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

August 4, 2020 updated by: Alexandra Prados Torres, Instituto Aragones de Ciencias de la Salud

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

593

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain
    • Andalucía
      • Málaga, Andalucía, Spain
    • Aragón
      • Zaragoza, Aragón, Spain

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 74 years (OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: HEALTH_SERVICES_RESEARCH
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto Aragones de Ciencias de la Salud

Collaborators

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

Investigators

  • Principal Investigator: Alexandra Prados-Torres, MD, PhD, Instituto Aragonés de Ciencias de la Salud (IACS)
  • Principal Investigator: Isabel Del Cura-González, MD, PhD, Gerencia de Atención Primaria, Madrid

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

August 5, 2016

First Submitted That Met QC Criteria

August 12, 2016

First Posted (ESTIMATE)

August 15, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 6, 2020

Last Update Submitted That Met QC Criteria

August 4, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI: 15/00572,15/00276,15/00996

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Multimorbidity

Clinical Trials on Usual care

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mexico

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe