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

<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>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.</p> <p>Trial registration</p> <p><a href="http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=2288">NTR2288</a></p

Is het proactieve zorgprogramma voor kwetsbare ouderen uitgevoerd zoals gepland? Een analyse van interventiegetrouwheid

Full text beschikbaar met HU-account. Het evalueren van de effectiviteit van een complexe interventie in een gerandomiseerde klinische trial is niet eenvoudig.1,2) In de literatuur wordt een interventie als effectief beschouwd wanneer er een positief resultaat op de primaire uitkomst is gevonden. Echter, om de validiteit en betrouwbaarheid van een interventie te beoordelen is kennis nodig over de mate waarin de interventie is uitgevoerd als gepland, ofwel de interventiegetrouwheid.3) Daarnaast geeft kennis over interventiegetrouwheid inzicht in hoeverre de implementatie succesvol was en daadwerkelijk een bijdrage heeft kunnen leveren aan de geobserveerde uitkomsten

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

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

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