STAMP: Sharing and Talking About My Preferences

Study Overview
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Brief Summary
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The purpose of this study is to examine the effect of an individually transtheoretical model (TTM) tailored intervention on the completion of advance care planning (ACP) behaviors.

Detailed Description
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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 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.

Official Title
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STAMP: Sharing and Talking About My Preferences

Conditions
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Advanced Care Planning (ACP)

Intervention / Treatment
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* Behavioral: Transtheoretical Model (TTM) of health behavior change
* Other: Usual Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be community-dwelling persons with an upcoming primary care visit in the study's practice settings. Exclusion Criteria: Severe hearing impairment, defined as being unable to participate in a telephone conversation. Severe visual impairment, defined as being unable to read large-print materials. Moderate to severe cognitive impairment, defined as either a diagnosis of dementia and/or short-term recall of <2/3 objects at 2 minutes. Primary language other than English. Having completed all of the four ACP behaviors that are the focus of this study.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TTM<br>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. | Behavioral: Transtheoretical Model (TTM) of health behavior change<br>* 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.<br>|
| Active Comparator: Usual Care<br>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. | Other: Usual Care<br>* 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. Participants in this group will not receive any components of the TTM intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Completed Four ACP Activities: Communication With Loved Ones About Quality Versus Quantity of Life, Completion of a Living Will, Assignment of a Healthcare Agent, and Confirmation of Documents in the Electronic Health Record. | The primary outcome of the study is to assess the proportion of participants that have completed the four ACP behaviors. The measure will be coded as a binary outcome where 'yes' indicates the completion of all 4 behaviors and 'no' indicates no completing the 4 behaviors. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Complete a Living Will |  | 6-months | 
| Number of Participants Who Assign a Healthcare Agent |  | 6 months | 
| Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transtheoretical Model (TTM)