Effect of Care Management on Diabetes Outcomes

Minneapolis Veterans Affairs Health Care System (VAHCS)

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Other: Case Management

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT00569556

VISN23

3823-A

Details and patient eligibility

About

The purpose of the study is to determine if a nurse managed, protocol driven, disease management process for diabetes results in improved attainment of therapeutic goals for diabetes compared to usual care. It is hypothesized that implementation of the disease management process will improve the percentage of diabetic individuals attaining all three therapeutic targets (HgbA1C<8.0%, LDL<100mg/dl, and BP<130/80mmHG) by 10% compared to usual care.

Enrollment: 550 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled at Minneapolis VAMC
• Type 1 or 2 diabetes
• Blood pressure at screening visit > 140mmHg systolic or > 90mmHg diastolic OR HgbA1C at screening visit > 9.0% OR LDL at screening visit > 100mg/dL

Exclusion criteria

• Primary care provider unwilling to have participant included in study
• Life expectancy < 1 year
• Unable to give consent
• Severe mental health condition
• pregnant or planning on becoming pregnant

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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550 participants in 2 patient groups

Usual Care

No Intervention group

Description:

Patients receive care through primary care provider

Treatment:

Other: Case Management

Case Management

Experimental group

Description:

Specially trained nurse case managers contact patients by telephone; monitor blood pressure, LDL, and HgbA1C;, and recommend lifestyle and medication changes as needed

Treatment:

Other: Case Management