Effect of an Integrated Care Pathway on Asthma Care in Hospital

Asthma Clinical Trial

Official title:

Cluster Randomised Controlled Trial of the Effect of the Introduction of an Acute Wheeze/Asthma Integrated Care Pathway on Patient Outcome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345267
• Other study ID #: 04/S1103/16
• Status: Completed
• Phase: N/A
• First received: June 26, 2006
• Last updated: June 26, 2006
• Start date: August 2004
• Est. completion date: March 2005

Study information

• Verified date: June 2006
• Source: University of Edinburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Department of Health
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: March 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 16 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• Integrated Care Pathway

Locations

Country	Name	City	State
United Kingdom	Dept of Respiratory and Sleep Medicine, Royal Hospital for Sick Children	Edinburgh	Scotland

Sponsors (3)

Lead Sponsor	Collaborator
University of Edinburgh	Edinburgh Sick Kids Friends Foundation, Hoffmann-La Roche

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Length of stay in hospital
Secondary	Speed of recovery of heart rate and respiratory rate
Secondary	Time to require no supplemental oxygen
Secondary	Time to achieve 4 hourly spacing of bronchodilator
Secondary	Number and degree of prescribing errors
Secondary	Provision of education to parents
Secondary	Provision of care adhering to asthma guidelines (accurate discharge dose of prednisolone from emergency dept, use of multidose salbutamol rather than nebuliser)
Secondary	Number of clinical contacts required with patients
Secondary	Staff opinion of ICP before and after introduction
Secondary	Parental opinion of care in different groups
Secondary	Parental recall of advice/education provided to them during admission
Secondary	Possible Hawthorne effect during period of the study
Secondary	Parental recall of advice to contact primary care