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ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT)

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ClinicalTrials.gov Identifier: NCT03141242
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Advance Care Planning Primary Health Care Behavioral: ENACT group visit Behavioral: Mailed Resources

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Refining an Advance Care Planning Group Visit Intervention - A Novel Intervention to Engage Older Adults in Advance Care Planning.
Actual Study Start Date : August 22, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020
Arms and Interventions

Arm Intervention/treatment
Active Comparator: ENACT Group Visit
Participants will engage in two 2-hour group visits related to advance care planning, including printed advance care planning resources.
Behavioral: ENACT group visit
Participation in two 2 hour group visits about advance care planning.
Placebo Comparator: Mailed Resources
Participants will receive printed advance care planning resources by mail.
Behavioral: Mailed Resources
Participants will receive advance care planning resources in the mail with instructions to follow up with their primary care provider.


Outcome Measures

Primary Outcome Measures :
  1. Change in documentation of the surrogate decision maker [ Time Frame: 0, 3, 6, 12 months ]
    An MDPOA form is in electronic medical chart


Secondary Outcome Measures :
  1. Change in advance directive in medical record [ Time Frame: 0, 3, 6, 12 months ]
    Any advance directive is present in the medical chart

  2. Change in readiness to engage in ACP [ Time Frame: 0, 6 months ]
    4 patient reported questions regarding readiness to engage in specific parts of the advance care planning process (i.e. signing official papers to name a medical decision maker; talking to the decision maker; talking to the doctor; signing official papers putting their wishes in writing)

  3. Change in participant choice of a surrogate decision maker [ Time Frame: 0, 6 months ]
    Patient report - "Have you decided who you want your medical decision maker to be?"

  4. Change in participant discussions of values and care preferences with surrogate decision maker [ Time Frame: 0, 6 months ]
    Patient report - "Have you talked with your decision maker about what kind of medical care you would want if you were very sick or near the end of life?"


Other Outcome Measures:
  1. Percent of Recruitment (Reach) [ Time Frame: From date of pre-screening until the date of participants' decision to enroll in study or not, up to 3 months ]
    Percent of individuals who participate of eligible patients, by clinic-based screening

  2. Percent of Retention [ Time Frame: Enrollment thru 6 month follow up ]
    Percent of individuals who complete the intervention and the 6 month follow up


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50 or older
  • Receive primary care through UCHealth, Colorado, USA.

Exclusion Criteria:

  • Severe cognitive impairment, known diagnoses of dementia
  • Severe hearing loss or deafness
Contacts and Locations

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): NCT03141242


Contacts
Contact: Hillary Lum, MD, PhD 303-724-1911 hillary.lum@ucdenver.edu

Locations
United States, Colorado
UCHealth Recruiting
Aurora, Colorado, United States, 80045
Contact: Hillary Lum, MD, PhD    303-724-1911    hillary.lum@ucdenver.edu   
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Hillary Lum, MD, PhD University of Colorado, Denver
More Information

Publications:
Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03141242     History of Changes
Other Study ID Numbers: 16-1922
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by University of Colorado, Denver:
Advance Care Planning
Group Medial Visit
Shared Medical Appointment