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Advance Care Planning for Older Latinos With Chronic Illness

Primary Purpose

Patient Engagement, End of Life, Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACP-I Plan
Sponsored by
San Diego State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Patient Engagement focused on measuring Latino, Advance Care Planning, Advance Directive

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • San Diego State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

ACP education

ACP education plus counseling

Arm Description

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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Completion Rates
Self report yes/no completed an advance directive document. We use the method that Douglas & Brown (2002) used ask about completion of advance directives at 2 points, baseline and 1-month follow-up. Questions have yes/no [Y/N], responses. Reference Douglas R, Brown HN. Patients' attitudes toward advance directives. Journal of Nursing Scholarship. 2002;34(1):61-65. We also use the Advance Directive Attitude Survey (ADAS) by Nolan has 16 items and asks questions (uses a 4-point Likert scale, Strongly Agree to Strongly Disagree with AD decision making). Sixteen questions are subscales and ask about: (a) opportunity for treatment choices, (b) effect of advance directives on the family, (c) effect of an AD on treatment, and (d) perception of illness. Nolan MT, Bruder M. Patients' attitudes toward advance directives and end-of-life treatment decisions. Nursing outlook. 1997;45(5):204-208.
Communication Readiness Provider
Barriers to ACP communication and readiness to talk with provider. We use a barrier scale developed to identify Barriers to Communication about Advance Care Planning (Nedjat-Haiem, 2022) which has 19 questions and uses a scale from 0 to 4, asking how much of a concern is this for you? Readiness to engage in communication about ACP will be assessed by three yes/no questions that ask about: (1) fear of death and dying, (2) difficulty engaging in EOL care communication, and (3) worry about illness severity. We also use a readiness scale (1-10) which asks: how ready are you to engage in ACP communication with your physician.
Communication Readiness Family
Self Report yes/no - Readiness to talk with a family member We also use one question to ask about about readiness using a scale (1-10) which asks: how ready are you to engage in ACP communication with your family member?

Full Information

First Posted
November 21, 2022
Last Updated
October 7, 2023
Sponsor
San Diego State University
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1. Study Identification

Unique Protocol Identification Number
NCT06081660
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 14, 2022 (Actual)
Primary Completion Date
April 16, 2023 (Actual)
Study Completion Date
April 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
San Diego State University

4. Oversight

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

5. Study Description

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: 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 To evaluate implementation of ACP-I Plan in a community setting and examine further need for adaption. Participants will be randomized into two groups: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patient Engagement, End of Life, Chronic Disease, Communication
Keywords
Latino, Advance Care Planning, Advance Directive

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Model Description
2 x 2 mixed factorial design, pre-test/posttest variables to examine impact on ACP
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ACP education
Arm Type
Active Comparator
Arm Description
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)
Arm Title
ACP education plus counseling
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
ACP-I Plan
Intervention Description
ACP-I Plan consisting of education, counseling, decisional support, and patient navigation
Primary Outcome Measure Information:
Title
Intervention Feasibility
Description
Feasibility We use benchmarks for feasibility. Number of Participants Recruited, and screening no more than 100 participants, tracking numbers of participants consented into the study, percent refused to participate and dropout, amount of time to screen participants and complete a baseline survey once consented into the study, ACP-I Plan intervention delivered for the first session <2 weeks from their recruitment and randomization date and second session <4 weeks from recruitment, identify missing data. Track the number of participants who indicate they returned a completed AD to their provider and/or talked with a family member regarding ACP.
Time Frame
12 months
Title
Satisfaction with intervention
Description
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.
Time Frame
1 month
Title
Retention and Attrition Rates
Description
Feasibility of recruitment and retention
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Completion Rates
Description
Self report yes/no completed an advance directive document. We use the method that Douglas & Brown (2002) used ask about completion of advance directives at 2 points, baseline and 1-month follow-up. Questions have yes/no [Y/N], responses. Reference Douglas R, Brown HN. Patients' attitudes toward advance directives. Journal of Nursing Scholarship. 2002;34(1):61-65. We also use the Advance Directive Attitude Survey (ADAS) by Nolan has 16 items and asks questions (uses a 4-point Likert scale, Strongly Agree to Strongly Disagree with AD decision making). Sixteen questions are subscales and ask about: (a) opportunity for treatment choices, (b) effect of advance directives on the family, (c) effect of an AD on treatment, and (d) perception of illness. Nolan MT, Bruder M. Patients' attitudes toward advance directives and end-of-life treatment decisions. Nursing outlook. 1997;45(5):204-208.
Time Frame
1 month
Title
Communication Readiness Provider
Description
Barriers to ACP communication and readiness to talk with provider. We use a barrier scale developed to identify Barriers to Communication about Advance Care Planning (Nedjat-Haiem, 2022) which has 19 questions and uses a scale from 0 to 4, asking how much of a concern is this for you? Readiness to engage in communication about ACP will be assessed by three yes/no questions that ask about: (1) fear of death and dying, (2) difficulty engaging in EOL care communication, and (3) worry about illness severity. We also use a readiness scale (1-10) which asks: how ready are you to engage in ACP communication with your physician.
Time Frame
1 month
Title
Communication Readiness Family
Description
Self Report yes/no - Readiness to talk with a family member We also use one question to ask about about readiness using a scale (1-10) which asks: how ready are you to engage in ACP communication with your family member?
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayala, PhD
Organizational Affiliation
San Diego State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
San Diego State University
City
San Diego
State/Province
California
ZIP/Postal Code
92182
Country
United States

12. IPD Sharing Statement

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Advance Care Planning for Older Latinos With Chronic Illness

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