Behavioral Sciences, Implementation Science, Inappropriate Prescribing
Conditions
Keywords
low-value pharmacological prescription, De-implementation, Stepped-wedge design, Benzodiazepines, Proton pump inhibitors, Opioids, audit and feedback
Brief summary
The objective is to estimate the effect attributable to a primary care pharmacist-led audit and feedback (AF) strategy compared to the currently used AF strategy as a management tool to evaluate healthcare performance focusing on processes and outcomes, for reducing the rate of patients over 65 years of age with potentially inappropriate prescribing (PIP) of benzodiazepines, proton pump inhibitors and opioids. A closed-cohort stepped-wedge cluster-randomised trial will be conducted in nine PC centres from Barakaldo-Sestao Integrated Health Organization, Basque Health Service (Osakidetza). All health centre clusters will start under the control condition, and after an initial study period of 4 months in the control phase, one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention, under which they will be exposed to an additional component of AF, namely, primary care pharmacist-led facilitation. Mixed-methods analysis will be performed, gathering quantitative data to assess the results of the implementations at health centre and clinician levels, and qualitative data to assess the feasibility and perceived impact of the de-implementation strategies from the clinicians' perspective, and explore the experience and satisfaction of patients regarding the healthcare received. This study will provide useful knowledge on the effect attributable to a more intensive AF strategy (facilitated AF) compared to standard procedures of AF reports, and of the characteristics of AF that are most effective.
Interventions
BEHAVIORALUsual AF
The strategy currently used as a management tool to evaluate healthcare performance focusing on processes and outcomes, as part of Osakidetza's operating contract: provision of AF, sent to PC centres every 4 months with data on overall rates of PIP, lists of patients over 65 years old who have a potentially inappropriate prescription of at least one of the drugs of interest, and provision of support materials related to appropriate prescribing and recommendations on deprescribing.
BEHAVIORALFacilitated AF
Based on a facilitation component delivered by PC pharmacy staff. Specifically, the PC pharmacists will conduct a facilitation session with the centre's clinicians in which they will review the magnitude of PIP in the centre (PIP rates), appropriateness/inappropriateness criteria, and guidelines to encourage deprescribing, and draw up an action plan at clinician and centre levels.
Sponsors
Basque Health Service
Biobizkaia Health Research Institute
Health Department of the Basque Government
European Union
Carlos III Health Institute (ISCIII), Spain
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
A closed-cohort stepped-wedge cluster-randomised trial will be conducted. All health centre clusters will start under the control condition, and after an initial study period of 4 months in the control phase, one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
PRIMARY CARE CENTERS IN THE BARAKALDO-SESTAO INTEGRATED HEALTHCARE ORGANISATION OF OSAKIDETZA-BASQUE HEALTH SERVICE: Inclusion Criteria: * collaboration is achieved from at least 51% of the General Practitioners (GP) or at least 4 GPs * At least 60 patients aged 65 years or older on at least one of the drugs of interest that may be potentially inappropriately prescribed
Exclusion criteria
* N/A PATIENTS ASSIGNED TO THE PARTICIPATING PC CENTERS: Inclusion Criteria: * Patients over 65 years of age with any of the following unsuitability criteria: * PIP of benzodiazepines: patients on benzodiazepines for more than 3 months * PIP of proton pump inhibitors: patients on proton pump inhibitors for more than 8 weeks without a diagnosed gastrointestinal disease and with no long-term prescription of gastrotoxic drugs. * PIP of opioids: patients on opioids for non-cancer pain for more than 3 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP | From baseline to 13 months | proportion of patients for whom appropriateness is achieved, either through deprescribing or tapering (for example, dose reduction) of any of the drugs potentially inappropriately prescribed in the patients included in the clusters. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary effectiveness: Proportion of patients with deprescribing or tapering for each PIP | From baseline to 13 months | proportion of patients in whom appropriateness is achieved for each of the potentially inappropriately prescribed drugs assessed separately |
| Secondary Effectiveness: Rate of new PIP | From baseline to 13 months | Rate of new PIP among patients over 65 years old seeking medical care during the study period |
| Adoption: Percentage of General Practitioners who agree to receive the active components of the strategies | From baseline to 13 months | Percentage of doctors, out of the total number invited to participate at the start of the intervention, who agree to receive the active components of the strategies, as well as the characteristics of those who do and do not agree to participate. |
| Degree of implementation fidelity | From baseline to 13 months | The degree of fidelity with which each strategy has been implemented compared to what was originally planned will be evaluated. For this, the implementation process and any adaptations made to the strategies or their active components will be recorded and subsequently described. Furthermore, we will evaluate the degree of exposure of GPs to the strategies. |
| General Practitioners´ perception of the feasibility and acceptability | From baseline to 19 months | GPs perception of the feasibility and acceptability of the deprescribing strategy based on the AF to adapt/reduce their practice of unnecessary pharmacological prescribing. |
Countries
Spain
Contacts
CONTACTAlvaro Sanchez Perez
Outcome results
None listed