Cardiometabolic Care-team Integration Improves Outcomes in Diabetes

Cardiometabolic Care-team Integration in Primary Care Improves Outcomes in Diabetes: a Pragmatic, Case-controlled Study

A pragmatic, quasi-experimental (non-randomized) design was used to evaluate clinical and cost outcomes among patients with type 1 or 2 diabetes (T1D or T2D) at two primary care clinics (n=1 intervention, n=1 usual care) between March 2012 and September 2014. At the intervention clinic, the 12-month Cardio-metabolic Care-Team Intervention (CMC-TI) was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months, and a process evaluation gauged CMC-TI feasibility and satisfaction.

Study Overview

• Status: Completed
• Conditions: Cardio-metabolic Care-Team Intervention (CMC-TI)
• Intervention / Treatment: Behavioral: Cardometabolic Team Intervention

• Study Type: Observational
• Enrollment (Actual): 475

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

- All patients with type 1 and type 2 diabetes within two primary care clinics at Scripps Coastal Medical Group.

Description

Inclusion Criteria:

• All patients with type 1 and type 2 diabetes

Exclusion Criteria:

• None

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
CMC-TI; Cardiometabolic Care Team Intervention	Behavioral: Cardometabolic Team Intervention; The CMC-TI team included a registered nurse/certified diabetes educator (RN/CDE) Care Manager, medical assistant (MA) Health Coach, and RN Depression Care Manager. Decision support tools guided therapy for glucose, BP, low-density lipoprotein cholesterol (LDL-c), and depression. At the intervention clinic, the 12-month CMC-TI was delivered to all qualifying patients; surveys were administered to evaluate relevant patient-reported outcomes over 12 months.
Non-Intervention Comparator site; Non intervention comparator site with usual care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c between Intervention and Comparator sites	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital/ER costs		12 months
LDL	Change in LDL between Intervention and Comparator sites	12 months
Blood pressure	Change in blood pressure between Intervention and Comparator sites	12 months

Collaborators and Investigators

• Sponsor: Scripps Whittier Diabetes Institute

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): September 30, 2014
• Study Completion (Actual): December 30, 2014

Study Registration Dates

• First Submitted: June 2, 2018
• First Submitted That Met QC Criteria: June 17, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Estimate): December 9, 2022
• Last Update Submitted That Met QC Criteria: December 7, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: CEDAR (Other Identifier: Allergan)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No