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| Name | Class |
|---|---|
| Gerencia de Atención Primaria, Madrid | OTHER_GOV |
| Aragon Institute for Health Research (IIS Aragón) | UNKNOWN |
| Andaluz Health Service | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MultiPAP Plus intervention | Experimental | Complex intervention with general practitioners and patients |
|
| Usual care | Active Comparator | Patients will recieve the usual clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MultiPAP Plus | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations and/or mortality | Difference in percentages in the final combined variable | From Baseline to Month 18 |
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalizations and/or mortality (T2) | Difference in percentages in the final combined variable | From Baseline to Month 12 |
| Therapeutic adherence questionnaire | Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Servicio Andaluz de Salud | Málaga | Andalusia | Spain | |||
| Instituto Aragonés de Ciencias de la Salud (IACS) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35681224 | Derived | 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. |
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| Fundación de Investigación e Innovación Biomédica Atención Primaria (FIIBAP) |
| UNKNOWN |
| Red de Investigación en Servicios de Salud en Enfermedades Crónicas | OTHER |
| Instituto de Salud Carlos III | OTHER_GOV |
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|
| Usual care | Other | Patients will receive the usual clinical care based on current clinical practice guidelines. |
|
| Baseline, 6, 12 and 18 months |
| 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 | Baseline, 6, 12 and 18 months |
| Use of health services | Number of Unscheduled and/or avoidable hospitalizations, number of visits to emergency services and primary care (Family Physician and nurse). | at 12 and at 18 months |
| 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. | Baseline, 12 and 18 months |
| 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. | Baseline, 12 and 18 months |
| 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 | at 6 and 18 months. |
| Zaragoza |
| Aragon |
| Spain |
| Gerencia Asistencial de Atención Primaria de Madrid | Madrid | Spain |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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