Advanced Care Planning (ACP)STAMPNCT03137459

STAMP: Sharing and Talking About My Preferences

A study testing Transtheoretical Model (TTM) of health behavior change in people with Advanced Care Planning (ACP), run by Yale University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 55 years and olderHealthy volunteers can take part
Conditions the study is for: Advanced Care Planning (ACP)
What is being tested?: Transtheoretical Model (TTM) of health behavior change
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 909 participants
Where: 1 siteUnited States
Study dates: 17 Jul 2017to 30 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Northeast Medical Groups
New Haven, Connecticut, 06511

Other trials in United States

About this study

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.

Read the 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.

Conditions: Advanced Care Planning (ACP)
Being tested: Transtheoretical Model (TTM) of health behavior change, Usual Care
Keywords: Transtheoretical Model (TTM)

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Transtheoretical Model (TTM) of health behavior changeBehavioural
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 CareOther
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.

Study groups in NCT03137459
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Usual Care

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months

Secondary outcomes (3)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

17 Jul 201730 Jun 2021

First posted2 May 2017
Study start17 Jul 2017
Primary completion30 Jun 2020
Study completion30 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Advanced Care Planning (ACP)Studies of the same condition, open and under way.
More trials run by Yale UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 909 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03137459
Sponsor's protocol ID: 1604017648
Other IDs: 1R01NR016007-01
Acronym: STAMP
Status last verified: Sep 2021
First submitted: 27 Apr 2017
Last updated: 29 Sep 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Publications

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.
PubMed 34461035
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.
PubMed 30099405

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Platform for End-of-life Awareness, Conversations, and Education (PEACE) Among Registered Nurses
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I CAN DO Surgical ACP
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Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid Tumors and High-Grade Brain Tumors
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Recruiting
The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco- Hematologic Disease
Leukemia, Multiple Mieloma
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All Advanced Care Planning (ACP) trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: STAMP: Sharing and Talking About My Preferences
ClinicalTrials.gov ID: NCT03137459
Acronym / sponsor ID: STAMP / 1604017648
Conditions: Advanced Care Planning (ACP)
Keywords: Transtheoretical Model (TTM)
Study type: Interventional
Recruitment status: Completed
Enrolment: 909 participants (actual)
Lead sponsor: Yale UniversityUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 17 Jul 2017 (actual)
Primary completion: 30 Jun 2020 (actual)
Study completion: 30 Jun 2021 (actual)
First posted: 2 May 2017 (actual)
Results: Posted 15 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
TTM	Experimental	Behavioral: Transtheoretical Model (TTM) of health behavior changeParticipants 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.
Usual Care	Active comparator	Other: Usual CareParticipants 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.

Who may qualify

Ages: 55 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Transtheoretical Model (TTM) of health behavior changeParticipants 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.	Behavioural	TTM
Usual CareParticipants 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.	Other	Usual Care

Primary outcome

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.

3 secondary outcomes

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

Results and safety

Results posted to the registry on 15 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report	455	387
Usual Care	454	412

Primary outcome: 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. Count of participants. Unit: Participants

Measure	STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report n = 455	Usual Care n = 454
Value	64	37

STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report vs Usual Care: Risk Difference (RD): .059 (95% CI .014 to .105)
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report vs Usual Care: Odds Ratio (OR): 1.83 (95% CI 1.14 to 2.93)

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
STAMP: Computer-Tailored Intervention Consisting of Assessment With Feedback Report	0 of 455 (0%)	0 of 455 (0%)	0 of 455
Usual Care	0 of 454 (0%)	0 of 454 (0%)	0 of 454

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34461035Fried 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.
Derived from this study: PubMed 30099405Fried 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.
Individual participant dataSharing planned: Undecided

Related trials for Advanced Care Planning (ACP)

Not yet recruiting
Platform for End-of-life Awareness, Conversations, and Education (PEACE) Among Registered Nurses
Death Anxiety, Death Attitude (Implicit/Explicit)
Recruiting
I CAN DO Surgical ACP
Surgical Advanced Care Planning
Recruiting
Educational Tools for the Improvement of Early Advance Care Planning in Adolescents and Young Adults With Advanced Solid Tumors and High-Grade Brain Tumors
Advanced Malignant Solid Neoplasm, Malignant Brain Neoplasm
Recruiting
The Implementation of the Go Wish Game to Promote Advance Care Planning in Onco- Hematologic Disease
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Not yet recruiting
Die-logue Program for Community Dwelling Adults: A Randomized Controlled Trial
Death Attitude (Implicit/Explicit), Death Anxiety

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Terri Fried, MD principal investigator

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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Transtheoretical Model (TTM) of health behavior change in people with Advanced Care Planning (ACP), run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03137459, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.