Healthy VolunteersNCT07751731
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
An observational study of Healthy Volunteers, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: About 180,000 of the people in US prisons are over 55 years old. Aging people often cannot make medical decisions on their own. People who cannot make their own decisions must rely on a "surrogate." A surrogate is someone who helps the person's doctor make decisions for them. Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Survey
- Type of treatment
- Pill or oral medicine
- How many people
- 75,000 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Nov 2026to 28 Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults who are currently incarcerated in the United States
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Currently incarcerated in a United States facility with Edovo educational tablets
- Ability to understand the consent form and survey
- Willingness to give informed consent
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1. Inability to read or write in English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
David Wendler, Ph.D., 301-496-2429, dwendler@mail.cc.nih.gov
About this study
Official title: Survey to Determine Incarcerated Persons Views on Surrogate Decision-Making
Background:
About 180,000 of the people in US prisons are over 55 years old. Aging people often cannot make medical decisions on their own. People who cannot make their own decisions must rely on a "surrogate." A surrogate is someone who helps the person's doctor make decisions for them. Researchers want to conduct a survey to ask people in prison who they would like to be their surrogates. But first, they need to find out if their survey questions are clear and easy to understand.
Read more
Objective:
To get imprisoned people's feedback on survey questions about surrogate decision making.
Eligibility:
People currently imprisoned in a US facility with access to Edovo. They must be able to read and write in English.
Design:
Participants will answer 26 survey questions. The questions will be on the Edovo Learn software platform. After each question, they will be asked: "Was this question clear? If not, please explain in the box below what you found unclear. Also, if you have any suggestions for how we might make the question clearer, please include them."
Participants will be asked to imagine themselves in a situation where they cannot make their own medical decisions. They may skip questions or stop the survey if they want. No information that identifies them will be collected.
The survey will take about 15 minutes.
Read the detailed description
Study Description:
Currently, different states have different practices for surrogate decision-making for incarcerated persons who are not able to make their own decisions. These differences raise the challenge of determining which approach or approaches are the best. To address this issue, our research team has developed a questionnaire for incarcerated persons. This questionnaire will be integrated into a software application known as Edovo (https://www.edovo.org/), which is tailored for use in correctional facilities. This research aims to gather incarcerated persons" preferences related to surrogate decision-making. The study team hopes to identify best practices that could inform practices and policies across states, ultimately enhancing the support provided to this vulnerable population.
Objectives:
Primary Objective:
Explore incarcerated persons' views regarding surrogate decision-making if they become unable to make their own medical decisions.
Endpoints:
Primary Endpoints:
- Describe incarcerated persons' preferences for surrogate decisionmakers if they become unable to make their own medical decisions.
- The proportion of incarcerated persons who endorse the use of a patient preference predictor (PPP) for surrogate decision-making if they become unable to make their own medical decisions.
Secondary Endpoint:
The discrepancy between incarcerated persons who endorse the use of a PPP in general, but not for their own treatment.
- Conditions
- Healthy Volunteers
- Being tested
- Survey
- Keywords
- Incarcerated, Surrogate, Survey
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Tablet based survey
| Study group | Role | What they receive |
|---|---|---|
| Incarcerated adults | Adults who are incarcerated in the United States Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Views on surrogates
Incarcerated persons preferences for surrogate decision-makers if they become unable to make their own medical decisions.
Measured: end of study
Views on PPP
Proportion of incarcerated persons who endorse the use of a PPP for medical decision-making for incarcerated persons who become unable to make their own medical decisions.
Measured: end of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2026
- Study start11 Nov 2026 (estimated)
- Primary completion29 Dec 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 75,000 participants (estimated)
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
- NCT07751731
- Sponsor's protocol ID
- 10002491
- Other IDs
- 002491-CC
- Status last verified
- 4 Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be collected.
Publications
Batbold S, Duke JD, Riggan KA, DeMartino ES. Decision-Making for Hospitalized Incarcerated Patients Lacking Decisional Capacity. JAMA Intern Med. 2024 Jan 1;184(1):28-35. doi: 10.1001/jamainternmed.2023.5794.
PubMed 38048093Helmly V, Garica M, Williams B, Howell BA. A review and content analysis of U.S. Department of Corrections end-of-life decision making policies. Int J Prison Health. 2022 Jun 2;18(2):165-175. doi: 10.1108/IJPH-06-2021-0060. Epub 2021 Dec 27.
PubMed 34939768Earp BD, Porsdam Mann S, Allen J, Salloch S, Suren V, Jongsma K, Braun M, Wilkinson D, Sinnott-Armstrong W, Rid A, Wendler D, Savulescu J. A Personalized Patient Preference Predictor for Substituted Judgments in Healthcare: Technically Feasible and Ethically Desirable. Am J Bioeth. 2024 Jul;24(7):13-26. doi: 10.1080/15265161.2023.2296402. Epub 2024 Jan 16.
PubMed 38226965Pope TM. Making medical decisions for patients without surrogates. N Engl J Med. 2013 Nov 21;369(21):1976-8. doi: 10.1056/NEJMp1308197. No abstract available.
PubMed 24256375
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survey to Determine Incarcerated Persons Views on Surrogate Decision-Making
- ClinicalTrials.gov ID
- NCT07751731
- Acronym / sponsor ID
- 10002491
- Conditions
- Healthy Volunteers
- Keywords
- Incarcerated, Surrogate, Survey
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75,000 participants (estimated)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 11 Nov 2026 (estimated)
- Primary completion
- 29 Dec 2026 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 7 Aug 2026 (actual)
- 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:
About 180,000 of the people in US prisons are over 55 years old. Aging people often cannot make medical decisions on their own. People who cannot make their own decisions must rely on a "surrogate." A surrogate is someone who helps the person's doctor make decisions for them. Researchers want to conduct a survey to ask people in prison who they would like to be their surrogates. But first, they need to find out if their survey questions are clear and easy to understand.
Objective:
To get imprisoned people's feedback on survey questions about surrogate decision making.
Eligibility:
People currently imprisoned in a US facility with access to Edovo. They must be able to read and write in English.
Design:
Participants will answer 26 survey questions. The questions will be on the Edovo Learn software platform. After each question, they will be asked: "Was this question clear? If not, please explain in the box below what you found unclear. Also, if you have any suggestions for how we might make the question clearer, please include them."
Participants will be asked to imagine themselves in a situation where they cannot make their own medical decisions. They may skip questions or stop the survey if they want. No information that identifies them will be collected.
The survey will take about 15 minutes.
Detailed description
Study Description:
Currently, different states have different practices for surrogate decision-making for incarcerated persons who are not able to make their own decisions. These differences raise the challenge of determining which approach or approaches are the best. To address this issue, our research team has developed a questionnaire for incarcerated persons. This questionnaire will be integrated into a software application known as Edovo (https://www.edovo.org/), which is tailored for use in correctional facilities. This research aims to gather incarcerated persons" preferences related to surrogate decision-making. The study team hopes to identify best practices that could inform practices and policies across states, ultimately enhancing the support provided to this vulnerable population.
Objectives:
Primary Objective:
Explore incarcerated persons' views regarding surrogate decision-making if they become unable to make their own medical decisions.
Endpoints:
Primary Endpoints:
- Describe incarcerated persons' preferences for surrogate decisionmakers if they become unable to make their own medical decisions.
- The proportion of incarcerated persons who endorse the use of a patient preference predictor (PPP) for surrogate decision-making if they become unable to make their own medical decisions.
Secondary Endpoint:
The discrepancy between incarcerated persons who endorse the use of a PPP in general, but not for their own treatment.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Incarcerated adults | – | Other: SurveyAdults who are incarcerated in the United States |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults who are currently incarcerated in the United States
Key inclusion criteria (4 listed)
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Currently incarcerated in a United States facility with Edovo educational tablets
- Ability to understand the consent form and survey
- Willingness to give informed consent
Key exclusion criteria (2 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 1. Inability to read or write in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SurveyTablet based survey | Other | Incarcerated adults |
Primary outcome
Views on surrogates
Time frame: end of study
Incarcerated persons preferences for surrogate decision-makers if they become unable to make their own medical decisions.
Views on PPP
Time frame: end of study
Proportion of incarcerated persons who endorse the use of a PPP for medical decision-making for incarcerated persons who become unable to make their own medical decisions.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 38048093Batbold S, Duke JD, Riggan KA, DeMartino ES. Decision-Making for Hospitalized Incarcerated Patients Lacking Decisional Capacity. JAMA Intern Med. 2024 Jan 1;184(1):28-35. doi: 10.1001/jamainternmed.2023.5794.
- Background: PubMed 34939768Helmly V, Garica M, Williams B, Howell BA. A review and content analysis of U.S. Department of Corrections end-of-life decision making policies. Int J Prison Health. 2022 Jun 2;18(2):165-175. doi: 10.1108/IJPH-06-2021-0060. Epub 2021 Dec 27.
- Background: PubMed 38226965Earp BD, Porsdam Mann S, Allen J, Salloch S, Suren V, Jongsma K, Braun M, Wilkinson D, Sinnott-Armstrong W, Rid A, Wendler D, Savulescu J. A Personalized Patient Preference Predictor for Substituted Judgments in Healthcare: Technically Feasible and Ethically Desirable. Am J Bioeth. 2024 Jul;24(7):13-26. doi: 10.1080/15265161.2023.2296402. Epub 2024 Jan 16.
- Background: PubMed 24256375Pope TM. Making medical decisions for patients without surrogates. N Engl J Med. 2013 Nov 21;369(21):1976-8. doi: 10.1056/NEJMp1308197. No abstract available.
- Individual participant dataSharing planned: No. No individual participant data will be collected.
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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.
David Wendler, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by National Institutes of Health Clinical Center (CC) at 1 site 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 4 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Wendler, Ph.D. ((301) 496-2429, dwendler@mail.cc.nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Views on surrogates (time frame: end of study). The study lists 2 primary outcomes in all. 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 NCT07751731, which also lists 4 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 6 Nov 2026.