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Completed

NCT Number: NCT03137459

STAMP: Sharing and Talking About My Preferences

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.

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Key information

Conditions

Advanced Care Planning (ACP)

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northeast Medical Groups

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transtheoretical Model (TTM) of health behavior change

Behavioral

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.

Usual Care

Other

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.

Primary outcomes

  1. 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.

    Time frame: 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 outcomes

  1. Number of Participants Who Complete a Living Will

    Time frame: 6-months

  2. Number of Participants Who Assign a Healthcare Agent

    Time frame: 6 months

  3. Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Nursing Research (NINR)

Registry information

Acronym: STAMP

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
May 2, 2017
Registry last updated
Sep 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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