Clinical trial NCT02429479: Preparing Family Caregivers to Make Medical Decisions for Their Loved Ones
Official title: Preparing Family Caregivers of Very Ill Patients for End-of-Life Decision Making
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Heart Failure
Kidney Diseases
Lung Diseases
Keywords: Advance Care Planning
Living Will
Family Caregiver
Advance Directive
Surrogate Decision Maker
Proxy
Self-Efficacy
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Brigham and Women's Hospital
First posted: 2015-04-29
Enrollment: 285
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Self-efficacy
timeFrame: 6 weeks
Secondary outcomes:
measure: Accuracy of medical decisions
timeFrame: 6 weeks
measure: Family caregivers' stress associated with actual (i.e., real-life) surrogate decision-making
timeFrame: 1-2 years
measure: Family caregiver knowledge
timeFrame: 6 weeks - 2 years
measure: Depth of communication
timeFrame: 2 years
measure: Satisfaction with advance care planning
timeFrame: 1st study visit
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham & Women's Hospital
state: Massachusetts
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center / Penn State College of Medicine
state: Pennsylvania
Study officials:
affiliation: Penn State Milton S. Hershey Medical Center / Penn State College of Medicine
name: Benjamin H Levi, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Penn State Milton S. Hershey Medical Center / Penn State College of Medicine
name: Michael J Green, MD MS
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thiede E, Levi BH, Lipnick D, Johnson R, Seo La I, Lehman EB, Smith T, Wiegand D, Green M, Van Scoy LJ. Effect of Advance Care Planning on Surrogate Decision Makers' Preparedness for Decision Making: Results of a Mixed-Methods Randomized Controlled Trial. J Palliat Med. 2021 Jul;24(7):982-993. doi: 10.1089/jpm.2020.0238. Epub 2020 Dec 29.
citation: Lipnick D, Green M, Thiede E, Smith TJ, Lehman EB, Johnson R, La IS, Wiegand D, Levi BH, Van Scoy LJ. Surrogate Decision Maker Stress in Advance Care Planning Conversations: A Mixed-Methods Analysis From a Randomized Controlled Trial. J Pain Symptom Manage. 2020 Dec;60(6):1117-1126. doi: 10.1016/j.jpainsymman.2020.07.001. Epub 2020 Jul 6.
citation: Foy AJ, Levi BH, Van Scoy LJ, Bucher A, Dimmock A, Green MJ. Patient Preference to Accept Medical Treatment Is Associated with Spokesperson Agreement. Ann Am Thorac Soc. 2019 Apr;16(4):518-521. doi: 10.1513/AnnalsATS.201806-428RL. No abstract available.