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
• Interventions: Other: Usual care; Other: MultiPAP Plus

• 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

Arm && Interventions

Group	Intervention	Description
Usual care	Usual care	Patients will recieve the usual clinical care
MultiPAP Plus intervention	Usual care	Complex intervention with general practitioners and patients
MultiPAP Plus intervention	MultiPAP Plus	Complex intervention with general practitioners and patients

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