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NCT Number: NCT07336550

Reduction of Low-value Prescribing Through Audit and Feedback

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.

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Key information

Conditions

Inappropriate Prescribing Behavioral Sciences Implementation Science

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Primary Care Research Unit of Bizkaia

Barakaldo, Bizkaia, 48903, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP

    Time frame: From baseline to 13 months

    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.

Secondary outcomes

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

    Time frame: From baseline to 13 months

    proportion of patients in whom appropriateness is achieved for each of the potentially inappropriately prescribed drugs assessed separately

  2. Secondary Effectiveness: Rate of new PIP

    Time frame: From baseline to 13 months

    Rate of new PIP among patients over 65 years old seeking medical care during the study period

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

    Time frame: From baseline to 13 months

    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.

  4. Degree of implementation fidelity

    Time frame: From baseline to 13 months

    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.

  5. General Practitioners´ perception of the feasibility and acceptability

    Time frame: From baseline to 19 months

    GPs perception of the feasibility and acceptability of the deprescribing strategy based on the AF to adapt/reduce their practice of unnecessary pharmacological prescribing.

Study contacts

Contact information is provided by the study sponsor or research team.

Alvaro Sanchez Perez

CONTACT

[email protected]

(+34)946006673

Sponsors and collaborators

Lead sponsor

Basque Health Service

Other Gov

Collaborators

  • Basque Government Department of Public Health
  • Biobizkaia Health Research Institute
  • Carlos III Health Institute (ISCIII), Spain
  • European Union

Registry information

Official study title

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.

Acronym: AFFAP

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2026
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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