NCT04147130

MultiPAP Plus: Improving Prescription in Primary Care Patients With Multimorbidity and Polypharmacy

Efectiveness of the MultiPAP Plus Intervention in Young-old Patients With Multimorbidity and Polypharmacy Aimed at Improving Prescription in Primary Care: Cluster RCT

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,162 (actual)
• Sponsor: Instituto Aragones de Ciencias de la Salud · Other Government
• Sex: All
• Age: 65 Years – 74 Years
• Healthy volunteers: Not accepted

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 hospitalization-mortality at six 6 (T1), 12 (T2) and 18 (T3) months from baseline compared to usual care.

Detailed description

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.

Conditions

• Multimorbidity
• Polypharmacy
• Comorbidities and Coexisting Conditions
• Clinical Decision-Support Systems

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2020-02-18
• Primary completion: 2023-12-26
• Completion: 2023-12-26
• First posted: 2019-10-31
• Last updated: 2023-12-27

Locations

3 sites across 1 country: Spain