Re-Engineered Discharge for Diabetes Care Transitions

Not Applicable

Not yet recruiting

• Conditions: Diabetes Mellitus Type 2; Social Determinants of Health (SDOH); Hospital Readmission

• Registration Number: NCT06869057
• Lead Sponsor: University of Massachusetts, Worcester

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.

Study Timeline

• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-06
• Study First Posted: 2025-03-11
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-16
• Study Start: 2025-08-01
• Primary Completion: 2028-12-01
• Study Completion: 2029-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 412

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to hospital service use post-discharge	90 days	The primary outcome is a composite measure on all types of hospital service use (emergency department, observation, or hospital readmissions), pre-specified as time-to-hospital reutilization, at 90-days post-hospital discharge. Source of the data are UMMH electronic health records and participant self-report.

Secondary Outcome Measures

Name	Time	Method
Changes in weight/body mass index (BMI)	Baseline, 30, and 90 days	Change in weight/BMI per electronic health record or Research Assistant assessment
Changes in Pain Management	Baseline, 30, and 90 days	Change in Pain and Pain interference scores assessed using two measures from the Patient-Reported Outcomes Measurement Information System (PROMIS).; 1. Pain Severity is scored using a T-score ranging from 20 to 80. T-scores that are 1 or more standard deviations above average are indicative of a poorer outcome (more pain).; 2. Pain Interference, which is a T-score ranging from 20 to 80. T-scores that are 1+ standard deviations above average are indicative of a poorer outcome (more problems with pain hindering activities).; PROMIS scores have an average of 50 and standard deviation (SD) of 10 in a referent population.
Changes in Self-Management Adherence	Baseline, 30, and 90 days	Change in patient-reported adherence to diabetes regimen from baseline to follow up assessed by administering the Changes in the Summary of Diabetes Self-Care Activities Assessment (SDSCA) \& Morisky Medication Adherence scale.; SDSCA - Scores are calculated for each of the five regimen areas assessed: Diet, Exercise, Blood-Glucose Testing, Foot Care, and Smoking Status.; Morisky Medication Adherence Scale - Scores range from 0 to 8. Higher scores indicate higher adherence.
Changes in Illness Burden perception	Baseline, 30, and 90 days	Change in experience of Illness Burden. Illness burden scale generates a T-score, ranging from 20 to 80. The average score is 50 with a standard deviation of 10. T-scores that are 1 or more standard deviations above average are indicative of a poorer outcome (indicate more illness burden).
Changes in Substance Use	Baseline, 30, and 90 days	Change in Substance Use will be assessed using a validated measure from the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS scores have an average of 50 and standard deviation (SD) of 10 in a referent population.; PROMIS Substance Use - Resulting scores are on a T-score metric ranging from 20 to 80. Scores that are 1 or more standard deviations above average are indicative of poor, self-reported health (greater severity of substance use).
Changes in Alcohol Use	Baseline, 30, and 90 days	Change in Alcohol Use will be assessed using a validated measure from the Patient-Reported Outcomes Measurement Information System (PROMIS). PROMIS scores have an average of 50 and standard deviation (SD) of 10 in a referent population.; PROMIS Alcohol Use: Resulting scores are on a T-score metric ranging from 20 to 80. Higher scores are indicative of poor self-reported health (more alcohol consumption, cravings, or difficulty controlling drinking).
Changes in Diabetes Stigma	Baseline, 30, and 90 days	Type 2 Diabetes Stigma Assessment Scale or DSAS-2 is a 19-item measure with three sub-scales: Treated Differently, Blame and Judgement, Self-Stigma. A total scale score can also be calculated. Items are scored 1 (strongly disagree) to 5 (strongly agree). Higher scores indicate worse outcomes (more perceived diabetes stigma).
Changes in Economic Quality of Life	Baseline, 30, and 90 days	Changes in 8-item custom short form from the Economic Quality of Life item bank. Items are related to finances and affordability of living expenses and range from 1 (Never) to 5 (Always). Resulting scores are on a T-score metric, ranging from 20 to 80. Higher scores indicate better economic quality of life.
Changes in Depressive Symptoms	Baseline, 30, and 90 days	Changes in depressive symptom burden are assessed using a measure from the Quality of Life in Neurological Disorders (NeuroQOL) measurement system.; Neuro-QoL Depression - Resulting scores are on a T-score metric, ranging from 20 to 80. Higher scores indicate poorer self-reported health (a greater presence of depressive symptoms).
Changes in Anxiety Symptoms	Baseline, 30, and 90 days	Changes in anxiety symptom burden are assessed using a measure from the Quality of Life in Neurological Disorders (NeuroQOL) measurement system.; Neuro-QoL Anxiety - Resulting scores are on a T-score metric, ranging from 20 to 80. Higher scores indicate poorer self-reported health (a greater presence of anxiety symptoms).
Changes in Emotional Support	Baseline, 30, and 90 days	Changes in emotional support scores assessed using measures from the Patient-Reported Outcomes Measurement Information System (PROMIS).; Resulting scores are on a T-score metric, ranging from 20 to 80. Higher scores indicate worse outcome (a greater degree of social isolation).
Changes in Health Seeking Behavior	Baseline, 30, and 90 days	Changes in Health Seeking Behavior scale, which includes 21 items including subscales related to Primary Care Provider, General, Family/Personal Friends, and Internet. Resulting scores are on a T metric, ranging from 20 to 80. Higher scores indicate a positive outcome (more health-seeking behavior).
Changes in Medication Adherence	Baseline, 30, and 90 days	Medication Adherence scores assessed by administering: Morisky Medication Adherence Scale - Scores range from 0 to 8. Higher scores indicate better self-reported health (higher adherence).
Changes in Perceived Competence	Baseline, 30, and 90 days	Change in Perceived Competence in Diabetes Scale (PCDS) score - items are rated on a scale 1-7. Higher total scores indicate better self-reported health (a greater perceived ability to manage diabetes).
Changes in Perceived diabetes self-efficacy	Baseline, 30, and 90 days	Change in Diabetes Self-Efficacy Scale (DSES) score - items are rated on a scale of 0-10 and summed for a total score. Higher total scores indicate better self-reported health (self-efficacy in managing diabetes).
Changes in Coping Skills	Baseline, 30, and 90 days	Changes in Brief Resilient Coping Scale scores. Items are rated 1 ("does not describe me at all") to 5 ("describes me very well") and summed for a total score. Higher scores indicate better self-reported health (higher coping resiliency).
Changes in Diabetes Knowledge	Baseline, 30, and 90 days	Change in Diabetes Knowledge and diabetes self-care will be assessed using the 23-item Revised Diabetes Knowledge Test (DKT2). DTK2 contains multiple choice questions to assess knowledge, and each question contains 4 responses for the respondent to choose from. Proportion of correct answers over total questions determine scoring.
Changes in Housing Insecurity	Baseline, 30, and 90 days	Change in Housing Insecurity scores, which is a 22-item assessment to evaluate affordability, safety, and home features. Resulting scores use a T-score metric, ranging from 20 to 80. Lower scores indicate poorer outcomes (more significant concerns with housing stability).
Quantity of unmet social needs	Baseline, 30, and 90 days	Absolute change in total number of SDOH domains identified with an unmet need (i.e., food insecurity, housing insecurity, etc.) as reported on Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) screening tool.
Changes in Glucose Control: HbA1c at point of care	Baseline and 90 days	Change in HbA1c values recorded from point-of-care tests or in the electronic health record at visits.
changes in Diabetes Distress	Baseline, 30, and 90 days	The Diabetes Distress Scale is a 17-item self-report instrument. Each item is rated on a 6-point scale from (1) "not a problem" to (6) "a very significant problem." The scale yields an overall distress score based on the average responses on the 1-6 scale for all 17 items. The scale also yields a score for each of 4 subscales based on the average response on the 1-6 scale on all of the items in that scale.; An average score of \< 2.0 = reflects little or no distress, an average score between 2.0 and 2.9 = reflects moderate distress, and an average score \> 3.0 = reflects high distress.
Time to hospital service use post-discharge	30 days	Time-to-hospital reutilization (defined as any type of hospital service use, e.g., emergency department, observation, or hospital readmissions), at 30-days post-hospital discharge. Source of the data are UMMH electronic health records and participant self-report.