NCT02866799

Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 593 (actual)
• Sponsor: Instituto Aragones de Ciencias de la Salud · Other Government
• Sex: All
• Age: 65 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multimorbidity
• Polypharmacy
• Other Diagnoses, Comorbidities, and Complications

Interventions

Type	Name	Description
OTHER	Multi-PAP	Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview.
OTHER	Usual care	Patients will receive the usual clinical care based on current clinical practice guidelines.

Timeline

• Start date: 2016-11-01
• Primary completion: 2018-02-01
• Completion: 2018-02-01
• First posted: 2016-08-15
• Last updated: 2020-08-06

Locations

3 sites across 1 country: Spain