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| ID | Type | Description | Link |
|---|---|---|---|
| 2018111085 | Other Grant/Funding Number | Health Department of the Basque Government | |
| 2021111024 | Other Grant/Funding Number | Health Department of the Basque Government | |
| PI21/00025 | Other Grant/Funding Number | Instituto de Salud Carlos III (ISCIII) and European Union (European Regional Development Fund "A way to make Europe") | |
| RD24/0005/0017 | Other Grant/Funding Number | Instituto de Salud Carlos III (ISCIII) and European Union | |
| RD21/0016/0003 | Other Grant/Funding Number | Instituto de Salud Carlos III (ISCIII) and European Union (NextGenerationEU funds, MRR) | |
| RD16/0007/0002 | Other Grant/Funding Number | Instituto de Salud Carlos III (ISCIII) and European Union (European Regional Development Fund "A way to make Europe") |
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| Name | Class |
|---|---|
| Biobizkaia Health Research Institute | OTHER_GOV |
| Basque Government Department of Public Health | OTHER |
| European Union | OTHER |
| Carlos III Health Institute (ISCIII), Spain |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | All health centre clusters will start under the control condition |
|
| Intervention | Experimental | one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual AF | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP | 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. | From baseline to 13 months |
| Measure | Description | Time Frame |
|---|---|---|
| Secondary effectiveness: Proportion of patients with deprescribing or tapering for each PIP | proportion of patients in whom appropriateness is achieved for each of the potentially inappropriately prescribed drugs assessed separately | From baseline to 13 months |
| Secondary Effectiveness: Rate of new PIP |
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PRIMARY CARE CENTERS IN THE BARAKALDO-SESTAO INTEGRATED HEALTHCARE ORGANISATION OF OSAKIDETZA-BASQUE HEALTH SERVICE:
Inclusion Criteria:
Exclusion Criteria:
PATIENTS ASSIGNED TO THE PARTICIPATING PC CENTERS:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alvaro Sanchez Perez | Contact | (+34)946006673 | ALVARO.SANCHEZPEREZ@osakidetza.eus |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Primary Care Research Unit of Bizkaia | Barakaldo | Bizkaia | 48903 | Spain |
Individual participant data that support future results will be shared, after deidentification
Starting 6 months after the publication of results
Since data supporting the present study will mostly concern routine data retrieved from the electronic health record of the Basque Health Service-Osakidetza, it will only be made available on reasonable request to the study guarantors (proposals should be directed to the Responsible Party). It will only be shared with researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
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| UNKNOWN |
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
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| Facilitated AF | Behavioral | 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. |
|
Rate of new PIP among patients over 65 years old seeking medical care during the study period |
| From baseline to 13 months |
| Adoption: Percentage of General Practitioners who agree to receive the active components of the strategies | 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. | From baseline to 13 months |
| Degree of implementation fidelity | 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. | From baseline to 13 months |
| General Practitioners´ perception of the feasibility and acceptability | GPs perception of the feasibility and acceptability of the deprescribing strategy based on the AF to adapt/reduce their practice of unnecessary pharmacological prescribing. | From baseline to 19 months |