Addressing Social Determinants in Diabetes Care: The REDD-CAT Health-related Social Needs Screening Tool
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Diabetes Mellitus, Type 2
- Sponsor
- Boston Medical Center
- Locations
- 1
- Primary Endpoint
- Feasibility - Recruitment potential: percentage of eligible patients willing to enroll in the study
- Status
- Withdrawn
- Last Updated
- 3 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Feasibility - Recruitment potential: percentage of eligible patients willing to enroll in the study
Time Frame: 6 months
Recruitment potential will be measured according to the percentage of eligible patients willing to enroll in the study. The source of this outcome data will be the hospital census and recruitment data.
Feasibility - Subject retention: percentage of patients who complete the 30-day follow-up time point
Time Frame: 30 days
Retention will be measured according to the percentage of patients who complete the 30-day follow-up time point; study records will provide this data.
Feasibility - Participant burden: time required for participants to complete data collection measures
Time Frame: 6 months
Participant burden will be measured according to the time required for participants to complete data collection measures; the data source will be data collected by research assistants
Feasibility - Implementation fidelity: percentage of indicated referrals that are made
Time Frame: 30 days
Implementation fidelity will be measured according to the percentage of indicated referrals that are made; discharge records and electronic medical records will provide this data.
Secondary Outcomes
- Limited Efficacy - Change in coping: Ways of Coping scale(baseline, 30 days)
- Limited Efficacy - Change in diabetes related distress: Diabetes Distress scale(baseline, 30 days)
- Limited Efficacy - 30-Day readmission rate(30 days)
- Limited Efficacy - Change in depression: Patient Health Questionnaire (PHQ-9)(baseline, 30 days)
- Limited Efficacy - Change in anxiety: The Generalized Anxiety Disorder 7 (GAD-7)(baseline, 30 days)