Clinical trial NCT06081660: Advance Care Planning for Older Latinos With Chronic Illness
Official title: Advance Care Planning for Older Latinos With Chronic Illness: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patient Engagement
End of Life
Chronic Disease
Communication
Keywords: Latino
Advance Care Planning
Advance Directive
Lead sponsor: San Diego State University
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2 mixed factorial design, pre-test/posttest variables to examine impact on ACP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, Advance Care Planning I Plan (ACP-I Plan), among older Latinos with chronic illnesses in community settings.

Detailed description: The goal of this study is to test the feasibility of a randomized controlled trial to learn about implementation of an intervention model, Advance Care Planning I Plan (ACP-I Plan), among older Latinos with chronic illnesses in community settings.

The questions of this study seek to explore implementation of the intervention model:

1. To evaluate feasibility, acceptability, and preliminary impact of ACP-I Plan to improve AD documentation and increase engagement in ACP communication with family and providers among older Latinos with chronic diseases (cancers and non-cancers); and
2. To evaluate implementation of ACP-I Plan in a community setting and examine further need for adaption.

Participants will be randomized into two groups:

1. ACP education consisting of

   * a brief social work screening,
   * an educational pamphlet,
   * advance directive forms (in English and Spanish), and
   * community resource materials (i.e., handout); and
2. ACP education plus counseling consisting of

   * motivational interviewing
   * decisional support, and
   * patient navigation to address barriers We anticipate that ACP-I Plan will be feasibly and acceptable. Participants who receive ACP-I Plan will show 1) greater likelihood of documenting an AD, 2) greater importance of and concern for engaging in ACP communication with family members and providers, and 3) reduced distress at 4-week post intervention.

Eligibility criteria: Inclusion Criteria:

* 50 years old or older
* Latino/Latina or Hispanic?
* Have 1 or more chronic health conditions

Exclusion Criteria:

* Schizophrenia
* Schizoaffective Disorder
* Dementia
* Alzheimer's disease

Primary outcomes:
measure: Intervention Feasibility
timeFrame: 12 months
measure: Satisfaction with intervention
timeFrame: 1 month
measure: Retention and Attrition Rates
timeFrame: 12 months
Secondary outcomes:
measure: Completion Rates
timeFrame: 1 month
measure: Communication Readiness Provider
timeFrame: 1 month
measure: Communication Readiness Family
timeFrame: 1 month
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: San Diego State University
name: Ayala, PhD
role: PRINCIPAL_INVESTIGATOR
References: