Clinical trial NCT03137459: STAMP: Sharing and Talking About My Preferences
Official title: STAMP: Sharing and Talking About My Preferences
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Advanced Care Planning (ACP)
Keywords: Transtheoretical Model (TTM)
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2017-05-02
Enrollment: 909
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: 6 months
Secondary outcomes:
measure: Number of Participants Who Complete a Living Will
timeFrame: 6-months
measure: Number of Participants Who Assign a Healthcare Agent
timeFrame: 6 months
measure: Number of Participants Who Communicate With a Loved One About Quality Versus Quantity of Life
timeFrame: 6 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Northeast Medical Groups
state: Connecticut
Study officials:
affiliation: Internal Medicine: Geriatrics: Claude D. Pepper Older Americans Independence Center; Dorothy Adler Geriatric Assessment Center
name: Terri Fried, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.