Advance Care Planning for Older Latinos With Chronic Illness

NCT ID: NCT06081660

Last Updated: 2023-10-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-14

Study Completion Date

2023-04-16

Brief Summary

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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

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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.

Conditions

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Patient Engagement End of Life Chronic Disease Communication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

2 x 2 mixed factorial design, pre-test/posttest variables to examine impact on ACP
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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ACP education

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)

Group Type ACTIVE_COMPARATOR

ACP-I Plan

Intervention Type BEHAVIORAL

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

ACP education plus counseling

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

Group Type EXPERIMENTAL

ACP-I Plan

Intervention Type BEHAVIORAL

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

Interventions

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ACP-I Plan

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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San Diego State University

OTHER

Sponsor Role lead

Responsible Party

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Frances Nedjat-Haiem

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ayala, PhD

Role: PRINCIPAL_INVESTIGATOR

San Diego State University

Locations

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San Diego State University

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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HS-2020-0175

Identifier Type: -

Identifier Source: org_study_id

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