Optimizing Management of Children Presenting With Acute Abdominal Pain in Primary Care: a Cluster Randomized Controlled Trial Evaluating the Impact of a Clinical Prediction Rule Including C-reactive Protein for Appendicitis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 566
- Locations
- 2
- Primary Endpoint
- Referral efficiency
Study Overview
Brief Summary
BACKGROUND Acute appendicitis (AA) in an early stage is difficult to distinguish from other (self-limiting) causes of acute abdominal pain (e.g. constipation and gastroenteritis), resulting in missing 19% of children with AA at first presentation in primary care and 70% of non-AA cases among referrals.
OBJECTIVE To evaluate the impact of the use of a diagnostic strategy for acute appendicitis (AA), which consists of a clinical prediction rule (cPR) including C-reactive protein point-of-care test (CRP POCT), on referral efficiency in children with acute abdominal pain in primary care, as compared to usual care.
STUDY DESIGN This is a cluster randomized controlled trial in primary care with a process evaluation. GPs in the intervention group will use an externally validated cPR based on symptoms and signs selectively followed by a CRP POCT in the medium risk group. GPs from general practices allocated to the control group will provide care and diagnosis as usual, i.e. following recommendations of the Dutch College of GPs guideline 'abdominal pain in children'.
STUDY POPULATION Children aged 4 to 18 years presenting to their general practitioner (GP) with acute abdominal pain.
OUTCOME MEASURES Primary outcome: referral efficiency (proportion non-referrals in non-AA patients during 30 days follow-up).
Secondary outcomes: safety (proportion of referrals in AA patients during the first consultation or planned reassessment), proportion of children with CRP-POCT, proportion of children with planned reassessment, child anxiety, parent or child satisfaction, quality of life, and costs.
Detailed Description
BACKGROUND About 10% of pediatric general practitioner (GP) consultations are for acute abdominal pain of which about 5% have acute appendicitis (AA). Delaying a diagnosis of AA and subsequent appendectomy increases the short and long-term morbidity. AA in an early stage is difficult to distinguish from other (self-limiting) causes of acute abdominal pain (e.g. urinary tract infection, constipation and gastroenteritis), resulting in missing 19% of children with AA at first presentation in primary care and 70% non-AA cases among referrals, which has a negative impact on the child and parents, such as anxiety and psychological distress.
As urgent illnesses other than AA are very rare in children with acute abdominal pain, the yield of referrals in terms of detecting other conditions than AA that need urgent specialist care is low. An evidence based diagnostic strategy for AA referral could help the GP in the diagnostic process, thereby reducing non-AA referrals without missing children with AA.
OBJECTIVE AND HYPOTHESIS The objective of this study is to evaluate the impact of a diagnostic strategy for AA, consisting of an externally validated cPR based on seven signs and symptoms, selectively followed by a CRP-POCT in the medium-risk group, on referral efficiency in children with acute abdominal pain in primary care, as compared with usual care. The hypothesis is that the diagnostic strategy will decrease the proportion of non-AA referrals, without delaying the diagnosis of AA.
STUDY DESIGN A pragmatic cluster RCT will be conducted with 1:1 permuted-block randomization of general practices to the intervention or control group using randomly varying block size. Stratification will be based on the GP practice size (greater or smaller than 5000 patients). Follow-up is 30 days for the primary outcome (efficiency) and 30 days and 3 months for secondary outcomes (7). Alongside the trial, a process evaluation will be performed according to the RE-AIM framework (Reach, Effectiveness, Adoption, Implementation, Maintenance).
STUDY POPULATION Inclusion criteria are: children, 4 to 18 years, presenting with acute abdominal pain (onset ≤ 7 days) in primary care.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- Single (Outcomes Assessor)
Masking Description
Even though the GP's and children can not be blinded to the allocation, researchers performing the analyses will be blinded to the assigned group.
Eligibility Criteria
- Ages
- 4 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •- Children aged 4 to 18 years with acute abdominal pain (onset ≤ 7 days) who present at the GP.
Exclusion Criteria
- •A history of appendectomy
- •Current pregnancy
- •Traumatic cause of abdominal pain
Arms & Interventions
Control
GPs in the control group provide care as usual, i.e. according to the Dutch College of GPs (NHG) guideline 'Abdominal pain in children', which does not include specific recommendations for AA referral and in which CRP POCT is not recommended. See for details: Detailed description - Usual care.
Diagnostic strategy
GPs in the intervention group will use a diagnostic strategy for AA referral, consisting of an externally validated cPR based on seven signs and symptoms, selectively followed by CRP-POCT in children in the medium risk group according to the cPR.
Intervention: Diagnostic strategy (Diagnostic Test)
Outcomes
Primary Outcomes
Referral efficiency
Time Frame: 30 days follow-up from baseline
The referral efficiency is defined as the proportion of non-referrals in patients without AA during 30 days follow-up (development of appendicitis beyond this period is extremely unlikely). This corresponds with the specificity of the diagnostic strategy. Medical records of the participating children in the GPs registry, including discharge letters (hospital data), will be screened by the researchers, in order to assess whether children were referred and whether they were or were not diagnosed with AA.
Secondary Outcomes
- Anxiety of child ≥8 years according to the Dutch version of the State-Trait Anxiety Inventory for Children(30 days and 3 months follow-up from baseline)
- Parent or child satisfaction with management according to the Parental Medical Interview Scale (P-MISS)(30 days follow-up from baseline)
- Quality of life of child according to the EuroQol 5D (EQ-5D)(30 days and 3 months follow-up from baseline)
- Costs (societal and healthcare perspective)(30 days and 3 months follow-up from baseline)
- Safety(30 days follow-up from baseline)
- Safety(30 days follow-up from baseline)
- Proportion of children with CRP-POCT(Baseline)
- Proportion of children with planned reassessment(Baseline)
- Anxiety of child ≥8 years according to the Dutch version of the State-Trait Anxiety Inventory for Children(30 days and 3 months follow-up from baseline)
- Parent or child satisfaction with management according to the Parental Medical Interview Scale (P-MISS)(30 days follow-up from baseline)
- Quality of life of child according to the EuroQol 5D (EQ-5D)(30 days and 3 months follow-up from baseline)
- Costs (societal and healthcare perspective)(30 days and 3 months follow-up from baseline)