Advance Care Planning for Older Latinos With Chronic Illness

Chronic Disease Clinical Trial

Official title:

Advance Care Planning for Older Latinos With Chronic Illness: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06081660
• Other study ID #: HS-2020-0175
• Status: Completed
• Phase: N/A
• Start date: September 14, 2022
• Est. completion date: April 16, 2023

Study information

• Verified date: October 2023
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 16, 2023
• Est. primary completion date: April 16, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Communication
• Death
• End of Life
• Patient Engagement

Intervention

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

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	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
Primary	Retention and Attrition Rates	Feasibility of recruitment and retention	12 months
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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?	1 month