BackgroundTo evaluate the effects of nurse-led multifactorial care to prevent disability in community-living older people.MethodsIn a cluster randomized trail, 11 practices (n = 1,209 participants) were randomized to the intervention group, and 13 practices (n = 1,074 participants) were randomized to the control group. Participants aged ≥ 70 years were at increased risk of functional decline based on a score ≥ 2 points on the Identification of Seniors at Risk- Primary Care, ISAR-PC. Participants in the intervention group received a systematic comprehensive geriatric assessment, and individually tailored multifactorial interventions coordinated by a trained community-care registered nurse (CCRN) with multiple follow-up home visits. The primary outcome was the participant’s disability as measured by the modified Katz activities of daily living (ADL) index score (range 0–15) at one year follow-up. Secondary outcomes were health-related quality of life, hospitalization, and mortality.ResultsAt baseline, the median age was 82.7 years (IQR 77.0–87.1), the median modified Katz-ADL index score was 2 (IQR 1–5) points in the intervention group and 3 (IQR 1–5) points in the control group. The follow-up rate was 76.8% (n = 1753) after one year and was similar in both trial groups. The adjusted intervention effect on disability was -0.07 (95% confidence interval -0.22 to 0.07; p = 0.33). No intervention effects were found for the secondary outcomes.ConclusionsWe found no evidence that a one-year individualized multifactorial intervention program with nurse-led care coordination was better than the current primary care in community-living older people at increased risk of functional decline in The Netherlands.Trial RegistrationNetherlands Trial Register NTR2653

Background Functional decline in community-dwelling older persons is associated with the loss of independence, the need for hospital and nursing-home care and premature death. The effectiveness of multifactorial interventions in preventing functional decline remains controversial. The aim of this study is to investigate whether functional decline in community-dwelling older persons can be delayed or prevented by a comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination. Methods/Design In a cluster randomized controlled trial, with the general practice as the unit of randomization, 1281 participants from 25 general practices will be enrolled in each condition to compare the intervention with usual care. The intervention will focus on older persons who are at increased risk for functional decline, identified by an Identification of Seniors at Risk Primary Care (ISAR-PC) score (≥ 2). These older persons will receive a comprehensive geriatric assessment, an individually tailored care and treatment plan, consisting of multifactorial, evidence-based interventions and subsequent nurse-led care coordination. The control group will receive 'care as usual' by the general practitioner (GP). The main outcome after 12 months is the level of physical functioning on the modified Katz-15 index score. The secondary outcomes are health-related quality of life, psychological and social functioning, healthcare utilization and institutionalization. Furthermore, a process evaluation and cost-effectiveness analysis will be performed. Discussion This study will provide new knowledge regarding the effectiveness and feasibility of a comprehensive geriatric assessment, multifactorial interventions and nurse-led elderly care in general practice. Trial registration NTR2653 Grant Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201

The MIC of both the Katz-ADL index and the Lawton IADL scale lie around half a point. The certainty of this conclusion is reduced by the variation across calculational methods.

An in-depth analysis of the context, modeling of the processes and outcomes, measurement and reporting of intervention fidelity, and implementation of effective training for interventionists is needed to enhance the development and replication of future complex interventions.