Focus Groups to Determine Surrogates Views Regarding Patient Preference Predictors

NCT02898194 | Completed

• 2 other identifiers: 16016816-CC-0168
• Study Type: observational
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Normal Physiology

Keywords

Surrogate Decision-making; Health Care; Medical Decisions; End of Life Care; Natural History

Outcome Measures

Primary Outcomes (1)

• Views of participants on PPP

  Level of acceptance regarding Patient Preference Predictor (PPP)

  Prior to, during, and immediately following the focus group session

Secondary Outcomes (1)

• Views of Participants on PPP as patients

  Prior to, during, and immediately following the focus group

Study Arms (1)

1/Patient Surrogates

Any eligible participant who have acted as a surrogate medical decision-maker.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead

Study Sites (2)

St. Elizabeths Hospital

Washington D.C., District of Columbia, 20032, United States

Location

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 17388655 BACKGROUND

• 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.

  PMID: 24526785 BACKGROUND

• 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.

  PMID: 25273677 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Study Officials

• David Wendler, Ph.D.

  National Institutes of Health Clinical Center (CC)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2016
• First Posted: September 13, 2016
• Study Start: December 31, 2018
• Primary Completion: February 20, 2020
• Study Completion: July 21, 2020
• Last Updated: October 29, 2024

Record last verified: 2024-10

Locations

US (2)