Dementia care in the general practice setting: a cluster randomized trial on the effectiveness and cost impact of three management strategies.

OBJECTIVE: To compare a complex nondrug intervention including actively approaching counseling and caregiver support groups with differing intensity against usual care with respect to time to institutionalization in patients with dementia. METHODS: Within this three-armed cluster-randomized controlled trial, 390 community-dwelling patients aged 65 years or older with physician-diagnosed mild to moderate dementia and their caregivers were enrolled via 129 general practitioners in Middle Franconia, Germany. The intervention included general practitioners' training in dementia care and their recommendation of support groups and actively approaching caregiver counseling. Primary study end point was time to institutionalization over 2 years. In addition, long-term intervention effects were assessed over a time horizon of 4 years. Secondary end points included cognitive functioning, (instrumental) activities of daily living, burden of caregiving, and health-related quality of life after 2 years. Frailty models with strict intention-to-treat approach and mixed linear models were applied to account for cluster randomization. Health care costs were assessed from the societal perspective. RESULTS: After 2 (4) years, 12% (24%) of the patients were institutionalized and another 21% (35%) died before institutionalization. No significant differences between study groups were observed with respect to time to institutionalization after 2 and 4 years (P 0.25 and 0.71, respectively). Secondary end points deteriorated, but differences were not significant between study groups. Almost 80% of the health care costs were due to informal care. Total annual costs amounted to more than €47,000 per patient and did not differ between study arms. CONCLUSION: The intervention showed no effects on time to institutionalization and secondary outcomes.

Effects of general practitioner training and family support services on the care of home-dwelling dementia patients--results of a controlled cluster-randomized study.

BACKGROUND: More than 90% of dementia patients are cared for by their general practitioners, who are decisively involved in the diagnosis, therapy and recommendation of support services. OBJECTIVE: To test whether special training of general practitioners alters the care of dementia patients through their systematic recommendation of caregiver counseling and support groups. METHOD: 129 general practitioners enrolled 390 dementia patients and their informal caregivers in a prospective, three-arm cluster-randomized 2-year study. Arm A constituted usual care, in Arm B and C support groups and caregiver counseling (in Arm B one year after baseline, in Arm C at baseline) were recommended by the general practitioners. The general practitioners received arm-specific training. Diagnostic and therapeutic behavior of physicians was recorded at baseline. Informal caregivers were questioned in follow-up after 2 years about the utilization of support services. RESULTS: The diagnostic behavior of the general practitioners conforms to relevant guidelines. The procedure in newly-diagnosed patients does not differ from previously diagnosed patients with the exception of the rate of referral to a specialist. About one-third of the newly-diagnosed dementia patients are given an anti-dementia drug. The utilization of support groups and counseling increased five- and fourfold, respectively. Utilization of other support services remained low (< 10%), with the exception of home nursing and institutional short-term nursing. CONCLUSION: Trained general practitioners usually act in conformity with guidelines with respect to diagnosing dementia, and partly in conformity with the guidelines with respect to recommended drug therapy. Recommendations of support services for informal caregivers by the general practitioner are successful. They result in a marked increase in the utilization rate for the recommended services compared to offers which are not recommended by the general practitioner. TRIAL REGISTRATION: ISRCTN68329593.

[IDA project--concept and implementation of a cluster-randomized trial on dementia management in a general practice setting]. / Projekt IDA - Konzept und Umsetzung einer cluster-randomisierten Studie zur Demenzver- sorgung im hausärztlichen Bereich.

Given the multiple deficits in dementia care IDA is a health services research project that addresses the key role of general practitioners in the early detection of dementia, patient and family education, therapy and referral to further counseling and supportive measures. Mid 2005 IDA was started by the AOK Bavaria as a pilot project targeting patients living at home. This three-armed cluster-randomized trial--currently including 180 participating general practitioners--is to compare two supportive measures of different intensity (counseling for care-giving relatives and care management) with the usual care in terms of time to nursing home placement. Additional outcomes investigated include the development of the patient's cognitive status and his abilities to perform activities of daily living, burden and quality of life of care-giving relatives as well as healthcare costs and costs of institutional care. Participating patients with initially mild to moderate disease will be observed for a period of two years. Data collection will proceed via general practitioners and caregivers and also utilize routine data of statutory health insurances and long-term care insurances. Keeping in mind that patient recruitment is ongoing throughout 2006 the initial analysis of 254 patients' data shows an average 80-year old patient in the early phase of moderate dementia. One third of the participants are cases with a first- time diagnosis obtained from their general practitioner. Final results for IDA are expected to be available in 2009.