NCT04147130

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,162

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 31, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

February 18, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 26, 2023

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

3.9 years

First QC Date

October 22, 2019

Last Update Submit

December 26, 2023

Conditions

MultimorbidityPolypharmacyComorbidities and Coexisting ConditionsClinical Decision-Support Systems

Keywords

Primary Health CareMedication AdherenceDisabilityPatient-Centered CareAriadne Principles

Outcome Measures

Primary Outcomes (1)

  • Hospitalizations and/or mortality

    Difference in percentages in the final combined variable

    From Baseline to Month 18

Secondary Outcomes (7)

  • Hospitalizations and/or mortality (T2)

    From Baseline to Month 12

  • Therapeutic adherence questionnaire

    Baseline, 6, 12 and 18 months

  • Medication Safety: Potentially Drug-Drug interactions (DDI), Potentially Innappropiate Medication (PIM), Adverse Drug Reactions

    Baseline, 6, 12 and 18 months

  • Use of health services

    at 12 and at 18 months

  • Disability

    Baseline, 12 and 18 months

  • +2 more secondary outcomes

Study Arms (2)

MultiPAP Plus intervention

EXPERIMENTAL

Complex intervention with general practitioners and patients

Other: MultiPAP PlusOther: Usual care

Usual care

ACTIVE COMPARATOR

Patients will recieve the usual clinical care

Other: Usual care

Interventions

MultiPAP PlusOTHER

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.

MultiPAP Plus intervention
Usual careOTHER

Patients will receive the usual clinical care based on current clinical practice guidelines.

MultiPAP Plus interventionUsual care

Eligibility Criteria

Age65 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Institutionalized patient at nursing homes or similar
  • Life expectancy \< 12 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Servicio Andaluz de Salud

Málaga, Andalusia, Spain

Location

Instituto Aragonés de Ciencias de la Salud (IACS)

Zaragoza, Aragon, Spain

Location

Gerencia Asistencial de Atención Primaria de Madrid

Madrid, Spain

Location

Related Publications (1)

  • 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.

    PMID: 35681224DERIVED

MeSH Terms

Conditions

Medication Adherence

Condition Hierarchy (Ancestors)

Patient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, MD, PhD

Study Record Dates

First Submitted

October 22, 2019

First Posted

October 31, 2019

Study Start

February 18, 2020

Primary Completion

December 26, 2023

Study Completion

December 26, 2023

Last Updated

December 27, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)