Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2026-03-01 @ 1:26 PM
Study NCT ID:
NCT02898194
Status:
COMPLETED
Last Update Posted:
2024-10-29
First Post:
2016-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Focus Groups to Determine Surrogates Views Regarding Patient Preference Predictors
Sponsor:
National Institutes of Health Clinical Center (CC)
Organization:
Study Overview
Official Title:
Focus Groups to Determine Surrogates' Views Regarding Patient Preference Predictors
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 16-CC-0168 | None | None | View |