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

Polypharmacy Clinical Trial

— MultiPAP Plus  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04147130
• Other study ID #: PI 18/01303,18/01515,18/01812
• Status: Completed
• Phase: N/A
• Start date: February 18, 2020
• Est. completion date: December 26, 2023

Study information

• Verified date: December 2023
• 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 hospitalization-mortality at six 6 (T1), 12 (T2) and 18 (T3) months from baseline compared to usual care.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1162
• Est. completion date: December 26, 2023
• Est. primary completion date: December 26, 2023
• 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

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

Intervention

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.
• Usual care
Patients will receive the usual clinical care based on current clinical practice guidelines.

Locations

Country	Name	City	State
Spain	Gerencia Asistencial de Atención Primaria de Madrid	Madrid
Spain	Servicio Andaluz de Salud	Málaga	Andalucía
Spain	Instituto Aragonés de Ciencias de la Salud (IACS)	Zaragoza	Aragón

Sponsors (7)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalizations and/or mortality	Difference in percentages in the final combined variable	From Baseline to Month 18
Secondary	Hospitalizations and/or mortality (T2)	Difference in percentages in the final combined variable	From Baseline to Month 12
Secondary	Therapeutic adherence questionnaire	Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence	Baseline, 6, 12 and 18 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.