NCT03082521

Brief Summary

This PAR (participatory action research) study to improve antibiotic prescribing quality in a GPC (general practitioner cooperative) during OOH-care (out-of-hours-care) uses a mixed methods approach using qualitative as well as quantitative techniques. In a first exploratory phase we will work on partnership development and mapping the existing issues. In a second phase the focus will be on facilitating change and implementing interventions through PDSA (plan do study act) cycles. In a third phase outcomes on prescribing quality during and outside office hours will be evaluated. Equally important is the process evaluation and theory building on improving antibiotic prescribing through PAR.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 7, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
15 days until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3 years

First QC Date

March 7, 2017

Last Update Submit

May 30, 2022

Conditions

Keywords

After hours care; Primary care; Antibiotics; Action Research

Outcome Measures

Primary Outcomes (5)

  • Interview study

    Semi-structured interview with the stakeholders on the experiences of prescribing antibiotics in OOH care and the willingness to participate in PAR.

    year 1

  • Antibiotic prescribing feedback using antibiotic prescribing quality indicators

    Using antibiotic prescribing quality indicators (APQI) feedback on the antibiotic prescription rates of the GPC will be generated. For the six most common indications for antibiotic prescribing (in descending order: acute bronchitis (ICPC (6) code R78), acute upper RTI (R74), cystitis/other urinary infection (UTI; U71), acute tonsillitis (R76), acute/chronic sinusitis (R75), and acute otitis media (H71)) and for pneumonia (R81) values of three valid antibiotic prescribing quality indicators (APQI)quality indicators will be calculated and fed back: (5) 1. = the percentage of patients with age and/or gender limitation prescribed an antibiotic; 2. = a. and receiving the guideline recommended antibiotic; 3. = a and receiving quinolones.

    year 1

  • Ethnographic study: explanatory and descriptive approach of observations, descriptions and interpretation of the phenomenon of prescribing antibiotics in OOH care

    Observations of consultations to get a better understanding of the context , difficulties, clinical issues, etc. of prescribing antibiotics in OOH care.

    year 2

  • Focus groups (descriptative & interpretative) & description of PDSA cycles on developing and implementing interventions on antibiotic prescribing in OOH care

    Qualitative and quantitative results of phase 1 will be fedback to the group of GPs. In reflective peer group sessions the issues and problems will be explored and interventions will be designed taking into account previous work. The implemented interventions and changes will be studied based on both outcome as process indicators. ESACs' Antibiotic Prescribing Quality Indicators (APQI) will be used to assess quality of antibiotic prescribing. Pocess indicators will depend on the chosen interventions.

    year 3

  • Process evaluation and sociological meso-theory building of PAR in the case of improving antibiotic prescribing behaviour in a GPC

    Evaluation of the study, theory building on optimising antibiotic use with PAR. Study of group-level interactions, descriptive.

    year 4

Secondary Outcomes (1)

  • Use of Antibiotics (quantity, type, use of broad-spectrum antibiotics,etc.) in daytime care

    year 5

Interventions

The goal is to improve the antibiotic prescribing quality of GPs in a GPC by setting up a participatory action research. The interventions will be co-designed with the GPs.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

General practitioners within a general practitioner cooperative during out-of-hours care.

You may qualify if:

  • GPs working in the GPC

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GPC Brabo

Antwerp, Belgium

Location

Related Publications (2)

  • Colliers A, Coenen S, Remmen R, Philips H, Anthierens S. How do general practitioners and pharmacists experience antibiotic use in out-of-hours primary care? An exploratory qualitative interview study to inform a participatory action research project. BMJ Open. 2018 Sep 28;8(9):e023154. doi: 10.1136/bmjopen-2018-023154.

  • Colliers A, Coenen S, Philips H, Remmen R, Anthierens S. Optimising the quality of antibiotic prescribing in out-of-hours primary care in Belgium: a study protocol for an action research project. BMJ Open. 2017 Oct 15;7(10):e017522. doi: 10.1136/bmjopen-2017-017522.

MeSH Terms

Conditions

Communicable Diseases

Condition Hierarchy (Ancestors)

InfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Samuel Coenen, MD, PhD

    Universiteit Antwerpen

    STUDY CHAIR
  • Sibyl Anthierens, PhD

    Universiteit Antwerpen

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
4 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 7, 2017

First Posted

March 17, 2017

Study Start

April 1, 2017

Primary Completion

March 15, 2020

Study Completion

January 1, 2022

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations