STAMP: Sharing and Talking About My Preferences

Not Applicable

Completed

• Conditions: Advanced Care Planning (ACP)
• Interventions: Other: Usual Care; Behavioral: Transtheoretical Model (TTM) of health behavior change

• Registration Number: NCT03137459
• Lead Sponsor: Yale University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2017-04-27
• Study First Submitted QC: 2017-04-27
• Study First Posted: 2017-05-02
• Study Start: 2017-07-17
• Primary Completion: 2020-06-30
• Results First Submitted: 2021-05-19
• Results First Submitted QC: 2021-05-19
• Results First Posted: 2021-06-15
• Study Completion: 2021-06-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-01
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 909

Inclusion Criteria

• Participants will be community-dwelling persons with an upcoming primary care visit in the study's practice settings.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Usual Care	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.
TTM	Transtheoretical Model (TTM) of health behavior change	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.

Primary Outcome Measures

Name	Time	Method
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.	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Assign a Healthcare Agent	6 months
Number of Participants Who Complete a Living Will	6-months
Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life	6 months

Trial Locations

Locations (1)

Northeast Medical Groups; 🇺🇸 New Haven, Connecticut, United States