Chronic DiseaseSTAMPVANCT03103828
Sharing and Talking About my Preferences
A study testing Computer-Tailored Intervention, Motivational Interviewing and Motivational Enhancement Therapy in people with Chronic Disease, run by VA Connecticut Healthcare System at 1 site in United States.
Trial summary
The purpose of this study is to figure out the best way to help veterans do advance care planning. This study will examine the effects of two theory based behavior interventions by randomizing veteran into 4 groups to see which veterans will complete the 4 step process of advance care planning. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Disease
- What is being tested?
- Computer-Tailored Intervention, Motivational Interviewing and Motivational Enhancement Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 484 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Oct 2017to 31 Jan 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
- Veteran
- ---Must have seen primary care provider in the past 12 months
- Primary language is English
Who cannot join
- Severe hearing or vision loss
- moderate-to-severe cognitive impairment
- active psychiatric illness
- No regular phone or permanent address
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Connecticut Healthcare System
West Haven, Connecticut, 06516
About this study
Official title: Promoting Healthcare Planning as a Healthy Behavior (STAMP VA)
The purpose of this study is to figure out the best way to help veterans do advance care planning. This study will examine the effects of two theory based behavior interventions by randomizing veteran into 4 groups to see which veterans will complete the 4 step process of advance care planning.
Read the detailed description
Purpose: The purpose of this study is to examine the effects of two theory-based behavior interventions on engagement of Veterans in advance care planning (ACP) by means of the following specific aim:
Primary Aim: To conduct a randomized controlled trial examining the effects of: a) usual care; b) computer-tailored intervention (CTI); c) motivational enhancement therapy (MET); d) CTI + MET on the proportion of middle-age and older Veterans receiving primary care at the VA who complete the process of ACP, defined as completing a total of 4 key ACP behaviors, including selecting a health care proxy, communicating with the proxy about goals of care, communicating with the clinician about goals of care, and documenting proxy selection and goals.
Primary Hypothesis: The proportion of Veterans completing ACP will be higher among those in each of the intervention groups compared to Veterans receiving usual care.
All of 4 groups will receive their assessments and, if, their interventions, by telephone and/or mail. The veterans will from the VA Connecticut Healthcare System. Participants will be identified through a data query of the Regional Data Warehouse who have had a primary care visit in the past 12 months. We will then be able to oversample female and minority Veterans.
- Conditions
- Chronic Disease
- Being tested
- Computer-Tailored Intervention, Motivational Interviewing, Motivational Enhancement Therapy
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-Tailored InterventionBehavioural
CTI will receive telephone contact at three time points: baseline, two, and four months. Each contact consists of an integrated assessment and intervention feedback report, using an expert system. 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.
Motivational InterviewingBehavioural
MET will receive telephone contact at three time points: baseline, two, and four months. They will undergo the assessment as described above receive and they will receive a second a telephone contact within two weeks of the assessment, which will consist of an MET session. If the surrogate has been enrolled in the study, the MET will be conducted with both the Veteran and the surrogate in a dyadic telephone interview. The goal of the interview is to strengthen commitment to engage in ACP and promote self-efficacy. The interviewer will also help the Veteran to reflect on the pros and cons of ACP engagement as elicited in the assessment process, to understand how to build on ACP behaviors already engaged in, and, if appropriate, to help the Veteran create a change plan for further ACP engagement.
Motivational Enhancement TherapyBehavioural
Participants assigned to CTI+MET will receive the CTI intervention at baseline, two months, and four months as described above. with a follow-up MET session as described above occurring within two weeks of each contact.
| Study group | Role | What they receive |
|---|---|---|
| Computer-tailored intervention | Active comparator | Not described Receives: Behavioral: Computer-Tailored Intervention |
| Motivational Interviewing | Active comparator | Not described Receives: Behavioral: Motivational Interviewing |
| Motivational Enhancement Therapy | Active comparator | Not described Receives: Behavioral: Motivational Enhancement Therapy |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predicted Probability) of Completing of 4 ACP Behaviors as a Percentage
The 4 ACP behaviors are completing a living will, assigning a health care agent, having communication with loved ones about quality versus quantity of life, having forms in medical record. The predicted probability is expressed in terms of a percentage.
Measured: 6 months
Secondary outcomes (1)
Movement on Each of 4 ACP Behaviors
Progression in readiness to change for each of the 4 ACP behaviors described above.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2017
- Study start2 Oct 2017
- Primary completion6 Jul 2020
- Study completion31 Jan 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 Chronic DiseaseStudies of the same condition, open and under way.
- 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
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Connecticut Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Terri Fried, MD, Principal investigator, VAConnecticut Healthcare System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03103828
- Sponsor's protocol ID
- TF0025
- Acronym
- STAMPVA
- Status last verified
- Sep 2022
- First submitted
- 31 Mar 2017
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Fried TR, Yang M, Martino S, Iannone L, Zenoni M, Blakley L, O'Leary JR, Redding CA, Paiva AL. Effect of Computer-Tailored Print Feedback, Motivational Interviewing, and Motivational Enhancement Therapy on Engagement in Advance Care Planning: A Randomized Clinical Trial. JAMA Intern Med. 2022 Dec 1;182(12):1298-1305. doi: 10.1001/jamainternmed.2022.5074.
PubMed 36342678Fried 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Promoting Healthcare Planning as a Healthy Behavior (STAMP VA)
- ClinicalTrials.gov ID
- NCT03103828
- Acronym / sponsor ID
- STAMPVA / TF0025
- Conditions
- Chronic Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- VA Connecticut Healthcare SystemUS federal agency
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 6 Jul 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 6 Apr 2017 (actual)
- Results
- Posted 29 Sep 2026
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 figure out the best way to help veterans do advance care planning. This study will examine the effects of two theory based behavior interventions by randomizing veteran into 4 groups to see which veterans will complete the 4 step process of advance care planning.
Detailed description
Purpose: The purpose of this study is to examine the effects of two theory-based behavior interventions on engagement of Veterans in advance care planning (ACP) by means of the following specific aim:
Primary Aim: To conduct a randomized controlled trial examining the effects of: a) usual care; b) computer-tailored intervention (CTI); c) motivational enhancement therapy (MET); d) CTI + MET on the proportion of middle-age and older Veterans receiving primary care at the VA who complete the process of ACP, defined as completing a total of 4 key ACP behaviors, including selecting a health care proxy, communicating with the proxy about goals of care, communicating with the clinician about goals of care, and documenting proxy selection and goals.
Primary Hypothesis: The proportion of Veterans completing ACP will be higher among those in each of the intervention groups compared to Veterans receiving usual care.
All of 4 groups will receive their assessments and, if, their interventions, by telephone and/or mail. The veterans will from the VA Connecticut Healthcare System. Participants will be identified through a data query of the Regional Data Warehouse who have had a primary care visit in the past 12 months. We will then be able to oversample female and minority Veterans.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Computer-tailored intervention | Active comparator | Behavioral: Computer-Tailored Intervention |
| Motivational Interviewing | Active comparator | Behavioral: Motivational Interviewing |
| Motivational Enhancement Therapy | Active comparator | Behavioral: Motivational Enhancement Therapy |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Veteran
- ---Must have seen primary care provider in the past 12 months
- Primary language is English
Key exclusion criteria (4 listed)
- Severe hearing or vision loss
- active psychiatric illness
- No regular phone or permanent address
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 |
|---|---|---|
| Computer-Tailored InterventionCTI will receive telephone contact at three time points: baseline, two, and four months. Each contact consists of an integrated assessment and intervention feedback report, using an expert system. 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. | Behavioural | Computer-tailored intervention |
| Motivational InterviewingMET will receive telephone contact at three time points: baseline, two, and four months. They will undergo the assessment as described above receive and they will receive a second a telephone contact within two weeks of the assessment, which will consist of an MET session. If the surrogate has been enrolled in the study, the MET will be conducted with both the Veteran and the surrogate in a dyadic telephone interview. The goal of the interview is to strengthen commitment to engage in ACP and promote self-efficacy. The interviewer will also help the Veteran to reflect on the pros and cons of ACP engagement as elicited in the assessment process, to understand how to build on ACP behaviors already engaged in, and, if appropriate, to help the Veteran create a change plan for further ACP engagement. | Behavioural | Motivational Interviewing |
| Motivational Enhancement TherapyParticipants assigned to CTI+MET will receive the CTI intervention at baseline, two months, and four months as described above. with a follow-up MET session as described above occurring within two weeks of each contact. | Behavioural | Motivational Enhancement Therapy |
Primary outcome
Predicted Probability) of Completing of 4 ACP Behaviors as a Percentage
Time frame: 6 months
The 4 ACP behaviors are completing a living will, assigning a health care agent, having communication with loved ones about quality versus quantity of life, having forms in medical record. The predicted probability is expressed in terms of a percentage.
1 secondary outcome
Movement on Each of 4 ACP Behaviors
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36342678Fried TR, Yang M, Martino S, Iannone L, Zenoni M, Blakley L, O'Leary JR, Redding CA, Paiva AL. Effect of Computer-Tailored Print Feedback, Motivational Interviewing, and Motivational Enhancement Therapy on Engagement in Advance Care Planning: A Randomized Clinical Trial. JAMA Intern Med. 2022 Dec 1;182(12):1298-1305. doi: 10.1001/jamainternmed.2022.5074.
- 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: No
Related trials for Chronic Disease
Recruiting
Dietary Intervention for Migraine Relief
Migraine
RecruitingPhase 2
Neurovascular Regulation During Exercise in Humans With Chronic Kidney Disease: Sympatholysis in CKD
Chronic Kidney Disease
Not yet recruiting
Combined Versus Multicomponent Training in People With Chronic Kidney Disease Stages 3a and 3b
Chronic Kidney Disease Stage 3A, Chronic Kidney Disease Stage 3B
RecruitingPhase 3
A Follow-up Study of Mezagitamab in Adults With Chronic Primary Immune Thrombocytopenia
Immune Thrombocytopenic Purpura (ITP)
Active, not recruitingPhase 3
Efficacy and Safety of Tezepelumab in Patients With Eosinophilic Esophagitis
Eosinophilic Esophagitis
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
VAConnecticut Healthcare System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-Tailored Intervention, Motivational Interviewing and Motivational Enhancement Therapy in people with Chronic Disease, run by VA Connecticut Healthcare System 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 3 inclusion and 4 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 2026. 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 29 Sep 2026). 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?
Predicted Probability) of Completing of 4 ACP Behaviors as a Percentage (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 NCT03103828, 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 2026.