STAMP: Sharing and Talking About My Preferences
Phase: NA
Conditions: Advanced Care Planning (ACP)
Sponsor: Yale University

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STAMP: Sharing and Talking about My Preferences 
NCT: 03137459 
 
Protocol: July, 2016 
 
 

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1. Statement of Purpose:  
This will be a randomized controlled trial examining the effect of an individually TTM-tailored 
intervention on the proportion of middle-age and older persons recruited from primary care 
practices and senior living communities who complete four ACP behaviors (completion of a 
living will, assignment of a health care proxy, and communication with loved ones and with 
their clinician about views on quality versus quantity of life) over six months, compared with 
usual care. 
 
2. Background:  
Advance care planning (ACP), the process by which individuals and their healthcare 
surrogate can prepare for future treatment decisions, remains underutilized. ACP addresses 
many of the issues that patients and their caregivers endorse as important in end-of-life 
care, including clear communication with loved ones, achieving closure, and remaining in 
control of medical decisions. However, there are many emotional, cognitive, and practical 
barriers to engaging in ACP. While it has been demonstrated that intervention can increase 
ACP engagement, this model requires a skilled, well-trained moderator meeting with 
patients and caregivers in lengthy encounters. This type of intensive intervention may be 
best suited for patients with serious chronic illnesses who are ready to think about their 
specific disease trajectories and the decisions they are likely to face. The recent Institute of 
Medicine (IOM) report “Dying in America: Improving Quality and Honoring Individual 
Preferences near the End of Life” proposes a continuous process of ACP, starting earlier in 
the lifespan with individuals in good health and an initial focus on identification of a 
surrogate decision maker and general communication about patients’ goals with more in-
depth and specific discussions coming later. This proposal describes the evaluation of an 
intervention to promote initial engagement in ACP. Taking a public health approach to ACP 
engagement, the intervention is designed to be able to reach a broad cross-section of 
individuals at modest expense.  
 
The intervention builds upon the Principal Investigator (PI)’s long history of studying the 
process of ACP and several key insights provided by her past work. First, ACP has 
historically been conceptualized as the process by which patients could specify in advance 
the treatment they would want to receive if they became decisionally incapable. It consisted 
of completion of advance directives (AD), which are documents such as living wills and 
health care proxies. However, it has been shown that this completion of documents, while 
most likely necessary, is not sufficient to improve end-of-life outcomes. The PI has argued 
that, instead of having patients make premature treatment decisions, which cannot take into 
account the specific details of future health scenarios and the clinical judgment of healthcare 
practitioners, ACP should instead be focused on preparing patients and their surrogates to 
make the best possible “in-the-moment” healthcare decisions. This goal for ACP is best met 
by conceptualizing ACP as acts of communication, between patients and surrogates, and 
between patients and physicians, that focus not on preferences for specific treatments but 
rather on broader goals of care. Second, the intervention treats ACP as a health behavior 
utilizing the Transtheoretical Model (TTM) of health behavior change. The TTM provides a 
framework for the delivery of tailored intervention materials based on an assessment of an 
individual’s readiness to engage in ACP along with the attitudes and beliefs influencing the 
desire, motivation, and ability to engage. The potential for this approach was recognized in 
the IOM report. The PI and her co-investigators have developed a TTM-tailored expert 
system intervention with stage-targeted brochures and demonstrated the acceptability of 
these materials to a diverse cohort of older adults. The proposed study represents the 

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logical next steps in this work, by examining the efficacy of the intervention on increased 
engagement in ACP. 
 
3. Research Plan: 
 
Participants and Recruitment 
Participants will be community-dwelling persons 55 years of age or older with an upcoming 
primary care visit in the NEMG practice or one of Yale New Haven Health System practices 
or individuals residing in senior living communities. Exclusion criteria include: a) severe 
hearing impairment, defined as being unable to participate in a telephone conversation; b) 
severe visual impairment, defined as being unable to read large-print materials; c) moderate 
to severe cognitive impairment, defined as either a diagnosis of dementia and/or short-term 
recall of <2/3 objects at 2 minutes d) primary language other than English, e) having 
completed all of the four ACP behaviors that are the focus of this study. 
 
Participants will be recruited from eight pairs of primary care practices belonging to 
Northeast Medical Group, an accountable care organization that includes practices in New 
Haven and Fairfield counties, and Yale New Haven Health System, or located in senior 
living communities with each pair matched in terms of size, proportion of patients age 55 
and older, and proportion of minority patients. Participants will also be recruited from 
similarly matched senior living communities. One site in each pair will serve as the 
intervention site, and the other as the control site. 
 
Physicians will review lists of upcoming patients and asked to identify patients meeting 
eligibility criteria who do not meet exclusion criteria. Physicians and/or staff will give a flyer 
to eligible participants the day of their visit. For senior living communities, we will solicit 
volunteers following a presentation by the Principal Investigator performed in the facility 
providing general information about advance care planning. 
 
Process of Consent/Assent 
For individuals recruited from practices, clinicians will provide their consent for potentially 
eligible persons to participate. If clinician consent is granted, then the clinician will be alerted 
when he/she is scheduled to see a potentially eligible and asked to obtain the patient’s 
assent to talk to the research associate about the study following the appointment. If the 
patient has the time, the research associate will explain the study and complete a process of 
written informed consent and HIPAA authorization. If the patient would like to participate but 
does not want to stay and would prefer to be contacted later by telephone, we will consent 
the participant in person and call them at the pre-arranged time.  If participant does not want 
to sign at that time the patient will be given copies of the written documents to review with 
the research associated by telephone to complete the process of consent, sending in the 
signed forms using a self-addressed stamped envelope.  
 
Individuals in senior living facilities will meet with the research assistant at the facility at a 
time of their choosing to complete the process of written informed consent and HIPAA 
authorization. The informed consent process will consist of the research associate and 
potential participant reading through the consent form together, with the research associate 
highlighting the study procedures, potential risks, and participants’ ability to withdraw. The 
associate will ask if the participant has any questions, and then ask several open-ended 
questions to assess the potential participant’s understanding.  

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Description of Intervention Group  
Participants enrolled at the intervention site will receive four contacts, at baseline, two, four 
and six months. Each of the first three contacts consists of an integrated assessment and 
intervention feedback report, using an expert system. This is a software system consisting of 
an assessment battery, normative data on which to base decision rules, and materials that 
can be assembled for feedback. The assessment battery includes the core TTM measures, 
including Stages of Change (how ready the participant is to engage), Decisional Balance 
(DB) (attitudes regarding the pros and cons of engagement), and Values/Beliefs (V/B) 
(medical and religious beliefs that can affect readiness to engage in ACP). Participants are 
assessed for four different behaviors that together represent complete ACP engagement: 
communication with loved ones about views on quality of life versus quantity of life, 
communication with clinicians about views on quality of life versus quantity of life, 
assignment of a health care surrogate, and completion of a living will. The system takes the 
results of the assessment and results in an individualized feedback report. For individuals in 
early stages of change for a given behavior, the feedback focuses on changing attitudes, a 
necessary prerequisite for changing behavior, by addressing common barriers and by 
reminding individuals they can engage in small steps. For individuals in later stages of 
change, the feedback provides specific actions they can perform. In addition, if the 
participant has engaged in one ACP behavior but not another, the feedback provides 
information on how they can utilize what they have already accomplished in order to help 
them participate in any remaining ACP activities. Participants with a low pros score receive 
feedback suggesting additional pros they may not have realized, while participants with a 
high cons score receive feedback providing general strategies for overcoming the most 
common barriers to ACP. Participants also receive specific feedback for up to three items 
they endorsed on the V/B scale. A general introduction provides a common opening for the 
feedback report, briefly describing ACP, why it is necessary, and why individuals should 
engage in ACP even when it seems too difficult to plan for declines in health and dying. 
Whereas the baseline feedback report provides individualized normative feedback, the 
follow-up reports also provide ipsative feedback, in which the participants’ current responses 
are compared to prior responses and feedback is provided on progress over time.  
 
In addition to their tailored feedback report, participants will receive one of two brochures 
that provides stage-matched information for each of the three ACP behaviors. In comparison 
to the tailored feedback reports, the brochures contain information that is salient to 
participants in a given stage of behavior change regardless of their individual decisional 
balance or use of processes. The brochure for individuals who are not ready to engage in 
any ACP behavior is brief, focusing on descriptions of strategies to overcome attitudinal 
barriers to engagement in ACP and the positive consequences of engagement. The 
brochure also includes two stories, adapted from the PI’s prior qualitative research. One 
illustrates the benefits to a spouse and children of her husband’s engagement in ACP, and 
the second describes the regrets of a daughter whose mother did not engage in ACP. The 
second brochure, for individuals who are ready to engage in one or more ACP activities, 
provides strategies for participating in each activity. This brochure, for example, provides 
“words to use” to approach a health care proxy, and questions for individuals and their 
surrogates to discuss regarding goals of care. In addition, participants will receive a 
pamphlet developed for the individual to give to his/her (potential) surrogate. This pamphlet, 
written from the perspective of the individual, explains to the surrogate how he/she can help 
the individual engage in ACP. The time points for assessment were selected to provide 

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sufficient time for the participant to reflect and act on the feedback received while 
maintaining the momentum to move forward by not waiting too long to provide follow-up. 
 
The baseline assessment and feedback will occur in person, directly after a scheduled office 
visit. The assessment will be done through a face-to-face interview with a trained research 
associate, who will enter participants’ responses into a laptop computer. The expert system 
feedback report will be delivered immediately via a portable color printer. The follow-up 
assessments will be conducted by telephone, with delivery of the feedback report and 
brochures by mail.  
 
The baseline assessment will also include questions assessing sociodemographic status, 
health status, and psychosocial status (see below).  
 
The six-month contact will assess participants for the outcome variables for the study, which 
is the stage of change for each of the four ACP behaviors. This contact will be performed by 
an interviewer who is blinded to the participant’s group assignment. 
  
Description of Control Group  
Participants enrolled in control sites will receive four assessment contacts on the same 
schedule and in the same manner as the participants enrolled in intervention sites. Their 
assessments will include the TTM constructs of Stages of Change, DB, and V/B, using the 
same scales as administered to participants in the intervention group. However, they will not 
receive any feedback. The purpose of this assessment is to control for historical trends and 
the potential reactivity of assessment alone. Apart from these assessments, participants 
enrolled in control sites will receive usual care. In order to minimize the effect of asking 
about ACP behaviors on participants’ engagement in these behaviors, the assessments will 
be masked. This will be accomplished by assessing participants’ Stages of Change for 
several other behaviors that are relevant to the health of older persons, including a healthy 
diet, physical activity, and fall prevention.  
 
Outcome Measures 
The primary and secondary outcomes will be based on the participant’s stage of behavior 
change for each of the four ACP behaviors targeted by the intervention materials (see 
C.1.c.) obtained at six months following the baseline assessment. The primary outcome will 
be the proportion of participants achieving the stage of action or maintenance for all four 
ACP behaviors. The secondary outcomes include the proportion of participants achieving 
each stage for each of the four ACP behaviors. 
These outcomes will be obtained through participant self-report by an interviewer who is 
blinded to the participant’s group assignment. Although there is a potential concern that 
social desirability bias could result in differential reporting by participants in the intervention 
and control groups, there are several reasons why self-report is the best way to ascertain 
outcomes. First, there is no gold-standard objective measure for these outcomes. There are 
no incentives for physicians to document communication with patients regarding values and 
goals, so that underreporting of this communication in the medical record is likely to be 
substantial. Physician and/or surrogate self-report of communication is subject to the same 
social desirability bias, especially for physicians in the practices randomized to the 
intervention. It would be possible to ask participants for copies of ADs, but, if the intervention 
is successful in increasing communication, these may be given to surrogates and not be 
immediately accessible. Second, the intervention minimizes the likelihood of social 
desirability bias. Because the feedback reports and brochures acknowledge the difficulties 

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associated with behavior change, they provide participants with the message of engaging in 
behaviors when they are ready to do so, rather than with a message of needing to 
accomplish a certain behavior. In addition to these outcomes, responses to the scales used 
for the assessment will be examined as secondary outcomes. 
Independent Variables 
The independent variables will be used to describe the study population and test for the 
adequacy of randomization. They will also be used as covariates in the models testing the 
study hypotheses. The independent variables will measure the constructs of 
sociodemographic status, health status, and psychosocial status. Sociodemographic 
variables include: age, gender, ethnicity, level of education, and income. Health status 
variables include: chronic conditions; functional status, measured using the instrumental 
activities of daily living scale,81 self-rated health,82 and self-rated quality of life. Psychosocial 
status variables include: religion and religiosity, measured using the Duke University 
Religion Index83; instrumental and emotional support, measured using the EPESE social 
support items;84 and depression, using the PHQ-2.85 Participants will also be asked items 
taken from an earlier study on familial experiences with end-of-life decision making, as this 
has been demonstrated to be associated with readiness to engage in ACP.79 The 
independent variables will be obtained by self-report in the baseline assessment.  
Power and Sample Size 
Based on our cross-sectional data demonstrating a prevalence of between 4 and 8%  for the 
primary outcome, we conservatively estimate that the prevalence of this outcome in the 
control group, which, because of our exclusion criteria, will be 0% at baseline, will be 5% at 
the Month 6 assessment. The sample size is based on the ability to detect an absolute 
increase of 10% for ACP for the treatment group over the control group at Month 6, 
consistent with effect sizes in previous TTM-tailored interventions and a judgment regarding 
a minimum clinically significant effect size. Sample size calculations assumed one-tailed 
significance testing at alpha = .05 and were based on a one-way analysis of variance for 
proportions with arcsine transformation and nested random effects for sites to accommodate 
the cluster-randomized design.86 Based on an enrollment of 16 sites for the study (8 
matched pairs), to achieve power of .80 for the primary outcome, a final sample size of 50 
individuals per site is needed, resulting in a final study sample size of 800. Assuming 20% 
loss to follow-up, a baseline sample size of 1000 is required.  
This sample size will also be sufficient for conducting process-to-outcome analyses 
assessing the effects of potential mediators and moderators of outcomes using multiple 
regression or structural equation modeling analyses.87,88 For example, for structural models 
of reasonable size (e.g., df = 40–50), and assuming a close fit criterion (RMSEA = .05), 
power is at least .80 for groups of about 240.  
Analysis 
The analysis is based on the study design of two groups (intervention, control) X four 
occasions (baseline, 2, 4, 6 months) with sites nested in groups based on cluster 
randomization of matched pairs of sites. Baseline analyses will include examination of group 
differences to evaluate the success of the matched-pairs randomization procedure and 
examination of potential covariates to reduce the expected within-groups dependency 
resulting from cluster randomization. 
Primary Outcome 
The main outcome hypothesis is that the proportion in Action/Maintenance for the four ACP 
behaviors is intervention group > control group at the final 6-month assessment. Several 
analytical approaches are available within a more general framework of random effects 

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modeling incorporating both time and site level effects in addition to potentially important 
covariates. The basic analytical approach will employ the generalized estimating equation 
(GEE) method to analyze intervention main effects and interaction (additive) effects.89 GEE 
enables use of linear, logistic and Poisson regression methods with repeated measures, 
providing consistent estimates of regression coefficients and robust variance estimates, 
even in the presence of unbalanced group data. It permits the clustering of sites by 
treatment condition and provides a direct estimate of the ICC.  
Secondary Outcomes  
Design and analysis approaches for secondary outcomes will be similar to those employed 
for the primary outcome variable. Subgroup analysis will explore the effects of the 
intervention according to demographic status, including age, gender, race/ethnicity, 
education, and according to the number of ACP behaviors completed at baseline.