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

Basque Health Service

Status: Not yet enrolling

Conditions: Implementation Science; Inappropriate Prescribing; Behavioral Sciences

Treatments: Behavioral: Facilitated AF; Behavioral: Usual AF

Study type: Interventional

Funder types: Other

Identifiers

NCT07336550

PI21/00025 (Other Grant/Funding Number)

RD24/0005/0017 (Other Grant/Funding Number)

2021111024 (Other Grant/Funding Number)

2024111054

RD16/0007/0002 (Other Grant/Funding Number)

RD21/0016/0003 (Other Grant/Funding Number)

2018111085

Details and patient eligibility

About

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.

Enrollment: 540 estimated patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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540 participants in 2 patient groups

Control

Active Comparator group

Description:

All health centre clusters will start under the control condition

Treatment:

Behavioral: Usual AF

Intervention

Experimental group

Description:

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

Treatment:

Behavioral: Usual AF

Behavioral: Facilitated AF