Inappropriate PrescribingAFFAPNCT07336550
Reduction of Low-value Prescribing Through Audit and Feedback
A study testing Usual AF and Facilitated AF in people with Inappropriate Prescribing and Implementation Science, run by Basque Health Service at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Inappropriate Prescribing, Implementation Science, Behavioral Sciences
- What is being tested?
- Usual AF and Facilitated AF
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 540 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official 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.
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.
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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.
- Being tested
- Usual AF, Facilitated AF
- Keywords
- low-value pharmacological prescription, De-implementation, Stepped-wedge design, Benzodiazepines, Proton pump inhibitors, Opioids, audit and feedback
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual AFBehavioural
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 AFBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | All health centre clusters will start under the control condition Receives: Behavioral: Usual AF |
| Intervention | Experimental | one centre per step at 1-month intervals will be randomly assigned to crossover to the intervention Receives: Behavioral: Usual AF; Behavioral: Facilitated AF |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to 13 months
Secondary outcomes (5)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From baseline to 19 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study startJun 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inappropriate PrescribingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A closed-cohort stepped-wedge cluster-randomised trial will be conducted. 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 540 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Basque Health Service
- Sponsor type
- Other government
- Collaborators
- Biobizkaia Health Research Institute, Basque Government Department of Public Health, European Union, Carlos III Health Institute (ISCIII), Spain
- Responsible party
- Principal investigator, Mikel Baza Bueno, Basque Health Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07336550
- Sponsor's protocol ID
- 2024111054
- Other IDs
- 2018111085, 2021111024, PI21/00025, RD24/0005/0017, RD21/0016/0003, RD16/0007/0002
- Acronym
- AFFAP
- Status last verified
- May 2026
- First submitted
- 17 Dec 2025
- Last updated
- 13 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that support future results will be shared, after deidentification
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07336550
- Acronym / sponsor ID
- AFFAP / 2024111054
- Keywords
- low-value pharmacological prescription, De-implementation, Stepped-wedge design, Benzodiazepines, Proton pump inhibitors, Opioids, audit and feedback
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 540 participants (estimated)
- Lead sponsor
- Basque Health ServiceOther government
- Collaborators
- Biobizkaia Health Research Institute, Basque Government Department of Public Health, European Union, Carlos III Health Institute (ISCIII), Spain
- Study start
- Jun 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- A closed-cohort stepped-wedge cluster-randomised trial will be conducted. 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
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Usual AFAll health centre clusters will start under the control condition |
| Intervention | Experimental | Behavioral: Usual AF, Behavioral: Facilitated AFone centre per step at 1-month intervals will be randomly assigned to crossover to the intervention |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (5 listed)
- N/A
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual AFThe 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. | Behavioural | Control, Intervention |
| Facilitated AFBased 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. | Behavioural | Intervention |
Primary outcome
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.
5 secondary outcomes
Secondary effectiveness: Proportion of patients with deprescribing or tapering for each PIP
Time frame: From baseline to 13 months
Secondary Effectiveness: Rate of new PIP
Time frame: From baseline to 13 months
Adoption: Percentage of General Practitioners who agree to receive the active components of the strategies
Time frame: From baseline to 13 months
Degree of implementation fidelity
Time frame: From baseline to 13 months
General Practitioners´ perception of the feasibility and acceptability
Time frame: From baseline to 19 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
- Individual participant dataSharing planned: Yes. Individual participant data that support future results will be shared, after deidentification
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Usual AF and Facilitated AF in people with Inappropriate Prescribing and Implementation Science, run by Basque Health Service at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alvaro Sanchez Perez ((+34)946006673, ALVARO.SANCHEZPEREZ@osakidetza.eus), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary effectiveness: Proportion of patients with deprescribing or tapering of any of the PIP (time frame: From baseline to 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2026.