Multi-PAP: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy

Polypharmacy Clinical Trial

— Multi-PAP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02866799
• Other study ID #: PI: 15/00572,15/00276,15/00996
• Status: Completed
• Phase: N/A
• Start date: November 2016
• Est. completion date: February 2018

Study information

• Verified date: August 2020
• Source: Instituto Aragones de Ciencias de la Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 593
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Multimorbidity
• Other Diagnoses, Comorbidities, and Complications
• Polypharmacy

Intervention

Other:
• Multi-PAP
Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview.
• Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines.

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Instituto Aragones de Ciencias de la Salud	Andaluz Health Service, Aragon Institute for Health Research (IIS Aragón), Gerencia de Atención Primaria, Madrid, Instituto de Salud Carlos III, Red de Investigación en Servicios de Salud y Enfermedades Crónicas (REDISSEC)

Country where clinical trial is conducted

Spain, 

References & Publications (6)

Lozano-Hernández CM, López-Rodríguez JA, Leiva-Fernández F, Calderón-Larrañaga A, Barrio-Cortes J, Gimeno-Feliu LA, Poblador-Plou B, Cura-González ID; MULTIPAP GROUP. Social support, social context and nonadherence to treatment in young senior patients wi — View Citation

Prados-Torres A, Cura-González ID, Prados-Torres JD, Muth C, Leiva-Fernández F, Lopez-Rodriguez JA, González-Rubio F. MULTIPAP Study: Improving healthcare for patients with multimorbidity. Br J Gen Pract. 2020 Jun;70(suppl 1). pii: bjgp20X711257. doi: 10. — View Citation

Prados-Torres A, Del Cura-González I, Prados-Torres D, López-Rodríguez JA, Leiva-Fernández F, Calderón-Larrañaga A, López-Verde F, Gimeno-Feliu LA, Escortell-Mayor E, Pico-Soler V, Sanz-Cuesta T, Bujalance-Zafra MJ, Morey-Montalvo M, Boxó-Cifuentes JR, Poblador-Plou B, Fernández-Arquero JM, González-Rubio F, Ramiro-González MD, Coscollar-Santaliestra C, Martín-Fernández J, Barnestein-Fonseca MP, Valderas-Martínez 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. — View Citation

Prados-Torres A, Del Cura-González I, Prados-Torres JD, Leiva-Fernández F, López-Rodríguez JA, Calderón-Larrañaga 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. — View Citation

Prados-Torres D, Del Cura-González 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. Spanish. — View 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 Wit — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Appropriateness Index (MAI) score		Change from baseline MAI score at 6 months
Secondary	Medication Appropriateness Index (MAI) score	Quality of Life	Change from baseline MAI score at 12 months
Secondary	Morisky-Green questionnaire	Therapeutic adherence questionnaire	Baseline, at six 6 months and at 12 months
Secondary	Haynes-Sackett test	Therapeutic adherence test	Baseline, at six 6 months and at 12 months
Secondary	Euroqol 5D-5L questionnaire		Baseline, at six 6 months and at 12 months
Secondary	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
Secondary	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
Secondary	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