Cardiometabolic Care-team Integration Improves Outcomes in Diabetes

Cardio-metabolic Care-Team Intervention (CMC-TI) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03561714
• Other study ID #: CEDAR
• Status: Completed
• Start date: March 1, 2012
• Est. completion date: December 30, 2014

Study information

• Verified date: December 2022
• Source: Scripps Whittier Diabetes Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 475
• Est. completion date: December 30, 2014
• Est. primary completion date: September 30, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• All patients with type 1 and type 2 diabetes

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Cardio-metabolic Care-Team Intervention (CMC-TI)

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Scripps Whittier Diabetes Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Change in HbA1c between Intervention and Comparator sites	12 months
Secondary	Hospital/ER costs		12 months
Secondary	LDL	Change in LDL between Intervention and Comparator sites	12 months
Secondary	Blood pressure	Change in blood pressure between Intervention and Comparator sites	12 months