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Protocol Details

Focus Groups to Determine Surrogates' Views Regarding Patient Preference Predictors

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

16-CC-0168

Sponsoring Institute

National Institutes of Health Clinical Center (CC)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18
Max Age: 90

Referral Letter Required

Yes

Population Exclusion(s)

Non-English Speaking;
Children

Keywords

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

Recruitment Keyword(s)

None

Condition(s)

Normal Physiology

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

NIH Clinical Center

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.

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Eligibility

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


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Citations:

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.

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.

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Contacts:

Principal Investigator

Referral Contact

For more information:

David Wendler, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 10C118
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8726
dwendler@mail.cc.nih.gov

David Wendler, Ph.D.
National Institutes of Health Clinical Center (CC)
National Institutes of Health
Building 10
Room 10C118
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8726
dwendler@mail.cc.nih.gov

David Wendler, Ph.D.
National Institutes of Health
Building 10
Room 10C118
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8726
dwendler@mail.cc.nih.gov

Clinical Trials Number:

NCT02898194

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