Comprehensive geriatric assessment, multifactorial interventions and nurse-led care coordination to prevent functional decline in community-dwelling older persons: protocol of a cluster randomized trial

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p><a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2653">NTR2653</a></p> <p>Grant</p> <p>Unrestricted grant 'The Netherlands Organisation for Health Research and development' no 313020201</p

Effects of Nurse-Led Multifactorial Care to Prevent Disability in Community-Living Older People: Cluster Randomized Trial

To evaluate the effects of nurse-led multifactorial care to prevent disability in community-living older people. In 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. At 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. We 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. Netherlands Trial Register NTR265

Minimal important change and minimal detectable change in activities of daily living in community-living older people

To estimate the minimal important change (MIC) and the minimal detectable change (MDC) of the Katz-activities of daily living (ADL) index score and the Lawton instrumental activities of daily living (IADL) scale. Data from a cluster-randomized clinical trial and a cohort study. General practices in the Netherlands. 3184 trial participants and 51 participants of the cohort study with a mean age of 80.1 (SD 6.4) years. At baseline and after 6 months, the Katz-ADL index score (0-6 points), the Lawton IADL scale (0-7 points), and self-perceived decline in (I)ADL were assessed using a self-reporting questionnaire. MIC was assessed using anchor-based methods: the (relative) mean change score; and using distributional methods: the effect size (ES), the standard error of measurement (SEM), and 0.5 SD. The MDC was estimated using SEM, based on a test-retest study (2-week interval) and on the anchor-based method. Anchor-based MICs of the Katz-ADL index score were 0.47 points, while distributional MICs ranged from 0.18 to 0.47 points. Similarly, anchor-based MICs of the Lawton IADL scale were between 0.31 and 0.54 points and distributional MICs ranged from 0.31 to 0.77 points. The MDC varies by sample size. For the MIC to exceed the MDC at least 482 patients are needed. 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

Comprehensive geriatric assessment:recognition of identified geriatric conditions by community-dwelling older persons

Objectives: to study (i) the prevalence of geriatric conditions in community-dwelling older persons at increased risk of functional decline and (ii) the extent to which older persons recognise comprehensive geriatric assessment (CGA)-identified conditions as relevant problems. Methods: trained registered nurses conducted a CGA in 934 out of 1209 older persons at increased risk of functional decline participating in the intervention arm of a randomised trial in the Netherlands. After screening for 32 geriatric conditions, participants were asked which of the identified geriatric conditions they recognised as relevant problems. Results: at baseline, the median age of participants was 82.9 years (interquartile range (IQR) 77.3-87.3 years). The median number of identified geriatric conditions per participant was 8 (IQR 6-11). The median number of geriatric conditions that were recognised was 1 (IQR 0-2). Functional dependency and (increased risk of) alcohol and drug dependency were the most commonly identified conditions. Pain was the most widely recognised problem. Conclusion: CGA identified many geriatric conditions, of which few were recognised as a problem by the person involved. Further study is needed to better understand how older persons interact with identified geriatric conditions, in terms of perceived relevance. This may yield a more efficient CGA and further improve a patient-centred approach

Cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people: Results of a cluster randomized trial

Objective To evaluate the cost-effectiveness of nurse-led multifactorial care to prevent or postpone new disabilities in community-living older people in comparison with usual care. Methods We conducted cost-effectiveness and cost-utility analyses alongside a cluster randomized trial with one-year follow-up. Participants were aged >= 70 years and at increased risk of functional decline. Participants in the intervention group (n = 1209) received a comprehensive geriatric assessment and individually tailored multifactorial interventions coordinated by a community-care registered nurse with multiple follow-up visits. The control group (n = 1074) received usual care. Costs were assessed from a healthcare perspective. Outcome measures included disability (modified Katz-Activities of Daily Living (ADL) index score), and quality-adjusted life-years (QALYs). Statistical uncertainty surrounding Incremental Cost-Effectiveness Ratios (ICERs) was estimated using bootstrapped bivariate regression models while adjusting for confounders. Results There were no statistically significant differences in Katz-ADL index score and QALYs between the two groups. Total mean costs were significantly higher in the intervention group (EUR 6518 (SE 472) compared with usual care (EUR 5214 (SE 338); adjusted mean difference (sic) 1457 (95% CI: 572; 2537). Cost-effectiveness acceptability curves showed that the maximum probability of the intervention being cost-effective was 0.14 at a willingness to pay (WTP) of EUR 50,000 per one point improvement on the Katz-ADL index score and 0.04 at a WTP of EUR 50,000 per QALY gained. Conclusion The current intervention was not cost-effective compared to usual care to prevent or postpone new disabilities over a one-year period. Based on these findings, implementation of the evaluated multifactorial nurse-led care model is not to be recommended

Changes in the in-hospital mortality and 30-day post-discharge mortality in acutely admitted older patients: retrospective observational study

Objectives: to compare changes over time in the in-hospital mortality and the mortality from discharge to 30 days postdischarge for six highly prevalent discharge diagnoses in acutely admitted older patients as well as to assess the effect of separately analysing the in-hospital mortality and the mortality from discharge to 30 days post-discharge. Study design and setting: retrospective analysis of Dutch hospital and mortality data collected between 2000 and 2010. Subjects: the participants included 263,746 people, aged 65 years and above, who were acutely admitted for acute myocardial infarction (AMI), heart failure (HF), stroke, chronic obstructive pulmonary disease, pneumonia or hip fracture. Methods: we compared changes in the in-hospital mortality and mortality from discharge to 30 days post-discharge in the Netherlands using a logistic- and a multinomial regression model. Results: for all six diagnoses, the mortality from admission to 30 days post-discharge declined between 2000 and 2009. The decline ranged from a relative risk ratio (RRR) of 0.41 [95% confidence interval (CI) 0.38-0.45] for AMI to 0.77 [0.73-0.82] for HF. In separate analyses, the in-hospital mortality decreased for all six diagnoses. The mortality from discharge to 30 days post-discharge in 2009 compared to 2000 depended on the diagnosis, and either declined, remained unchanged or increased. Conclusions: the decline in hospital mortality in acutely admitted older patients was largely attributable to the lower in-hospital mortality, while the change in the mortality from discharge to 30 days post-discharge depended on the diagnosis. Separately reporting the two rate estimates might be more informative than providing an overall hospital mortality rate

Een gevalideerd screeningsinstrument voorspelt functieverlies bij thuiswonende ouderen: de Identification of Seniors at Risk--Primary Care (ISAR-PC)

To modify and validate in primary healthcare the Identification of Seniors At Risk (ISAR) screening questionnaire to identify older persons at increased risk of functional decline and to compare this strategy with risk stratification by age alone. Prospective development (n=790) and validation cohorts (n=2,573) of community-dwelling persons aged ≥70 years. Functional decline at 12 months was defined as an increase of at least one point on the modified Katz-activities of daily living index score compared with baseline or death. Three items were independently associated with functional decline: age (odds ratio [OR] 1.06 per year; 95% confidence interval [CI] 1.02, 1.10) dependence in instrumental activities of daily living (OR: 2.17; 95% CI: 1.46, 3.22), and impaired memory (OR: 2.22; 95% CI: 1.41, 3.51). The area under the receiver operating characteristics curve (AUC) range of the ISAR-primary care model was 0.67-0.70 and 40.6% was identified at increased risk. Validation yielded an AUC range of 0.63-0.64. Age≥75 years alone yielded an AUC range of 0.56-0.57 and identified 65.0% at increased risk in the validation cohort. Although the ISAR-Primary Care (ISAR-PC) has moderate predictive value, application of the ISAR-PC is more efficient than selection based on age alone in identifying persons at increased risk of functional decline. This paper is a translated and adjusted version based on a publication in Journal of Clinical Epidemiology, 67 (2014) 1121-113

Flow of practices and participants through the trial.

<p>Numbers do not add up because persons who did not return a questionnaire at 6 months (n = 119) could return a questionnaire at 12, 18 and/or 24 months. Eleven practices were randomized to the intervention group and 13 practices were randomized to the control group. In both groups around 35% of the invited persons were at increased risk of functional decline and participated in the study. In both groups the follow-up rates were around 77% and 76% after one and two years respectively.</p

Effect of the intervention on secondary outcomes.

<p>The effect of the intervention was small and statistically not significant for all secondary outcomes across all follow-up moments except for after-hours primary care were a small effect was found at six months. Note that the scales on the y-axis do not cover the full range of the measurement instrument.</p