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

• ClinicalTrials.gov Identifier: NCT04147130
• Recruitment Status: Recruiting
• First Posted: October 31, 2019
• Last Update Posted: February 28, 2020
• Sponsor: Instituto Aragones de Ciencias de la Salud
• Collaborators: Gerencia de Atención Primaria, Madrid; Aragon Institute for Health Research (IIS Aragón); Andaluz Health Service; Fundación de Investigación e Innovación Biomédica Atención Primaria (FIIBAP); 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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Multimorbidity; Polypharmacy; Comorbidities and Coexisting Conditions; Clinical Decision-Support Systems	Other: MultiPAP Plus; Other: Usual care	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 1234 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Health Services Research
• 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
• Actual Study Start Date: February 18, 2020
• Estimated Primary Completion Date: May 2021
• Estimated Study Completion Date: May 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Hospitalizations and/or mortality [ Time Frame: From Baseline to Month 18 ]
   Difference in percentages in the final combined variable

Secondary Outcome Measures :

1. Hospitalizations and/or mortality (T2) [ Time Frame: From Baseline to Month 12 ]
   Difference in percentages in the final combined variable
2. Therapeutic adherence questionnaire [ Time Frame: Baseline, 6, 12 and 18 months ]
   Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence
3. Medication Safety: Potentially Drug-Drug interactions (DDI), Potentially Innappropiate Medication (PIM), Adverse Drug Reactions [ Time Frame: Baseline, 6, 12 and 18 months ]
   Number of Potentially Drug-Drug interactions (DDI) per patient, Number of Potentially Innappropiate Medication (PIM) per patient, Number of Adverse Drug Reactions per patient
4. Use of health services [ Time Frame: at 12 and at 18 months ]
   Number of Unscheduled and/or avoidable hospitalizations, number of visits to emergency services and primary care (Family Physician and nurse).
5. Disability [ Time Frame: Baseline, 12 and 18 months ]
   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.
6. Perceived Quality of Life: Euroqol 5D-5L questionnaire [ Time Frame: Baseline, 12 and 18 months ]

   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.

7. System Usability Scale of the CDSS [ Time Frame: at 6 and 18 months. ]
   It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree

Eligibility Criteria

• Ages Eligible for Study: 65 Years to 74 Years (Older Adult)
• 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

Contacts

Contact: Alexandra Prados-Torres, MD, PhD; +34 976 76 5500 ext 5370; sprados.iacs@aragon.es

Contact: Juan A Lopez-Rodriguez, MD, PhD; +34913700697 ext 300717; juanantonio.lopez@salud.madrid.org

Locations

Spain

Servicio Andaluz de Salud; Recruiting

Málaga, Andalucía, Spain

Contact: Daniel Prados-Torres, MD, PhD +34 951 290 310 juand.prados.sspa@juntadeandalucia.es

Sub-Investigator: Francisca Leiva-Fernández, MD, PhD

Sub-Investigator: Alessandra Marengoni, MD, PhD

Sub-Investigator: Fernando López-Verde, MD

Sub-Investigator: Josefa Bujalance-Zafra, MD, PhD

Sub-Investigator: José M Ruiz-San-Basilio, MD

Sub-Investigator: Nuria García-Aguas-Soler, Pharm, PhD

Sub-Investigator: María I Márquez-Chamizo, MD

Sub-Investigator: María P Barnestein-Fonseca, PhD

Sub-Investigator: Rubén Vázquez Alarcón, MD, PhD

Sub-Investigator: Miguel Domínguez Santaella, MD

Sub-Investigator: Inmaculada Moraga Ropero, Pharmacist

Sub-Investigator: Antonio Jiménez Rios, MD

Instituto Aragonés de Ciencias de la Salud (IACS); Recruiting

Zaragoza, Aragón, Spain

Contact: Alexandra Prados-Torres, MD, PhD +34976765500 ext 5370 sprados.iacs@aragon.es

Sub-Investigator: Amaia Calderón-Larrañaga, PhD

Sub-Investigator: Beatriz Poblador-Plou, Statistician, PhD

Sub-Investigator: Antonio Gimeno-Miguel, PhD

Sub-Investigator: Victoria Pico-Soler, MD

Sub-Investigator: Javier Marta-Moreno, MD, PhD

Sub-Investigator: Mercedes Aza-Pascual-Salcedo, Pharma, PhD

Sub-Investigator: Mercedes Clerencia-Sierra, MD

Sub-Investigator: Carlos Coscollar-Santaliestra, MD

Sub-Investigator: Christiane Muth, MD, PhD

Sub-Investigator: Antonio Poncel-Falcó, MD

Sub-Investigator: Francisca González-Rubio, MD

Sub-Investigator: Luis A Gimeno-Feliu, MD, PhD

Sub-Investigator: Mónica Machón Sobrado, Biologist

Sub-Investigator: Jesús Diez Manglano, MD, PhD

Sub-Investigator: Ana Cristina Bandrés Liso, Pharmacist

Sub-Investigator: Aida Moreno Juste, MD

Sub-Investigator: Inmaculada Guerrero Fernández de Alba, MD

Sub-Investigator: María Bestué Cardiel, MD, PhD

Gerencia Asistencial de Atención Primaria de Madrid; Recruiting

Madrid, Spain

Contact: Isabel Del Cura-González, MD, PhD +34913700697 isabel.cura@salud.madrid.org

Sub-Investigator: Teresa Sanz-Cuesta, MD

Sub-Investigator: Ricardo Rodriguez-Barrientos, MD

Sub-Investigator: Mercedes Rumayor-Zarzuelo, MD

Sub-Investigator: Eugenia Tello-Bernabé, Nurse

Sub-Investigator: Elena Polentinos-Castro, MD, PhD

Sub-Investigator: Ángel Mataix-SanJuan, Pharmacist

Sub-Investigator: Marta Alcaraz-Borrajo, Pharmacist

Sub-Investigator: Virginia Hernández-Santiago, MD

Sub-Investigator: Gloria Ariza-Cardiel, MD

Sub-Investigator: Luis Sánchez-Perruca, MD, PhD

Sub-Investigator: Francisca García-De-Blas, MD

Sub-Investigator: Eloisa Rogero-Blanco, MD

Sub-Investigator: Mar Álvarez-Villalba, MD

Sub-Investigator: Amaya Azcoaga-Lorenzo, MD, PhD

Sub-Investigator: Ana I González-González, MD

Sub-Investigator: Jesús Martín-Fernández, MD, PhD

Sub-Investigator: José M Valderas-Martínez, MD, PhD

Sub-Investigator: Mariel Morey-Montalvo, MD

Sub-Investigator: Juan A López-Rodríguez, MD, PhD

Sub-Investigator: Juan C Gil-Moreno, Statistician

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

Fundación de Investigación e Innovación Biomédica Atención Primaria (FIIBAP)

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 Asistencial de Atención Primaria, Madrid

More Information

• Responsible Party: Alexandra Prados Torres, Principal Investigator, MD, PhD, Instituto Aragones de Ciencias de la Salud
• ClinicalTrials.gov Identifier: NCT04147130
• Other Study ID Numbers: PI 18/01303,18/01515,18/01812
• First Posted: October 31, 2019
• Last Update Posted: February 28, 2020
• Last Verified: February 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Alexandra Prados Torres, Instituto Aragones de Ciencias de la Salud:

Primary Health Care; Medication Adherence; Disability; Patient-Centered Care; Ariadne Principles