Preparing Family Caregivers to Make Medical Decisions for Their Loved Ones

Study Overview
=================
Brief Summary
-----------------
The overarching goal of the project is to improve the process and experience of surrogate decision-making by family caregivers. Since feeling unprepared to make surrogate decisions is a major contributor to caregiver stress, the primary outcome is caregiver self-efficacy --i.e., caregivers' assessment of how well prepared they feel to serve effectively as a surrogate decision-maker. Through follow-on Renewal funding, we are now also qualitatively examining family caregivers' experience with surrogate decision-making.

Detailed Description
-----------------
The long-term goal is to help family caregivers of seriously ill patients be better prepared to serve as surrogate decision-makers when their loved ones can no longer make medical decisions for themselves. Research shows that family caregivers find surrogate decision-making highly stressful and emotionally burdensome, in part because they feel unprepared for surrogate decision-making. To date, no studies have determined which advance care planning (ACP) process best prepares caregivers for this role. The investigators' prior work shows that a computer-based decision aid can help patients make more informed decisions and communicate their wishes more effectively. The investigators now propose to determine if family caregivers of patients with life-threatening illnesses are better prepared for surrogate decision-making: 1) when they engage in a structured ACP process together with patients; and 2) when they use this online decision aid for ACP. This will be accomplished via a randomized, controlled trial with a 2 x 2 factorial design comprising 4 groups: Standard ACP/Patient Alone (Group 1), Decision Aid/Patient Alone (Group 2), Standard ACP/Patients and Caregivers Together (Group 3), and Decision Aid/Patients and Caregivers Together (Group 4).

Official Title
-----------------
Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making

Conditions
-----------------
Neoplasms, Heart Failure, Kidney Diseases, Lung Diseases

Intervention / Treatment
-----------------
* Behavioral: Making Your Wishes Known
* Behavioral: Standard advance care planning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Diagnosis of kidney disease (e.g. chronic kidney disease, end stage renal disease ) OR advanced cancer (Stage IV disease or having an estimated survival of <2 years) OR severe heart failure (e.g. New York Heart Assoc. Class III or Class IV) OR severe lung disease (e.g. Stage III or Stage IV COPD by modified GOLD Spirometric Classification, Idiopathic Pulmonary Fibrosis). Able to read and understand English at an 8th grade level (word 26 on either blue or tan version of the WRAT-3 reading subtest) Neuro-cognitively able to engage in ACP (Mini Mental State Exam (MMSE) score >23) No active suicidal ideations (i.e., score of 0 or 1 on item 9 of the BDI-II). Exclusion Criteria: Failure on any of the above inclusion criteria.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard ACP/Patient Alone<br>Patients (without their family caregiver) complete a standard living will form online. | Behavioral: Standard advance care planning<br>* This is a online simple living will form.<br>|
| Experimental: Decision Aid/Patient Alone<br>Patients (without their family caregiver) complete Making Your Wishes Known, an online decision aid for advance care planning. | Behavioral: Making Your Wishes Known<br>* Making Your Wishes Known provides tailored education, values clarification exercises, and a sophisticated decision aid that translates an individual's goals and preferences into a specific medical plan that can be implemented by a healthcare team.<br>|
| Active Comparator: Standard ACP/Together<br>Patients and their family caregiver together complete a standard living will form online. | Behavioral: Standard advance care planning<br>* This is a online simple living will form.<br>|
| Experimental: Decision Aid/Together<br>Patients and their family caregiver together complete Making Your Wishes Known, an online decision aid for advance care planning. | Behavioral: Making Your Wishes Known<br>* Making Your Wishes Known provides tailored education, values clarification exercises, and a sophisticated decision aid that translates an individual's goals and preferences into a specific medical plan that can be implemented by a healthcare team.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy | Family caregiver self-efficacy is measured using a validated questionnaire to determine if they feel better prepared to serve as surrogates for their loved one. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of medical decisions | Family caregiver responses to treatment decisions hypothetical clinical vignettes will be compared to the decisions for the same vignettes made by their loved one. Each vignette has 6-8 associated treatment decisions; the family caregiver's response for each item will be compared with the loved one's (i.e., patient's) response, and a total concordance (i.e., number of items for which there is agreement) will be calculated. | 6 weeks | 
| Family caregivers' stress associated with actual (i.e., real-life) surrogate decision-making | Using validated instruments and semi-structured interviews, family caregivers who have made a major medical decision on behalf of their loved one will report their level of distress, decisional conflict, satisfaction with decision, and experience with surrogate decision-making. | 1-2 years | 
| Family caregiver knowledge | Family caregivers will complete a questionnaire that assess their knowledge of surrogate responsibilities and end-of-life medical conditions and treatments | 6 weeks - 2 years | 
| Depth of communication | Family Caregivers are interviewed about the depth of communication with their loved one (frequency, content, helpfulness of discussions) regarding advance care planning issues. | 2 years | 
| Satisfaction with advance care planning | Participants who complete the advance care planning interventions fill out an evaluation of the intervention using a 16-item questionnaire. This instrument comprises: Twelve 5-point Likert-style questions on how the program presented various kinds of information; helped the user clarify values, choose a spokesperson, etc.; and helped the user document or be prepared communicate their wishes to others. Three 10-point Likert-style questions on user overall satisfaction, with the advance directive created by the intervention, and the amount of information provided. One open-ended item asking how the intervention was helpful. | 1st study visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advance Care Planning, Living Will, Family Caregiver, Advance Directive, Surrogate Decision Maker, Proxy, Self-Efficacy