NCT02429479

Preparing Family Caregivers to Make Medical Decisions for Their Loved Ones

Completed NA Last updated 26 January 2024

What this trial tests

NA trial testing Making Your Wishes Known in Neoplasms in 285 participants. Completed in 30 June 2021.

Timeline

1 June 2013

Primary endpoint
30 June 2017

30 June 2021

Quick facts

Lead sponsor	Milton S. Hershey Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	supportive care
Enrollment	285
Start date	1 June 2013
Primary completion	30 June 2017
Estimated completion	30 June 2021
Sites	2 locations across United States

Drugs / interventions tested

• Making Your Wishes Known
• Standard advance care planning

Conditions studied

• Neoplasms — all drugs for Neoplasms →
• Heart Failure — all drugs for Heart Failure →
• Kidney Diseases — all drugs for Kidney Diseases →
• Lung Diseases — all drugs for Lung Diseases →

Sponsor

Milton S. Hershey Medical Center

Who can join

18 and older, any sex, with Neoplasms or Heart Failure. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. A Randomized Controlled Trial of Strategies to Improve Family Members' Preparedness for Surrogate Decision-Making.
   Green MJ, Van Scoy LJ, Foy AJ, Stewart RR, et al · · 2018 · cited 37× · PMID 29186982 · DOI 10.1177/1049909117744554
2. Advance care planning for adults with heart failure.
   Nishikawa Y, Hiroyama N, Fukahori H, Ota E, et al · · 2020 · cited 30× · PMID 32104908 · DOI 10.1002/14651858.cd013022.pub2
3. Effect of Advance Care Planning on Surrogate Decision Makers' Preparedness for Decision Making: Results of a Mixed-Methods Randomized Controlled Trial.
   Thiede E, Levi BH, Lipnick D, Johnson R, et al · · 2021 · cited 14× · PMID 33373538 · DOI 10.1089/jpm.2020.0238
4. Surrogate Decision Maker Stress in Advance Care Planning Conversations: A Mixed-Methods Analysis From a Randomized Controlled Trial.
   Lipnick D, Green M, Thiede E, Smith TJ, et al · · 2020 · cited 14× · PMID 32645452 · DOI 10.1016/j.jpainsymman.2020.07.001
5. Family Caregivers' Characterization of Conversations Following an ACP Event.
   Schubart JR, Reading JM, Penrod J, Stewart RR, et al · · 2018 · cited 12× · PMID 30071784 · DOI 10.1177/1049909118760302
6. What Surrogates Understand (and Don't Understand) About Patients' Wishes After Engaging Advance Care Planning: A Qualitative Analysis.
   Simmons DB, Levi BH, Green MJ, La IS, et al · · 2022 · cited 7× · PMID 34164999 · DOI 10.1177/10499091211026674
7. Intrinsic Traits Such as Personality and Decision-Making Style are Predictive of Stress in Surrogate Decision-Makers.
   Van Scoy LJ, Bliton CF, Smith T, Badzek L, et al · · 2023 · cited 5× · PMID 36266775 · DOI 10.1177/10499091221135594
8. Conceptualization of Surrogate Decision-making Among Spokespersons for Chronically Ill Patients.
   Van Scoy LJ, Green MJ, Smith T, VanDyke E, et al · · 2022 · cited 4× · PMID 36480203 · DOI 10.1001/jamanetworkopen.2022.45608