department of Psychiatry, University of Rochester Medical Center, Rochester,
New York, USA
Full list of author information is available at the end of the article
© 2013 Hoerger et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative
Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and
reproduction in any medium, provided the original work is properly cited.
Hoerger et al. BMC Cancer 2013, 13:188
http://www.biomedcentral.com/1471-2407/13/188
http://clinicaltrials.gov/ct2/show/NCT01485627
mailto:michael_hoerger@urmc.rochester.edu
http://creativecommons.org/licenses/by/2.0
Background
Crafting care that is concordant with the patient’s wishes
in the context of serious illness requires clear, patient-
centered communication [1]. Most patients with advanced
cancer (>80%) want frank yet sensitive discussions with
their physicians about prognosis and treatment choices,
and want to be involved and informed about decisions
regarding their care, regardless of whether they wish to
assume responsibility for making major health care
decisions [2]. Yet, few actually have these discussions
[3]. Consequently, patients often overestimate prognoses,
underestimate disease severity, and have unrealistic expec-
tations for cure [2-5]. Having frank, sensitive discussions
is associated with more realistic prognostic estimates and
decisions that are better aligned with patients’ wishes
[3,5-8]. When these discussions occur before patients are
critically ill, patients report greater well-being and have
fewer unwanted aggressive interventions in the last weeks
of life, with no detrimental effect on survival [3,5,9].
The VOICE (Values and Options In Cancer Care) Study
is a randomized controlled trial of a patient-centered
communication intervention for oncologists, patients with
advanced cancer, and their caregivers. Initial study findings
are expected to be published in 2013, with follow-up
complete in 2015. This article describes the empirical and
theoretical rationale for the study, the tailored education
and coaching communication intervention, the study mea-
sures and administration procedures, the planned analytic
approach, and potential implications of this research.
Patient-centered communication
VOICE targets important gaps in cancer communication
research. Since the SUPPORT study [10], in which an
ICU-based nurse intervention failed to influence care for
critically ill patients with dire prognoses, there has been
insufficient progress in improving clinical communication
in the context of serious illness. The 2007 NCI monograph,
Patient-centered Communication and Cancer Care [1], the
Institute of Medicine [11], the American Society for Clinical
Oncology, and the National Priorities Partnership all call
for improvements in communication with patients who
have serious and life-limiting illnesses, citing the effects of
good communication on quality of care and quality of life.
Poor communication is common in advanced cancer,
leading to healthcare decisions that are inadequately
informed by patients’ preferences. Physicians often misjudge
patients’ treatment preferences, desire for information,
needs, and level of understanding [2,12]. Despite evidence
that individuals with advanced cancer and their caregivers
benefit from being informed about prognosis and treatment
choices [1,2,13], physicians often intentionally overestimate
survival [14] and avoid discussing prognosis until the
patient has symptoms or there are no other treatments to
offer, leading to inflated patient expectations about survival
and the benefits of cytotoxic treatment [4,15]. Patients who
have not discussed prognosis and treatment choices with
their physicians are 3 to 8 times more likely to receive
aggressive treatments in the last week of life [3,5], reducing
physical and emotional quality of life and perhaps longevity
[9]. Additionally, patients often alter their treatment choices
when adequately informed [16]. Furthermore, although
physicians and patients find prognostic discussions stressful,
concealing the truth can be more harmful [17]. Indeed,
evidence suggests that these discussions neither appear
to cause harm nor diminish hope [18,19].
Communication about prognosis and treatment choices
is essential for informed decision making in advanced
cancer. Our intervention is designed to promote patient-
centeredness [20], which is defined by the Institute of
Medicine [21] as “care that is respectful of and responsive
to individual patient preferences, needs, and values.”
The intervention targets four key communication skills:
Engaging patients and their caregivers to participate in
consultations and decisions regarding the patient’s care,
Responding to patients’ concerns, Informing patients
about treatment choices, and Framing prognosis using
balanced information about best and worst case scenarios.
In other settings, these skills have been associated with
improvements in psychological well-being, quality of life,
symptoms, adherence to treatment, patient satisfaction,
and caregiver bereavement, as well as reductions in racial
and ethnic disparities [1,12,22-24]. If our hypotheses are
supported, patients and their caregivers will be better
informed, less psychologically distressed, and better able to
participate in discussions about prognosis and treatment
choices. As a result, they will be more likely to make
decisions that lead to improved quality of life, a greater
sense of peace, and better quality of death.
Ecological framework
VOICE was designed to test an innovative synergistic
intervention for improving communication between
patients with advanced cancer and oncologists. Nearly
all communication intervention studies have been indi-
vidually focused on either patient or clinician behavior,
or have used third parties to broker communication
[25]. Such efforts have been insufficient to improve
shared understanding and patient well-being. Interven-
tions designed to help patients with serious illnesses to
ask questions and express concerns have been more
effective when physicians also encourage active patient
participation [22,26,27]. Brief physician training can im-
prove some aspects of communication, such as empathy.
More intensive interventions have been necessary to
reach broader communication goals [12,27,28]. Mindful
that it may be challenging for physicians to set aside
2–3 days from a busy practice to complete training
workshops, the VOICE intervention provides brief,
Hoerger et al. BMC Cancer 2013, 13:188 Page 2 of 14
http://www.biomedcentral.com/1471-2407/13/188
highly-skilled and individually-tailored training em-
bedded within the oncology practice. Further, previous
research and pilot work undertaken for this trial have
noted physician frustration and patient dissatisfaction
when assertive patients encounter physicians who are
not adequately prepared [12,22]. This suggests the
need to intervene simultaneously with patients and
physicians. Our trial, based on ecological theory, is the
first rigorous test of an intervention that intercedes at the
level of the physician-patient-caregiver relationship.
Street’s ecological theory of patient-centered com-
munication (see Figure 1) [29] was used to derive the
aims, intervention, and outcome measures for this
trial. Ecological theory is a systems-oriented theory
[30]. As such, it suggests that clinical communication
research should address multiple levels, namely the
mutual interactions between physicians and patients as
well as the social and clinical contexts, rather than
merely targeting the individual’s communication behavior.
On the interactional level, ecological theory suggests that
two factors – patients’ and caregivers’ assertive behaviors,
and physicians’ facilitative behaviors – interact to reinforce
patients’ ongoing participation in discussions regarding
their care over time [27,31]. As a result, these discussions
will more closely address patients’ wishes and concerns,
and patients will get more useful information, support,
and empathy as well as participate in decision making to a
greater degree [32,33].
Ecological theory has successfully predicted that (a)
assertive patient behaviors such as making requests, asking
questions, and expressing opinions generally promote phy-
sicians’ patient-centered behaviors [29,32,34], (b) physicians’
facilitative behaviors such as addressing patients’ concerns
and helping patients to participate in care reinforce patient
assertiveness [13,35], and (c) when caregivers are present in
consultations, they can align the efforts of clinicians
and patients towards common communication goals
and help patients to understand and use relevant
information [36,37]. Ecological theory also partially
explains paradoxical results in which some outcomes,
such as patient satisfaction and physician frustration,
worsen when patients are trained to communicate
assertively and physicians are unprepared for change
[22,34]. Because of these findings, our outcome measures
Figure 1 Ecological model of patient-centered communication.
Hoerger et al. BMC Cancer 2013, 13:188 Page 3 of 14
http://www.biomedcentral.com/1471-2407/13/188
consider both individual communication behaviors and
mutual interactions.
Importantly, ecological theory has been informed by
experimental research on how Framing affects patient
understanding and decision-making [38,39]; as well as how
Informing patients about treatment options, Responding to
emotional concerns, and Engaging patients by exploring
assumptions and beliefs [40-42] help patients to be more
active participants in care [43,44]. Ecological theory
emphasizes that patients’ desire for information should
be considered by first asking patients what they wish to
know and in what format, providing desired information,
then checking understanding, a paradigm known as the
“Ask-Tell-Ask” approach [45]. Bidirectional exchange of
tailored and desired information thus leads to better
shared understanding, prepares patients to be involved in
decisions, and promotes trust that important information
is not being withheld [17,26].
Current investigation
Drawing upon this ecological framework, the VOICE
intervention is designed to help physicians, patients with
advanced cancer, and caregivers to communicate more
effectively about issues likely to influence decision making.
In doing so, this investigation brings together research on
communication and medical decision making, which have
historically been two separate approaches addressing
common issues but without a common frame of reference.
Moreover, the intervention targets patients diagnosed with
incurable cancer before they become critically ill, anticipat-
ing the need for information and strong patient-physician
relationships as the illness progresses. We hypothesize that,
relative to care as usual, the intervention will improve
physician-patient-caregiver communication about progno-
sis and treatment choices (Aim 1a), improve the physician-
patient relationship and increase shared understanding of
prognosis (Aim 1b), improve patient well-being (Aim 2),
and affect health services utilization by both reducing the
number of aggressive interventions that may undermine
the quality of life in the last weeks of life and increasing
the use of guideline-concordant palliative care and hospice
services (Aim 3).
Methods/design
Study design
The study is a cluster RCT conducted in multiple oncology
practices and cancer centers in the Rochester/Buffalo, NY
and Sacramento, CA regions, designed to evaluate the
effects of a theory-based intervention to improve commu-
nication between oncologists and patients with advanced
cancer and their caregivers. The methods were developed
in collaboration with Phyllis Butow, Martin Tattersall,
Adam Walczak and colleagues, who are conducting a
parallel study in Sydney, Australia called Conversations with
Your Doctor: Making the Most of Medical Consultations.
That study incorporates similar interventions but a
different study design. The VOICE RCT incorporates
many elements of effectiveness studies, such as broad
eligibility criteria, usual-care controls, tailored interven-
tions, patient-oriented outcome measures, and intention-
to-treat analyses. The study design and all consent forms
have the approval of the Institutional Review Boards at
each institution.
The study procedures (see Figure 2) are separated into
two phases. Phase 1 involves preparation, physician
recruitment, piloting, and pre-randomization data collec-
tion of physicians’ communication behaviors. Three Phase
1 patients and their caregivers are recruited for each
physician. Each of these patients has one office visit audio
recorded, allowing us to assess physicians’ baseline com-
munication behaviors for potential use as a covariate in
the RCT analyses. Phase 1 patients and caregivers also
complete pilot versions of some study measures pre- and
post- office visit to inform finalized versions of the
measures for the RCT.
Phase 2 is the cluster RCT. Physicians are the unit of
randomization and are randomly assigned to the interven-
tion or control condition. Up to seven Phase 2 patients
(and caregivers) are recruited per physician. Patients and
their caregivers are randomly assigned by proxy: patients of
physicians in the intervention condition are assigned to the
intervention, and patients of physicians in the control con-
dition are assigned to the control group. Patients complete
measures at study entry, participate in the intervention or
control condition, agree to have an oncology office visit
audio recorded, and complete follow-up measures immedi-
ately after the office visit, approximately 2–4 days after the
office visit, and every 3 months for up to 3 years or until
death. Caregivers, where available, also participate in
the study and complete measures periodically, including
measures one-month post-mortem.
Following completion of Phase 2, data analysis will
ensue. After the study has closed, physicians from the
control group will be offered the opportunity to receive
the intervention, both as an incentive to participate and
to further their professional development. In addition to
the primary VOICE trial, additional studies are using the
procedures described here to examine patient, caregiver,
and oncologist emotional processes [46] that drive
decision making, and the effect of the intervention on
caregiver bereavement outcomes. Prior research [24]
suggests that improvements in end-of-life care can
mitigate bereavement-related morbidity.
Selection of study sites
In the Rochester region, oncologists (n = 25) were
recruited from academic and private practices in western
New York; recruitment is complete. In the Sacramento
Hoerger et al. BMC Cancer 2013, 13:188 Page 4 of 14
http://www.biomedcentral.com/1471-2407/13/188
region, all oncologists are recruited from the UC Davis
Comprehensive Cancer Center (n = 14), and recruitment
is nearly complete. One Rochester physician withdrew
from the study prior to any data collection due to lack
of time. We anticipate a total of 40 oncologists.
Eligibility, recruitment, consent, and randomization
Ethical approval was obtained from the IRBs of the five
affiliated institutions where the study is being conducted.
All participants (i.e., patients, caregivers, and oncologists)
complete written informed consent documents. Specific
inclusion and exclusion criteria are presented in Table 1,
and participant eligibility is verified immediately prior to
completing baseline study measures.
Oncologists
Medical oncologists who care for patients with solid
(non-hematologic) cancers are solicited for participation
through presentations about the study at grand rounds
and faculty meetings, or through personal contacts via
cancer center directors or project investigators. Interested
oncologists then meet with study personnel (e.g., project
manager, research assistant, or research oncologist) to
achieve a clear understanding of all study components,
provide written consent, and complete the baseline surveys.
The consent document seeks each oncologist’s agreement
to (a) guide recruitment efforts among their patients
by determining eligibility, (b) participate in an educa-
tional program to enhance their communication skills,
(c) audiotape one clinic encounter per enrolled patient,
and (d) complete brief surveys at baseline, after each
audio-recorded office visit, and the study conclusion.
Oncologists are told “the purpose of this study is to
assess the impact of brief educational interventions on
clinical care and outcomes of patients with cancer and their
caregivers. Outcomes of interest include communication
between patients, caregivers, and physicians, as well as pa-
tient well-being and health services utilization.” Oncologists
receive $600 for completing surveys and identifying eligible
patients for the study.
Patients
Research assistants identify all patients by working
closely with participating oncologists and their clinic
staff to review clinic rosters in detail to ascertain that all
potentially eligible patients are identified. Depending on
the site and differing IRB requirements, potentially
eligible patients are either (a) approached by physicians
or practice nurses and then by the research assistant or
(b) sent a letter, a study brochure, and an opt-out card.
Patients approached by physicians or clinic staff are
asked if they would be willing to speak to a research
assistant to learn more about the study. Patients who
receive recruitment materials by mail are contacted via
Recruit
Oncologists R
Oncologist
Training
Intervention
Oncologist
Control
Patient/Caregiver
Coaching
Intervention
Patient/Caregiver
Control
PRIMARY
OUTCOME
MEASURES
Audio-Recorded
Office Visit
SECONDARY
OUTCOME
MEASURES
Patient/Caregiver
Follow-up Surveys
Medical Record Audit
Pre-RCT Audio
Recordings
Figure 2 VOICE study design.
Table 1 Inclusion and exclusion criteria for oncologists, patients, and caregivers
Participant Inclusion criteria Exclusion criteria
Oncologist ● Currently in clinical practice at participating institutions ● Non-physicians and physicians who are not oncologists
● Oncologist that cares for patients with solid tumors
● Not planning to leave the practice during the next 6 months
● Oncologists who exclusively care for patients with
hematological malignancies
Patient ● Currently a patient of an enrolled physician
● Age 21 years or older
● Anticipating bone marrow transplantation or diagnosed
with leukemia or lymphoma
● Diagnosis of Stage III or IV solid (non-hematological) cancer a ● Unable to complete orally-administered surveys in English
● Able to understand spoken English
(study personnel to read materials to low literacy patients)
● Hospitalized or in hospice care at recruitment or for
baseline measures
Caregiver ● Caregiver of a patient currently enrolled in the study ● Unable to complete orally-administered surveys in English
● Age 21 years or older ● Supported the patient primarily through a professional
role (e.g., clergy)● Able to understand spoken English
(study personnel to read materials to low literacy caregivers)
a Patients with Stage III cancer are included only if they have a limited prognosis. Their oncologist must affirm that they “would not be surprised” if the patient
died within 12 months, thereby excluding patients with potentially curable Stage III cancers, such as Stage IIIc testicular cancer or Stage IIIa colon cancer.
Hoerger et al. BMC Cancer 2013, 13:188 Page 5 of 14
http://www.biomedcentral.com/1471-2407/13/188
phone by a research assistant if an opt-out card is not
returned to the research office within 7 days. The research
assistant provides them with study information, and gives
them time to deliberate about participation and ask ques-
tions. The screening and consent process continues until
the research assistant feels that the potential participant
fully understands all aspects of study involvement. The
research assistant then schedules a time to meet and
obtains written consent from those who voluntarily wish to
enroll, using IRB-approved consent forms. Patients are
reminded that they can opt out at any time. All patients are
asked to complete baseline surveys and to give permission
to have one of their oncology office visits audio recorded.
The research assistant orally administers the baseline
surveys as well as other study materials as needed. If
consent documentation and baseline survey measures
are completed in separate visits, eligibility criteria are
reviewed immediately prior to survey administration to
ensure continued eligibility.
Phase 1 patients complete two sets of orally-administered
surveys, one before and one after the audio-recorded office
visit with their oncologist. Phase 2 patients (a) have
one audio-recorded office visit with their oncologist,
(b) complete surveys prior to and immediately after their
office visit, then 2–4 days after the office visit, and every
three months for up to three years, and (c) give permission
for research staff to access their medical records to ascer-
tain their use of health services such as emergency
department visits, hospital admissions, cancer treatments,
and community-based nursing services. The initial survey
takes up to 60 minutes with later surveys taking anywhere
from 10 to 30 minutes. Patients receive $15 for each
set of surveys, for a maximum of $30 in Phase 1 and
$180 in Phase 2.
Caregivers
All patients are asked to identify a “family member, partner,
friend or someone else who is involved with your health
care issues, for example, someone who you talk to about
personal issues including medical decisions or who comes
to doctor appointments with you. This person may also
help with routine day-to-day activities, like transportation
or paperwork.” The term “caregiver” is used to describe
these persons for scientific purposes, and patients are not
required to self-identify individuals as such. Patients are
asked to identify up to three potential caregivers, rank them
in order of the likelihood that they will attend oncology
office visits, and provide permission to contact the primary
caregiver (or others caregivers, if needed) and provide them
with a study brochure.
Once identified, the research assistant independently
approaches the caregiver in person or by telephone and
asks if they would be willing to participate and provide
written consent. Caregivers often accompany patients at
the time of the patient consent. The research assistant
reviews the consent form in detail with the caregiver
and advises them that they can opt out of the study at
any time. Caregivers are told the same study details as
the patients and complete surveys at approximately the
same time intervals as the patients. Caregivers are asked
for permission to be contacted in the event that the
patient dies within three years of enrollment in order to
meet with a research assistant (or speak on the telephone if
preferred) to complete a survey. The survey is completed
approximately one month after the death of the patient.
The research assistant responds to caregivers’ questions
until it is clear that the caregiver has full comprehension
of the consent form and their involvement in the study.
Caregivers receive $15 for each set of surveys, for a
maximum of $30 in Phase 1 and $180 in Phase 2.
Randomization
A stratified block-randomization scheme is used to assure
balanced assignment by clinic site and cancer focus.
Oncologists are grouped into a site according to their
health center, clinic, or practice of employment. Within
each site, oncologists are randomly assigned approximately
evenly across the treatment and control conditions. Sites
with a single oncologist are grouped with a similar site for
randomization purposes. Oncologists are also categorized
by their cancer focus, including breast-cancer oncology
(≥50% of patients have diagnoses of breast cancer) and
non-breast cancer oncology groups. Within these areas of
focus, oncologists are randomly assigned approximately
evenly across the treatment and control conditions. This
accounts for any biases that may be introduced by the low
prevalence of breast cancer in men and the potential
that breast cancer patients may be more “activated”
than patients with other cancers. For each site/focus
combination in the study, separate sequences of ran-
dom numbers have been generated for use in assigning
oncologists to the intervention and control groups. To
preserve blinding, assignment to the treatment or control
conditions is maintained by the study statistician and
not explicitly revealed to transcriptionists or coders of
the audio-recorded office visits.
Visit procedures
For the initial baseline surveys, a time is arranged to
meet with the patient and caregiver, either together or
separately, in a private area based on the participant’s
comfort and preference. This may include a meeting
room in the cancer center, the infusion suite, the partici-
pant’s home, or a local coffee shop with private areas.
Once both the patient and caregiver have completed
these surveys, the research assistant answers any questions
and reviews the next steps of the study, the audio-recorded
office visit and post-visit survey. For that visit, the research
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assistant usually meets the patient and caregiver in the
physician’s waiting room and accompanies them to the
clinic room, turns on and places two audio recorders in
the room, and leaves. If another person attends the visit,
the research assistant obtains verbal permission to record
them. The research assistant collects the recorders after
the office visit and meets with the patient and caregiver
to administer brief surveys. This completes Phase 1. In
Phase 2, the scenario is identical, except that the patients
and caregivers in the intervention arm receive a 1-hour
coaching session prior to the office visit. After the audio-
recorded office visit, the patient completes a survey, and
the research assistant explains to the patient and caregiver
that they will be contacted in 2–4 days by phone to answer
some additional questions. The patient and caregiver are
also called three months after the audio-recorded visit to
complete surveys and every three months thereafter for up
to three years.
Description of the intervention and control conditions
Intervention condition
Oncologists randomized to the intervention arm participate
in a multifaceted tailored educational intervention involving
standardized patients instructors (SPIs). Patients and
caregivers complete a coaching intervention to facilitate
prioritizing and discussing questions and concerns.
Oncologist training Oncologists completing the interven-
tion meet with SPIs for two in-office educational outreach
sessions [47], including a 60-minute training session and a
45-minute booster session [48]. At the first session, the
SPIs show them a 15-minute DVD created by the study
investigators specifically for this project, which presents
actual clinical examples to outline key skills in discussing
prognosis and treatment choices with patients with
advanced cancer and their caregivers. Oncologists receive
a copy of the DVD to keep and receive a 1-page summary
of evidence-based guidelines for communication in ad-
vanced cancer [13]. They are also given a Communication
Guide “reminder” card prompting them to discuss topics,
such as prognosis and symptoms that appear on the
patients’ Question Prompt List, such as prognosis and
symptoms (see below, QPL).
After viewing the DVD, the oncologist is asked to
select one or two of the key skills to practice with two
SPIs who portray a 60-year-old man with incurable
cancer and his wife. A few days prior to the session, the
oncologist is sent a medical “chart” to review in anticipation
of the SPI visit, containing a comprehensive prior con-
sultation note which includes radiographic and laboratory
results. In the “chart,” the patient is described as having
metastatic colon cancer with progression despite one
course of state-of-the art chemotherapy, and intolerance
of a second course of chemotherapy. Current symptoms
include severe diarrhea, nausea, and fatigue. The SPIs
present as facing important treatment decisions over the
next few weeks, while having an unclear idea of prognosis.
The SPIs engage the oncologist in a role play exercise with
specific tailored feedback on the key communication skills
described in the DVD; oncologists are then given the
opportunity to rehearse areas of difficulty. Oncologists
also receive a follow up letter from the SPIs that includes
a version of the communication guide with individually-
tailored comments. The guide shows the four key skills
discussed in training and summarizes what was agreed to
by the oncologist and SPIs during the session, such as the
physician’s demonstrated areas of strength, as well as those
areas jointly identified as challenges for further growth.
One month later, oncologists complete a 45-minute
reinforcement session, which uses a similar format.
Specifically, the same SPIs return for a simulated follow-up
visit, where the cancer has “progressed” despite third-line
treatment. Key communication skills highlighted in the
DVD and SPI feedback (see Table 2) were chosen based
on ecological theory and evidence that they (a) promote
discussions of prognosis and treatment choice, (b) can be
taught in brief interventions, and (c) are associated with
patient trust and lower anxiety [13,49-51].
Patient and caregiver coaching Patients and caregivers
completing the intervention meet with a coach trained
to facilitate health communication. During the coaching
session, the coach gives each patient and caregiver a
Question Prompt List (QPL), which is organized in a
booklet called My Cancer Care. The QPL includes
questions about diagnosis, prognosis, treatment options,
symptom management, transitions in care, self-care, and
family needs. Sample questions include, “What are the
pros and cons of further treatment for my cancer?” and
“How can I help my family and children understand
what is happening?” The QPL was developed in
Australia, adapted for the United States, and piloted
simultaneous in both countries [60]. Using the QPL as a
guide, patients are coached to (a) identify and prioritize
2–3 personally relevant questions on the list, (b) ask
these questions during the visit, (c) ask their oncologist
for clarification when they do not understand, (d) express
desire to participate more actively in discussions about
prognosis and treatment choices, and (e) prepare for the
future [22,26,54,61]. These skills promote the same goals
as the physician intervention. The coach makes follow-up
phone calls at monthly intervals for up to three months to
reinforce the coaching intervention and address patients’
concerns [62]. The coaches include a nurse and social
workers with healthcare backgrounds, similar to prior
studies [61]; they do not provide disease-specific informa-
tion. All Rochester and UC-Davis coaches participate in
local training, video conferences, and a 3-day intensive
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training, using methods and materials similar to our
previous studies [63]. All intervention sessions are audio-
recorded and progress notes are written after each of the
3 coaching follow-up telephone calls. The coaches hold
weekly conference calls to fine-tune, discuss, and review
their coaching sessions.
Control condition
The control group involves care as usual. Oncologists as
well as patients/caregivers meet with the research assistants
to complete the same surveys as intervention participants
but receive no training.
Measures
Oncologist-patient-caregiver communication
The audio-recorded office visits for all participants are
coded for each of the four domains of communication
behaviors hypothesized to be affected by the intervention:
Engaging, Responding, Informing, and Framing (see Table 2).
The Active Patient Participation Coding (APPC) [32]
scheme is used to measure Engaging communication be-
haviors, such as patient assertive behaviors and oncologist
facilitative behaviors, that promote patient participation in
the decision-making process. The Verona VR-CoDES
system [64] is used to code for sequences of Responding to
emotion, such as patient expression of emotional cues and
concerns and oncologist responses to these expressions of
emotion. The Prognostic and Treatment Choices (PTCC)
[65] system is used to code Informing behaviors, such as
the oncologist addressing patients’ wishes for information
regarding prognosis and treatment choices. The Opti-
mism/Pessimism subscale of the Framing of Prognostic In-
formation (FPI) [6] system is used to code Framing
behaviors, such as oncologists’ balance in expressions
of optimistic and pessimistic perspectives about “what
to expect.” Several exploratory measures assess the
level of patient and caregiver question asking [26,54] and
the degree of shared decision making [66,67].
Patient survey measures
The survey measures completed by patients in Phase 2
are outlined in Table 3. Several scales measure aspects of
the quality of interactions between physicians and patients.
The quality of the Physician-Patient Relationship is
measured with The Human Connection (THC) [68] sur-
vey. Characteristics of the Physician-Patient Interaction
are measured with the Health Care Communication
Questionnaire (HCCQ) [69], the Mishel Uncertainty in
Illness Scale (MUIS) [70], and the Information Preference
Scale (IPS) [71]. Patient Communicational Self-Efficacy is
measured using an adaptation of the Perceived Efficacy
in Patient-Physician Interactions (PEPPI) [43] survey.
The Physician-Patient Conversations survey assesses topics
discussed in recent oncology office visits, such as prognosis,
end-of-life care, and emotional issues, supplementing
information obtained from the single audio-recorded
oncology office visit.
Several scales relate to patient attitudes, values and
beliefs. Patients’ Preferred Decision Role is measured with
the Control Preferences Scale [72], which is compared to
an adapted version assessing patients’ Actual Decision Role
in oncology office visits. The Treatment Preferences survey
measures preferences for experimental treatments, life
support, and palliative care, in the event that no further
anti-cancer treatments would be helpful. Illness Acceptance
is measured with the Peaceful Acceptance subscale of the
PEACE [7]. Prognostic Forecasting is measured using items
[5] assessing patients’ beliefs about their chances of living
two years and chances of being cured.
Finally, Well-being is measured with the Global Quality
of Life, Psychological Well-being, and Existential Well-
being subscales of the McGill Quality of Life (MQOL) [73]
survey as well as the Physical Well-being and Social/Family
Well-being subscales of the Functional Assessment of
Cancer Therapy – General (FACT-G) [74] survey.
Each of these surveys has been tailored to improve clar-
ity and relevance, reduce respondent burden, and reflect
American English. Most of these measures have been
piloted with patients in Phase 1 and refined as needed to
Table 2 Oncologist communication behaviors targeted in the tailored educational intervention
Behavior Description of intervention
Engaging Oncologists are coached to (a) clarify the patient’s concerns early in the visit [52] – this corrects the tendency to address the
first concern mentioned at the expense of more important issues [53], (b) acknowledge the Question Prompt List (QPL) to
increase its effectiveness [26], (c) encourage questions, and (d) encourage participation in healthcare decision making [26,54,55].
Responding Emotional expression and empathy are uncommon in oncology consultations [51,56,57]; therefore, oncologists are coached to
respond to the emotional components of patients’ concerns with empathy and support.
Informing Based on recent studies [58,59], oncologists are coached to use an “Ask-Tell-Ask” protocol – asking patients about their
wishes regarding information about prognosis and treatment choices, providing desired information in a desired format,
and then checking patient understanding.
Framing Based on recent studies [6,58], oncologists are trained to present information for both optimistic or “best case” and pessimistic
or “worst case” scenarios. Balanced information appears to better align patients’ and physicians’ efforts by reducing bias
introduced by one-sided presentation of data.
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reduce ceiling and floor effects or further improve item
wording.
Caregiver survey measures
The survey measures completed by caregivers in Phase 2
are outlined in Table 4. Measures of the Physician-Caregiver
Relationship, Physician-Caregiver Interaction, and Caregiver
Communicational Self-Efficacy have been adapted from
patient versions of the same scales. Using measures
adapted from patient versions, caregivers also provide
informant ratings of Patient Treatment Preferences,
Patient Illness Acceptance, and Patient Well-being, and
complete a measure of Prognostic Forecasting. They
report on Patient Quality of Death via qualitative ques-
tions about the healthcare decision-making process,
the Quality of Life Near Death (QOLND) [75] survey,
and items from the Quality of Death Long-Term Care –
Cognitively intact (QOD-LTC-C) [76] survey. As with the
patient measures, each of these surveys has been tailored
for the current study.
Oncologist survey measures
The survey measures completed by physicians are
outlined in Table 5. Communication Skills are measured
Table 3 Survey measures completed by patients in the RCT
Domain Measures Study entry Post- visit 2-4 day
follow-up
Quarterly
follow-up
Demographics Gender, age, race/ethnicity, SES, relationship
status, religion
X
Physician-Patient Relationship THC X
X Xa
Physician-Patient Interaction HCCQ + MUIS + IPS X
Patient Communicational Self-Efficacy PEPPI X X Xa
Physician-Patient Conversations Topics discussed in recent medical encounters
X X
Preferred Decision Role CPS X X
Actual Decision Role Modified CPS X X
Treatment Preferences Preferences for experimental treatments,
life support, palliative care
X X
Illness Acceptance PEACE X X
Well-being MQOL + FACT-G X X
Prognostic Forecasting Estimate of prognosis X X
Note. SES, Socioeconomic status; THC, The human connection scale; HCCQ, Health care communication questionnaire; MUIS, Mishel uncertainty in illness scale; IPS,
Illness preference scale; PEPPI, Perceived efficacy in patient-physician interaction; CPS, Control preferences scale; PEACE, Peace, equanimity, and acceptance in the
cancer experience; MQOL, McGill quality of life; FACT-G, Functional assessment of cancer therapy – general.
a Administered at only the first quarterly follow-up.
Table 4 Survey measures completed by caregivers in the RCT
Domain Measures Study
entry
2-4 Day
follow-up
Quarterly
follow-up
Post- mortem
Demographics Gender, age, race/ethnicity, SES, relationship with patient X
Physician-Caregiver Relationship THC X Xb
Physician-Caregiver Interaction HCCQ X
MUIS X Xa
Caregiver Communicational Self-Efficacy PECPI X Xa
Patient Treatment Preferences Caregiver’s beliefs about patient preferences for
experimental treatments, life support, palliative care
X Xa
Patient Illness Acceptance PEACE X Xb
Patient Well-being MQOL + FACT-G X Xb
Prognostic Forecasting Estimate of patient’s prognosis X X
Patient Quality of Death Qualitative questions + QOLND + QOD-LTC-C Xb
Note. PECPI, Perceived efficacy in caregiver-physician interaction; QOLND, Quality of life near death; QOD-LTC-C, Quality of death long-term care – cognitively
intact; other acronyms defined previously (see Table 3).
a Administered at only the first quarterly follow-up.
b Retrospective rating of the death/dying experience, rather than the current moment.
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with a pilot-tested survey derived for this study, which
assesses perceived skills in discussing prognosis and
end-of-life issues, such as giving bad news, expressing
empathy, and discussing referrals to palliative care. Decision
Making Skills are measured with a survey adapted from a
prior measure [72] in order to assess physician comfort
with decision making across varying levels of patient
involvement (e.g., physician makes the decision, patient
makes the decision, shared decision making). Several
measures have been adapted from the patient self-report
surveys: physician beliefs about Patient Treatment
Preferences, physician beliefs about Patient Illness Accept-
ance, and Prognostic Forecasting about patients’ prognoses
(e.g., chances of a cure, chances of living two years, patients’
understanding thereof). Patient Disease Status is assessed
via several survey items, which supplement information
from patient medical records.
Medical chart abstraction
The death of participating patients is ascertained by
checking in regularly with participating oncologists,
through scheduled follow-up sessions with patients and
caregivers, by reviewing death notices (obituaries) in the
local press, and by periodically reviewing electronic
health records. Once a death is identified, study staff
identify all emergency department visits or hospital over-
night stays occurring in the last 30 days before death
and abstract the corresponding medical records for the
following data elements: (1) date of death, (2) dates and
circumstances of attendance at a hospital, emergency
department, and intensive care unit, (3) use of intuba-
tion, cardiopulmonary resuscitation (CPR), hemodialysis,
permanent enternal feeding tube, and chemotherapy,
(4) involvement of hospice and palliative care services,
and (5) completion of Do Not Resuscitate/Do Not Intubate
(DNR/DNI) forms and Advanced Directives. Outpatient
records are abstracted to identify any chemotherapy agent
given in the last 14 days before death and any new
chemotherapeutic regimen started in the last 30 days
before death, the absence of which indicate higher quality
end-of-life care [77].
Implementation fidelity
Both the oncologist and patient/caregiver components of
the intervention are monitored for fidelity. For the
oncologist training sessions, all audio recordings are
reviewed by all SPI trainers. For the patient/caregiver
component, audio recordings are reviewed for each
coach’s first five coaching sessions, every subsequent
session until >95% fidelity, and at least every fifth session
thereafter, including in-person and phone sessions.
To assess fidelity and ensure standardization of survey
administration procedures, each research assistant’s first
five sessions are monitored by direct observation and
reinforced every 4–6 months during data collection. In
addition, audio-recordings of qualitative survey items are
reviewed thereafter as needed.
Sample size determination
This is a stratified cluster randomized study, with the
physician as the unit of randomization. Based on prior
studies, we have made the following assumptions: physician
attrition 0-3%, patient attrition <5% for audio-recordings,
and 10%, 30% and 35% for the 2–4 day, 3-month, and
6-month post-visit patient surveys [78,79], 80% patient
mortality during 3-year follow up, availability of 85% of
caregivers for post-death interviews [3,24], availability of
90% of medical records for audit [3,5,80], no differential
attrition between the intervention and control groups, and
an intraclass correlation coefficient (ICC) of .10 or less
for within-physician clustering on patient and caregiver
survey measures [81,82].
Prior work found that activation training increases
physician communication behaviors two to three fold
[26,28,29]. This equates to an effect size of 2.0 standard
deviation (SD) units. Thus, for our primary outcome
(Aim 1a), we expect a 2.0 SD improvement across each
communication measure; 0.5 SD is clinically significant.
Table 5 Survey measures completed by physicians
Domain Measures Study
entry
Post-visit Study
conclusion
Demographics Age, race/ethnicity, gender, training background, practice characteristics X
Communication Skills Skills in discussing prognosis and end-of-life care X X
Decision Making Skills Comfort with decision making across varying levels of patient involvement X X
Patient Disease Status Cancer site, progression, treatment planning X
Patient Treatment Preferences Physician’s beliefs about patient preferences for experimental treatments,
life support, palliative care
X
Patient Illness Acceptance PEACE X
Prognostic Forecasting Physician’s estimate of prognosis, and beliefs about patient’s estimate of prognosis X
Note. PEACE, Peace, equanimity, and acceptance in the cancer experience.
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Power is based on a single measurement of communi-
cation during the oncology office visit. With at least 19
oncologists in each group, 7 patients per oncologist,
and an ICC of .10, the minimum detectable effect size
is 0.50 SD.
For our survey outcomes (Aims 1b & 2), we rely on
observational data [83] indicating effect sizes of 0.40 to
0.70 SD for the relationship between communication
and patient well-being. With an intervention we would
expect these differences to be larger. The power analysis
takes advantage of a repeated-measures design [84]. For
patient data, we assume one pre-intervention measure
and two post-intervention measures, and an average
correlation among repeated measures of .50. Our proposed
sample size is sufficient to detect an effect size of 0.40 SD
with power of .80. For our utilization outcomes, we
rely on data that suggest 3- to 8-fold differences in use
of aggressive treatments during the final week of life
between patients who have had discussions compared
to those who have not [3,5]. Thus, the study will be
adequately powered, even considering attrition.
Planned analytic approach
This is a cluster-randomized trial, where our primary
communication outcomes (Aim 1a) are measured at the
level of the physician-patient dyad and our secondary
outcomes (Aims 1b, 2, & 3) are measured at the level of
the patient. Analyses are based on published guidelines
for group (cluster) RCTs [85], in this case, clustering at the
site and physician level. Prior to hypothesis testing, prelim-
inary analyses will examine whether random assignment
produced comparable groups in terms of patient disease
status, patient well-being, and pre-RCT (Phase 1) physician
communication styles. Any confounders will be included in
remaining analyses. Hypothesis testing will involve compar-
isons of the two randomized groups. Since the patients are
nested within oncologists, methods for panel data will be
applied, and random effects for physicians may be added to
account for the within-physician correlations of each dyad.
We will use both generalized estimating equations (GEE)
and generalized linear mixed-effects models (GLMM). The
primary outcomes (Aim 1a) are unlikely to require substan-
tial attention to attrition, since measurement occurs shortly
after randomization, and will not require methods for
repeated measures. Hierarchical linear models with nested
random coefficients will be applied where secondary
outcomes that are measured repeatedly (Aims 1b, 2, & 3).
As missing values are likely, we will examine the nature of
the missing data and use weighted GEE (WGEE), or
multiple imputation and sensitivity analyses, if necessary.
In assessing significance across multiple tests, we will use
procedures to control the false discovery rate (FDR) at 5%
within sets of related analyses [86].
Discussion
The VOICE Study is a multi-site randomized controlled
trial designed to facilitate communication about prognosis
and healthcare decision making among oncologists,
patients with advanced cancer, and their caregivers
(defined as family, friends, or other non-professionals
who are involved in their care). The investigation is
unique in bringing together research on patient-centered
communication and medical decision making, intervening
with both physicians and patients/caregivers, and its
upstream focus, targeting patients with advanced cancer
before they are critically ill.
The proposed intervention anticipates future needs. In
the future, patients with advanced cancer will have more
complex and numerous treatment options, including
biologicals, genetically-tailored therapies, and new devices.
This complexity will present challenges for physicians in
providing the best possible quality of care for incurable
conditions while maintaining realistic hope. Thus, the need
for effective communication in the context of incurable
cancer will increase. Furthermore, effective communication
is integral to current health reform efforts. Programs to
enhance communication will potentially be met favorably
by health systems, insurers, and federal agencies who value
the patient-physician relationship and by the public who
value having control over their own care. The proposed
intervention is also scalable for dissemination using new
technologies. Currently, a trained Standardized Patient
Instructor (SPI) and coach can visit dozens of practices at a
reasonable cost, and training materials and question prompt
lists can be adapted for the Web and embedded in elec-
tronic health records. In the future, increasing bandwidth
will permit adaptation of the SPI and coaching interven-
tions to live web-SP technology [87,88], offering live training
to clinicians and patients regardless of location.
There have been several meaningful challenges in
implementing VOICE. In order to recruit physicians, it
has been important to contact senior physicians within
each practice to garner support for the study and work
closely with nursing and office staff in order to minimize
the burden of physician participation. To maintain the
fidelity of the intervention, well-trained supervisors of
SPIs and coaches are needed, who can provide timely
and meaningful feedback to those implementing the
intervention based on a detailed review of audio recordings
of intervention sessions. Measurement issues also required
attention, as several scales needed to be adapted (a) from
British or Australian English to American English, (b) to
improve the consistency of response scales to reduce cogni-
tive load, (c) to increase the number of response options to
mitigate ceiling and floor effects in our sample, and (d) to
reduce the number of items to prevent respondent burden
in a sample of seriously ill participants. Inclusion and exclu-
sion criteria also warranted attention; for example, a patient
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with two malignancies, one hematologic and one solid, was
excluded because the hematologic malignancy was active
and progressing.
The pragmatic design of the intervention should facilitate
dissemination of the program if proven effective. The main
challenges of the study have been related to implementa-
tion issues (e.g., SPI and coach training and monitoring)
and study design issues (e.g., respondent burden, IRB issues,
and opt-out cards). The former presented few difficulties,
and the study design challenges would not be present if the
program were to be widely disseminated.
Competing interests
The authors declare that they have no competing interests.
Authors’ contributions
RME and RLK are dual-PIs of VOICE and developed the original study
protocol. MH, RME, KF, PRD, RG, SGM, SP, DT, AV, CC, GE, CF, DG, BH, BL, LL,
MR, PS, and RLK planned, coordinated, and conducted the study. PCW and
WT provided statistical and methodological support, and PCW oversaw data
management. PNB, PRK, AW, and ALB provided consultation aimed at
improving the study design. MH coordinated the survey measurement
group and drafted the initial version of the manuscript. All authors reviewed
and approved the final version of manuscript.
Acknowledgements
This study was funded by R01CA140419 from the National Cancer Institute.
Dr. Hoerger was also supported during the project period by T32MH018911
from the National Institute of Mental Health. We are grateful for the
contributions of our research study staff, including Kristen Greenlee, Donna
Makowski, Tina Slee, and Ted Wun. We are also grateful for the support and
cooperation from the physicians and office staff of the 8 oncology practices
(comprising 14 locations) participating in the study. Finally, we wish to thank
Martin Tattersall, MD, at the University of Sydney for his mentorship and
guidance in the development of the original concept for this study.
Author details
1Rochester Healthcare Decision-Making Group, University of Rochester
Medical Center, Rochester, New York, USA. 2Department of Psychiatry,
University of Rochester Medical Center, Rochester, New York, USA. 3James P.
Wilmot Cancer Center, University of Rochester Medical Center, Rochester,
New York, USA. 4Center for Communication and Disparities Research,
Department of Family Medicine, University of Rochester Medical Center,
Rochester, New York, USA. 5Centre for Medical Psychology and Evidence-
based Medicine, School of Psychology, The University of Sydney, Sydney,
NSW, Australia. 6Department of Internal Medicine, University of California,
Davis, Sacramento, California, USA. 7Department of Biostatistics and
Computational Biology, University of Rochester Medical Center, Rochester,
New York, USA. 8Department of Medicine, University of Washington, Fred
Hutchinson Cancer Research Center, Seattle, Washington, USA. 9Center for
Healthcare Policy and Research, University of California, Davis, Sacramento,
California, USA. 10University of Rochester Medical Center, 300 Crittenden
Blvd, Rochester, NY, USA.
Received: 25 February 2013 Accepted: 26 March 2013
Published: 9 April 2013
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doi:10.1186/1471-2407-13-188
Cite this article as: Hoerger et al.: Values and options in cancer care
(VOICE): study design and rationale for a patient-centered
communication and decision-making intervention for physicians,
patients with advanced cancer, and their caregivers. BMC Cancer 2013
13:188.
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