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Effect of an Integrated Care Pathway on Asthma Care in Hospital

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Integrated Care Pathway
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Children, Integrated Care Pathway, Evidence based medicine, Prescribing errors

Eligibility Criteria

2 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Dept of Respiratory and Sleep Medicine, Royal Hospital for Sick Children

Outcomes

Primary Outcome Measures

Length of stay in hospital

Secondary Outcome Measures

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
Parental recall of advice to contact primary care

Full Information

First Posted
June 26, 2006
Last Updated
June 26, 2006
Sponsor
University of Edinburgh
Collaborators
Roche Educational Grant, Edinburgh Sick Kids Friends Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00345267
Brief Title
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

2. Study Status

Record Verification Date
June 2006
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
March 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University of Edinburgh
Collaborators
Roche Educational Grant, Edinburgh Sick Kids Friends Foundation

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Children, Integrated Care Pathway, Evidence based medicine, Prescribing errors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (false)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Cunningham, MD, PhD
Organizational Affiliation
University of Edinburgh
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Robin Prescott, PhD, FRCP
Organizational Affiliation
University of Edinburgh
Official's Role
Study Director
Facility Information:
Facility Name
Dept of Respiratory and Sleep Medicine, Royal Hospital for Sick Children
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH9 1LF
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
18280833
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.
Results Reference
derived

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Effect of an Integrated Care Pathway on Asthma Care in Hospital

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