Study Stopped
This study was never conducted due to Covid. Key informant interviews were conducted instead.
Re-Engineered Discharge for Diabetes-Computer Adaptive Testing (REDD-CAT)
Addressing Social Determinants in Diabetes Care: The REDD-CAT Health-related Social Needs Screening Tool
2 other identifiers
interventional
N/A
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2021
Shorter than P25 for not_applicable diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 22, 2019
CompletedFirst Posted
Study publicly available on registry
March 26, 2019
CompletedStudy Start
First participant enrolled
March 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2021
CompletedMarch 6, 2023
March 1, 2023
1 month
March 22, 2019
March 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Feasibility - Recruitment potential: percentage of eligible patients willing to enroll in the study
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.
6 months
Feasibility - Participant burden: time required for participants to complete data collection measures
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
6 months
Feasibility - Subject retention: percentage of patients who complete the 30-day follow-up time point
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.
30 days
Feasibility - Implementation fidelity: percentage of indicated referrals that are made
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.
30 days
Secondary Outcomes (5)
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 - 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
Limited Efficacy - 30-Day readmission rate
30 days
Other Outcomes (1)
Process Outcome- Referral Completion: percentage of patients who receive services post-referral
30 days
Study Arms (1)
REDD-CAT Recipient
EXPERIMENTALThe 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.
Interventions
After obtaining informed consent from a participant and gathering baseline data, the study RA will send a flag in the 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Suzanne E Mitchell, MD
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 22, 2019
First Posted
March 26, 2019
Study Start
March 2, 2021
Primary Completion
April 13, 2021
Study Completion
April 13, 2021
Last Updated
March 6, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share