ENgaging in Advance Care Planning Talks Group Visit Intervention (ENACT)
|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: NCT03141242|
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : August 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Advance Care Planning Primary Health Care||Behavioral: ENACT group visit Behavioral: Mailed Resources||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Randomized Controlled Trial|
|Masking:||None (Open Label)|
|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|
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.
- Change in documentation of the surrogate decision maker [ Time Frame: 0, 3, 6, 12 months ]An MDPOA form is in electronic medical chart
- Change in advance directive in medical record [ Time Frame: 0, 3, 6, 12 months ]Any advance directive is present in the medical chart
- 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)
- 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?"
- 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?"
- 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
- Percent of Retention [ Time Frame: Enrollment thru 6 month follow up ]Percent of individuals who complete the intervention and the 6 month follow up
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
|Contact: Hillary Lum, MD, PhDfirstname.lastname@example.org|
|United States, Colorado|
|Aurora, Colorado, United States, 80045|
|Contact: Hillary Lum, MD, PhD 303-724-1911 email@example.com|
|Principal Investigator:||Hillary Lum, MD, PhD||University of Colorado, Denver|