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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04147130
Recruitment Status : Recruiting
First Posted : October 31, 2019
Last Update Posted : February 28, 2020
Sponsor:
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

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.

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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

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.




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



Information from the National Library of Medicine

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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

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): NCT04147130


Contacts
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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
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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
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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
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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    Key Record Dates
Last Update Posted: February 28, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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