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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02866799

Acronym

Multi-PAP

Enrollment

593

Registered

2016-08-15

Start date

2016-11-30

Completion date

2018-02-28

Last updated

2020-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multimorbidity, Other Diagnoses, Comorbidities, and Complications, Polypharmacy

Keywords

Multimorbidity, Primary Health Care, Polypharmacy, Comorbidity, Medication Adherence, Medication Appropriateness Index, Patient-Centered Care

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.

Interventions

OTHERMulti-PAP

Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview.

OTHERUsual care

Patients will receive the usual clinical care based on current clinical practice guidelines.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

HEALTH_SERVICES_RESEARCH

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to 74 Years

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

Design outcomes

Primary

Measure	Time frame
Medication Appropriateness Index (MAI) score	Change from baseline MAI score at 6 months

Secondary

Measure	Time frame	Description
Morisky-Green questionnaire	Baseline, at six 6 months and at 12 months	Therapeutic adherence questionnaire
Haynes-Sackett test	Baseline, at six 6 months and at 12 months	Therapeutic adherence test
Euroqol 5D-5L questionnaire	Baseline, at six 6 months and at 12 months	—
Medication Appropriateness Index (MAI) score	Change from baseline MAI score at 12 months	Quality of Life
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
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.
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).

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026