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MultimorbidityMultiPAP PlusNCT04147130

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

A study testing MultiPAP Plus 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 hospitalization-mortality at six 6 (T1), 12 (T2) and 18 (T3) months from baseline compared to usual care. Read more about this study

Who is it for?
Ages 65 to 74 years
What is being tested?
MultiPAP Plus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,162 participants
Where
3 sitesSpain
Study dates
18 Feb 2020to 26 Dec 2023
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

  • Gerencia Asistencial de Atención Primaria de Madrid

    Madrid

  • Servicio Andaluz de Salud

    Málaga, Andalusia

  • Instituto Aragonés de Ciencias de la Salud (IACS)

    Zaragoza, Aragon

Other trials in Spain

About this study

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

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.

Read the 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.

Being tested
MultiPAP Plus, Usual care
Keywords
Primary Health Care, Medication Adherence, Disability, Patient-Centered Care, Ariadne Principles
Medical subject headings
Medication Adherence

What participants receive

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

  • 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.

  • Usual careOther

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

Study groups in NCT04147130
Study groupRoleWhat they receive
MultiPAP Plus interventionExperimentalComplex intervention with general practitioners and patients
Receives: Other: MultiPAP Plus; Other: Usual care
Usual careActive comparatorPatients will recieve 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. Hospitalizations and/or mortality

    Difference in percentages in the final combined variable

    Measured: From Baseline to Month 18

Secondary outcomes (7)

  1. Hospitalizations and/or mortality (T2)

    Difference in percentages in the final combined variable

    Measured: From Baseline to Month 12

  2. Therapeutic adherence questionnaire

    Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence

    Measured: Baseline, 6, 12 and 18 months

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

    Number of Potentially Drug-Drug interactions (DDI) per patient, Number of Potentially Innappropiate Medication (PIM) per patient, Number of Adverse Drug Reactions per patient

    Measured: Baseline, 6, 12 and 18 months

  4. Use of health services

    Number of Unscheduled and/or avoidable hospitalizations, number of visits to emergency services and primary care (Family Physician and nurse).

    Measured: at 12 and at 18 months

  5. Disability

    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.

    Measured: Baseline, 12 and 18 months

  6. Perceived Quality of Life: Euroqol 5D-5L questionnaire

    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.

    Measured: Baseline, 12 and 18 months

  7. System Usability Scale of the CDSS

    It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree

    Measured: at 6 and 18 months.

Timeline

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

  1. First posted31 Oct 2019
  2. Study start18 Feb 2020
  3. Primary completion26 Dec 2023
  4. Study completion26 Dec 2023

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
Participant, Investigator
Enrolment
1,162 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04147130
Sponsor's protocol ID
PI 18/01303,18/01515,18/01812
Acronym
MultiPAP Plus
Status last verified
Dec 2023
First submitted
22 Oct 2019
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 35681224

Questions about this trial

What is this clinical trial studying?

A study testing MultiPAP Plus 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 27 Dec 2023. 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?

Hospitalizations and/or mortality (time frame: From Baseline to Month 18). 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 NCT04147130, which also lists 1 linked publication.

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 27 Dec 2023.

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