Background The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process. Objective To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care. Methods/design This is a pragmatic cluster-randomized clinical trial with a follow-up of 18 months in health centres of the Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient. Population Patients aged 65–74 years with multimorbidity (≥ 3 chronic diseases) and polypharmacy (≥ 5 drugs) during the previous 3 months were included. Sample size n = 1148 patients (574 per study arm). Intervention Complex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system. Outcomes The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome, and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables. Statistical analysis The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle. Discussion It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT-enhanced routine clinical practice could improve the prescription process in patient care. Trial registration ClinicalTrials.gov NCT04147130. Registered on 22 October 2019
Background: The progressive ageing of the population is leading to an increase in multimorbidity and polypharmacy, which in turn may increase the risk of hospitalization and mortality. The enhancement of care with information and communications technology (ICT) can facilitate the use of prescription evaluation tools and support system for decision-making (DSS) with the potential of optimizing the healthcare delivery process.Objective: To assess the effectiveness and cost-effectiveness of the complex intervention MULTIPAP Plus, compared to usual care, in improving prescriptions for young-old patients (65-74 years old) with multimorbidity and polypharmacy in primary care. Methods/Design: This is a pragmatic cluster randomized clinical trial with a follow-up of 18 months in health centres Spanish National Health System. Unit of randomization: family physician. Unit of analysis: patient. Population: Patients aged 65–74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs) during the previous three months were included.Sample size: n = 1148 patients (574 per study arm). Intervention: complex intervention based on the ARIADNE principles with three components: (1) Family Physicians (FP) training, (2) FP-patient interview, and (3) decision-making support system. Outcomes: The primary outcome is a composite endpoint of hospital admission or death during the observation period measured as a binary outcome and the secondary outcomes are number of hospital admission, all-cause mortality, use of health services, quality of life (EQ-5D-5L), functionality (WHODAS), falls, hip fractures, prescriptions and adherence to treatment. Clinical and sociodemographic factors will be explanatory variables.Statistical Analysis: The main result is the difference in percentages in the final composite endpoint variable at 18 months, with its corresponding 95% CI. Adjustments by the main confounding and prognostic factors will be performed through a multilevel analysis. All analyses will be carried out in accordance to the intention-to-treat principle.Discussion: It is important to prevent the cascade of negative health and health care impacts attributable to the multimorbidity-polypharmacy binomial. ICT enhanced routine clinical practice could improve the prescription process in patient care. Trial registration: ClinicalTrials.gov, Identifier: NCT04147130. Registered 22 October 2019https://clinicaltrials.gov/ct2/show/NCT04147130
Mean age was 75 (±9.3), 63.7% males with a BMI of 29.4 (±7.1), and 21% active smokers. Mean FEV1, 48.2% (±18.7). Mean exacerbations in the first period, 2.86 (±2.29) and in the second 1.36 (±1.56) (P<.001). Mean hospital admissions in the first and second period, 0.56 (±0.94) and 0.31 (±0.66) (P<.001), respectively. The decrease in the number of exacerbations was directly associated with having ≥2 exacerbations in the first period, reviewed in Primary Care, and inversely with heart failure and with having ≥2 exacerbations in the second period (R2=0.28; P<.001) CONCLUSIONS: The number of exacerbations and admissions decreased significantly in both periods assessed. However, the evaluated process indicators did not improve. Prospective intervention studies are necessary to establish the possible causal relationship.
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