Trial Outcomes & Findings for Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression (NCT NCT00468676)

Results Overview

A scaled marginal model approach was used to jointly describe the four 12 month outcomes (SCL-20, HbA1c, systolic BP, LDL: all data submitted as Outcome Measures #2-5 below) and allowed use to test for a primary effect of the intervention among outcomes, scaling each outcome by its standard error, so the intervention effects could be interpreted as effect sizes.The model was estimated by iterating between estimation of the covariance associated with the outcomes and generalized-estimating equation estimation of scaled outcomes. Effect size is estimated as Cohen d effect size that was use for the depression outcome is the difference in change from baseline to 12 months in the intervention and usual care groups divided by the pooled base line standard deviation. Thus, a d of 0.25 indicates that one-quarter of a standard deviation separates the two means. Cohen has suggested that an effect size of 0.20 would be considered small, 0.50 medium and 0.80 large.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

214 participants

Primary outcome timeframe

Baseline to 12 months

Results posted on

2014-05-02

Participant Flow

Participants were recruited from may 2007 to october 2009 from 14 primary care clinics of Group Health Cooperative in Washington State

Exclusion criteria: terminal illness, residence in long-term care facility, bipolar/schizophrenia, mental confusion suggesting dementia, pregnancy/breast-feeding, use of antipsychotic/mood stabilizer med, severe hearing loss, planned bariatric surgery within 3 months, ongoing psychiatric care

Participant milestones

Participant milestones
Measure	Usual Care Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL	Care Management Intervention Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
Overall Study STARTED	108	106
Overall Study COMPLETED	92	94
Overall Study NOT COMPLETED	16	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Usual Care Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL	Care Management Intervention Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
Overall Study Lost to Follow-up	14	11
Overall Study Death	2	1

Baseline Characteristics

Nurse-led Case Management for Diabetes and Cardiovascular Disease Patients With Depression