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
- 28 Oct 2026to 28 Feb 2027
- Phase
- Observational
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 start28 Oct 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
- 23 Oct 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