CompletedNot Applicable

Focus Groups to Determine Surrogates Views Regarding Patient Preference Predictors

United States27 participantsStarted 2018-12-31

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

* 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Views of participants on PPP

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

Trial details

NCT IDNCT02898194

SponsorNational Institutes of Health Clinical Center (CC)

Sponsor typeNIH

Study typeOBSERVATIONAL

Primary completion2020-02-20

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