Clinical trial NCT06869057: Re-Engineered Discharge for Diabetes Care Transitions
Official title: Re-Engineered Discharge for Diabetes Care Transitions: Screening and Addressing Social Determinants of Health Needs at Hospital Discharge
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus Type 2
Social Determinants of Health (SDOH)
Hospital Readmission
Keywords: diabetes
social determinants of health
hospital readmission
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
name: Regents of the University of Michigan
First posted: 2025-03-11
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: The investigators are conducting this research to test a computer-based screening tool and a care coordination protocol to help people with type 2 diabetes who report unmet social determinants of health.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to hospital service use post-discharge
timeFrame: 90 days
Secondary outcomes:
measure: Changes in weight/body mass index (BMI)
timeFrame: Baseline, 30, and 90 days
measure: Changes in Pain Management
timeFrame: Baseline, 30, and 90 days
measure: Changes in Self-Management Adherence
timeFrame: Baseline, 30, and 90 days
measure: Changes in Illness Burden perception
timeFrame: Baseline, 30, and 90 days
measure: Changes in Substance Use
timeFrame: Baseline, 30, and 90 days
measure: Changes in Alcohol Use
timeFrame: Baseline, 30, and 90 days
measure: Changes in Diabetes Stigma
timeFrame: Baseline, 30, and 90 days
measure: Changes in Economic Quality of Life
timeFrame: Baseline, 30, and 90 days
measure: Changes in Depressive Symptoms
timeFrame: Baseline, 30, and 90 days
measure: Changes in Anxiety Symptoms
timeFrame: Baseline, 30, and 90 days
measure: Changes in Emotional Support
timeFrame: Baseline, 30, and 90 days
measure: Changes in Health Seeking Behavior
timeFrame: Baseline, 30, and 90 days
measure: Changes in Medication Adherence
timeFrame: Baseline, 30, and 90 days
measure: Changes in Perceived Competence
timeFrame: Baseline, 30, and 90 days
measure: Changes in Perceived diabetes self-efficacy
timeFrame: Baseline, 30, and 90 days
measure: Changes in Coping Skills
timeFrame: Baseline, 30, and 90 days
measure: Changes in Diabetes Knowledge
timeFrame: Baseline, 30, and 90 days
measure: Changes in Housing Insecurity
timeFrame: Baseline, 30, and 90 days
measure: Quantity of unmet social needs
timeFrame: Baseline, 30, and 90 days
measure: Changes in Glucose Control: HbA1c at point of care
timeFrame: Baseline and 90 days
measure: changes in Diabetes Distress
timeFrame: Baseline, 30, and 90 days
measure: Time to hospital service use post-discharge
timeFrame: 30 days
Other outcomes:
Locations:
Study officials:
References: