NCT00345267

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Aug 2004

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 28, 2006

Completed
Last Updated

June 28, 2006

Status Verified

June 1, 2006

First QC Date

June 26, 2006

Last Update Submit

June 26, 2006

Conditions

Keywords

AsthmaChildrenIntegrated Care PathwayEvidence based medicinePrescribing errors

Outcome Measures

Primary Outcomes (1)

  • Length of stay in hospital

Secondary Outcomes (12)

  • 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

  • +7 more secondary outcomes

Interventions

Eligibility Criteria

Age2 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Edinburgh, Scotland, EH9 1LF, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Steve Cunningham, MD, PhD

    University of Edinburgh

    STUDY DIRECTOR
  • Robin Prescott, PhD, FRCP

    University of Edinburgh

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 26, 2006

First Posted

June 28, 2006

Study Start

August 1, 2004

Study Completion

March 1, 2005

Last Updated

June 28, 2006

Record last verified: 2006-06

Locations