Clinical trial NCT02866799: Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multimorbidity
Polypharmacy
Other Diagnoses, Comorbidities, and Complications
Keywords: Multimorbidity
Primary Health Care
Polypharmacy
Comorbidity
Medication Adherence
Medication Appropriateness Index
Patient-Centered Care
Lead sponsor: Instituto Aragones de Ciencias de la Salud
Sponsor class: OTHER_GOV
Collaborators: name: Gerencia de Atención Primaria, Madrid
name: Aragon Institute for Health Research (IIS Aragón)
name: Andaluz Health Service
name: Red de Investigación en Servicios de Salud en Enfermedades Crónicas
name: Instituto de Salud Carlos III
First posted: 2016-08-15
Enrollment: 593
Sex: ALL
Minimum age (years): 65
Maximum age (years): 74
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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 usual care.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Medication Appropriateness Index (MAI) score
timeFrame: Change from baseline MAI score at 6 months
Secondary outcomes:
measure: Medication Appropriateness Index (MAI) score
timeFrame: Change from baseline MAI score at 12 months
measure: Morisky-Green questionnaire
timeFrame: Baseline, at six 6 months and at 12 months
measure: Haynes-Sackett test
timeFrame: Baseline, at six 6 months and at 12 months
measure: Euroqol 5D-5L questionnaire
timeFrame: Baseline, at six 6 months and at 12 months
measure: Use of health services
timeFrame: at six 6 months and at 12 months
measure: Medication safety
timeFrame: at six 6 months and at 12 months
measure: Patient perception of shared decision-making
timeFrame: Baseline and at six 6 months and at 12 months
Other outcomes:
Locations:
city: Málaga
country: Spain
state: Andalucía
city: Zaragoza
country: Spain
state: Aragón
city: Madrid
country: Spain
Study officials:
affiliation: Instituto Aragonés de Ciencias de la Salud (IACS)
name: Alexandra Prados-Torres, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Servicio Andaluz de Salud (Andaluz Health Service)
name: Daniel Prados-Torres, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gerencia de Atención Primaria, Madrid
name: Isabel Del Cura-González, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.