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

Instituto Aragones de Ciencias de la Salud1,162 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

Conditions

Multimorbidity Polypharmacy Comorbidities and Coexisting Conditions Clinical Decision-Support Systems

Interventions

MultiPAP PlusOTHER

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 careOTHER

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

Eligibility

Sex: ALLMin age: 65 YearsMax age: 74 Years

Medical Language ↔ Plain English

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

Locations (3)

Servicio Andaluz de Salud

Málaga, Andalusia, Spain

Instituto Aragonés de Ciencias de la Salud (IACS)

Zaragoza, Aragon, Spain

Gerencia Asistencial de Atención Primaria de Madrid

Madrid, Spain

Outcomes

Primary Outcomes

Hospitalizations and/or mortality

Difference in percentages in the final combined variable

Time frame: From Baseline to Month 18

Secondary Outcomes

Hospitalizations and/or mortality (T2)

Difference in percentages in the final combined variable

Time frame: From Baseline to Month 12

Therapeutic adherence questionnaire

Morisky-Green questionnaire. Dicotomous variable. Any wrong answer to any of the four questions would mean worse adherence

Time frame: Baseline, 6, 12 and 18 months

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

Time frame: Baseline, 6, 12 and 18 months

Use of health services

Number of Unscheduled and/or avoidable hospitalizations, number of visits to emergency services and primary care (Family Physician and nurse).

Time frame: at 12 and at 18 months

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.

Time frame: Baseline, 12 and 18 months

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.

Data from ClinicalTrials.gov

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