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Sharing and Talking About my Preferences (STAMPVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03103828
Recruitment Status : Recruiting
First Posted : April 6, 2017
Last Update Posted : January 9, 2020
Sponsor:
Information provided by (Responsible Party):
VA Connecticut Healthcare System

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
Chronic Disease Behavioral: Computer-Tailored Intervention Behavioral: Motivational Interviewing Behavioral: Motivational Enhancement Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 2, 2017
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Completion of 4 ACP behaviors [ Time Frame: 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 [ Time Frame: 6 months ]
    Progression in readiness to change for each of the 4 ACP behaviors described above.



Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03103828


Contacts
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Contact: Lynne Iannone, MS 203-932-5711 ext 2403 lynne.iannone@va.gov
Contact: Maria zenoni, MS 203-932-5711 ext 2711 maria.zenoni@va.gov

Locations
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United States, Connecticut
VA Connecticut Healthcare System Recruiting
West Haven, Connecticut, United States, 06516
Sponsors and Collaborators
VA Connecticut Healthcare System
Investigators
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Principal Investigator: Terri Fried, MD VAConnecticut Healthcare System
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: VA Connecticut Healthcare System
ClinicalTrials.gov Identifier: NCT03103828    
Other Study ID Numbers: TF0025
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: January 9, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Chronic Disease
Disease Attributes
Pathologic Processes