Reduction of Low-value Prescribing Through Audit and Feedback (AFFAP)

AFFAP Trial: The Comparative Evaluation of Audit and Feedback-based De-implementation Strategies to Reduce Low-value Prescribing in Primary Care in Patients Over 65 Years of Age.

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Implementation Science; Inappropriate Prescribing; Behavioral Sciences
• Intervention / Treatment: Behavioral: Usual AF; Behavioral: Facilitated AF

• Study Type: Interventional
• Enrollment (Estimated): 540
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Alvaro Sanchez Perez; Phone Number: (+34)946006673; Email: ALVARO.SANCHEZPEREZ@osakidetza.eus

Study Locations

• Spain
  • Bizkaia
    • Barakaldo, Bizkaia, Spain, 48903
      • Primary Care Research Unit of Bizkaia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

PRIMARY CARE CENTERS IN THE BARAKALDO-SESTAO INTEGRATED HEALTHCARE ORGANISATION OF OSAKIDETZA-BASQUE HEALTH SERVICE:

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

Exclusion Criteria:

• N/A

PATIENTS ASSIGNED TO THE PARTICIPATING PC CENTERS:

Inclusion Criteria:

• 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:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control; All health centre clusters will start under the control condition	Behavioral: 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.
Experimental: Intervention; one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention	Behavioral: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Basque Health Service
• Collaborators: European Union; Health Department of the Basque Government; Carlos III Health Institute (ISCIII), Spain; Biobizkaia Health Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: December 17, 2025
• First Submitted That Met QC Criteria: December 30, 2025
• First Posted (Actual): January 13, 2026

Study Record Updates

• Last Update Posted (Actual): May 13, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Benzodiazepines; Opioids; Proton pump inhibitors; audit and feedback; De-implementation; low-value pharmacological prescription; Stepped-wedge design
• Other Study ID Numbers: 2024111054; 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")); 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")); RD21/0016/0003 (Other Grant/Funding Number: Instituto de Salud Carlos III (ISCIII) and European Union (NextGenerationEU funds, MRR)); RD24/0005/0017 (Other Grant/Funding Number: Instituto de Salud Carlos III (ISCIII) and European Union)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that support future results will be shared, after deidentification
• IPD Sharing Time Frame: Starting 6 months after the publication of results
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No