Re-Engineered Discharge for Diabetes Care Transitions
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Massachusetts, Worcester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
pregnancy
discharge to short or long-term nursing facility or hospital
medical contraindication
cognitive impairment
Trial design
Design model
Parallel
Treatments tested in this trial
REDDCAT2 Post-Discharge Navigation
BehavioralThose 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)
Other interventionTAU 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.
Treatment groups
412 Participants
are divided into 2 treatment groupsGroup A: ControlOther 1 intervention
Group B: InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Time to hospital service use post-discharge
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.
Time frame
90 daysSecondary outcomes
1
Changes in weight/body mass index (BMI)
Change in weight/BMI per electronic health record or Research Assistant assessment
Time frame
Baseline, 30, and 90 days2
Changes in Pain Management
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.
Time frame
Baseline, 30, and 90 days3
Changes in Self-Management Adherence
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) \& Re-Engineered Discharge for Diabetes Computer Adaptive Test (REDD-CAT) for Medication Adherence. SDSCA - Scores are calculated for each of the five regimen areas assessed: Diet, Exercise, Blood-Glucose Testing, Foot Care, and Smoking Status. REDD-CAT Medication Adherence scale is measured using T-scores. Scores greater that 1 standard deviation of 10.0 away from the mean of 50.0 represent a greater or lesser degree of adherence, depending on direction. Higher scores are indicative of a positive outcome (more adherence).
Time frame
Baseline, 30, and 90 days4
Changes in Illness Burden perception
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).
Time frame
Baseline, 30, and 90 daysSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Massachusetts, Worcester
Lead sponsor
National Institute of Nursing Research (NINR)
Collaborator
Regents of the University of Michigan
Collaborator
Source ClinicalTrials.gov