Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
412 participants
INTERVENTIONAL
2026-02-01
2029-05-30
Brief Summary
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Detailed Description
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Social determinants of health (SDOH) are the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks. - Office of Disease Prevention and Health Promotion Examples of SDOH include factors such as housing, transportation, education, job opportunities, income, and access to healthy food, clean air and water, and health care services. Participants who join this research will be asked to complete a screening survey about their health. Then, participants will be randomly assigned (like pulling a name out of a hat) to one of two groups:
* Those in Group 1 will be partnered with a patient navigator whose role will be to review the results of the screening survey and help coordinate care before leaving the hospital and for 90 days after.
* Those in Group 2 will receive treatment as usual. A list of community-based resources will be provided.
Participants in both groups will complete surveys at the beginning of the study and again at 30 and 90 days after leaving the hospital. The investigators will make reminder calls to participants in both groups about data collection and will collect information from the medical record for as long as 90 days after leaving the hospital.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Control
Treatment as usual (TAU)
Treatment as Usual (TAU)
TAU participants will receive standard care from the UMass Memorial Healthcare (UMMH) hospitalist team as appropriate. Participants will receive a printed list of community resources. No study-related patient navigation support will be provided.
In 2024, Centers for Medicare and Medicaid Services mandated social determinants of health (SDOH) screening for inpatients. UMMH will use a checklist social needs screener. It will be up to the hospitalist teams to act on SDOH screening results. The UMMH hospitalist teams may consult endocrinology and/or inpatient social services to provide support and consultation for all patients regardless of study participation or group assignment. If medically appropriate, the endocrinology service may manage medications and provide referrals for continued treatment post discharge. All services that are normally provided by hospital care teams will remain available.
Intervention
REDDCAT2 Intervention
REDDCAT2 Post-Discharge Navigation
Those in the REDDCAT2 intervention group will be partnered with a patient navigator whose role will be to review the results of the screening survey completed at the beginning of the study. The patient navigator will help coordinate the participant's care before leaving the hospital and for 90 days after. Together, the participant and navigator will form an action plan intended to help address personal, social, or community factors affecting the participant's health. The navigator is expected to contact the participant every 2 weeks, though this can be adjusted based on their preference.
Interventions
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REDDCAT2 Post-Discharge Navigation
Those in the REDDCAT2 intervention group will be partnered with a patient navigator whose role will be to review the results of the screening survey completed at the beginning of the study. The patient navigator will help coordinate the participant's care before leaving the hospital and for 90 days after. Together, the participant and navigator will form an action plan intended to help address personal, social, or community factors affecting the participant's health. The navigator is expected to contact the participant every 2 weeks, though this can be adjusted based on their preference.
Treatment as Usual (TAU)
TAU participants will receive standard care from the UMass Memorial Healthcare (UMMH) hospitalist team as appropriate. Participants will receive a printed list of community resources. No study-related patient navigation support will be provided.
In 2024, Centers for Medicare and Medicaid Services mandated social determinants of health (SDOH) screening for inpatients. UMMH will use a checklist social needs screener. It will be up to the hospitalist teams to act on SDOH screening results. The UMMH hospitalist teams may consult endocrinology and/or inpatient social services to provide support and consultation for all patients regardless of study participation or group assignment. If medically appropriate, the endocrinology service may manage medications and provide referrals for continued treatment post discharge. All services that are normally provided by hospital care teams will remain available.
Eligibility Criteria
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Inclusion Criteria
* diagnosed with type 2 diabetes
* hospitalized at Univ of Massachusetts-affiliated hospital
* endorsed at least 1 unmet social need via screening survey
Exclusion Criteria
* discharge to short or long-term nursing facility or hospital
* medical contraindication
* cognitive impairment
* unable to provide informed consent
18 Years
ALL
No
Sponsors
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National Institute of Nursing Research (NINR)
NIH
Regents of the University of Michigan
UNKNOWN
University of Massachusetts, Worcester
OTHER
Responsible Party
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Suzanne Mitchell
Associate Professor
Central Contacts
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Provided Documents
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Document Type: Informed Consent Form
Other Identifiers
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STUDY00002129
Identifier Type: -
Identifier Source: org_study_id
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