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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02866799
First Posted: August 15, 2016
Last Update Posted: October 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Gerencia de Atención Primaria, Madrid
Aragon Institute for Health Research (IIS Aragón)
Andaluz Health Service
Red de Investigación en Servicios de Salud y Enfermedades Crónicas (REDISSEC)
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Alexandra Prados Torres, Instituto Aragones de Ciencias de la Salud
  Purpose
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.

Condition Intervention
Multimorbidity Polypharmacy Other Diagnoses, Comorbidities, and Complications Other: Multi-PAP Other: Usual care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Health Services Research
Official 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)

Further study details as provided by Alexandra Prados Torres, Instituto Aragones de Ciencias de la Salud:

Primary Outcome Measures:
  • Medication Appropriateness Index (MAI) score [ Time Frame: Change from baseline MAI score at 6 months ]

Secondary Outcome Measures:
  • Medication Appropriateness Index (MAI) score [ Time Frame: Change from baseline MAI score at 12 months ]
    Quality of Life

  • Morisky-Green questionnaire [ Time Frame: Baseline, at six 6 months and at 12 months ]
    Therapeutic adherence questionnaire

  • Haynes-Sackett test [ Time Frame: Baseline, at six 6 months and at 12 months ]
    Therapeutic adherence test

  • Euroqol 5D-5L questionnaire [ Time Frame: 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).

  • 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

  • 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.


Estimated Enrollment: 400
Actual Study Start Date: November 2016
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: November 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multi-PAP intervention
Complex intervention with general practitioners and patients
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.
Other: Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines.
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.

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 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 CI95%); multilevel analysis will be used to adjust models. Estimated quality-adjusted life years (QALYs) gained at the population level. Calculation of cost-utility ratio.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02866799


Locations
Spain
Málaga, Andalucía, Spain
Zaragoza, Aragón, Spain
Madrid, Spain
Sponsors and Collaborators
Instituto Aragones de Ciencias de la Salud
Gerencia de Atención Primaria, Madrid
Aragon Institute for Health Research (IIS Aragón)
Andaluz Health Service
Red de Investigación en Servicios de Salud y Enfermedades Crónicas (REDISSEC)
Instituto de Salud Carlos III
Investigators
Principal Investigator: Alexandra Prados-Torres, MD, PhD Instituto Aragonés de Ciencias de la Salud (IACS)
Principal Investigator: Daniel Prados-Torres, MD, PhD Servicio Andaluz de Salud (Andaluz Health Service)
Principal Investigator: Isabel Del Cura-González, MD, PhD Gerencia de Atención Primaria, Madrid
  More Information

Publications:
Responsible Party: Alexandra Prados Torres, Medical Doctor, PhD, Instituto Aragones de Ciencias de la Salud
ClinicalTrials.gov Identifier: NCT02866799     History of Changes
Other Study ID Numbers: PI: 15/00572,15/00276,15/00996
First Submitted: August 5, 2016
First Posted: August 15, 2016
Last Update Posted: October 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Alexandra Prados Torres, Instituto Aragones de Ciencias de la Salud:
Multimorbidity
Primary Health Care
Polypharmacy
Comorbidity
Medication Adherence
Medication Appropriateness Index
Patient-Centered Care