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Completed

NCT Number: NCT06081660

Advance Care Planning for Older Latinos With Chronic Illness

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.

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Key information

Conditions

Patient Engagement Behavior Chronic Disease Communication Death Disease Attributes End of Life Health Behavior Pathologic Processes Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Participation Treatment Adherence and Compliance

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

San Diego State University

San Diego, California, 92182, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ACP-I Plan

Behavioral

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

Primary outcomes

  1. Intervention Feasibility

    Time frame: 12 months

    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.

  2. Satisfaction with intervention

    Time frame: 1 month

    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.

  3. Retention and Attrition Rates

    Time frame: 12 months

    Feasibility of recruitment and retention

Secondary outcomes

  1. Completion Rates

    Time frame: 1 month

    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.

  2. Communication Readiness Provider

    Time frame: 1 month

    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.

  3. Communication Readiness Family

    Time frame: 1 month

    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?

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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