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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 means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-PAP intervention | Experimental | Complex intervention with general practitioners and patients |
|
| Usual care | Active Comparator | Patients will receive the usual clinical care |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-PAP | Other | Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Medication Appropriateness Index (MAI) score | Change from baseline MAI score at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Medication Appropriateness Index (MAI) score | Quality of Life | Change from baseline MAI score at 12 months |
| Morisky-Green questionnaire | Therapeutic adherence questionnaire |
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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 de Atención Primaria, Madrid | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Málaga | Andalusia | Spain | ||||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28449721 | Background | 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. | |
| 28427915 |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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| 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, at six 6 months and at 12 months |
| Haynes-Sackett test | Therapeutic adherence 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 | Unscheduled and/or avoidable hospitalizations, use of emergency services and primary care (FP and nurse). | at six 6 months and at 12 months |
| Medication safety | measured as the incidence of adverse drug reactions and potentially hazardous interactions, classified using the taxonomy proposed by Otero-López | at six 6 months and at 12 months |
| Patient perception of shared decision-making | measured using a single, multiple choice question, formulated ad hoc. | Baseline and at six 6 months and at 12 months |
| Zaragoza |
| Aragon |
| Spain |
| Madrid | Spain |
| Background |
| 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. |
| 28089227 | Background | 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. |
| 32149715 | Result | 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. |
| 32554653 | Result | 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. |
| 32579616 | Result | 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. |
| 35629175 | Derived | 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. |
| 32946885 | Derived | 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. |
| D001519 | Behavior |