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
Qualifiers
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
Treatments tested in this trial
- Usual AF
- Facilitated AF
Treatment groups
Sponsors and collaborators
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