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

Not Applicable

Completed

• Conditions: Multimorbidity; Polypharmacy; Other Diagnoses, Comorbidities, and Complications

• 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.

Study Timeline

• Study First Submitted: 2016-08-05
• Study First Submitted QC: 2016-08-12
• Study First Posted: 2016-08-15
• Study Start: 2016-11
• Primary Completion: 2018-02
• Study Completion: 2018-02
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-04
• Last Update Posted: 2020-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 593

Inclusion Criteria

• 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.

Exclusion Criteria

• Institutionalized patient at nursing homes or similar
• Life expectancy < 12 months

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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