Table 10.

Randomised Controlled Trials - Care Manager Roles – Level II Evidence

Article	Sample	Intervention	Control	Outcome measures	Outcomes/results	Conclusion
Callahan et al., 2006 [47] United States of America NCT00246896	N = 153 older adults with Alzheimer’s Disease and their caregivers from two large primary care practices. Physicians were randomised not participants.	• N = 84 • One year of care management and education for the caregiver by an interdisciplinary team lead by an advanced practice nurse integrated within primary care • Standard protocols were used to initiate treatment and identify, monitor and treat behavioural and psychological symptoms of dementia, stressing non-pharmacological management. • Intervention participants all recommended for cholinesterase inhibitors	• N = 69 • Augmented usual care including counselling, written educational material and referral to community resources	Interviews at 6, 12 and 18 months with: • Neuropsychiatric Inventory (NPI) • Activities of Daily Living • Health care resource use • Telephone Interview for Cognitive Status Caregivers: • Cornell Scale for Depression in Dementia for the patient • Caregiver portion of NPI • Patient Health Questionnaire-9 • Alzheimer’s Disease Cooperative Study health resource use questionnaire	• No loss to follow-up • Intervention group significantly fewer behaviour and psychological symptoms of dementia measured by the total NPI scores at 12 and 18 months • Caregivers had significant improvements in stress (caregiver NPI) at 12 months but not 18 months • Significant improvement in caregiver depression at 18 months (patient health questionnaire scores) • No group differences in CSDD < cognition, activities of daily living, rates of hospitalisation, nursing home placement or death.	Preliminary level II high quality evidence for 1 year of collaborative care management for people with Alzheimer’s Disease and their caregivers in significantly reducing behavioural and psychological symptoms of dementia and stress and depression in carers when compared to augmented usual care.
Chodosh et al., 2012 [44] United States of America ISRCTN72577751	N = 408 older adults with dementia and their caregivers from 18 primary care clinics Secondary analysis of intervention arm data (N = 238) from Vickrey study (2006) [46]	• N = 238 • More than 12 months of a disease management program led by trained dementia care managers (primarily social workers)) in a health care organisation and community agency • An Internet based care management software system was used for care planning and coordination • Care manager collaborated with the caregiver to: prioritise problem areas; teach problem-solving skills; initiate care plan actions; and send an assessment summary, a problem list, and selected recommendations to the patient’s primary care physician and other designated providers. • The care management protocol included ongoing follow-up, usually by telephone, with frequency based on need and a formal in home reassessment every 6 months to assess the need for major care-plan revisions. • Each dyad could have one or more community agency care managers	• No control group in this analysis. • Encounters with healthcare organisation care managers, community agency care managers and healthcare organisation primary care providers over 18-months were compared.	• Encounters with healthcare organisation care managers, community agency care mangers and healthcare organisation primary care provides over 18-months • Quality domains of assessment treatment, education. support and safety measured from medical records and caregiver surveys	• Exposure to any care management provider type resulted in significantly higher mean percentages of met dementia quality indicators across all four domains • The successive addition of case management exposure types demonstrated a significant increase in the mean percentage of indicators met within all four domains • Statistically significant association between higher levels of met indicators in all four quality domains and increasing frequency of healthcare organisation care managers encounters per month	Preliminary level III-2, evidence for healthcare organisation care managers to improve quality of dementia care over a 1 year period in a case managed intervention group. Additional coordinated interactions with primary care and community agency staff yielded even higher quality of care.
Duru et al., 2009 [45] United States of America	N = 408 older adults with dementia and their caregivers from 18 primary care clinics Cost evaluation analysis of Vickrey study (2006) [46]	• N = 238 • Intervention same as Chodosh et al., 2012 [44]	• N = 170 • Usual care – not offered any of the intervention protocols	Caregiver surveys at baseline, 12 months and 18 months to collect information on: • Patient healthcare utilisation • Paid and unpaid care giving hours • Costs of paid nonprofessional caregivers • Out of pocket expenses	• 71 % follow-up data for intervention group, 74 % control group • No significant differences in inpatient or outpatient utilisation or mean monthly cost of healthcare and care giving services	Lack of level II, high quality evidence for a 1 year dementia care management intervention to lower costs or provide a significant cost offset compared to the costs of usual care at 18-month follow up.
Specht et al., 2009 [48] United States of America Not registered	N = 8 countries enrolled 249 client dyads with a minimal inclusion criteria of memory impairment	• N = 167 • Dementia Nurse Care Manager provided a model of dementia care for people with dementia and their caregivers. At least monthly contact with continually availability by phone.	• N = 82 • Traditional case management service. Monthly phone contact and quarterly face-to-face contact emphasise on coordination of services not delivery of direct services	• Care recipient outcomes – MMSE, Global Deterioration Scale, Lawton and Brody’s modified IADL/ADL measure, Behaviour Rating Checklist Caregiver Outcomes – health status, well-being, stressors, endurance potential, MOS-36 SF, Nursing Outcomes Classification	• 64 % follow up data intervention; 49 % control • No significant differences in care recipient outcomes between groups • Caregiver outcomes stress, well-being and endurance potential significantly improved in the intervention group and this improvement was consistent over time.	Preliminary level II high quality evidence for a Dementia Nurse Care Manager intervention to significantly improve caregiver stress, well-being and endurance potential over time when compared to a traditional case management service.
Vickrey et al., 2006 [46] United States of America	N = 408 older adults with dementia and their caregivers	• N = 238 • Intervention same as Chodosh et al., 2012 [44]	• N = 170 • Usual care – not offered any of the intervention protocols	Adherence to 23 dementia guideline recommendations at follow-up (four domains: assessment, treatment, education and support and safety) obtained by: • Medical records • Caregiver surveys Secondary outcomes: • Caregiver surveys measuring a range of quality of life and health outcomes	• 12-month response rate 88 %, 18-month 82 %, Medicare data 97.5 % • Mean percentage of per-patient guideline recommendations to which care was adherent was significantly higher in the intervention group • Participants who received the intervention had significantly higher care quality on 21 of 23 guidelines	Preliminary level II, high quality evidence for a 1 year dementia-guideline disease management program to improve quality of care for people with dementia