Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
- Conditions
- MultimorbidityPolypharmacyOther Diagnoses, Comorbidities, and Complications
- Interventions
- Other: Multi-PAPOther: Usual care
- Registration Number
- NCT02866799
- Lead Sponsor
- Instituto Aragones de Ciencias de la Salud
- Brief Summary
This study assesses the effectiveness of a complex intervention in young-old patients with multimorbidity and polypharmacy aimed at improving physician drug prescription in primary care, measured by means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.
- Detailed Description
Design: Pragmatic cluster randomized clinical trial with 12 months follow-up.
Unit of randomization: general practitioner.
Unit of analysis: patient.
Setting: Primary Health Care Centres in three different Spanish Autonomous Communities (Aragón, Madrid and Andalucía).
Population: Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months). N=400 patients (200 in each arm, 5 patients per physician) will be recruited by general practitioners before randomization.
Intervention: complex intervention.
Control group: usual care.
Variables: MAI, health care utilization, quality of life (Euroqol 5 Dimensions (5D-5L), drug therapy and adherence (Morisky-Green, Haynes-Sackett), clinical and socio-demographic factors. Economic appraisal variables: time spent training FPs, cost of teaching staff, time spent on physician-patient interviews, utilities measured using the EuroQol 5D-5L.
Analysis: All analyses will be carried out adhering to the intention-to-treat principle. Description of baseline characteristics. Basal comparison between groups. Analysis of main and secondary effectiveness (between-group difference in T1-T0 MAI score, with corresponding 95% Confidence Interval); multilevel analysis will be used to adjust models. Estimated quality-adjusted life years (QALYs) gained at the population level. Calculation of cost-utility ratio.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 593
- Patients 65-74 years of age with multimorbidity (3 or more chronic diseases) and polypharmacy (5 or more drugs taken for at least three months).
- Informed consent.
- Institutionalized patient at nursing homes or similar
- Life expectancy < 12 months
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Multi-PAP intervention Usual care Complex intervention with general practitioners and patients Usual care Usual care Patients will receive the usual clinical care Multi-PAP intervention Multi-PAP Complex intervention with general practitioners and patients
- Primary Outcome Measures
Name Time Method Medication Appropriateness Index (MAI) score Change from baseline MAI score at 6 months
- Secondary Outcome Measures
Name Time Method Morisky-Green questionnaire Baseline, at six 6 months and at 12 months Therapeutic adherence questionnaire
Medication Appropriateness Index (MAI) score Change from baseline MAI score at 12 months Quality of Life
Euroqol 5D-5L questionnaire Baseline, at six 6 months and at 12 months Use of health services at six 6 months and at 12 months Unscheduled and/or avoidable hospitalizations, use of emergency services and primary care (FP and nurse).
Patient perception of shared decision-making Baseline and at six 6 months and at 12 months measured using a single, multiple choice question, formulated ad hoc.
Haynes-Sackett test Baseline, at six 6 months and at 12 months Therapeutic adherence test
Medication safety at six 6 months and at 12 months measured as the incidence of adverse drug reactions and potentially hazardous interactions, classified using the taxonomy proposed by Otero-López