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Clinical Trials/NCT05421728
NCT05421728
Active, Not Recruiting
N/A

Effectiveness of Engaging in Advance Care Planning Talks (ENACT) Group Visits in Primary Care for Older Adults With and Without Alzheimer's Disease

University of Colorado, Denver8 sites in 1 country516 target enrollmentJuly 26, 2022

Overview

Phase
N/A
Intervention
Not specified
Conditions
Advance Care Planning
Sponsor
University of Colorado, Denver
Enrollment
516
Locations
8
Primary Endpoint
Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 6 Months
Status
Active, Not Recruiting
Last Updated
7 months ago

Overview

Brief Summary

The main goal of the ENACT (ENgaging in Advance Care planning Talks) Group Visit intervention is to integrate a patient-centered advance care planning process into primary care, ultimately helping patients to receive medical care that is aligned with their values. The ENACT Group Visit intervention involves two group discussions about advance care planning with 8-10 patients who meet for 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. This study will compare the ENACT Group Visit intervention to mailed advance care planning materials.

Detailed Description

This pilot feasibility randomized controlled study will determine the feasibility, acceptability and preliminary efficacy of the ENACT Group Visit intervention compared to a comparison arm. The ENACT Group Visit intervention aims to engage patients in an interactive discussion of key ACP concepts and support patient-initiated ACP actions (i.e. choosing decision-maker(s), deciding on preferences during serious illness, discussing preferences with decision-makers and healthcare providers, and documenting advance directives). The group visits involve two 2-hour sessions, one month apart, facilitated by a geriatrician and a social worker. The ENACT Group Visit is based on an intervention manual that guides the structure, facilitator considerations, session format, and documentation and billing details. The discussions include sharing experiences related to ACP, considering values related to serious illness, choosing a surrogate decision-maker(s), flexibility in decision making, and having conversations with decision-makers and healthcare providers. The facilitators support an interactive discussion that promotes opportunities for patients to learn from others' experiences.

Registry
clinicaltrials.gov
Start Date
July 26, 2022
End Date
May 1, 2027
Last Updated
7 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 70 or older
  • At least one clinic visit in past year
  • No advanced care planning (ACP) document in electronic health record based on a clinic-level, population-based report
  • Preferred language English for UCHealth clinics or preferred language English or Spanish for Denver Health clinic

Exclusion Criteria

  • Inability to demonstrate informed consent
  • Does not have ready access to a telephone
  • Inability to travel to clinic
  • Moving out of area in 6 months
  • Inability to participate in group visits due to hearing impairment as determined by clinic and/or study staff
  • A household member (same address) is already enrolled
  • Inclusion Criteria:
  • Age 18 and older
  • Preferred language English for UCHealth clinics or preferred language English or Spanish for Denver Health clinic
  • Patient with potential cognitive impairment consented to participate in study

Outcomes

Primary Outcomes

Number of Participants with New Advanced Care Planning (ACP) documentation in their electronic health record at 6 Months

Time Frame: 6 months

Number of Participants with New Advanced Care Planning (ACP) documentation in the electronic health record inclusive of advance directives (i.e., easy-to-read advance directive, medical durable power of attorney forms, living wills), and medical orders (POLST forms or CPR directives. If an advanced care planning document is completed and in patient's electronic health record, the participant will be counted as having a New ACP.

Secondary Outcomes

  • Measure of readiness for ACP(Baseline, 6 months)
  • Composite of advanced care planning documentation(Baseline, 6 months)
  • The Quality of Communication (QOC)(Baseline, 6 months)
  • Measure of decision self-efficacy(Baseline, 6 months)

Study Sites (8)

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