MultiPAP Plus: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
NCT ID: NCT04147130
Last Updated: 2023-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1162 participants
INTERVENTIONAL
2020-02-18
2023-12-26
Brief Summary
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Detailed Description
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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=1234 patients (617 in each arm, 8 patients per physician) will be recruited by general practitioners before randomization.
Intervention: Complex intervention incorporating previous MultiPAP intervention (based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient-centered clinical interview) And it adds a clinical-decision support system to help structured treatment-plan review.
Control group: usual care.
Variables: First level (Patient): a) Main: hospitalizations and/or mortality; b) Secondary: health services use, quality of life (Euroqol 5D-5L), disability (WHODAS), fractures, pharmacotherapy and adherence to treatment (Morisky-Green), clinical and socio-demographic. Second level (Physician): a) Socio-demographic. b) CDSS use: acceptance and satisfaction of health care provider use c) Professional background: time in the position, center characteristics and medical education involvement.
Analysis: All analyses will be carried out adhering to the intention-to-treat principle. Description of baseline characteristics. Basal comparison between groups. Analysis of primary outcome: difference in percentages in the final combined variable from 0 (T0) to 18 months (T3), with its corresponding 95% CI. Adjustement by main confounding and prognostic factors will be performed through a multilevel analysis.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
DOUBLE
Study Groups
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MultiPAP Plus intervention
Complex intervention with general practitioners and patients
MultiPAP Plus
Complex intervention incorporating previous MultiPAP intervention (based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient-centered clinical interview) And it adds a clinical-decision support system to help structured treatment-plan review.
Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines.
Usual care
Patients will recieve the usual clinical care
Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines.
Interventions
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MultiPAP Plus
Complex intervention incorporating previous MultiPAP intervention (based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient-centered clinical interview) And it adds a clinical-decision support system to help structured treatment-plan review.
Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines.
Eligibility Criteria
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Inclusion Criteria
* Informed consent.
Exclusion Criteria
* Life expectancy \< 12 months
65 Years
74 Years
ALL
No
Sponsors
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Gerencia de Atención Primaria, Madrid
OTHER_GOV
Aragon Institute for Health Research (IIS Aragón)
UNKNOWN
Andaluz Health Service
OTHER_GOV
Fundación de Investigación e Innovación Biomédica Atención Primaria (FIIBAP)
UNKNOWN
Red de Investigación en Servicios de Salud en Enfermedades Crónicas
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Instituto Aragones de Ciencias de la Salud
OTHER_GOV
Responsible Party
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Alexandra Prados Torres
Principal Investigator, MD, PhD
Principal Investigators
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Alexandra Prados-Torres, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto Aragonés de Ciencias de la Salud (IACS)
Daniel Prados-Torres, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Servicio Andaluz de Salud (Andaluz Health Service)
Isabel Del Cura-González, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Gerencia Asistencial de Atención Primaria, Madrid
Locations
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Servicio Andaluz de Salud
Málaga, Andalusia, Spain
Instituto Aragonés de Ciencias de la Salud (IACS)
Zaragoza, Aragon, Spain
Gerencia Asistencial de Atención Primaria de Madrid
Madrid, , Spain
Countries
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References
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Del Cura-Gonzalez I, Lopez-Rodriguez JA, Leiva-Fernandez F, Gimeno-Feliu LA, Pico-Soler V, Bujalance-Zafra MJ, Dominguez-Santaella M, Polentinos-Castro E, Poblador-Plou B, Ara-Bardaji P, Aza-Pascual-Salcedo M, Rogero-Blanco M, Castillo-Jimenez M, Lozano-Hernandez C, Gimeno-Miguel A, Gonzalez-Rubio F, Medina-Garcia R, Gonzalez-Hevilla A, Gil-Conesa M, Martin-Fernandez J, Valderas JM, Marengoni A, Muth C, Prados-Torres JD, Prados-Torres A; MULTIPAP PLUS Group. Effectiveness of the MULTIPAP Plus intervention in youngest-old patients with multimorbidity and polypharmacy aimed at improving prescribing practices in primary care: study protocol of a cluster randomized trial. Trials. 2022 Jun 9;23(1):479. doi: 10.1186/s13063-022-06293-x.
Other Identifiers
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PI 18/01303,18/01515,18/01812
Identifier Type: -
Identifier Source: org_study_id