NCT03103828

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
484

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 6, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

October 2, 2017

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

January 9, 2020

Status Verified

January 1, 2020

Enrollment Period

3.5 years

First QC Date

March 31, 2017

Last Update Submit

January 6, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Movement on each of 4 ACP behaviors

    6 months

Study Arms (4)

Computer-tailored intervention

ACTIVE COMPARATOR
Behavioral: Computer-Tailored Intervention

Motivational Interviewing

ACTIVE COMPARATOR
Behavioral: Motivational Interviewing

Motivational Enhancement Therapy

ACTIVE COMPARATOR
Behavioral: Motivational Enhancement Therapy

Control Group

NO INTERVENTION

Interventions

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.

Computer-tailored intervention

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 Interviewing

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.

Motivational Enhancement Therapy

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veteran
  • Must have seen primary care provider in the past 12 months
  • Primary language is English

You may not qualify if:

  • Severe hearing or vision loss
  • moderate-to-severe cognitive impairment
  • active psychiatric illness
  • No regular phone or permanent address

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Connecticut Healthcare System

West Haven, Connecticut, 06516, United States

RECRUITING

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Chronic Disease

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Terri Fried, MD

    VAConnecticut Healthcare System

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Lynne Iannone, MS

CONTACT

Maria zenoni, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 6, 2017

Study Start

October 2, 2017

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

January 9, 2020

Record last verified: 2020-01

Locations