Recruiting

SDOH Screening

Sponsor:

University of Massachusetts, Worcester

Code:

NCT06869057

Conditions

Diabetes Mellitus Type 2

Social Determinants of Health (SDOH)

Hospital Readmission

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

REDDCAT2 Post-Discharge Navigation

Treatment as Usual (TAU)

Study Details

Brief summary:

The goal of this project is to test a novel bedside SDOH screening intervention coupled with post-discharge navigation for hospitalized patients with a diabetes diagnosis to reduce unmet social needs, compared to usual care.

Conditions

Diabetes Mellitus Type 2

Social Determinants of Health (SDOH)

Hospital Readmission

Study ID

NCT06869057

Start date

Jun 8, 2026

Status verified date

Jan, 2026

Completion date

May 30, 2029

Anticipated

Primary completion date

Dec 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • adult aged 18 years or older
  • diagnosed with type 2 diabetes
  • hospitalized at Univ of Massachusetts-affiliated hospital
  • endorsed at least 1 unmet social need via screening survey

Exclusion Criteria:

  • pregnancy
  • discharge to short or long-term nursing facility or hospital
  • medical contraindication
  • cognitive impairment
  • unable to provide informed consent

Study Design

Enrollment

412 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

other: Control

Treatment as usual (TAU)

experimental: Intervention

REDDCAT2 Intervention

Interventions

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.

Primary outcome measure

  • Time to hospital service use post-discharge [ Time Frame: 90 days ]

Central Contacts and Locations

Central contacts

Locations

UMASS Memorial Healthcare System

Recruiting

Worcester, Massachusetts, United States, 01665

Contacts

More Information

Sponsor

University of Massachusetts, Worcester

Last update posted

Jun 30, 2026

Last verified

Jan, 2026

Keywords

  • diabetes
  • social determinants of health
  • hospital readmission

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Massachusetts, Worcester on 2026-06-30.