Background: Adherence to dementia guidelines is poor despite evidence that some guideline recommendations can improve symptoms and delay institutionalization of patients.

Objective: To test the effectiveness of a dementia guideline-based disease management program on quality of care and outcomes for patients with dementia.

Design: Clinic-level, cluster randomized, controlled trial.

Setting: 3 health care organizations collaborating with 3 community agencies in southern California.

Participants: 18 primary care clinics and 408 patients with dementia age 65 years or older paired with 408 informal caregivers.

Intervention: Disease management program led by care managers and provided to 238 patient-caregiver pairs at 9 intervention clinics for more than 12 months.

Measurements: Adherence to 23 guideline recommendations (primary outcome) and receipt of community resources and patient and caregiver health and quality-of-care measures (secondary outcomes).

Results: The mean percentage of per-patient guideline recommendations to which care was adherent was significantly higher in the intervention group than in the usual care group (63.9% vs. 32.9%, respectively; adjusted difference, 30.1% [95% CI, 25.2% to 34.9%]; P < 0.001). Participants who received the intervention had higher care quality on 21 of 23 guidelines (P < or = 0.013 for all), and higher proportions received community agency assistance (P < or = 0.03) than those who received usual care. Patient health-related quality of life, overall quality of patient care, caregiving quality, social support, and level of unmet caregiving assistance needs were better for participants in the intervention group than for those in the usual care group (P < 0.05 for all). Caregiver health-related quality of life did not differ between the 2 groups.

Limitations: Participants were well-educated, were predominantly white, had a usual source of care, and were not institutionalized. Generalizability to other patients and geographic regions is unknown. Also, costs of a care management program under fee-for-service reimbursement may impede adoption.

Conclusions: A dementia guideline-based disease management program led to substantial improvements in quality of care for patients with dementia. Current Controlled Trials identifier: ISRCTN72577751.