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 means of the Medication Appropriateness Index (MAI)-score at six 6 (T1) and 12 (T2) months from baseline compared to usual care.
Design: Pragmatic cluster randomized clinical trial with 12 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=400 patients (200 in each arm, 5 patients per physician) will be recruited by general practitioners before randomization. Intervention: complex intervention. Control group: usual care. Variables: MAI, health care utilization, quality of life (Euroqol 5 Dimensions (5D-5L), drug therapy and adherence (Morisky-Green, Haynes-Sackett), clinical and socio-demographic factors. Economic appraisal variables: time spent training FPs, cost of teaching staff, time spent on physician-patient interviews, utilities measured using the EuroQol 5D-5L. Analysis: All analyses will be carried out adhering to the intention-to-treat principle. Description of baseline characteristics. Basal comparison between groups. Analysis of main and secondary effectiveness (between-group difference in T1-T0 MAI score, with corresponding 95% Confidence Interval); multilevel analysis will be used to adjust models. Estimated quality-adjusted life years (QALYs) gained at the population level. Calculation of cost-utility ratio.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE
Enrollment
593
Complex intervention based on the ARIADNE principles with two main components: 1) Training of general practitioners and 2) Patient centered clinical interview.
Patients will receive the usual clinical care based on current clinical practice guidelines.
Unnamed facility
Málaga, Andalusia, Spain
Unnamed facility
Zaragoza, Aragon, Spain
Unnamed facility
Madrid, Spain
Medication Appropriateness Index (MAI) score
Time frame: Change from baseline MAI score at 6 months
Medication Appropriateness Index (MAI) score
Quality of Life
Time frame: Change from baseline MAI score at 12 months
Morisky-Green questionnaire
Therapeutic adherence questionnaire
Time frame: Baseline, at six 6 months and at 12 months
Haynes-Sackett test
Therapeutic adherence test
Time frame: Baseline, at six 6 months and at 12 months
Euroqol 5D-5L questionnaire
Time frame: Baseline, at six 6 months and at 12 months
Use of health services
Unscheduled and/or avoidable hospitalizations, use of emergency services and primary care (FP and nurse).
Time frame: at six 6 months and at 12 months
Medication safety
measured as the incidence of adverse drug reactions and potentially hazardous interactions, classified using the taxonomy proposed by Otero-López
Time frame: at six 6 months and at 12 months
Patient perception of shared decision-making
measured using a single, multiple choice question, formulated ad hoc.
Time frame: Baseline and at six 6 months and at 12 months
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