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Sharing and Talking About my Preferences (STAMPVA)

Primary Purpose

Chronic Disease

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Computer-Tailored Intervention
Motivational Interviewing
Motivational Enhancement Therapy
Sponsored by
VA Connecticut Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • VA Connecticut Healthcare SystemRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

No Intervention

Arm Label

Computer-tailored intervention

Motivational Interviewing

Motivational Enhancement Therapy

Control Group

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
March 31, 2017
Last Updated
January 6, 2020
Sponsor
VA Connecticut Healthcare System
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1. Study Identification

Unique Protocol Identification Number
NCT03103828
Brief Title
Sharing and Talking About my Preferences
Acronym
STAMPVA
Official Title
Promoting Healthcare Planning as a Healthy Behavior (STAMP VA)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2, 2017 (Actual)
Primary Completion Date
March 31, 2021 (Anticipated)
Study Completion Date
March 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Connecticut Healthcare System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
484 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Computer-tailored intervention
Arm Type
Active Comparator
Arm Title
Motivational Interviewing
Arm Type
Active Comparator
Arm Title
Motivational Enhancement Therapy
Arm Type
Active Comparator
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Computer-Tailored Intervention
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motivational Enhancement Therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Completion of 4 ACP behaviors
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Movement on each of 4 ACP behaviors
Description
Progression in readiness to change for each of the 4 ACP behaviors described above.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lynne Iannone, MS
Phone
203-932-5711
Ext
2403
Email
lynne.iannone@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Maria zenoni, MS
Phone
203-932-5711
Ext
2711
Email
maria.zenoni@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Terri Fried, MD
Organizational Affiliation
VAConnecticut Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Connecticut Healthcare System
City
West Haven
State/Province
Connecticut
ZIP/Postal Code
06516
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
36342678
Citation
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.
Results Reference
derived
PubMed Identifier
30099405
Citation
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.
Results Reference
derived

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Sharing and Talking About my Preferences

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