Reduction of Low-value Prescribing Through Audit and Feedback
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorBasque Health Service
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
N/A
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Usual AF
BehavioralThe 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.
Facilitated AF
BehavioralBased 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.
Treatment groups
540 Participants
are divided into 2 treatment groupsGroup A: ControlActive comparator 1 intervention
Group B: InterventionExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
From baseline to 13 monthsSecondary outcomes
1
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
Time frame
From baseline to 13 months2
Secondary Effectiveness: Rate of new PIP
Rate of new PIP among patients over 65 years old seeking medical care during the study period
Time frame
From baseline to 13 months3
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.
Time frame
From baseline to 13 months4
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.
Time frame
From baseline to 13 monthsSponsors and contacts
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Basque Health Service
Lead sponsor
Biobizkaia Health Research Institute
Collaborator
Health Department of the Basque Government
Collaborator
European Union
Collaborator
Carlos III Health Institute (ISCIII), Spain
Collaborator
Source ClinicalTrials.gov
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