Reduction of Low-value Prescribing Through Audit and Feedback

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

540 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-02-28

Study Completion Date

2027-11-30

Brief Summary

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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 at each step, some three centres 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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Detailed Description

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Conditions

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Inappropriate Prescribing Implementation Science Behavioral Sciences

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A closed-cohort stepped-wedge cluster-randomised trial will be conducted. All health centre clusters will start under the control condition, and at each step, three centres will be randomly assigned to crossover to the intervention.

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control

All health centre clusters will start under the control condition

Group Type ACTIVE_COMPARATOR

Usual AF

Intervention Type 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.

Intervention

At each step, three centres will be randomly assigned to crossover to the intervention

Group Type EXPERIMENTAL

Usual AF

Intervention Type 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.

Facilitated AF

Intervention Type 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.

Interventions

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Usual 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.

Intervention Type BEHAVIORAL

Facilitated 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

* 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.

Exclusion Criteria

* N/A

PATIENTS ASSIGNED TO THE PARTICIPATING PC CENTERS:

* Patients who, in the opinion of the general practitioner, are not suitable candidates for tapering or discontinuation of the potentially inappropriately prescribed drug
* Patients residing in care homes
* Patients receiving palliative care

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes