Patient Provider Partnership: Improving Diabetes Care in the Community

Diabetes Clinical Trial

Official title:

Patient Provider Partnership: Improving Diabetes Care in the Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167284
• Other study ID #: 010157
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: September 9, 2005
• Start date: October 2001
• Est. completion date: February 2005

Study information

• Verified date: September 2005
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

With the advent of managed care, increasing responsibility for the care of patients with diabetes is being placed on primary care physicians. Evidence exists that physicians are not meeting established practice guidelines, and outcomes in patients with diabetes are less than optimal. It is thus the objective of this study to institute a community-based diabetes education intervention for both physicians and patients to enhance adherence to guidelines and improve patient outcomes.

We will conduct a chart review (submitted under a separate IRB: #000733) in primary care practices to determine health status and guideline adherence. Following the chart review, physician practices will be assigned to one of three groups: physician + patient education, physician education alone, and usual care. Following the intervention, a repeat chart review will be conducted. Pre and posttest comparisons will be conducted to examine changes primarily in glycemic control, quality of life, patient knowledge, and physician adherence to practice guidelines. Secondarily, we will examine changes in therapeutic intervention, body mass index, and barriers to diabetes care. We will also examine individual barriers to diabetes care and their influence on outcomes in this population. The last phase of the study will encompass a second follow-up visit in which we will examine behavioral factors related to clinical change and sustainability of the intervention.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• over age 18, diagnosed diabetes, physician is participating in study

Exclusion Criteria:

• pregnancy, imprisonment

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Diabetes

Intervention

Behavioral:
• physician and patient education; physician practice redesign

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	UPMC Office of Community Initiatives

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A1c
Primary	Blood Pressure
Primary	Lipids
Secondary	Quality of Well Being
Secondary	Empowerment
Secondary	Physician attitudes
Secondary	Patient and physician barriers to diabetes care