AsthmaNCT00345267
Effect of an Integrated Care Pathway on Asthma Care in Hospital
A study testing Integrated Care Pathway in people with Asthma, run by University of Edinburgh at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 2 to 16 years
- Conditions the study is for
- Asthma
- What is being tested?
- Integrated Care Pathway
- Type of treatment
- Medical device
- How many people
- 180 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2004to Mar 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 2-16 years (inclusive) arriving at the Emergency Department with acute wheeze/asthma
Who cannot join
- Children requiring high dependency care
- Children with significant neurological or cardiac disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dept of Respiratory and Sleep Medicine, Royal Hospital for Sick Children
Edinburgh, Scotland, EH9 1LF
About this study
Official title: Cluster Randomised Controlled Trial of the Effect of the Introduction of an Acute Wheeze/Asthma Integrated Care Pathway on Patient Outcome
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.
Read the 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
- Conditions
- Asthma
- Being tested
- Integrated Care Pathway
- Keywords
- Asthma, Children, Integrated Care Pathway, Evidence based medicine, Prescribing errors
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrated Care PathwayDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startAug 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Educational Grant, Edinburgh Sick Kids Friends Foundation
- Investigators
- Steve Cunningham, MD, PhD, Study director, University of EdinburghRobin Prescott, PhD, FRCP, Study director, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345267
- Sponsor's protocol ID
- 04/S1103/16
- Status last verified
- Jun 2006
- First submitted
- 26 Jun 2006
- Last updated
- 28 Jun 2006
- Results posted
- No
Publications
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.
PubMed 18280833
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomised Controlled Trial of the Effect of the Introduction of an Acute Wheeze/Asthma Integrated Care Pathway on Patient Outcome
- ClinicalTrials.gov ID
- NCT00345267
- Acronym / sponsor ID
- 04/S1103/16
- Conditions
- Asthma
- Keywords
- Asthma, Children, Integrated Care Pathway, Evidence based medicine, Prescribing errors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 180 participants
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- Roche Educational Grant, Edinburgh Sick Kids Friends Foundation
- Study start
- Aug 2004
- Study completion
- Mar 2005
- First posted
- 28 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 2 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children aged 2-16 years (inclusive) arriving at the Emergency Department with acute wheeze/asthma
Key exclusion criteria (2 listed)
- Children requiring high dependency care
- Children with significant neurological or cardiac disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Integrated Care Pathway | Device | – |
Primary outcome
Length of stay in hospital
12 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2006.
- Derived from this study: PubMed 18280833Cunningham 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steve Cunningham, MD, PhD study director
University of Edinburgh
Robin Prescott, PhD, FRCP study director
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrated Care Pathway in people with Asthma, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in hospital. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00345267, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2006.