Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
484 participants
INTERVENTIONAL
2017-10-02
2021-03-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
SINGLE
Study Groups
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Computer-tailored intervention
Computer-Tailored Intervention
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 Interviewing
Motivational Interviewing
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 Therapy
Motivational Enhancement Therapy
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.
Control Group
No interventions assigned to this group
Interventions
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Computer-Tailored Intervention
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 Interviewing
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 Therapy
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.
Eligibility Criteria
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Inclusion Criteria
---Must have seen primary care provider in the past 12 months
* Primary language is English
Exclusion Criteria
* moderate-to-severe cognitive impairment
* active psychiatric illness
* No regular phone or permanent address
55 Years
ALL
Yes
Sponsors
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VA Connecticut Healthcare System
FED
Responsible Party
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Principal Investigators
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Terri Fried, MD
Role: PRINCIPAL_INVESTIGATOR
VAConnecticut Healthcare System
Locations
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VA Connecticut Healthcare System
West Haven, Connecticut, United States
Countries
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Central Contacts
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References
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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.
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.
Other Identifiers
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TF0025
Identifier Type: -
Identifier Source: org_study_id
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