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Completed

NCT Number: NCT02866799

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

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.

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Key information

Conditions

Multimorbidity Behavior Health Behavior Medication Adherence Other Diagnoses, Comorbidities, and Complications Patient Acceptance of Health Care Patient Compliance Polypharmacy Treatment Adherence and Compliance

Age range

65 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Málaga, Andalusia, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Multi-PAP

Other

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

Usual Care

Other

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

Primary outcomes

  1. Medication Appropriateness Index (MAI) score

    Time frame: Change from baseline MAI score at 6 months

Secondary outcomes

  1. Medication Appropriateness Index (MAI) score

    Time frame: Change from baseline MAI score at 12 months

    Quality of Life

  2. Morisky-Green questionnaire

    Time frame: Baseline, at six 6 months and at 12 months

    Therapeutic adherence questionnaire

  3. Haynes-Sackett test

    Time frame: Baseline, at six 6 months and at 12 months

    Therapeutic adherence test

  4. Euroqol 5D-5L questionnaire

    Time frame: Baseline, at six 6 months and at 12 months

  5. Use of health services

    Time frame: at six 6 months and at 12 months

    Unscheduled and/or avoidable hospitalizations, use of emergency services and primary care (FP and nurse).

  6. Medication safety

    Time frame: 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

  7. Patient perception of shared decision-making

    Time frame: Baseline and at six 6 months and at 12 months

    measured using a single, multiple choice question, formulated ad hoc.

Sponsors and collaborators

Lead sponsor

Instituto Aragones de Ciencias de la Salud

Other Gov

Collaborators

  • Andaluz Health Service
  • Aragon Institute for Health Research (IIS Aragón)
  • Gerencia de Atención Primaria, Madrid
  • Instituto de Salud Carlos III
  • Red de Investigación en Servicios de Salud en Enfermedades Crónicas

Registry information

Official study title

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)

Acronym: Multi-PAP

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 15, 2016
Registry last updated
Aug 6, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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