ClinicalTrials.gg
RecruitingNCT07751731Updated Nov 10, 2026

Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making

An observational study in Healthy Volunteers, sponsored by National Institutes of Health Clinical Center (CC). Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Institutes of Health Clinical Center (CC) · Observational

Updated Nov 10, 2026Start date movedGo to Updates ↓
Study type
Observational
Model
Other
Time perspective
Cross-sectional
Enrollment
75,000
Ages
18 Years to 120 Years
Sex
All
01

Study 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. 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.

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:

  1. Describe incarcerated persons' preferences for surrogate decisionmakers if they become unable to make their own medical decisions.
  2. 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.

02

Conditions studied

  • Healthy Volunteers

Keywords

  • Incarcerated
  • Surrogate
  • Survey
03

In context

Lead sponsor

National Institutes of Health Clinical Center (CC) is the lead sponsor of 375 studies on the registry; 27 are open to participants now.

Of its 23 completed or terminated interventional studies of FDA-regulated products, 19 (83%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Adults who are currently incarcerated in the United States

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  1. Currently incarcerated in a United States facility with Edovo educational tablets
  2. Ability to understand the consent form and survey
  3. Willingness to give

Exclusion criteria

EXCLUSION CRITERIA:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Cross-sectional
Enrollment
75,000 participants (estimated)

Groups and cohorts

  • Incarcerated adults

    Adults who are incarcerated in the United States

    Other: Survey

Interventions

  • OtherSurvey

    Tablet based survey

06

What researchers measure

Primary outcomes

  1. Views on surrogates

    Incarcerated persons preferences for surrogate decision-makers if they become unable to make their own medical decisions.

    Time frame: end of study

  2. 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.

    Time frame: end of study

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
08

References and documents

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 38048093 ↗
  • Helmly 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 34939768 ↗
  • Earp 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 38226965 ↗
  • Pope 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 ↗

Individual participant data

Plan to share: No — No individual participant data will be collected.

09

Updates

32 registry updates since Sep 25, 2026
Start date
Sep 29, 2026→Nov 15, 2026
moved 32 times, Sep 25, 2026 – Nov 10, 2026
Show all 32 updates
  1. Nov 10, 2026
    Start date Nov 12, 2026→Nov 15, 2026
  2. Nov 9, 2026
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  3. Nov 6, 2026
    Start date Nov 10, 2026→Nov 11, 2026
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  8. Oct 30, 2026
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  9. Oct 29, 2026
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  10. Oct 28, 2026
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  11. Oct 27, 2026
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  19. Oct 15, 2026
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  21. Oct 13, 2026
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  22. Oct 9, 2026
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  23. Oct 8, 2026
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  24. Oct 7, 2026
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  25. Oct 6, 2026
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  26. Oct 5, 2026
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  27. Oct 2, 2026
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  28. Oct 1, 2026
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  29. Sep 30, 2026
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  30. Sep 29, 2026
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  31. Sep 28, 2026
    Start date Sep 30, 2026→Oct 1, 2026
  32. Sep 25, 2026
    Start date Sep 29, 2026→Sep 30, 2026

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07751731
Responsible party
Sponsor
First posted
Aug 7, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Dec 29, 2026 (estimated)
Completion
Feb 28, 2027 (estimated)
Last update
Nov 10, 2026

Study contacts

David Wendler, Ph.D.
Contact
dwendler@mail.cc.nih.gov
(301) 496-2429
David Wendler, Ph.D.
principal investigator · National Institutes of Health Clinical Center (CC)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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