AsthmaNAPNCT02037841
The Impact of Implementing a Nursing-driven Clinical Pathway for Inpatient Management of Children With Asthma
A study testing Nursing-driven clinical pathway for management of inpatient asthma in people with Asthma, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
Asthma is the most common chronic disease of childhood and is responsible for large portion of pediatric admissions to Canadian hospitals. There is evidence that clinical pathways allow for optimal delivery of care and may result in decreased length of stay, leading to important economic benefits. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Nursing-driven clinical pathway for management of inpatient asthma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 113 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2012to Oct 2015
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children admitted during the study period with a diagnosis of asthma exacerbation, reactive airway disease, or wheezing
- Children aged 2 to 17 years
Who cannot join
- Children under the age of 2 years
- Children with congenital heart disease
- Children with chronic lung diseases other than asthma, including cystic fibrosis and bronchopulmonary dysplasia
- Children with severe neurological impairment
- Children with other significant co-morbid disorders
- Children whose caregivers do not understand English or French
- Children whose caregivers cannot be reached by phone for the 14-day follow up
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Implementing a Nursing-driven Clinical Pathway for Inpatient Management of Children Admitted to a Tertiary Care Centre With a Diagnosis of Asthma: A Randomized Controlled Trial
Asthma is the most common chronic disease of childhood and is responsible for large portion of pediatric admissions to Canadian hospitals. There is evidence that clinical pathways allow for optimal delivery of care and may result in decreased length of stay, leading to important economic benefits. Weaning of asthma medications prescribed for asthma exacerbation is not standardized in the current model of care. Currently, weaning is performed by ward physicians; in a teaching hospital, this most often done by residents staff. Differences in practice between different physicians, delays in patient assessment and adjustment of doctor's orders, likely prolong the hospital stay for children admitted with asthma.
This study's main objective is to determine the effect of a nursing-driven clinical pathway on children's length of stay when admitted to hospital with a diagnosis of acute asthma exacerbation. The pathway will allow nurses to wean a specific type of medication(β2-agonist), as compared to the current standard of care, which dictates that a physician writes an order to wean the medication. Number of administered β2-agonist treatments will be compared between both groups, as well as asthma-related health care utilization within two weeks of hospital discharge. Nursing, physician, and patients' satisfaction with the pathway will be evaluated, and a cost minimization analysis will be performed.
This study has the potential to improve resource use efficiency, increase patient safety by avoiding administration of unnecessary medications, and ameliorate quality of care by standardizing the care of children admitted to the hospital with a diagnosis of acute asthma exacerbation. The results of the study will be disseminated across the Canadian Health Care System with the goal of improving outcomes of children admitted to hospitals with acute asthma exacerbations.
- Conditions
- Asthma
- Being tested
- Nursing-driven clinical pathway for management of inpatient asthma
- Keywords
- Asthma, Nursing, Protocol, PRAM, Length of Stay, Weaning, Clinical pathway, Asthma exacerbation
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nursing-driven clinical pathway for management of inpatient asthmaOther
| Study group | Role | What they receive |
|---|---|---|
| Nursing-driven Asthma protocol | Experimental | Children randomized to the intervention group will have their β2-agonist medication weaned by the nurse, according to the steps outlined in the clinical pathway. The nurse will ensure that the patient's family is booked for asthma teaching, and will also remind the physicians to fill out an asthma action plan on discharge. Detailed information as to when to contact physicians in the event of an acute deterioration of the patient is included in the clinical pathway. Receives: Other: Nursing-driven clinical pathway for management of inpatient asthma |
| Physician-driven asthma management | No intervention | Patients in the control group will continue receiving the current standard of care, which consists of physicians weaning the β2-agonist medication when called to the bedside by the nurse or when deemed necessary by a physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital admission, in hours
The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.
Measured: Duration of hospital admission, average 2-3 days
Secondary outcomes (6)
The number of inhaled or nebulized β2-agonist treatments given
The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.
Measured: Duration of hospital admission, average 2 -3 days
number of children transferred to the ICU
The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.
Measured: During admission to hospital, average 2-3 days
number of families attending asthma teaching sessions
The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.
Measured: Duration of hospital admission, average 2-3 days
number of children seeking medical attention for asthma-related issues
Follow up will occur to assess all children who seeked medical attention for concerns related to asthma for two weeks post-discharge from hospital
Measured: Within 2 weeks of hospital discharge date
Nursing and physician satisfaction with the pathway
Measured: At study completion, expected within 2 to 3 years
patient satisfaction with the care received in hospital
Follow up satisfaction questionaire will be completed within two weeks of discharge from hospital
Measured: Within 2 weeks of hospital discharge date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startMar 2012
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- CHAMO Innovation Fund
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02037841
- Sponsor's protocol ID
- #11/10E
- Acronym
- NAP
- Status last verified
- Jan 2014
- First submitted
- 4 Jul 2013
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Implementing a Nursing-driven Clinical Pathway for Inpatient Management of Children Admitted to a Tertiary Care Centre With a Diagnosis of Asthma: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02037841
- Acronym / sponsor ID
- NAP / #11/10E
- Conditions
- Asthma
- Keywords
- Asthma, Nursing, Protocol, PRAM, Length of Stay, Weaning, Clinical pathway, Asthma exacerbation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- CHAMO Innovation Fund
- Study start
- Mar 2012
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 16 Jan 2014 (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.
Asthma is the most common chronic disease of childhood and is responsible for large portion of pediatric admissions to Canadian hospitals. There is evidence that clinical pathways allow for optimal delivery of care and may result in decreased length of stay, leading to important economic benefits. Weaning of asthma medications prescribed for asthma exacerbation is not standardized in the current model of care. Currently, weaning is performed by ward physicians; in a teaching hospital, this most often done by residents staff. Differences in practice between different physicians, delays in patient assessment and adjustment of doctor's orders, likely prolong the hospital stay for children admitted with asthma.
This study's main objective is to determine the effect of a nursing-driven clinical pathway on children's length of stay when admitted to hospital with a diagnosis of acute asthma exacerbation. The pathway will allow nurses to wean a specific type of medication(β2-agonist), as compared to the current standard of care, which dictates that a physician writes an order to wean the medication. Number of administered β2-agonist treatments will be compared between both groups, as well as asthma-related health care utilization within two weeks of hospital discharge. Nursing, physician, and patients' satisfaction with the pathway will be evaluated, and a cost minimization analysis will be performed.
This study has the potential to improve resource use efficiency, increase patient safety by avoiding administration of unnecessary medications, and ameliorate quality of care by standardizing the care of children admitted to the hospital with a diagnosis of acute asthma exacerbation. The results of the study will be disseminated across the Canadian Health Care System with the goal of improving outcomes of children admitted to hospitals with acute asthma exacerbations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing-driven Asthma protocol | Experimental | Other: Nursing-driven clinical pathway for management of inpatient asthmaChildren randomized to the intervention group will have their β2-agonist medication weaned by the nurse, according to the steps outlined in the clinical pathway. The nurse will ensure that the patient's family is booked for asthma teaching, and will also remind the physicians to fill out an asthma action plan on discharge. Detailed information as to when to contact physicians in the event of an acute deterioration of the patient is included in the clinical pathway. |
| Physician-driven asthma management | No intervention | –Patients in the control group will continue receiving the current standard of care, which consists of physicians weaning the β2-agonist medication when called to the bedside by the nurse or when deemed necessary by a physician |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Children admitted during the study period with a diagnosis of asthma exacerbation, reactive airway disease, or wheezing
- Children aged 2 to 17 years
Key exclusion criteria (7 listed)
- Children under the age of 2 years
- Children with congenital heart disease
- Children with chronic lung diseases other than asthma, including cystic fibrosis and bronchopulmonary dysplasia
- Children with severe neurological impairment
- Children with other significant co-morbid disorders
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 |
|---|---|---|
| Nursing-driven clinical pathway for management of inpatient asthma | Other | Nursing-driven Asthma protocol |
Primary outcome
Length of hospital admission, in hours
Time frame: Duration of hospital admission, average 2-3 days
The participants will be followed for the duration of their hostpital admission, an expected average of 2-3 days.
6 secondary outcomes
The number of inhaled or nebulized β2-agonist treatments given
Time frame: Duration of hospital admission, average 2 -3 days
number of children transferred to the ICU
Time frame: During admission to hospital, average 2-3 days
number of families attending asthma teaching sessions
Time frame: Duration of hospital admission, average 2-3 days
number of children seeking medical attention for asthma-related issues
Time frame: Within 2 weeks of hospital discharge date
Nursing and physician satisfaction with the pathway
Time frame: At study completion, expected within 2 to 3 years
patient satisfaction with the care received in hospital
Time frame: Within 2 weeks of hospital discharge date
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 1 Feb 2016.
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Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nursing-driven clinical pathway for management of inpatient asthma in people with Asthma, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 2 inclusion and 7 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 1 Feb 2016. 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 Canada. 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 hospital admission, in hours (time frame: Duration of hospital admission, average 2-3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2016.