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Effect of an Integrated Care Pathway on Asthma Care in Hospital

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00345267
First Posted: June 28, 2006
Last Update Posted: June 28, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Roche Educational Grant
Edinburgh Sick Kids Friends Foundation
Information provided by:
University of Edinburgh
  Purpose
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.

Condition Intervention
Asthma Device: Integrated Care Pathway

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cluster Randomised Controlled Trial of the Effect of the Introduction of an Acute Wheeze/Asthma Integrated Care Pathway on Patient Outcome

Resource links provided by NLM:


Further study details as provided by University of Edinburgh:

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

Estimated Enrollment: 180
Study Start Date: August 2004
Estimated Study Completion Date: March 2005
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

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345267


Locations
United Kingdom
Dept of Respiratory and Sleep Medicine, Royal Hospital for Sick Children
Edinburgh, Scotland, United Kingdom, EH9 1LF
Sponsors and Collaborators
University of Edinburgh
Roche Educational Grant
Edinburgh Sick Kids Friends Foundation
Investigators
Study Director: Steve Cunningham, MD, PhD University of Edinburgh, UK
Study Director: Robin Prescott, PhD, FRCP University of Edinburgh, UK
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00345267     History of Changes
Other Study ID Numbers: 04/S1103/16
First Submitted: June 26, 2006
First Posted: June 28, 2006
Last Update Posted: June 28, 2006
Last Verified: June 2006

Keywords provided by University of Edinburgh:
Asthma
Children
Integrated Care Pathway
Evidence based medicine
Prescribing errors

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases