Background
Objectives
Primary
Secondary
Method/design
Design
Scope of study
Study population
FP selection criteria
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Employed in current position for at least 1 year.
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Stable employment situation, with no intention of leaving their position during the course of the study.
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Agree to participate and provide written informed consent.
Patient selection criteria
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Age 65 to 74 years.
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Multimorbidity, defined as ≥3 chronic diseases as per O’Halloran [34].
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Polypharmacy, defined as ≥5 drugs prescribed over at least the 3 months prior to inclusion in the study.
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At least one visit to the FP in the past year.
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Agree to participate and provide written informed consent.
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Institutionalized patients.
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Life expectancy of less than 12 months, as determined by the FP.
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Mental and/or physical conditions considered by the FP to prevent fulfilment of study requirements.
Sample size
Recruitment
Randomization
Intervention
Intervention group
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First phase: FP training. This will consist of a previously designed training activity, delivered using the massive online open courses (MOOC) format, including basic concepts relating to multimorbidity, appropriateness of prescribing, treatment adherence, the Ariadne principles, and physician-patient shared decision making.
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Second phase: Physician-patient interview based on the Ariadne principles.
Control group
Variables
T0 (baseline) | T1 (6 months) | T2 (12 months) | Responsible entity | ||
---|---|---|---|---|---|
Confirm inclusion/exclusion criteria | X | FP | |||
Written informed consent | X | FP | |||
Socio-demographic variables | X | FP | |||
Morbidity variables and drug treatment plan | X | X | X | FP | |
Randomization of FPs | X | RU | |||
FP intervention (intervention group) | X | RT | |||
Patient intervention (intervention group) | X | X | FP | ||
Use of health services | X | X | X | RT | |
Medication adherence | X | X | X | FP | |
Medication safety | X | X | FP | ||
Quality of life | X | X | X | FP | |
Costs | X | RT | |||
MAI | X | X | X | EE EC |
Primary outcome
Secondary outcomes
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Use of health services: unplanned and/or avoidable hospitalizations, use of emergency services and PC (FP and nurse).
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Medication safety: measured as the incidence of adverse drug reactions and potentially hazardous interactions, classified using the taxonomy proposed by Otero-López [40].
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Patient perception of shared decision making: measured using a single, multiple choice question, formulated ad hoc.
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Cost-utility: time spent on training FPs, cost of teaching staff, time spent on physician-patient interviews, utilities measured using the EuroQol 5D-5L.
Explanatory and adjustment variables
Patient (first level) variables
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Socio-demographics: age, sex, nationality, AC of residence, marital status, socioeconomic status (monthly salary expressed as multiples of the minimum wage), family composition (number of people living at home), housing indicators, social support (Dukes-UNC-11 questionnaire adapted to Spanish [43]), profession, and social class [44].
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Morbidity: number and description of chronic diseases based on the International Classification of Diseases in PC (ICPC).
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Pharmacotherapeutic treatment plan: number and type of drugs prescribed, active ingredient, and dose of each drug.
FP (second level) variables
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Socio-demographics: age, sex.
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Professional performance: years of professional experience, tutor of residents (yes/no), average workload measured as the average number of daily consultations per FP during the year previous to the start of the study.
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Prior training: in polypharmacy, multimorbidity, and/or shared decision making.