STAMP: Sharing and Talking About My Preferences

NCT03137459 | Completed Results

• 2 other identifiers: 16040176481R01NR016007-01
• Study Type: interventional
• Target: 909
• Locations: 1 country
• Sites: 1

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.

Conditions

Advanced Care Planning (ACP)

Keywords

Transtheoretical Model (TTM)

Outcome Measures

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.

  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 Outcomes (3)

• 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

Study Arms (2)

TTM

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

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.

TTM

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.

Usual Care

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

Northeast Medical Groups

New Haven, Connecticut, 06511, United States

Location

Related Publications (2)

• 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.

  PMID: 34461035 DERIVED

• 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.

  PMID: 30099405 DERIVED

MeSH Terms

Interventions

Transtheoretical Model

Intervention Hierarchy (Ancestors)

Health Belief Model; Models, Theoretical; Investigative Techniques; Models, Psychological

Results Point of Contact

• Title: Dr. Terri Fried
• Organization: Yale School of Medicine

terri.fried@yale.edu

203-932-5711

Study Officials

• Terri Fried, MD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: July 17, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2021
• Last Updated: September 29, 2021
• Results First Posted: June 15, 2021

Record last verified: 2021-09

Locations

US (1)