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

Not Applicable

Completed

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

• Registration Number: NCT04147130
• Lead Sponsor: Instituto Aragones de Ciencias de la Salud

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 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.

Study Timeline

• Study First Submitted: 2019-10-22
• Study First Submitted QC: 2019-10-30
• Study First Posted: 2019-10-31
• Study Start: 2020-02-18
• Status Verified: 2023-12
• Primary Completion: 2023-12-26
• Study Completion: 2023-12-26
• Last Update Submitted: 2023-12-26
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1162

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospitalizations and/or mortality	From Baseline to Month 18	Difference in percentages in the final combined variable

Secondary Outcome Measures

Name	Time	Method
Therapeutic adherence questionnaire	Baseline, 6, 12 and 18 months	Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence
Hospitalizations and/or mortality (T2)	From Baseline to Month 12	Difference in percentages in the final combined variable
Use of health services	at 12 and at 18 months	Number of Unscheduled and/or avoidable hospitalizations, number of visits to emergency services and primary care (Family Physician and nurse).
Disability	Baseline, 12 and 18 months	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.
Medication Safety: Potentially Drug-Drug interactions (DDI), Potentially Innappropiate Medication (PIM), Adverse Drug Reactions	Baseline, 6, 12 and 18 months	Number of Potentially Drug-Drug interactions (DDI) per patient, Number of Potentially Innappropiate Medication (PIM) per patient, Number of Adverse Drug Reactions per patient
Perceived Quality of Life: Euroqol 5D-5L questionnaire	Baseline, 12 and 18 months	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.
System Usability Scale of the CDSS	at 6 and 18 months.	It consists of a 10 item questionnaire with five response options for respondents; from Strongly agree to Strongly disagree

Trial Locations

Locations (3)

Servicio Andaluz de Salud; 🇪🇸 Málaga, Andalucía, Spain

Instituto Aragonés de Ciencias de la Salud (IACS); 🇪🇸 Zaragoza, Aragón, Spain

Gerencia Asistencial de Atención Primaria de Madrid; 🇪🇸 Madrid, Spain