Advance Care Planning for Older Latinos With Chronic Illness

NCT06081660 | Completed

• 1 other identifier: HS-2020-0175
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Patient Engagement; End of Life; Chronic Disease; Communication

Keywords

Latino; Advance Care Planning; Advance Directive

Outcome Measures

Primary Outcomes (3)

• Intervention Feasibility

  Feasibility We use benchmarks for feasibility. 1. Number of Participants Recruited, and screening no more than 100 participants, 2. tracking numbers of participants consented into the study, 3. percent refused to participate and dropout, amount of time to screen participants and complete a baseline survey once consented into the study, 4. ACP-I Plan intervention delivered for the first session \<2 weeks from their recruitment and randomization date and second session \<4 weeks from recruitment, 5. identify missing data. 6. Track the number of participants who indicate they returned a completed AD to their provider and/or talked with a family member regarding ACP.

  12 months

• Satisfaction with intervention

  Acceptability of the intervention Satisfaction survey questions includes 14 questions using "I" statements and a 5-point Likert scale: Strongly Disagree to Strongly Agree). Improved scores at follow up indicate satisfaction of information delivery. Reference Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJJJopm. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. 2009;12(4):363-372.

  1 month

• Retention and Attrition Rates

  Feasibility of recruitment and retention

  12 months

Secondary Outcomes (3)

• Completion Rates

  1 month

• Communication Readiness Provider

  1 month

• Communication Readiness Family

  1 month

Study Arms (2)

ACP education

ACTIVE COMPARATOR

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)

Behavioral: ACP-I Plan

ACP education plus counseling

EXPERIMENTAL

ACP education plus counseling consisting of * a brief social work screening, * an educational pamphlet, * advance directive forms (in English and Spanish), and * community resource materials (i.e., handout); * motivational interviewing * decisional support, and * patient navigation to address barriers

Behavioral: ACP-I Plan

Interventions

ACP-I Plan BEHAVIORAL

ACP-I Plan consisting of education, counseling, decisional support, and patient navigation

ACP education; ACP education plus counseling

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

San Diego State University

San Diego, California, 92182, United States

Location

MeSH Terms

Conditions

Patient Participation; Death; Chronic Disease; Communication

Condition Hierarchy (Ancestors)

Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Officials

• Ayala, PhD

  San Diego State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 2 x 2 mixed factorial design, pre-test/posttest variables to examine impact on ACP

Study Record Dates

• First Submitted: November 21, 2022
• First Posted: October 13, 2023
• Study Start: September 14, 2022
• Primary Completion: April 16, 2023
• Study Completion: April 16, 2023
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

US (1)