Reduction of Low-value Prescribing Through Audit and Feedback

NCT07336550 | Not Yet Recruiting

• 7 other identifiers: 202411105420181110852021111024PI21/00025RD24/0005/0017RD21/0016/0003RD16/0007/0002
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Inappropriate Prescribing; Implementation Science; Behavioral Sciences

Keywords

low-value pharmacological prescription; De-implementation; Stepped-wedge design; Benzodiazepines; Proton pump inhibitors; Opioids; audit and feedback

Outcome Measures

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.

  From baseline to 16 months

Secondary Outcomes (5)

• Secondary effectiveness: Proportion of patients with deprescribing or tapering for each PIP

  From baseline to 16 months

• Secondary Effectiveness: Rate of new PIP

  From baseline to 16 months

• Adoption: Percentage of General Practitioners who agree to receive the active components of the strategies

  From baseline to 16 months

• Degree of implementation fidelity

  From baseline to 16 months

• General Practitioners´ perception of the feasibility and acceptability

  From baseline to 22 months

Study Arms (2)

Control

ACTIVE COMPARATOR

All health centre clusters will start under the control condition

Behavioral: Usual AF

Intervention

EXPERIMENTAL

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

Behavioral: Usual AF; Behavioral: Facilitated AF

Interventions

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.

Control; Intervention

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.

Intervention

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• N/A
• PATIENTS ASSIGNED TO THE PARTICIPATING PC CENTERS:
• 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.
• 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

Sponsors & Collaborators

• Basque Health Service: lead
• Biobizkaia: collaborator
• Health Department of the Basque Government: collaborator
• European Union: collaborator
• Carlos III Health Institute (ISCIII), Spain: collaborator

Study Sites (1)

Primary Care Research Unit of Bizkaia

Barakaldo, Bizkaia, 48903, Spain

Location

Central Study Contacts

Alvaro Sanchez Perez

CONTACT

(+34)946006673; ALVARO.SANCHEZPEREZ@osakidetza.eus

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 13, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: January 13, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Starting 6 months after the publication of results
• Access Criteria: 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.

Locations

ES (1)