STAMPVA: Sharing and Talking About my Preferences

Sponsor
VA Connecticut Healthcare System (U.S. Fed)
Overall Status
Unknown status
CT.gov ID
NCT03103828
Collaborator
(none)
484
1
4
41.9
11.5

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Computer-Tailored Intervention
  • Behavioral: Motivational Interviewing
  • Behavioral: Motivational Enhancement Therapy
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
484 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Promoting Healthcare Planning as a Healthy Behavior (STAMP VA)
Actual Study Start Date :
Oct 2, 2017
Anticipated Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Computer-tailored intervention

Behavioral: 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.

Active Comparator: Motivational Interviewing

Behavioral: 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.

Active Comparator: Motivational Enhancement Therapy

Behavioral: 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.

No Intervention: Control Group

Outcome Measures

Primary Outcome Measures

  1. Completion of 4 ACP behaviors [6 months]

    Having completed 4 ACP behaviors: living will, health care agent, communication with loved ones about quality versus quantity of life, having forms in medical record

Secondary Outcome Measures

  1. Movement on each of 4 ACP behaviors [6 months]

    Progression in readiness to change for each of the 4 ACP behaviors described above.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Veteran

---Must have seen primary care provider in the past 12 months

  • Primary language is English
Exclusion Criteria:
  • Severe hearing or vision loss

  • moderate-to-severe cognitive impairment

  • active psychiatric illness

  • No regular phone or permanent address

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA Connecticut Healthcare System West Haven Connecticut United States 06516

Sponsors and Collaborators

  • VA Connecticut Healthcare System

Investigators

  • Principal Investigator: Terri Fried, MD, VAConnecticut Healthcare System

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Connecticut Healthcare System
ClinicalTrials.gov Identifier:
NCT03103828
Other Study ID Numbers:
  • TF0025
First Posted:
Apr 6, 2017
Last Update Posted:
Jan 9, 2020
Last Verified:
Jan 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 9, 2020