MultiPAP Plus: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy (MultiPAP Plus)
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| ClinicalTrials.gov Identifier: NCT04147130 |
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Recruitment Status :
Active, not recruiting
First Posted : October 31, 2019
Last Update Posted : March 31, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Multimorbidity Polypharmacy Comorbidities and Coexisting Conditions Clinical Decision-Support Systems | Other: MultiPAP Plus Other: Usual care | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 1162 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 : | August 31, 2023 |
| Estimated Study Completion Date : | August 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: MultiPAP Plus intervention
Complex intervention with general practitioners and patients
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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. |
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Active Comparator: Usual care
Patients will recieve the usual clinical care
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Other: Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines. |
- Hospitalizations and/or mortality [ Time Frame: From Baseline to Month 18 ]Difference in percentages in the final combined variable
- Hospitalizations and/or mortality (T2) [ Time Frame: From Baseline to Month 12 ]Difference in percentages in the final combined variable
- 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
- 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
- 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).
- 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.
- 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.
- 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
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| Ages Eligible for Study: | 65 Years to 74 Years (Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
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
| Spain | |
| Servicio Andaluz de Salud | |
| Málaga, Andalucía, Spain | |
| Instituto Aragonés de Ciencias de la Salud (IACS) | |
| Zaragoza, Aragón, Spain | |
| Gerencia Asistencial de Atención Primaria de Madrid | |
| Madrid, Spain | |
| 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 |
| 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: | March 31, 2022 |
| Last Verified: | March 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Primary Health Care Medication Adherence Disability Patient-Centered Care Ariadne Principles |