NCT02866799

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 means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) 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
593

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

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

August 5, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 15, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2018

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

1.3 years

First QC Date

August 5, 2016

Last Update Submit

August 4, 2020

Conditions

MultimorbidityPolypharmacyOther Diagnoses, Comorbidities, and Complications

Keywords

MultimorbidityPrimary Health CarePolypharmacyComorbidityMedication AdherenceMedication Appropriateness IndexPatient-Centered Care

Outcome Measures

Primary Outcomes (1)

  • Medication Appropriateness Index (MAI) score

    Change from baseline MAI score at 6 months

Secondary Outcomes (7)

  • Medication Appropriateness Index (MAI) score

    Change from baseline MAI score at 12 months

  • Morisky-Green questionnaire

    Baseline, at six 6 months and at 12 months

  • Haynes-Sackett test

    Baseline, at six 6 months and at 12 months

  • Euroqol 5D-5L questionnaire

    Baseline, at six 6 months and at 12 months

  • Use of health services

    at six 6 months and at 12 months

  • +2 more secondary outcomes

Study Arms (2)

Multi-PAP intervention

EXPERIMENTAL

Complex intervention with general practitioners and patients

Other: Multi-PAPOther: Usual care

Usual care

ACTIVE COMPARATOR

Patients will receive the usual clinical care

Other: Usual care

Interventions

Multi-PAPOTHER

Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview.

Multi-PAP intervention
Usual careOTHER

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

Multi-PAP 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)

Unknown Facility

Málaga, Andalusia, Spain

Location

Unknown Facility

Zaragoza, Aragon, Spain

Location

Unknown Facility

Madrid, Spain

Location

Related Publications (8)

  • Prados-Torres A, Del Cura-Gonzalez I, Prados-Torres D, Lopez-Rodriguez JA, Leiva-Fernandez F, Calderon-Larranaga A, Lopez-Verde F, Gimeno-Feliu LA, Escortell-Mayor E, Pico-Soler V, Sanz-Cuesta T, Bujalance-Zafra MJ, Morey-Montalvo M, Boxo-Cifuentes JR, Poblador-Plou B, Fernandez-Arquero JM, Gonzalez-Rubio F, Ramiro-Gonzalez MD, Coscollar-Santaliestra C, Martin-Fernandez J, Barnestein-Fonseca MP, Valderas-Martinez JM, Marengoni A, Muth C; Multi-PAP Group. Effectiveness of an intervention for improving drug prescription in primary care patients with multimorbidity and polypharmacy: study protocol of a cluster randomized clinical trial (Multi-PAP project). Implement Sci. 2017 Apr 27;12(1):54. doi: 10.1186/s13012-017-0584-x.

    PMID: 28449721BACKGROUND

  • Prados-Torres A, Del Cura-Gonzalez I, Prados-Torres JD, Leiva-Fernandez F, Lopez-Rodriguez JA, Calderon-Larranaga A, Muth C. [Multimorbidity in general practice and the Ariadne principles. A person-centred approach]. Aten Primaria. 2017 May;49(5):300-307. doi: 10.1016/j.aprim.2016.11.013. Epub 2017 Apr 17. Spanish.

    PMID: 28427915BACKGROUND

  • Prados-Torres D, Del Cura-Gonzalez I, Prados-Torres A. [Towards a multimorbidity care model in Primary Care]. Aten Primaria. 2017 May;49(5):261-262. doi: 10.1016/j.aprim.2016.11.004. Epub 2017 Jan 11. No abstract available. Spanish.

    PMID: 28089227BACKGROUND

  • Rogero-Blanco E, Lopez-Rodriguez JA, Sanz-Cuesta T, Aza-Pascual-Salcedo M, Bujalance-Zafra MJ, Cura-Gonzalez I; MultiPAP Group. Use of an Electronic Clinical Decision Support System in Primary Care to Assess Inappropriate Polypharmacy in Young Seniors With Multimorbidity: Observational, Descriptive, Cross-Sectional Study. JMIR Med Inform. 2020 Mar 3;8(3):e14130. doi: 10.2196/14130. Erratum In: JMIR Med Inform. 2020 Nov 19;8(11):e25678. doi: 10.2196/25678.

    PMID: 32149715RESULT

  • Prados-Torres A, Cura-Gonzalez ID, Prados-Torres JD, Muth C, Leiva-Fernandez F, Lopez-Rodriguez JA, Gonzalez-Rubio F. MULTIPAP Study: Improving healthcare for patients with multimorbidity. Br J Gen Pract. 2020 Jun;70(suppl 1):bjgp20X711257. doi: 10.3399/bjgp20X711257.

    PMID: 32554653RESULT

  • Lozano-Hernandez CM, Lopez-Rodriguez JA, Leiva-Fernandez F, Calderon-Larranaga A, Barrio-Cortes J, Gimeno-Feliu LA, Poblador-Plou B, Cura-Gonzalez ID; MULTIPAP GROUP. Social support, social context and nonadherence to treatment in young senior patients with multimorbidity and polypharmacy followed-up in primary care. MULTIPAP Study. PLoS One. 2020 Jun 24;15(6):e0235148. doi: 10.1371/journal.pone.0235148. eCollection 2020.

    PMID: 32579616RESULT

  • Del Cura-Gonzalez I, Lopez-Rodriguez JA, Leiva-Fernandez F, Gimeno-Miguel A, Poblador-Plou B, Lopez-Verde F, Lozano-Hernandez C, Pico-Soler V, Bujalance-Zafra MJ, Gimeno-Feliu LA, Aza-Pascual-Salcedo M, Rogero-Blanco M, Gonzalez-Rubio F, Garcia-de-Blas F, Polentinos-Castro E, Sanz-Cuesta T, Castillo-Jimena M, Alonso-Garcia M, Calderon-Larranaga A, Valderas JM, Marengoni A, Muth C, Prados-Torres JD, Prados-Torres A; Multi-Pap Group. How to Improve Healthcare for Patients with Multimorbidity and Polypharmacy in Primary Care: A Pragmatic Cluster-Randomized Clinical Trial of the MULTIPAP Intervention. J Pers Med. 2022 May 6;12(5):752. doi: 10.3390/jpm12050752.

    PMID: 35629175DERIVED

  • Leiva-Fernandez F, Prados-Torres JD, Prados-Torres A, Del-Cura-Gonzalez I, Castillo-Jimena M, Lopez-Rodriguez JA, Rogero-Blanco ME, Lozano-Hernandez CM, Lopez-Verde F, Bujalance-Zafra MJ, Pico-Soler MV, Gimeno-Feliu LA, Poblador-Plou B, Martinez-Canavate MT, Muth C; MULTIPAP Group. Training primary care professionals in multimorbidity management: Educational assessment of the eMULTIPAP course. Mech Ageing Dev. 2020 Dec;192:111354. doi: 10.1016/j.mad.2020.111354. Epub 2020 Sep 15.

    PMID: 32946885DERIVED

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 de Atención Primaria, Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor, PhD

Study Record Dates

First Submitted

August 5, 2016

First Posted

August 15, 2016

Study Start

November 1, 2016

Primary Completion

February 1, 2018

Study Completion

February 1, 2018

Last Updated

August 6, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will not share

Locations

ES(3)