Effectiveness and Safety of Dementia Care Management in Primary Care: A Randomized Clinical Trial.

Importance: Dementia care management (DCM) can increase the quality of care for people with dementia. Methodologically rigorous clinical trials on DCM are lacking. Objective: To test the effectiveness and safety of DCM in the treatment and care of people with dementia living at home and caregiver burden (when available). Design, Setting, and Participants: This pragmatic, general practitioner-based, cluster-randomized intervention trial compared the intervention with care as usual at baseline and at 12-month follow-up. Simple 1:1 randomization of general practices in Germany was used. Analyses were intent to treat and per protocol. In total, 6838 patients were screened for dementia (eligibility: 70 years and older and living at home) from January 1, 2012, to March 31, 2016. Overall, 1167 (17.1%) were diagnosed as having dementia, and 634 (9.3%) provided written informed consent to participate. Interventions: Dementia care management was provided for 6 months at the homes of patients with dementia. Dementia care management is a model of collaborative care, defined as a complex intervention aiming to provide optimal treatment and care for patients with dementia and support caregivers using a computer-assisted assessment determining a personalized array of intervention modules and subsequent success monitoring. Dementia care management was targeted at the individual patient level and was conducted by 6 study nurses with dementia care-specific qualifications. Main Outcomes and Measures: Quality of life, caregiver burden, behavioral and psychological symptoms of dementia, pharmacotherapy with antidementia drugs, and use of potentially inappropriate medication. Results: The mean age of 634 patients was 80 years. A total of 407 patients received the intended treatment and were available for primary outcome measurement. Of these patients, 248 (60.9%) were women, and 204 (50.1%) lived alone. Dementia care management significantly decreased behavioral and psychological symptoms of dementia (b = -7.45; 95% CI, -11.08 to -3.81; P < .001) and caregiver burden (b = -0.50; 95% CI, -1.09 to 0.08; P = .045) compared with care as usual. Patients with dementia receiving DCM had an increased chance of receiving antidementia drug treatment (DCM, 114 of 291 [39.2%] vs care as usual, 31 of 116 [26.7%]) after 12 months (odds ratio, 1.97; 95% CI, 0.99 to 3.94; P = .03). Dementia care management significantly increased quality of life (b = 0.08; 95% CI, 0 to 0.17; P = .03) for patients not living alone but did not increase quality of life overall. There was no effect on potentially inappropriate medication (odds ratio, 1.86; 95% CI, 0.62 to 3.62; P = .97). Conclusions and Relevance: Dementia care management provided by specifically trained nurses is an effective collaborative care model that improves relevant patient- and caregiver-related outcomes in dementia. Implementing DCM in different health care systems should become an active area of research. Trial Registration: clinicaltrials.gov Identifier: NCT01401582.