Clinical trial NCT00345267: Effect of an Integrated Care Pathway on Asthma Care in Hospital
Official title: Cluster Randomised Controlled Trial of the Effect of the Introduction of an Acute Wheeze/Asthma Integrated Care Pathway on Patient Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: Asthma
Children
Integrated Care Pathway
Evidence based medicine
Prescribing errors
Lead sponsor: University of Edinburgh
Sponsor class: OTHER
Collaborators: name: Roche Educational Grant
name: Edinburgh Sick Kids Friends Foundation
First posted: 2006-06-28
Enrollment: 180
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Integrated care pathways (ICP) coalesce medical and nursing work practices, unifying and directing care in line with current best practice and guidelines. We wish to examine the introduction of an ICP for children with wheeze/asthma admitted to our hospital. We will determine whether more rigid, but guided care results in faster recovery, quicker discharge with better education and fewer prescribing errors, but also determine whether staff feel alienated by the rigidity of practice, and parents perceive any benefit to the changes introduced.This will be a cluster randomised trial (random weeks) of standard or ICP care in 180 patients admitted to Sick Kids with wheeze/asthma. Parents will be asked to complete a questionnaire on admission and contacted at 10-14 days post discharge and asked to recall education provided at discharge; no other patient or parent intervention will be required.It is expected to take 40 weeks to recruit 180 patients.

Detailed description: Children admitted to hospital with wheeze/asthma are provided with care by a large number of clinicians with varying levels of skills and experiences. Providing a uniform, safe level of care, according to evidence based guidelines is challenging given the levels of experience within each hospital. Integrated care pathways are a multidisciplinary document incorporating medical, nursing, pharmacy and observational charts within a single chronological document. The study is to assess whether such documents can speed recovery and discharge, with care adhering more closely to evidence based guidelines for treatment and education. In addition we wish to assess patient safety (through prescribing errors) and parental and staff attitudes to the ICP introduction. Children arriving at the emergency department will be provided with care by either intergrated care pathway or standard care in 7 day clusters, randomised in 8 week blocks.

Comparison: We will compare the time from arrival at hospital to discharge from the ward as our primary outcome.

Other comparisons to be made for: Speed of recovery of heart rate and respiratory rate Time to require no supplemental oxygen Time to achieve 4 hourly spacing of bronchodilator Number and degree of prescribing errors Provision of education to parents Provision of care adhering to asthma guidelines (accurate discharge dose of prednisolone from emergency dept, use of multidose salbutamol rather than nebuliser) Number of clinical contacts required with patients Staff opinion of ICP before and after introduction Parental opinion of care in different groups Parental recall of advice/education provided to them during admission Possible Hawthorne effect during period of the study

Eligibility criteria: Inclusion Criteria:

* Children aged 2-16 years (inclusive) arriving at the Emergency Department with acute wheeze/asthma

Exclusion Criteria:

* Children requiring high dependency care
* Children with significant neurological or cardiac disease

Primary outcomes:
measure: Length of stay in hospital
Secondary outcomes:
measure: Speed of recovery of heart rate and respiratory rate
measure: Time to require no supplemental oxygen
measure: Time to achieve 4 hourly spacing of bronchodilator
measure: Number and degree of prescribing errors
measure: Provision of education to parents
measure: Provision of care adhering to asthma guidelines (accurate discharge dose of prednisolone from emergency dept, use of multidose salbutamol rather than nebuliser)
measure: Number of clinical contacts required with patients
measure: Staff opinion of ICP before and after introduction
measure: Parental opinion of care in different groups
measure: Parental recall of advice/education provided to them during admission
measure: Possible Hawthorne effect during period of the study
measure: Parental recall of advice to contact primary care
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Dept of Respiratory and Sleep Medicine, Royal Hospital for Sick Children
state: Scotland
Study officials:
affiliation: University of Edinburgh
name: Steve Cunningham, MD, PhD
role: STUDY_DIRECTOR
affiliation: University of Edinburgh
name: Robin Prescott, PhD, FRCP
role: STUDY_DIRECTOR
References:
citation: Cunningham S, Logan C, Lockerbie L, Dunn MJ, McMurray A, Prescott RJ. Effect of an integrated care pathway on acute asthma/wheeze in children attending hospital: cluster randomized trial. J Pediatr. 2008 Mar;152(3):315-20. doi: 10.1016/j.jpeds.2007.09.033. Epub 2007 Nov 26.