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MultimorbidityMulti-PAPNCT02866799

Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy

A study testing Multi-PAP in people with Multimorbidity and Polypharmacy, run by Instituto Aragones de Ciencias de la Salud at 3 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 65 to 74 years
What is being tested?
Multi-PAP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
593 participants
Where
3 sitesSpain
Study dates
Nov 2016to Feb 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 74 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

Spain3 sites

  • Study site

    Madrid

  • Study site

    Málaga, Andalusia

  • Study site

    Zaragoza, Aragon

Other trials in Spain

About this study

Official title: 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)

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.

Read the detailed description

Design: Pragmatic cluster randomized clinical trial with 12 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=400 patients (200 in each arm, 5 patients per physician) will be recruited by general practitioners before randomization.

Intervention: complex intervention.

Control group: usual care.

Variables: MAI, health care utilization, quality of life (Euroqol 5 Dimensions (5D-5L), drug therapy and adherence (Morisky-Green, Haynes-Sackett), clinical and socio-demographic factors. Economic appraisal variables: time spent training FPs, cost of teaching staff, time spent on physician-patient interviews, utilities measured using the EuroQol 5D-5L.

Analysis: All analyses will be carried out adhering to the intention-to-treat principle. Description of baseline characteristics. Basal comparison between groups. Analysis of main and secondary effectiveness (between-group difference in T1-T0 MAI score, with corresponding 95% Confidence Interval); multilevel analysis will be used to adjust models. Estimated quality-adjusted life years (QALYs) gained at the population level. Calculation of cost-utility ratio.

Being tested
Multi-PAP, Usual care
Keywords
Multimorbidity, Primary Health Care, Polypharmacy, Comorbidity, Medication Adherence, Medication Appropriateness Index, Patient-Centered Care
Medical subject headings
Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Multi-PAPOther

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

  • Usual careOther

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

Study groups in NCT02866799
Study groupRoleWhat they receive
Multi-PAP interventionExperimentalComplex intervention with general practitioners and patients
Receives: Other: Multi-PAP; Other: Usual care
Usual careActive comparatorPatients will receive the usual clinical care
Receives: Other: Usual care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Medication Appropriateness Index (MAI) score

    Measured: Change from baseline MAI score at 6 months

Secondary outcomes (7)

  1. Medication Appropriateness Index (MAI) score

    Quality of Life

    Measured: Change from baseline MAI score at 12 months

  2. Morisky-Green questionnaire

    Therapeutic adherence questionnaire

    Measured: Baseline, at six 6 months and at 12 months

  3. Haynes-Sackett test

    Therapeutic adherence test

    Measured: Baseline, at six 6 months and at 12 months

  4. Euroqol 5D-5L questionnaire

    Measured: Baseline, at six 6 months and at 12 months

  5. Use of health services

    Unscheduled and/or avoidable hospitalizations, use of emergency services and primary care (FP and nurse).

    Measured: at six 6 months and at 12 months

  6. Medication safety

    measured as the incidence of adverse drug reactions and potentially hazardous interactions, classified using the taxonomy proposed by Otero-López

    Measured: at six 6 months and at 12 months

  7. Patient perception of shared decision-making

    measured using a single, multiple choice question, formulated ad hoc.

    Measured: Baseline and at six 6 months and at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2016 (estimated)
  2. Study startNov 2016
  3. Primary completionFeb 2018
  4. Study completionFeb 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
593 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02866799
Sponsor's protocol ID
PI: 15/00572,15/00276,15/00996
Acronym
Multi-PAP
Status last verified
Aug 2020
First submitted
5 Aug 2016
Last updated
6 Aug 2020
Results posted
No
Data monitoring committee
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 28449721

  • 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.

    PubMed 28427915

  • 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.

    PubMed 28089227

  • 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.

    PubMed 32149715

  • 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.

    PubMed 32554653

  • 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.

    PubMed 32579616

  • 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.

    PubMed 35629175

  • 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.

    PubMed 32946885

Questions about this trial

What is this clinical trial studying?

A study testing Multi-PAP in people with Multimorbidity and Polypharmacy, run by Instituto Aragones de Ciencias de la Salud at 3 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication Appropriateness Index (MAI) score (time frame: Change from baseline MAI score at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02866799, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2020.

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