Sharing and Talking About my Preferences

Chronic Disease Clinical Trial

— STAMPVA  

Official title:

Promoting Healthcare Planning as a Healthy Behavior (STAMP VA)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03103828
• Other study ID #: TF0025
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: March 31, 2021

Study information

• Verified date: January 2020
• Source: VA Connecticut Healthcare System
• Contact: Lynne Iannone, MS
• Phone: 203-932-5711
• Email: lynne.iannone[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 484
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease

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.
• 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.

Locations

Country	Name	City	State
United States	VA Connecticut Healthcare System	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Connecticut Healthcare System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Completion of 4 ACP behaviors	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	6 months
Secondary	Movement on each of 4 ACP behaviors	Progression in readiness to change for each of the 4 ACP behaviors described above.	6 months