An RCT Evaluation of a Diabetes Dashboard Team Model in Primary Care

Study Overview
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Brief Summary
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To compare a comprehensive diabetes team care condition (IC) involving the diabetes team's use of a diabetes dashboard with a usual diabetes team care condition (UDC) that does not have access to the diabetes dashboard.

Detailed Description
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To compare a usual diabetes care condition (UDC) to a comprehensive diabetes care intervention condition (IC) involving a diabetes dashboard clinical decision support tool used by the diabetes team in primary care. The investigators used a parallel-groups randomized design. The diabetes team (i.e., diabetes nurses, diabetes dietitians, and providers) delivered a 5-visit, 6-month intervention to n=199 poorly-controlled (HbA1c >7.5%) Latino T2D patients (mean age=55 years, 60% female) seen at 2 urban community health centers. This intervention was compared to an established, in-house diabetes team care program (n=200) for its impact on blood glucose control and key psychosocial outcomes (diabetes distress, depression, social distress).

Official Title
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Case Management for Underserved Hispanic Type 2 Diabetes Populations

Conditions
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Diabetes

Intervention / Treatment
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* Behavioral: Diabetes Dashboard Intervention
* Behavioral: Usual Diabetes Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 years or older, self-identified Hispanic ethnicity, diagnosis of T2D, HbA1c >7.5%, and provider approval given for patient participation Exclusion Criteria: inability to consent, pregnant or planning to become pregnant in the next year, taking glucocorticoid therapy, or having serious psychiatric or medical complications (e.g., late stage diabetes complications, seizures, dementia, psychiatric hospitalization) that would prevent participation in study activities.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: dashboard team care intervention<br>Dashboard team | Behavioral: Diabetes Dashboard Intervention<br>* The Diabetes Dashboard Intervention Condition involved a program of five, in-person, one-on-one diabetes education and behavior change visits with a diabetes nurse or diabetes dietician, scheduled at baseline, two weeks, one month, three months, and six months post-enrollment.<br>|
| Active Comparator: usual diabetes team control<br>usual clinical diabetes team with no access to the diabetes dashboard | Behavioral: Usual Diabetes Care<br>* The UDC condition was delivered by four bicultural, bilingual diabetes nurses and diabetes dietitians who comprised the clinical site's long-standing, in-house diabetes program.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | Change in HbA1c over 6 months | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diabetes distress | Patient reported diabetes distress associated with Type 2 diabetes and its treatment measured using the PAID scale | 6 months | 
| Depression | Patient-reported depression status based on the PHQ scale | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hispanic, clinical decision support, diabetes, Hba1c, psychosocial