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

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Behavioral: Usual Diabetes Care; Behavioral: Diabetes Dashboard Intervention

• Registration Number: NCT02156037
• Lead Sponsor: Baystate Medical Center

Brief Summary

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

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).

Study Timeline

• Study Start: 2009-07
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-06
• Study First Submitted: 2014-06-03
• Study First Submitted QC: 2014-06-04
• Last Update Submitted: 2014-06-04
• Study First Posted: 2014-06-05
• Last Update Posted: 2014-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 399

Inclusion Criteria

• age 18 years or older,
• self-identified Hispanic ethnicity,
• diagnosis of T2D,
• HbA1c >7.5%, and
• provider approval given for patient participation

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
usual diabetes team control	Usual Diabetes Care	usual clinical diabetes team with no access to the diabetes dashboard
dashboard team care intervention	Diabetes Dashboard Intervention	Dashboard team

Primary Outcome Measures

Name	Time	Method
HbA1c	6 months	Change in HbA1c over 6 months

Secondary Outcome Measures

Name	Time	Method
Diabetes distress	6 months	Patient reported diabetes distress associated with Type 2 diabetes and its treatment measured using the PAID scale
Depression	6 months	Patient-reported depression status based on the PHQ scale

Trial Locations

Locations (1)

Baystate Medical Center; 🇺🇸 Springfield, Massachusetts, United States