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

Instituto Aragones de Ciencias de la Salud

Status: Completed

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

Treatments: Other: Usual care; Other: Multi-PAP

Study type: Interventional

Funder types: Other

Identifiers

NCT02866799

PI: 15/00572,15/00276,15/00996

Details and patient eligibility

About

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.

Full 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.

Enrollment: 593 patients

Sex: All

Ages: 65 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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593 participants in 2 patient groups

Multi-PAP intervention

Experimental group

Description:

Complex intervention with general practitioners and patients

Treatment:

Other: Usual care

Other: Multi-PAP

Usual care

Active Comparator group

Description:

Patients will receive the usual clinical care

Treatment:

Other: Usual care