Dataset Information

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

ABSTRACT:

Background

Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the aim of prioritizing and sharing realistic treatment goals that guide an individualized management. The aim of this study is to evaluate the effectiveness of a complex intervention that implements the Ariadne principles in a population of young-old patients with multimorbidity and polypharmacy. The intervention seeks to improve the appropriateness of prescribing in primary care (PC), as measured by the medication appropriateness index (MAI) score at 6 and 12 months, as compared with usual care.

Methods/design

Design: pragmatic cluster randomized clinical trial. Unit of randomization: family physician (FP). Unit of analysis: patient.

Scope

PC health centres in three autonomous communities: Aragon, Madrid, and Andalusia (Spain).

Population

patients aged 65-74 years with multimorbidity (≥3 chronic diseases) and polypharmacy (≥5 drugs prescribed in ≥3 months).

Sample size

n = 400 (200 per study arm).

Intervention

complex intervention based on the implementation of the Ariadne principles with two components: (1) FP training and (2) FP-patient interview.

Outcomes

MAI score, health services use, quality of life (Euroqol 5D-5L), pharmacotherapy and adherence to treatment (Morisky-Green, Haynes-Sackett), and clinical and socio-demographic variables.

Statistical analysis

primary outcome is the difference in MAI score between T0 and T1 and corresponding 95% confidence interval. Adjustment for confounding factors will be performed by multilevel analysis. All analyses will be carried out in accordance with the intention-to-treat principle.

Discussion

It is essential to provide evidence concerning interventions on PC patients with polypharmacy and multimorbidity, conducted in the context of routine clinical practice, and involving young-old patients with significant potential for preventing negative health outcomes.

Trial registration

Clinicaltrials.gov, NCT02866799.

SUBMITTER: Prados-Torres A

PROVIDER: S-EPMC5406997 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Publications

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

Prados-Torres Alexandra A Del Cura-González Isabel I Prados-Torres Daniel D López-Rodríguez Juan A JA Leiva-Fernández Francisca F Calderón-Larrañaga Amaia A López-Verde Fernando F Gimeno-Feliu Luis A LA Escortell-Mayor Esperanza E Pico-Soler Victoria V Sanz-Cuesta Teresa T Bujalance-Zafra Mª Josefa MJ Morey-Montalvo Mariel M Boxó-Cifuentes José Ramón JR Poblador-Plou Beatriz B Fernández-Arquero José Manuel JM González-Rubio Francisca F Ramiro-González María D MD Coscollar-Santaliestra Carlos C Martín-Fernández Jesús J Barnestein-Fonseca Mª Pilar MP Valderas-Martínez José María JM Marengoni Alessandra A Muth Christiane C

Implementation science : IS 20170427 1

<h4>Background</h4>Multimorbidity is associated with negative effects both on people's health and on healthcare systems. A key problem linked to multimorbidity is polypharmacy, which in turn is associated with increased risk of partly preventable adverse effects, including mortality. The Ariadne principles describe a model of care based on a thorough assessment of diseases, treatments (and potential interactions), clinical status, context and preferences of patients with multimorbidity, with the ...[more]

PMID: 28449721

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Project description:BackgroundThe 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.ObjectiveTo 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/designThis 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.PopulationPatients aged 65-74 years with multimorbidity (≥ 3 chronic diseases) and polypharmacy (≥ 5 drugs) during the previous 3 months were included.Sample sizen = 1148 patients (574 per study arm).InterventionComplex intervention based on the ARIADNE principles with three components: (1) family physician (FP) training, (2) FP-patient interview, and (3) decision-making support system.OutcomesThe 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 analysisThe 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.DiscussionIt 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 registrationClinicalTrials.gov NCT04147130 . Registered on 22 October 2019.

Project description:ObjectivesTo assess the effectiveness of a pharmacist-led systematic review of medications on: potentially inappropriate medications (PIM), health outcomes and costs.DesignProspective, open, controlled and cluster-randomized clinical trial.SettingSix primary care clinics from Balearic Islands.ParticipantsForty-two clusters (21 per group), and 549 patients aged ≥65 years and ≥5 chronic medications were included; of which 277 were allocated to Intervention Group (IG) and 272 to Control Group (CG). Patients were excluded if they were: institutionalized, temporarily displaced, routinely monitored under private healthcare, or home care.InterventionPIM detection by the pharmacist using a combination of explicit and implicit methods; and communication of the most appropriate therapeutic strategies to the physician.MeasurementsProportion of patients with PIM and mean number of PIM/patient (main outcomes); and morbidity, mortality, and costs (secondary outcomes) were assessed.Statistical planFollowing an intention-to-treat approach, quantitative and qualitative outcomes variables were compared by T-Student and Chi-square tests, respectively. Results were providing as difference in proportions for qualitative outcomes and difference in means for quantitative outcomes with respective 95% confidence intervals (95% CI).ResultsAfter intervention, proportion of patients with PIM decreased by 13.7% (95% CI: 9.3; 18.2) more in IG than CG. Mean number of PIM/patient and mean cost of PIM/patient decreased by 0.43 (95% CI: 0.32; 0.54) and 72.11€ (95% CI: 26.15; 118.06) more in IG than CG, respectively. However, no statistically significant differences were observed in morbidity, mortality or costs of healthcare resources.ConclusionsPIM detection and recommendations provided by pharmacist could contribute to reduce significantly PIM and drug expenditure; but without reaching statistically significant differences in morbidity, mortality, and healthcare resources costs.

Project description:ObjectiveTo study the effects of a primary care medication review intervention centred around an electronic clinical decision support system (eCDSS) on appropriateness of medication and the number of prescribing omissions in older adults with multimorbidity and polypharmacy compared with a discussion about medication in line with usual care.DesignCluster randomised clinical trial.SettingSwiss primary care, between December 2018 and February 2021.ParticipantsEligible patients were ≥65 years of age with three or more chronic conditions and five or more long term medications.InterventionThe intervention to optimise pharmacotherapy centred around an eCDSS was conducted by general practitioners, followed by shared decision making between general practitioners and patients, and was compared with a discussion about medication in line with usual care between patients and general practitioners.Main outcome measuresPrimary outcomes were improvement in the Medication Appropriateness Index (MAI) and the Assessment of Underutilisation (AOU) at 12 months. Secondary outcomes included number of medications, falls, fractures, and quality of life.ResultsIn 43 general practitioner clusters, 323 patients were recruited (median age 77 (interquartile range 73-83) years; 45% (n=146) women). Twenty one general practitioners with 160 patients were assigned to the intervention group and 22 general practitioners with 163 patients to the control group. On average, one recommendation to stop or start a medication was reported to be implemented per patient. At 12 months, the results of the intention-to-treat analysis of the improvement in appropriateness of medication (odds ratio 1.05, 95% confidence interval 0.59 to 1.87) and the number of prescribing omissions (0.90, 0.41 to 1.96) were inconclusive. The same was the case for the per protocol analysis. No clear evidence was found for a difference in safety outcomes at the 12 month follow-up, but fewer safety events were reported in the intervention group than in the control group at six and 12 months.ConclusionsIn this randomised trial of general practitioners and older adults, the results were inconclusive as to whether the medication review intervention centred around the use of an eCDSS led to an improvement in appropriateness of medication or a reduction in prescribing omissions at 12 months compared with a discussion about medication in line with usual care. Nevertheless, the intervention could be safely delivered without causing any harm to patients.Trial registrationNCT03724539Clinicaltrials.gov NCT03724539.

Project description:BackgroundIncreased physical activity (PA) has positive effects on health and longevity. In Swedish healthcare, the physical activity on prescription (PAP) method reportedly increases patients' PA levels for up to 12 months, but long-term follow ups are lacking. As it remains difficult to maintain lifestyle changes, our aim was to evaluate adherence and clinical effects at a 5-year follow-up of PAP treatment in primary healthcare.MethodsThis longitudinal, prospective cohort study included 444 patients, (56% female), aged 27-85 years, with at least one metabolic risk factor. Participants were offered PAP by nurses or physiotherapists. The PAP intervention included an individualised dialogue, a PA recommendation by written prescription, and individually adjusted follow-up over 5 years, according to the Swedish PAP model. Patient PA level, metabolic risk factors, and health related quality of life (HRQoL) were measured at baseline and at the 6-month, 1.5-year, 2.5-year, 3.5-year, and 5-year follow-ups. Estimated latent growth curves were used to examine levels and rates of change in the outcomes.ResultsThe study dropout rate was 52%, with 215 of 444 patients completing the 5-year follow-up. At follow-up, the mean PA level had increased by 730 MET-minutes per week or 3 hours of moderate-intensity PA/week when compared to baseline. During the 5-year intervention, we observed significant positive changes (p ≤ 0.05) in 9 of 11 metabolic risk factors and HRQoL parameters: body mass index, waist circumference, systolic and diastolic blood pressure, fasting plasma glucose, triglycerides, cholesterol, high-density lipoprotein, and mental component summary.ConclusionThis first evaluation of a 5-year PAP intervention in primary care demonstrated positive long-term (5 years) effects regarding PA level, metabolic health, and HRQoL. The recorded long-term adherence was ~50%, which is in line with medical treatment. Despite limitations, PAP can have long-term effects in an ordinary primary care setting.

Project description:ObjectivesInvestigate the effectiveness of a complex intervention aimed at improving the appropriateness of medication in older patients with multimorbidity in general practice.DesignPragmatic, cluster randomised controlled trial with general practice as unit of randomisation.Setting72 general practices in Hesse, Germany.Participants505 randomly sampled, cognitively intact patients (≥60 years, ≥3 chronic conditions under pharmacological treatment, ≥5 long-term drug prescriptions with systemic effects); 465 patients and 71 practices completed the study.InterventionsIntervention group (IG): The healthcare assistant conducted a checklist-based interview with patients on medication-related problems and reconciled their medications. Assisted by a computerised decision support system, the general practitioner optimised medication, discussed it with patients and adjusted it accordingly. The control group (CG) continued with usual care.Outcome measuresThe primary outcome was a modified Medication Appropriateness Index (MAI, excluding item 10 on cost-effectiveness), assessed in blinded medication reviews and calculated as the difference between baseline and after 6 months; secondary outcomes after 6 and 9 months' follow-up: quality of life, functioning, medication adherence, and so on.ResultsAt baseline, a high proportion of patients had appropriate to mildly inappropriate prescriptions (MAI 0-5 points: n=350 patients). Randomisation revealed balanced groups (IG: 36 practices/252 patients; CG: 36/253). Intervention had no significant effect on primary outcome: mean MAI sum scores decreased by 0.3 points in IG and 0.8 points in CG, resulting in a non-significant adjusted mean difference of 0.7 (95% CI -0.2 to 1.6) points in favour of CG. Secondary outcomes showed non-significant changes (quality of life slightly improved in IG but continued to decline in CG) or remained stable (functioning, medication adherence).ConclusionsThe intervention had no significant effects. Many patients already received appropriate prescriptions and enjoyed good quality of life and functional status. We can therefore conclude that in our study, there was not enough scope for improvement.Trial registration numberISRCTN99526053. NCT01171339; Results.

Project description:ObjectivesTo evaluate the effectiveness of an intervention, with and without a height adjustable desk, on daily sitting time, and to investigate the relative effectiveness of the two interventions, and the effectiveness of both interventions on physical behaviours and physical, biochemical, psychological, and work related health and performance outcomes.DesignCluster three arm randomised controlled trial with follow-up at three and 12 months.SettingLocal government councils in Leicester, Liverpool, and Greater Manchester, UK.Participants78 clusters including 756 desk based employees in defined offices, departments, or teams from two councils in Leicester, three in Greater Manchester, and one in Liverpool.InterventionsClusters were randomised to one of three conditions: the SMART Work and Life (SWAL) intervention, the SWAL intervention with a height adjustable desk (SWAL plus desk), or control (usual practice).Main outcomes measuresThe primary outcome measure was daily sitting time, assessed by accelerometry, at 12 month follow-up. Secondary outcomes were accelerometer assessed sitting, prolonged sitting, standing and stepping time, and physical activity calculated over any valid day, work hours, workdays, and non-workdays, self-reported lifestyle behaviours, musculoskeletal problems, cardiometabolic health markers, work related health and performance, fatigue, and psychological measures.ResultsMean age of participants was 44.7 years, 72.4% (n=547) were women, and 74.9% (n=566) were white. Daily sitting time at 12 months was significantly lower in the intervention groups (SWAL -22.2 min/day, 95% confidence interval -38.8 to -5.7 min/day, P=0.003; SWAL plus desk -63.7 min/day, -80.1 to -47.4 min/day, P<0.001) compared with the control group. The SWAL plus desk intervention was found to be more effective than SWAL at changing sitting time (-41.7 min/day, -56.3 to -27.0 min/day, P<0.001). Favourable differences in sitting and prolonged sitting time at three and 12 month follow-ups for both intervention groups and for standing time for the SWAL plus desk group were observed during work hours and on workdays. Both intervention groups were associated with small improvements in stress, wellbeing, and vigour, and the SWAL plus desk group was associated with improvements in pain in the lower extremity, social norms for sitting and standing at work, and support.ConclusionsBoth SWAL and SWAL plus desk were associated with a reduction in sitting time, although the addition of a height adjustable desk was found to be threefold more effective.Trial registrationISRCTN Registry ISRCTN11618007.

Dataset Information

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

Background

Methods/design

Scope

Population

Sample size

Intervention

Outcomes

Statistical analysis

Discussion

Trial registration

Publications

Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project).

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