Cost-Effectiveness of a Proactive Primary Care Program for Frail Older People: A Cluster-Randomized Controlled Trial.

BACKGROUND: A proactive integrated approach has shown to preserve daily functioning among older people in the community. The aim is to determine the cost-effectiveness of a proactive integrated primary care program. METHODS: Economic evaluation embedded in a single-blind, 3-armed, cluster-randomized controlled trial with 12 months' follow-up in 39 general practices in the Netherlands. General practices were randomized to one of 3 trial arms: (1) an electronic frailty screening instrument using routine medical record data followed by standard general practitioner (GP) care; (2) this screening instrument followed by a nurse-led care program; or (3) usual care. Health resource utilization data were collected using electronic medical records and questionnaires. Associated costs were calculated. A cost-effectiveness analysis from a societal perspective was undertaken. The incremental cost per quality-adjusted life-year was calculated comparing proactive screening arm with usual care, and screening plus nurse-led care arm with usual care, as well as the screening arm with screening plus nurse-led care arm. RESULTS: Out of 7638 potential participants, 3092 (40.5%) older adults participated. Whereas effect differences were minor, the total costs per patient were lower in both intervention groups compared with usual care. The probability of cost-effectiveness at €20,000 per QALY threshold was 87% and 91% for screening plus GP care versus usual care and for screening plus nurse-led care compared to usual care, respectively. For screening plus nurse-led care vs screening plus standard GP care, the probability was 55%. CONCLUSION: A proactive screening intervention has a high probability of being cost-effective compared to usual care. The combined intervention showed less value for money.

Effectiveness of a Proactive Primary Care Program on Preserving Daily Functioning of Older People: A Cluster Randomized Controlled Trial.

OBJECTIVES: To determine the effectiveness of a proactive primary care program on the daily functioning of older people in primary care. DESIGN: Single-blind, three-arm, cluster-randomized controlled trial with 1-year follow-up. SETTING: Primary care setting, 39 general practices in the Netherlands. PARTICIPANTS: Community-dwelling people aged 60 and older (N = 3,092). INTERVENTIONS: A frailty screening intervention using routine electronic medical record data to identify older people at risk of adverse events followed by usual care from a general practitioner; after the screening intervention, a nurse-led care program consisting of a comprehensive geriatric assessment, evidence-based care planning, care coordination, and follow-up; usual care. MEASUREMENTS: Primary outcome was daily functioning measured using the Katz-15 (6 activities of daily living (ADLs), 8 instrumental activities of daily living (IADLs), one mobility item (range 0-15)); higher scores indicate greater dependence. Secondary outcomes included quality of life, primary care consultations, hospital admissions, emergency department visits, nursing home admissions, and mortality. RESULTS: The participants in both intervention arms had less decline in daily functioning than those in the usual care arm at 12 months (mean Katz-15 score: screening arm, 1.87, 95% confidence interval (CI) = 1.77-1.97; screening and nurse-led care arm, 1.88, 95% CI = 1.80-1.96; control group, 2.03, 95% CI = 1.92-2.13; P = .03). No differences in quality of life were observed. CONCLUSION: Participants in both intervention groups had less decline than those in the control group at 1-year follow-up. Despite the statistically significant effect, the clinical relevance is uncertain at this point because of the small differences. Greater customizing of the intervention combined with prolonged follow-up may lead to more-robust results.

Treatment Fidelity of an Evidence-Based Nurse-Led Intervention in a Proactive Primary Care Program for Older People.

BACKGROUND: In a large randomized trial, Utrecht PROactive Frailty Intervention Trial (U-PROFIT), we evaluated the effectiveness of an integrated program on the preservation of daily functioning in older people in primary care that consisted of a frailty identification tool and a multicomponent nurse-led care program. Examination of treatment fidelity is critical to successful translation of evidence-based interventions into practice. AIMS: To assess treatment delivery, dose and content of nursing care delivered within the nurse-led care program, and to explore if the delivery may have influenced the trial results. METHODS: A mixed-methods study was conducted. Type and dose of nursing care were collected during the trial. Shortly after the trial, a focus group with nurses was conducted to explore reasons for the observed differences between the type and dose of nursing care delivered. RESULTS: A total of 835 older persons were included in the nurse-led care program. The mean age was 75 years, 64% were female and 53.5% were living alone. The most frequent self-reported conditions were loneliness (60.8%) and cognitive problems (59.4%). One-third of the patients with a geriatric condition received an additional assessment (e.g., Mini-Mental State Examination), and the majority of these patients received at least one nurse intervention (>85%). Most nursing care was delivered to patients at risk of falling and to those with urinary incontinence. Patients with nutrition problems seldom received nursing interventions. The nurses explained that differences in type and dose were influenced by the preference of the patient, the type of geriatric problem, and the time required to apply a nurse intervention. LINKING EVIDENCE TO ACTION: All intervention components were delivered; however, differences were observed in the type and dose of nursing care delivered across geriatric conditions. The findings better explain the treatment fidelity and suggest that there is room for improvement that may result in more beneficial patient outcomes.

Screening for frailty in primary care: a systematic review of the psychometric properties of the frailty index in community-dwelling older people.

BACKGROUND: To better accommodate for the complex care needs of frail, older people, general practitioners must be capable of easily identifying frailty in daily clinical practice, for example, by using the frailty index (FI). To explore whether the FI is a valid and adequate screening instrument for primary care, we conducted a systematic review of its psychometric properties. METHODS: We searched the Cochrane, PubMed and Embase databases and included original studies focusing on the criterion validity, construct validity and responsiveness of the FI when applied in community-dwelling older people. We evaluated the quality of the studies included using the Quality in Prognosis Studies (QUIPS) tool. This systematic review was conducted based on the PRISMA statement. RESULTS: Of the twenty studies identified, eighteen reported on FIs derived from research data, one reported upon an FI derived from an administrative database of home-care clients, and one reported upon an FI derived from routine primary care data. In general, the FI showed good criterion and construct validity but lacked studies on responsiveness. When compared with studies that used data gathered for research purposes, there are indications that the FI mean score and range might be different in datasets using routine primary care data; however, this finding needs further investigation. CONCLUSIONS: Our results suggest that the FI is a valid frailty screening instrument. However, further research using routine Electronic Medical Record data is necessary to investigate whether the psychometric properties of the FI are generalizable to a primary care setting and to facilitate its interpretation and implementation in daily clinical practice. TRIAL REGISTRATION: PROSPERO systematic review register number: CRD42013003737.

Identifying frailty: do the Frailty Index and Groningen Frailty Indicator cover different clinical perspectives? a cross-sectional study.

BACKGROUND: Early identification of frailty is important for proactive primary care. Currently, however, there is no consensus on which measure to use. Therefore, we examined whether a Frailty Index (FI), based on ICPC-coded primary care data, and the Groningen Frailty Indicator (GFI) questionnaire identify the same older people as frail. METHODS: We conducted a cross-sectional, observational study of 1,580 patients aged ≥ 60 years in a Dutch primary care center. Patients received a GFI questionnaire and were surveyed on their baseline characteristics. Frailty-screening software calculated their FI score. The GFI and FI scores were compared as continuous and dichotomised measures. RESULTS: FI data were available for 1549 patients (98%). 663 patients (42%) returned their GFI questionnaire. Complete GFI and FI scores were available for 638 patients (40.4%), mean age 73.4 years, 52.8% female. There was a positive correlation between the GFI and the FI (Pearson's correlation coefficient 0.544). Using dichotomised scores, 84.3% of patients with a low FI score also had a low GFI score. In patients with a high FI score, 55.1% also had a high GFI score. A continuous FI score accurately predicted a dichotomised GFI score (AUC 0.78, 95% CI 0.74 to 0.82). Being widowed or divorced was an independent predictor of both a high GFI score in patients with a low FI score, and a high FI score in patients with a low GFI score. CONCLUSIONS: The FI and the GFI moderately overlap in identifying frailty in community-dwelling older patients. To provide optimal proactive primary care, we suggest an initial FI screening in routine healthcare data, followed by a GFI questionnaire for patients with a high FI score or otherwise at high risk as the preferred two-step frailty screening process in primary care.

Factors associated with increasing functional decline in multimorbid independently living older people.

OBJECTIVES: With increasing age the levels of activities of daily living (ADL) deteriorate. In this study we aimed to investigate which demographic characteristics and disorders are associated with ADL disabilities in multi-morbid older people. STUDY DESIGN: We performed a cross-sectional study with baseline patient data from a large Dutch trial in independently living multi-morbid older people combined with the reimbursed healthcare data for the same subjects. MAIN OUTCOME MEASURES: The primary outcome of our study was the level of independence of activities of daily living (ADL) as assessed with the Modified Katz Activities of Daily Living (KATZ-15) scale. RESULTS: In our study we were able to include 1187 persons (63.0% female) for whom both questionnaire data and reimbursed healthcare data was available. In total, 59% had a Katz-15 score of 1 or higher. The strongest associations with ADL disabilities in women were psychiatric disorders, with prevalence rate (PR) estimates of 1.37 (95% confidence interval (CI): 1.17-1.60) and transient ischaemic attacks and cerebrovasculair accidents in men, with PR estimates of 1.94 (95% CI: 1.41-2.66). Although univariate analysis seemed to also reveal associations with socio-demographic factors such as living together with a partner or the socio-economic status, these factors were not independently associated with ADL disabilities. CONCLUSIONS: In this cross-sectional study we found that 71% of the multi-morbid female elderly had a sub-optimal level of activities of daily living, as assessed with the Katz-15 scale. The results of our study show that multiple disorders are associated with ADL disabilities in multi-morbid older men and women. We found socio-demographic characteristics not to be independently associated ADL disabilities.

Exploring the expectations, needs and experiences of general practitioners and nurses towards a proactive and structured care programme for frail older patients: a mixed-methods study.

AIM: To report the expectations and experiences of general practitioners and practice nurses regarding the U-CARE programme, to gain a better understanding of the barriers and facilitators in providing proactive, structured care to frail older people and to determine whether implementation is feasible. BACKGROUND: Care for older patients with complex care needs in primary care is fragmented, reactive and time consuming. A structured, proactive care programme was developed to improve physical functioning and quality of life in frail older patients. DESIGN: An explanatory mixed-methods study nested in a cluster-randomized trial. METHODS: The barriers to and needs for the provision of structured, proactive care, and expectations regarding the U-CARE programme were assessed with pre-questionnaires sent to all participating general practitioners (n = 32) and practice nurses (n = 21) in October 2010. Postquestionnaires measured experiences with the programme after 5 months. Twelve months later, focus group meetings were conducted. RESULTS: Practice nurses and general practitioners reported that it was difficult to provide proactive and structured care to older patients with multi-morbidity, different cultural backgrounds and low socioeconomic status. Barriers were a lack of time and financial compensation. Most general practitioners and practice nurses indicated that the programme added value for the coordination of care and allowed them to provide structured care. CONCLUSION: This explanatory mixed-methods study showed that general practitioners and practice nurses perceived the U-CARE programme as feasible in general practice. A transition was made from reactive, ad hoc care towards a proactive and preventive care approach.

Development of a proactive care program (U-CARE) to preserve physical functioning of frail older people in primary care.

PURPOSE: Care for older patients in primary care is currently reactive, fragmented, and time consuming. An innovative structured and proactive primary care program (U-CARE) has been developed to preserve physical functioning and enhance quality of life of frail older people. This study describes in detail the development process of the U-CARE program to allow its replication. METHODS: The framework of the Medical Research Council (MRC) for the development and evaluation of complex interventions was used as a theoretical guide for the design of the U-CARE program. An extended stepwise multimethod procedure was used to develop U-CARE. A team of researchers, general practitioners, registered practice nurses, experts, and an independent panel of older persons was involved in the development process to increase its feasibility in clinical practice. A systematic review of the literature and of relevant guidelines, combined with clinical practice experience and expert opinion, was used for the development of the intervention. FINDINGS: Based on predefined potentially effective guiding components, the U-CARE program comprises three steps: a frailty assessment, a comprehensive geriatric assessment at home followed by a tailor-made care plan, and multiple follow-up visits. Evidence-based care plans were developed for 11 geriatric conditions. The feasibility in clinical practice was tested and approved by experienced registered practice nurses. CONCLUSIONS: Using the MRC Framework, a detailed description of the development process of the innovative U-CARE program is provided, which is often missing in reports of complex intervention trials. Based on our feasibility-pilot study, the general practitioners and the registered practice nurses indicated that the U-CARE intervention is feasible in clinical practice. CLINICAL RELEVANCES: The U-CARE program consists of promising components and has the potential to improve the care of older patients.

Prediction of adverse health outcomes in older people using a frailty index based on routine primary care data.

BACKGROUND: A general frailty indicator could guide general practitioners (GPs) in directing their care efforts to the patients at highest risk. We investigated if a Frailty Index (FI) based on the routine health care data of GPs can predict the risk of adverse health outcomes in community-dwelling older people. METHODS: This was a retrospective cohort study with a 2-year follow-up period among all patients in an urban primary care center aged 60 and older: 1,679 patients (987 women [59%], median age, 73 years [interquartile range, 65-81]). For each patient, a baseline FI score was computed as the number of health deficits present divided by the total number of 36 deficits on the FI. Adverse health outcomes were defined as the first registered event of an emergency department (ED) or after-hours GP visit, nursing home admission, or death. RESULTS: In total, 508 outcome events occurred within the sample population. Kaplan-Meier survival curves were constructed according to FI tertiles. The tertiles were able to discriminate between patients with low, intermediate, and high risk for adverse health outcomes (p value < .001). With adjustments for age, consultation gap, and sex, a one deficit increase in the FI score was associated with an increased hazard for adverse health outcomes (hazard ratio, 1.166; 95% confidence interval [CI], 1.129-1.210) and a moderate predictive ability for adverse health outcomes (c-statistic, 0.702; 95% CI, 0.680-0.724). CONCLUSIONS: An FI based on International Classification of Primary Care (ICPC)-encoded routine health care data does predict the risk of adverse health outcomes in elderly population.

Proactive and integrated primary care for frail older people: design and methodological challenges of the Utrecht primary care PROactive frailty intervention trial (U-PROFIT).

BACKGROUND: Currently, primary care for frail older people is reactive, time consuming and does not meet patients' needs. A transition is needed towards proactive and integrated care, so that daily functioning and a good quality of life can be preserved. To work towards these goals, two interventions were developed to enhance the care of frail older patients in general practice: a screening and monitoring intervention using routine healthcare data (U-PRIM) and a nurse-led multidisciplinary intervention program (U-CARE). The U-PROFIT trial was designed to evaluate the effectiveness of these interventions. The aim of this paper is to describe the U-PROFIT trial design and to discuss methodological issues and challenges. METHODS/DESIGN: The effectiveness of U-PRIM and U-CARE is being tested in a three-armed, cluster randomized trial in 58 general practices in the Netherlands, with approximately 5000 elderly individuals expected to participate. The primary outcome is the effect on activities of daily living as measured with the Katz ADL index. Secondary outcomes are quality of life, mortality, nursing home admission, emergency department and out-of-hours General Practice (GP), surgery visits, and caregiver burden. DISCUSSION: In a large, pragmatic trial conducted in daily clinical practice with frail older patients, several challenges and methodological issues will occur. Recruitment and retention of patients and feasibility of the interventions are important issues. To enable broad generalizability of results, careful choices of the design and outcome measures are required. Taking this into account, the U-PROFIT trial aims to provide robust evidence for a structured and integrated approach to provide care for frail older people in primary care. TRIAL REGISTRATION: NTR2288.