Clinical trial NCT04147130: MultiPAP Plus: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
Official title: Efectiveness of the MultiPAP Plus Intervention in Young-old Patients With Multimorbidity and Polypharmacy Aimed at Improving Prescription in Primary Care: Cluster RCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Polypharmacy
Comorbidities and Coexisting Conditions
Clinical Decision-Support Systems
Keywords: Primary Health Care
Medication Adherence
Disability
Patient-Centered Care
Ariadne Principles
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Sponsor class: OTHER_GOV
Collaborators: name: Gerencia de Atención Primaria, Madrid
name: Aragon Institute for Health Research (IIS Aragón)
name: Andaluz Health Service
name: Fundación de Investigación e Innovación Biomédica Atención Primaria (FIIBAP)
name: Red de Investigación en Servicios de Salud en Enfermedades Crónicas
name: Instituto de Salud Carlos III
First posted: 2019-10-31
Enrollment: 1162
Sex: ALL
Minimum age (years): 65
Maximum age (years): 74
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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 hospitalization-mortality at six 6 (T1), 12 (T2) and 18 (T3) months from baseline compared to usual care.

Detailed description: Design: Pragmatic cluster randomized clinical trial with 18 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=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.

Eligibility 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

Primary outcomes:
measure: Hospitalizations and/or mortality
timeFrame: From Baseline to Month 18
Secondary outcomes:
measure: Hospitalizations and/or mortality (T2)
timeFrame: From Baseline to Month 12
measure: Therapeutic adherence questionnaire
timeFrame: Baseline, 6, 12 and 18 months
measure: Medication Safety: Potentially Drug-Drug interactions (DDI), Potentially Innappropiate Medication (PIM), Adverse Drug Reactions
timeFrame: Baseline, 6, 12 and 18 months
measure: Use of health services
timeFrame: at 12 and at 18 months
measure: Disability
timeFrame: Baseline, 12 and 18 months
measure: Perceived Quality of Life: Euroqol 5D-5L questionnaire
timeFrame: Baseline, 12 and 18 months
measure: System Usability Scale of the CDSS
timeFrame: at 6 and 18 months.
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Servicio Andaluz de Salud
state: Andalucía
city: Zaragoza
country: Spain
facility: Instituto Aragonés de Ciencias de la Salud (IACS)
state: Aragón
city: Madrid
country: Spain
facility: Gerencia Asistencial de Atención Primaria de Madrid
Study officials:
affiliation: Instituto Aragonés de Ciencias de la Salud (IACS)
name: Alexandra Prados-Torres, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio Andaluz de Salud (Andaluz Health Service)
name: Daniel Prados-Torres, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gerencia Asistencial de Atención Primaria, Madrid
name: Isabel Del Cura-González, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.