Abstract
Objectives: Conducting randomised controlled trials (RCTs) in primary care is challenging; recruiting patients during time-limited or remote consultations can increase selection bias and physical access to patients’ notes is costly and time-consuming. We investigated barriers and facilitators to running a more efficient design.
Design: An RCT aiming to reduce antibiotic prescribing among children presenting with acute cough and a respiratory tract infection with a clinician-focused intervention, embedded at the practice-level. By using aggregate-level, routinely collected data for the co-primary outcomes, we removed the need to recruit individual participants.
Setting: Primary care
Participants: Baseline data from GP practices and interviews with individuals from Clinical Research Networks (CRNs) in England who helped recruit practices and Clinical Commission Groups (CCGs) who collected outcome data.
Intervention: The intervention included: i) explicit elicitation of parental concerns, ii) a prognostic algorithm to identify children at low risk of hospitalisation and iii) provision of a printout for carers including safety-netting advice.
Co-Primary outcomes: For 0-9 year olds - i) Dispensing data for amoxicillin and macrolide antibiotics and ii) hospital admission rate for RTI.
Results: We recruited 294 of the intended 310 practices (95%) representing 336,496 registered 0-9 year-olds (5% of all 0-9 year-old children). Included practices were slightly larger, had slightly lower baseline prescribing rates and were located in more deprived areas reflecting the national distribution. Engagement with CCGs and their understanding of their role in this research was variable. Engagement with CRNs and installation of the intervention was straight-forward although the impact of updates to practice IT systems and lack of familiarity required extended support in some practices. Data on the co-primary outcomes was almost 100%.
Conclusions: The infrastructure for trials at the practice level using routinely collected data for primary outcomes is viable in England and should be promoted for primary care research where appropriate.
Trial registration: ISRCTN11405239
Design: An RCT aiming to reduce antibiotic prescribing among children presenting with acute cough and a respiratory tract infection with a clinician-focused intervention, embedded at the practice-level. By using aggregate-level, routinely collected data for the co-primary outcomes, we removed the need to recruit individual participants.
Setting: Primary care
Participants: Baseline data from GP practices and interviews with individuals from Clinical Research Networks (CRNs) in England who helped recruit practices and Clinical Commission Groups (CCGs) who collected outcome data.
Intervention: The intervention included: i) explicit elicitation of parental concerns, ii) a prognostic algorithm to identify children at low risk of hospitalisation and iii) provision of a printout for carers including safety-netting advice.
Co-Primary outcomes: For 0-9 year olds - i) Dispensing data for amoxicillin and macrolide antibiotics and ii) hospital admission rate for RTI.
Results: We recruited 294 of the intended 310 practices (95%) representing 336,496 registered 0-9 year-olds (5% of all 0-9 year-old children). Included practices were slightly larger, had slightly lower baseline prescribing rates and were located in more deprived areas reflecting the national distribution. Engagement with CCGs and their understanding of their role in this research was variable. Engagement with CRNs and installation of the intervention was straight-forward although the impact of updates to practice IT systems and lack of familiarity required extended support in some practices. Data on the co-primary outcomes was almost 100%.
Conclusions: The infrastructure for trials at the practice level using routinely collected data for primary outcomes is viable in England and should be promoted for primary care research where appropriate.
Trial registration: ISRCTN11405239
| Original language | English |
|---|---|
| Article number | e061574 |
| Pages (from-to) | 1-9 |
| Journal | BMJ Open |
| Volume | 12 |
| Issue number | 7 |
| DOIs | |
| Publication status | Published - 1 Jul 2022 |
Bibliographical note
Funding Information:This research is funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme (funder ref: 16/31/98).
Publisher Copyright:
© Author(s) (or their employer(s)) 2022.
Research Groups and Themes
- BTC (Bristol Trials Centre)
- Centre for Academic Primary Care
Keywords
- respiratory tract infection
- antibiotic prescribing
- primary care
- efficient design