Re-Engineered Discharge for Diabetes-Computer Adaptive Testing (REDD-CAT)

Boston Medical Center (BMC)

Status: Withdrawn

Conditions: Diabetes Mellitus, Type 2

Treatments: Other: REDD-CAT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03889600

R21DK121092 (U.S. NIH Grant/Contract)

H-38545

Details and patient eligibility

About

Over 27 million Americans are diagnosed with Type 2 Diabetes Mellitus (T2DM), and their health outcomes, including hospitalization, emergency department use, and hospital readmission, are largely driven by social determinants; diabetes complications are largely attributable to unmet health-related social needs. Investigators will conduct a pilot feasibility trial of the Re-Engineered Discharge for Diabetes-Computer Adaptive Testing (REDD-CAT) system to inform the design of a future, fully-powered randomized controlled trial. REDD-CAT will allow clinical staff to preemptively link patients with community-based social services tailored to meet their unique needs in order to reduce avoidable hospitalization and emergency department visits.

Full description

Investigators will conduct a pilot study with 30 patients to evaluate the feasibility and limited efficacy of the REDD-CAT social service screening and referral intervention to inform the design of a fully-powered trial. The study will determine the feasibility of delivering the REDD-CAT intervention in a clinical, point-of-care context to inform the design and implementation strategy for a fully powered clinical trial. It is not the purpose of this pilot clinical trial to determine sample size for a larger, fully-powered trial, as investigators already have data from prior readmissions research supporting sample size and power estimates using readmission rates as a primary outcome measure. After obtaining informed consent from a participant and gathering baseline data, the study research assistant (RA) will send a flag in the electronic medical record (EMR) to notify the nurse care manager that a patient has enrolled in the REDD-CAT pilot. The nurse care manager will then incorporate the administration of the REDD-CAT to the patient as part of standard care discharge planning. He or she will utilize the REDD-CAT results report as a guideline for generating appropriate referrals to address unmet social needs identified. To inform secondary measure selection for a future larger study, the RA will administer to enrolled patients a number of standardized measures, including the PHQ-9, GAD-7, Ways of Coping Questionnaire, and Diabetes Distress Scale. All baseline measures will be re-administered at 30-day follow-up to patients via the telephone. Data on hospitalizations and ED visits during the 30-day period post-discharge will be obtained from patients' medical records, and all data gathered will be stored in a REDCap electronic database.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Boston Medical Center inpatient
• Lives in the greater Boston area
• Diagnosis of Type 2 diabetes
• English- speaking
• Demonstrated willingness and capacity to consent
• Age 18 or older
• Has reliable telephone access

Exclusion criteria

• Currently pregnant
• Has plans to leave the area for >2 weeks in the 45 days following enrollment in the study
• Diagnosis of dementia, memory loss, or memory deficit

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

REDD-CAT Recipient

Experimental group

Description:

The nurse care manager will incorporate the administration of the REDD-CAT to the patient as part of the standard care discharge planning. He or she will utilize the REDD-CAT results report as a guideline for generating appropriate referrals to address unmet social needs identified.

Treatment:

Other: REDD-CAT