Clinical trial NCT03889600: Re-Engineered Discharge for Diabetes-Computer Adaptive Testing (REDD-CAT)
Official title: Addressing Social Determinants in Diabetes Care: The REDD-CAT Health-related Social Needs Screening Tool
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Keywords: Diabetes Mellitus, Type 2
Social determinants
Readmission
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: University of Michigan
name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-03-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Recruitment potential: percentage of eligible patients willing to enroll in the study
timeFrame: 6 months
measure: Feasibility - Participant burden: time required for participants to complete data collection measures
timeFrame: 6 months
measure: Feasibility - Subject retention: percentage of patients who complete the 30-day follow-up time point
timeFrame: 30 days
measure: Feasibility - Implementation fidelity: percentage of indicated referrals that are made
timeFrame: 30 days
Secondary outcomes:
measure: Limited Efficacy - Change in coping: Ways of Coping scale
timeFrame: baseline, 30 days
measure: Limited Efficacy - Change in diabetes related distress: Diabetes Distress scale
timeFrame: baseline, 30 days
measure: Limited Efficacy - Change in depression: Patient Health Questionnaire (PHQ-9)
timeFrame: baseline, 30 days
measure: Limited Efficacy - Change in anxiety: The Generalized Anxiety Disorder 7 (GAD-7)
timeFrame: baseline, 30 days
measure: Limited Efficacy - 30-Day readmission rate
timeFrame: 30 days
Other outcomes:
measure: Process Outcome- Referral Completion: percentage of patients who receive services post-referral
timeFrame: 30 days
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Suzanne E Mitchell, MD
role: PRINCIPAL_INVESTIGATOR
References: