Diabetes Mellitus, Type 2NCT03889600
Re-Engineered Discharge for Diabetes-Computer Adaptive Testing (REDD-CAT)
A study testing REDD-CAT in people with Diabetes Mellitus, Type 2, run by Boston Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- REDD-CAT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Mar 2021to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Addressing Social Determinants in Diabetes Care: The REDD-CAT Health-related Social Needs Screening Tool
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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- REDD-CAT
- Keywords
- Diabetes Mellitus, Type 2, Social determinants, Readmission
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REDD-CATOther
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.
| Study group | Role | What they receive |
|---|---|---|
| REDD-CAT Recipient | Experimental | 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. Receives: Other: REDD-CAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 30 days
Secondary outcomes (5)
Limited Efficacy - Change in coping: Ways of Coping scale
Coping will be assessed using the Ways of Coping scale which is a 66 item scale with potential responses from 1 to 4, with higher scores indicative of more frequent use of a particular strategy.
Measured: baseline, 30 days
Limited Efficacy - Change in diabetes related distress: Diabetes Distress scale
Diabetes related stress will be assessed using the Diabetes Distress scale which comprises 17 items with potential responses ranging from 1 to 6, with lower scores indicating that an item is less of a problem and higher scores indicating that an item poses a greater problem.
Measured: baseline, 30 days
Limited Efficacy - Change in depression: Patient Health Questionnaire (PHQ-9)
Change in depression will be assessed using the Patient Health Questionnaire (PHQ-9), which is a 9-item questionnaire that asks how often an individual has been bothered by a given item over the last 2 weeks. Scores range from 0 ("not at all") to 3 ("nearly every day.") A higher overall score indicates a greater level of depression.
Measured: baseline, 30 days
Limited Efficacy - Change in anxiety: The Generalized Anxiety Disorder 7 (GAD-7)
The Generalized Anxiety Disorder 7 (GAD-7) will be used to assess changes in anxiety. The GAD-7 is a 7-item questionnaire that asks how often an individual has been bothered by a given item over the last 2 weeks. Scores range from 0 ("not at all") to 3 ("nearly every day.") A higher overall score indicates a greater level of anxiety.
Measured: baseline, 30 days
Limited Efficacy - 30-Day readmission rate
30-Day readmission rate will be measured according to the percent difference between readmission rates for a historical control versus pilot readmission rates; this data will be collected via the EMR and clinical data warehouse
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2019
- Study start2 Mar 2021 (estimated)
- Primary completion13 Apr 2021 (estimated)
- Study completion13 Apr 2021 (estimated)
Why it stopped: This study was never conducted due to Covid. Key informant interviews were conducted instead.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Sponsor
- Investigators
- Suzanne E Mitchell, MD, Principal investigator, Boston Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03889600
- Sponsor's protocol ID
- H-38545
- Other IDs
- R21DK121092
- Status last verified
- Mar 2023
- First submitted
- 22 Mar 2019
- Last updated
- 6 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Addressing Social Determinants in Diabetes Care: The REDD-CAT Health-related Social Needs Screening Tool
- ClinicalTrials.gov ID
- NCT03889600
- Acronym / sponsor ID
- H-38545
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes Mellitus, Type 2, Social determinants, Readmission
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was never conducted due to Covid. Key informant interviews were conducted instead.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Collaborators
- University of Michigan, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 2 Mar 2021 (estimated)
- Primary completion
- 13 Apr 2021 (estimated)
- Study completion
- 13 Apr 2021 (estimated)
- First posted
- 26 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| REDD-CAT Recipient | Experimental | Other: REDD-CATThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Boston Medical Center inpatient
- Lives in the greater Boston area
- Diagnosis of Type 2 diabetes
- English- speaking
- Demonstrated willingness and capacity to consent
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REDD-CATAfter 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. | Other | REDD-CAT Recipient |
Primary outcome
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 - 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 - 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 - 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.
5 secondary outcomes
Limited Efficacy - Change in coping: Ways of Coping scale
Time frame: baseline, 30 days
Limited Efficacy - Change in diabetes related distress: Diabetes Distress scale
Time frame: baseline, 30 days
Limited Efficacy - Change in depression: Patient Health Questionnaire (PHQ-9)
Time frame: baseline, 30 days
Limited Efficacy - Change in anxiety: The Generalized Anxiety Disorder 7 (GAD-7)
Time frame: baseline, 30 days
Limited Efficacy - 30-Day readmission rate
Time frame: 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suzanne E Mitchell, MD principal investigator
Boston Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REDD-CAT in people with Diabetes Mellitus, Type 2, run by Boston Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Recruitment potential: percentage of eligible patients willing to enroll in the study (time frame: 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2023.