Summary

Research question

Can implementation of an evidence based educational intervention, focussed on accurate diagnosis of appendicitis, safely reduce unnecessary admissions to hospital in patients with suspected appendicitis?

Background

Acute appendicitis is one of the most common surgical emergencies. Over 55,000 operations for appendicitis are performed each year in the UK. However, a significant proportion of patients with right iliac fossa (RIF) pain are misdiagnosed and placed on incorrect care pathways. Most of these patients receive unnecessary hospital admissions for monitoring and do not undergo an intervention. Some admissions result in patients receiving a negative appendicectomy, exposing them to unnecessary pain and complications. Furthermore, this leads to delayed treatment for the underlying condition they initially presented to hospital with.

Aim

To improve right iliac fossa care pathways by reducing unnecessary admissions to hospital.

Design

Multicentre, parallel cluster randomised controlled trial with an effectiveness-implementation design. This type of trial combines elements of both implementation and effectiveness research to address the real-world effectiveness of an intervention while also considering how well it can be implemented in practice. Each cluster corresponds to an acute care hospital. 

Eligibility

Any hospital in the UK providing an acute general surgery service. Additionally, the hospital must have the ability to admit patients overnight and to schedule follow up in the surgical admissions unit or ambulatory clinic. 

Participants

Members of the acute surgical team involved in the assessment of patients with RIF pain and suspected appendicitis. 

PICO:

Population: Data from hospital notes will be collected from consecutive patients aged 16 to 39 years old (inclusive) attending hospital with right iliac fossa pain over an 8-week period.

Intervention: The intervention is the CLARITY accurate diagnosis package, which is made up of three components: the evidence based education programme (EBP), an implementation checklist and local implementation strategies. The EBP is considered the main component of our intervention and will be delivered using a digital education platform to intervention sites.

Comparison: Routine clinical care (sites without CLARITY EBP).

Primary outcome: Non-operative admission rate (NOAR) – defined as admission without operation.

Secondary Outcome: Safety (including negative appendicectomy, postoperative complication rate, readmission, missed disease).

Sample size

40 clusters (20 per arm) of 120 patients would be required to detect a 25% reduction in non-operative admission rate (4800 patients in total, power = 0.90, ɑ = 0.05).

Randomisation

Hospitals will be categorised by bed size (<400 or >400 beds) and randomised using a 1:1 minimisation algorithm.

Follow-up

This will be carried out by reviewing hospital notes 30 days after attendance/admission. 

Analysis

Intention to treat, including implementation analyses.

Potential impact

  1. Improved patient care, with a reduction in unnecessary admissions and negative appendectomies.
  2. Reduction in healthcare costs by preventing unnecessary surgeries.
  3. More efficient allocation of emergency resources, reducing hospital stays and admissions.