Focus Groups to Determine Surrogates Views Regarding Patient Preference Predictors

Focus Groups to Determine Surrogates' Views Regarding Patient Preference Predictors

Background:

Some people cannot make medical treatment decisions on their own. The people who make decisions on their behalf are called medical surrogates. Sometimes surrogates cannot predict which treatment course the person or their loved ones would have chosen. The surrogates often become distressed because of making these decisions. Researchers think a tool called a Patient Preference Predictor (PPP) may be able to make the process easier. The PPP would predict what treatment the person would want. This is based on treatment preferences of similar people in a similar circumstance. Researchers want to interview surrogates to explore their views on the PPP.

Objective:

To explore surrogates views on incorporating a PPP into shared medical decision-making.

Eligibility:

People 18 years or older who:

Have acted as a surrogate medical decision-maker within the past 3 years. This includes decisions about

treatment, medication, hospice care, hospital admission, or discharge.

Are not pregnant

Design:

Participants will be screened by meeting with clinicians in person or by phone to discuss the study.

Participants will take part in a focus group. This is a small group of people discussing their thoughts and opinions. This will last for about 2 hours.

Participants will be served a light meal.

Participants will provide information about themselves and their views. They will talk about their past experiences making medical decisions for someone. They will discuss how they felt about these decisions.

The PPP will be explained to participants. They will give their views on it.

The research team will audio record the focus group and take notes.

Participants will fill out questionnaires.

Study Overview

• Status: Completed
• Conditions: Normal Physiology

Detailed Description

Current clinical practice relies on shared decision-making between clinicians and surrogates to make treatment decisions for patients who cannot decide on their own. This decision-making process is meant to promote medical care that accords with the patient s own preferences and values. However, empirical data suggest that this model faces two significant challenges. First, both surrogates and clinicians have trouble predicting which treatment course patients would have chosen. Second, given the nature of the decisions, surrogates often experience significant emotional distress as a result of making treatment decisions. To address these concerns it has been suggested that the shared decision-making process might be supplemented with a Patient Preference Predictor (PPP). A PPP would provide a prediction of which treatment a given patient would want based on the treatment preferences of similar patients in similar circumstances. The present study proposes to interview surrogates who have been involved in making decisions for an incapacitated patient to explore their perspectives on the PPP and how to incorporate it into medical decision-making for incapacitated patients..

• Study Type: Observational
• Enrollment (Actual): 27

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20032
      • St. Elizabeths Hospital
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • National Institutes of Health Clinical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Any individual who acted as a surrogate decision maker for individuals undergoing any treatment.

Description

• INCLUSION CRITERIA:
• 18 years or older
• Experience making at least one medical decision on behalf of an incompetent patient within the past 3 years. A medical decision for the purposes of this study is defined as making a decision in a context in which there was more than 1 feasible or reasonable option.
• Ability to provide informed consent

EXCLUSION CRITERIA:

• Inability to speak, understand, or read English
• The patient on behalf of whom the individual acted as surrogate is deceased for less than two months.
• In the view of the referring clinician, participation in the study is deemed excessively burdensome.
• Candidate for study is pregnant
• Court appointed surrogate

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1/Patient Surrogates; Any eligible participant who have acted as a surrogate medical decision-maker.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Views of participants on PPP	Level of acceptance regarding Patient Preference Predictor (PPP)	Prior to, during, and immediately following the focus group session

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Views of Participants on PPP as patients	Level of acceptance regarding PPP	Prior to, during, and immediately following the focus group

Collaborators and Investigators

• Sponsor: National Institutes of Health Clinical Center (CC)
• Investigators: Principal Investigator: David Wendler, Ph.D., National Institutes of Health Clinical Center (CC)

Publications and helpful links

General Publications

• Shalowitz DI, Garrett-Mayer E, Wendler D. How should treatment decisions be made for incapacitated patients, and why? PLoS Med. 2007 Mar;4(3):e35. doi: 10.1371/journal.pmed.0040035. No abstract available.
• Rid A, Wendler D. Use of a patient preference predictor to help make medical decisions for incapacitated patients. J Med Philos. 2014 Apr;39(2):104-29. doi: 10.1093/jmp/jhu001. Epub 2014 Feb 13.
• Rid A, Wesley R, Pavlick M, Maynard S, Roth K, Wendler D. Patients' priorities for treatment decision making during periods of incapacity: quantitative survey. Palliat Support Care. 2015 Oct;13(5):1165-83. doi: 10.1017/S1478951514001096. Epub 2014 Oct 2.

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): February 20, 2020
• Study Completion (Actual): July 21, 2020

Study Registration Dates

• First Submitted: September 10, 2016
• First Submitted That Met QC Criteria: September 10, 2016
• First Posted (Estimated): September 13, 2016

Study Record Updates

• Last Update Posted (Actual): October 29, 2024
• Last Update Submitted That Met QC Criteria: October 25, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Natural History; Health Care; End of Life Care; Surrogate Decision-making; Medical Decisions
• Other Study ID Numbers: 160168; 16-CC-0168

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No