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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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)

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

Intervention / Treatment
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* Other: Multi-PAP
* Other: Usual care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multi-PAP intervention<br>Complex intervention with general practitioners and patients | Other: Multi-PAP<br>* Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview.<br>Other: Usual care<br>* Patients will receive the usual clinical care based on current clinical practice guidelines.<br>|
| Active Comparator: Usual care<br>Patients will receive the usual clinical care | Other: Usual care<br>* Patients will receive the usual clinical care based on current clinical practice guidelines.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Appropriateness Index (MAI) score |  | Change from baseline MAI score at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Medication Appropriateness Index (MAI) score | Quality of Life | Change from baseline MAI score at 12 months | 
| Morisky-Green questionnaire | Therapeutic adherence questionnaire | Baseline, at six 6 months and at 12 months | 
| Haynes-Sackett test | Therapeutic adherence test | Baseline, at six 6 months and at 12 months | 
| Euroqol 5D-5L questionnaire |  | Baseline, at six 6 months and at 12 months | 
| Use of health services | Unscheduled and/or avoidable hospitalizations, use of emergency services and primary care (FP and nurse). | at six 6 months and at 12 months | 
| Medication safety | measured as the incidence of adverse drug reactions and potentially hazardous interactions, classified using the taxonomy proposed by Otero-López | at six 6 months and at 12 months | 
| Patient perception of shared decision-making | measured using a single, multiple choice question, formulated ad hoc. | Baseline and at six 6 months and at 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multimorbidity, Primary Health Care, Polypharmacy, Comorbidity, Medication Adherence, Medication Appropriateness Index, Patient-Centered Care