Preparing Family Caregivers to Make Medical Decisions for Their Loved Ones

Penn State Health

Status: Completed

Conditions: Kidney Diseases; Lung Diseases; Neoplasms; Heart Failure

Treatments: Behavioral: Standard advance care planning; Behavioral: Making Your Wishes Known

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02429479

1R01NR012757-01A1 (U.S. NIH Grant/Contract)

37476

Details and patient eligibility

About

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.

Full 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).

Enrollment: 285 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18 years of age or older
2. 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).
3. 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)
4. Neuro-cognitively able to engage in ACP (Mini Mental State Exam (MMSE) score >23)
5. 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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285 participants in 4 patient groups

Standard ACP/Patient Alone

Active Comparator group

Description:

Patients (without their family caregiver) complete a standard living will form online.

Treatment:

Behavioral: Standard advance care planning

Decision Aid/Patient Alone

Experimental group

Description:

Patients (without their family caregiver) complete Making Your Wishes Known, an online decision aid for advance care planning.

Treatment:

Behavioral: Making Your Wishes Known

Standard ACP/Together

Active Comparator group

Description:

Patients and their family caregiver together complete a standard living will form online.

Treatment:

Behavioral: Standard advance care planning

Decision Aid/Together

Experimental group

Description:

Patients and their family caregiver together complete Making Your Wishes Known, an online decision aid for advance care planning.

Treatment:

Behavioral: Making Your Wishes Known