STAMP: Sharing and Talking About My Preferences

NCT ID: NCT03137459

Last Updated: 2021-09-29

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

909 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-17

Study Completion Date

2021-06-30

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.

Conditions

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Advanced Care Planning (ACP)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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TTM

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.

Group Type EXPERIMENTAL

Transtheoretical Model (TTM) of health behavior change

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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Transtheoretical Model (TTM) of health behavior change

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.

Intervention Type BEHAVIORAL

Usual Care

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.

Intervention Type OTHER

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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute of Nursing Research (NINR)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Terri Fried, MD

Role: PRINCIPAL_INVESTIGATOR

Internal Medicine: Geriatrics: Claude D. Pepper Older Americans Independence Center; Dorothy Adler Geriatric Assessment Center

Locations

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Northeast Medical Groups

New Haven, Connecticut, United States

Site Status

Countries

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United States

References

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Fried TR, Paiva AL, Redding CA, Iannone L, O'Leary JR, Zenoni M, Risi MM, Mejnartowicz S, Rossi JS. Effect of the STAMP (Sharing and Talking About My Preferences) Intervention on Completing Multiple Advance Care Planning Activities in Ambulatory Care : A Cluster Randomized Controlled Trial. Ann Intern Med. 2021 Nov;174(11):1519-1527. doi: 10.7326/M21-1007. Epub 2021 Aug 31.

Reference Type DERIVED
PMID: 34461035 (View on PubMed)

Fried TR, Redding CA, Martino S, Paiva A, Iannone L, Zenoni M, Blakley LA, Rossi JS, O'Leary J. Increasing engagement in advance care planning using a behaviour change model: study protocol for the STAMP randomised controlled trials. BMJ Open. 2018 Aug 10;8(8):e025340. doi: 10.1136/bmjopen-2018-025340.

Reference Type DERIVED
PMID: 30099405 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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1R01NR016007-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1604017648

Identifier Type: -

Identifier Source: org_study_id

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