Normal PhysiologyNCT02898194
Focus Groups to Determine Surrogates Views Regarding Patient Preference Predictors
An observational study of Normal Physiology, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Normal Physiology
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 31 Dec 2018to 21 Jul 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any individual who acted as a surrogate decision maker for individuals undergoing any treatment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
St. Elizabeths Hospital
Washington D.C., District of Columbia, 20032
About this study
Official title: 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.
Read more
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.
Read the 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..
- Conditions
- Normal Physiology
- Keywords
- Surrogate Decision-making, Health Care, Medical Decisions, End of Life Care, Natural History
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1/Patient Surrogates | Any eligible participant who have acted as a surrogate medical decision-maker. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Views of participants on PPP
Level of acceptance regarding Patient Preference Predictor (PPP)
Measured: Prior to, during, and immediately following the focus group session
Secondary outcomes (1)
Views of Participants on PPP as patients
Level of acceptance regarding PPP
Measured: Prior to, during, and immediately following the focus group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start31 Dec 2018
- Primary completion20 Feb 2020
- Study completion21 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Normal PhysiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- David Wendler, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02898194
- Sponsor's protocol ID
- 160168
- Other IDs
- 16-CC-0168
- Status last verified
- Oct 2024
- First submitted
- 10 Sep 2016
- Last updated
- 29 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 17388655Rid 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.
PubMed 24526785Rid 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.
PubMed 25273677
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus Groups to Determine Surrogates' Views Regarding Patient Preference Predictors
- ClinicalTrials.gov ID
- NCT02898194
- Acronym / sponsor ID
- 160168
- Conditions
- Normal Physiology
- Keywords
- Surrogate Decision-making, Health Care, Medical Decisions, End of Life Care, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 20 Feb 2020 (actual)
- Study completion
- 21 Jul 2020 (actual)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/Patient Surrogates | – | –Any eligible participant who have acted as a surrogate medical decision-maker. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any individual who acted as a surrogate decision maker for individuals undergoing any treatment.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Views of participants on PPP
Time frame: Prior to, during, and immediately following the focus group session
Level of acceptance regarding Patient Preference Predictor (PPP)
1 secondary outcome
Views of Participants on PPP as patients
Time frame: Prior to, during, and immediately following the focus group
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Background: PubMed 17388655Shalowitz 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.
- Background: PubMed 24526785Rid 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.
- Background: PubMed 25273677Rid 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Wendler, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Physiology, run by National Institutes of Health Clinical Center (CC) at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Views of participants on PPP (time frame: Prior to, during, and immediately following the focus group session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02898194, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2024.