Improving chronic disease care by adding laypersons to the primary care team: a parallel randomized trial.

Background: Improving the quality and efficiency of chronic disease care is an important goal.

Objective: To test whether patients with chronic disease working with lay "care guides" would achieve more evidence-based goals than those receiving usual care.

Design: Parallel-group randomized trial, stratified by clinic and conducted from July 2010 to April 2012. Patients were assigned in a 2:1 ratio to a care guide or usual care. Patients, providers, and persons assessing outcomes were not blinded to treatment assignment. (ClinicalTrials.gov: NCT01156974).

Setting: 6 primary care clinics in Minnesota.

Patients: Adults with hypertension, diabetes, or heart failure.

Intervention: 2135 patients were given disease-specific information about standard care goals and asked to work toward goals for 1 year, with or without the help of a care guide. Care guides were 12 laypersons who received brief training about these diseases and behavior change.

Measurements: The primary end point for each patient was change in percentage of goals met 1 year after enrollment.

Results: The percentage of goals met increased in both the care guide and usual care groups (changes from baseline, 10.0% and 3.9%, respectively). Patients with care guides achieved more goals than usual care patients (82.6% vs. 79.1%; odds ratio, 1.31 [95% CI, 1.16 to 1.47]; P < 0.001); reduced unmet goals by 30.1% compared with 12.6% for usual care patients; and improved more than usual care patients in meeting several individual goals, including not using tobacco. Estimated cost was $286 per patient per year.

Limitations: Providers' usual care may have been influenced by contact with care guides. Last available data in the electronic health record were used to assess end points.

Conclusion: Adding care guides to the primary care team can improve care for some patients with chronic disease at low cost.