MultiPAP Plus: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy (MultiPAP Plus)

Efectiveness of the MultiPAP Plus Intervention in Young-old Patients With Multimorbidity and Polypharmacy Aimed at Improving Prescription in Primary Care: Cluster RCT

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.

Study Overview

• Status: Completed
• Conditions: Multimorbidity; Polypharmacy; Comorbidities and Coexisting Conditions; Clinical Decision-Support Systems
• Intervention / Treatment: Other: MultiPAP Plus; Other: 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.

• Study Type: Interventional
• Enrollment (Actual): 1162
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Gerencia Asistencial de Atención Primaria de Madrid
  • Andalucía
    • Málaga, Andalucía, Spain
      • Servicio Andaluz de Salud
  • Aragón
    • Zaragoza, Aragón, Spain
      • Instituto Aragonés de Ciencias de la Salud (IACS)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 63 years to 72 years (Older Adult)
• Accepts Healthy Volunteers: No

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

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MultiPAP Plus intervention; Complex intervention with general practitioners and patients	Other: 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.; Other: Usual care; Patients will receive the usual clinical care based on current clinical practice guidelines.
Active Comparator: Usual care; Patients will recieve 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	Measure Description	Time Frame
Hospitalizations and/or mortality	Difference in percentages in the final combined variable	From Baseline to Month 18

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospitalizations and/or mortality (T2)	Difference in percentages in the final combined variable	From Baseline to Month 12
Therapeutic adherence questionnaire	Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence	Baseline, 6, 12 and 18 months
Medication Safety: Potentially Drug-Drug interactions (DDI), Potentially Innappropiate Medication (PIM), Adverse Drug Reactions	Number of Potentially Drug-Drug interactions (DDI) per patient, Number of Potentially Innappropiate Medication (PIM) per patient, Number of Adverse Drug Reactions per patient	Baseline, 6, 12 and 18 months
Use of health services	Number of Unscheduled and/or avoidable hospitalizations, number of visits to emergency services and primary care (Family Physician and nurse).	at 12 and at 18 months
Disability	World Health Organization Disabilty Assessment (WHODAS). 12-items abbreviated scale (0=No Difficulty, 1=Mild Difficulty, 2=Moderate Difficulty, 3=Severe Difficulty, and 4=Extreme Difficulty or Cannot Do). Maximum 48 points.	Baseline, 12 and 18 months
Perceived Quality of Life: Euroqol 5D-5L questionnaire	EQ5D is one of the most widely used health states descriptive system and has a valuation in Spain. EQ-5D questionnaires have 5 dimensions: "Mobility", "Human Autonomy," "Current Activities", "Pain / Discomfort", "Anxiety / Depression" and all dimensions are described by 5 problem levels corresponding to patient response choices. A quality of life score is obtained according to the answers to the questionnaires.	Baseline, 12 and 18 months
System Usability Scale of the CDSS	It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree	at 6 and 18 months.

Collaborators and Investigators

• 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); Fundación de Investigación e Innovación Biomédica Atención Primaria (FIIBAP)
• 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 Asistencial de Atención Primaria, Madrid; Principal Investigator: Daniel Prados-Torres, MD, PhD, Servicio Andaluz de Salud (Andaluz Health Service)

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2020
• Primary Completion (Actual): December 26, 2023
• Study Completion (Actual): December 26, 2023

Study Registration Dates

• First Submitted: October 22, 2019
• First Submitted That Met QC Criteria: October 30, 2019
• First Posted (Actual): October 31, 2019

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 26, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Primary Health Care; Disability; Medication Adherence; Patient-Centered Care; Ariadne Principles
• Other Study ID Numbers: PI 18/01303,18/01515,18/01812

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No