Evaluation of HomeCare RN Respiratory EducationNCT04559932
Paediatric Chronic Tracheostomy Care: An Evaluation of an Innovative Competency-based Education Program for Community Health Care Providers
A study testing Tracheostomy Training Course in people with Evaluation of HomeCare RN Respiratory Education, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This project will evaluate a new course developed for nurses that provide care to children with breathing technology including breathing tubes and home breathing machines. The investigators plan to assess the nurses' knowledge and comfort of their ability to care for these medical technologies prior to the course as… Read more about this study
- Who is it for?
- Ages Up to 99 years
- Conditions the study is for
- Evaluation of HomeCare RN Respiratory Education
- What is being tested?
- Tracheostomy Training Course
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- 15 Nov 2017to 30 Sep 2019
- 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 Up to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Course registrants for the competency-based tracheostomy education course from VHA Home Healthcare agency
- Consent to study participation
- English speaking
Who cannot join
- Previously attended the competency-based tracheostomy course at SickKids
Trial locations and contacts
1 site in 1 country.
About this study
This project will evaluate a new course developed for nurses that provide care to children with breathing technology including breathing tubes and home breathing machines. The investigators plan to assess the nurses' knowledge and comfort of their ability to care for these medical technologies prior to the course as well as their ability to retain their knowledge 6 weeks and 6 months after course completion.
Read the detailed description
A structured program evaluation considering a hierarchy of outcomes is essential to determine whether the tracheostomy module is associated with improved knowledge and skills for CHPs (community health providers). This investigators proposed study is guided by the evaluation of knowledge acquisition and self-efficacy as a theoretical framework 24. CHPs' sense of self-efficacy or perceived capability in caring for this population is important to foster to potentially mitigate significant morbidity and mortality, while ultimately striving for safe, high-quality clinical care for these medically complex children.
- Being tested
- Tracheostomy Training Course
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tracheostomy Training CourseOther
A standardized competency-based education tracheostomy module has been developed by the investigator group in collaboration with Respiratory Medicine, Complex Care, Respiratory Therapy, Nursing Education, Family Advisory Network and the Learning Institute at SickKids. Instructional methods for the full module are based on principles of adult learning and evidence from the procedure education literature and include the use of interactive, small-group teaching, hands-on simulation-based learning stations with relevant equipment as well as a formal assessment of knowledge and skills using simulation. Pre-learning packages are sent to course attendees at the time of registration to facilitate higher level discussions on the day of the course. While investigators have rigorously developed the curriculum and evaluation measures, the course outcomes remain unknown.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The knowledge and self-efficacy pre-tests will be completed at the start of the course and the post-test will be completed after the course at the end of the day. Study participants will complete tests independently using paper and pencil. Six weeks and six months post course completion, the knowledge and self-efficacy tests will be completed using REDcap (Research Electronic Data Capture), a secure web application for building and managing online surveys and databases or via telephone as per participant preference. Study participants will be sent a link to complete the tests online for the subsequent study visits. Study participants will receive 2 reminder emails (1 week apart) and 1 reminder phone call after the email reminders (if applicable) to complete the tests. Monthly telephone calls by the RA will be made to review the HCP experience logs. Receives: Other: Tracheostomy Training Course |
| Control | No intervention | Study participants in the control arm will be offered complementary attendance in the Health Tech Junior enterostomy and vascular access competency based training course while awaiting their session. This is being done to minimize the potential confound of generalized improvements in self-efficacy that may occur as a result of participating in an 8 hour learning opportunity at SickKids. The control group will also complete the tracheostomy course during session 3 and 4 but this will occur outside the window of data collection for the study procedures. Data collection intervals as described above for the intervention group will be followed for the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The difference in the immediate knowledge retention scores of tracheostomy course participants versus controls at 6 week follow-up
Knowledge Assessment - Tracheostomy Tubes: Multiple choice question (MCQ) tests have been developed by clinical experts. These tests focus on the important knowledge required to care for a child with a tracheostomy tube. Major themes include: i) clinical assessment; ii) safety; iii) general care; iv) troubleshooting/ emergency management. Higher Scores mean better knowledge retention.
Measured: 6 weeks
Secondary outcomes (2)
The difference in the sustained knowledge retention scores of course participants versus controls at 6 month follow-up
Knowledge Assessment - Tracheostomy Tubes: Multiple choice question (MCQ) tests have been developed by clinical experts. These tests focus on the important knowledge required to care for a child with a tracheostomy tube. Major themes include: i) clinical assessment; ii) safety; iii) general care; iv) troubleshooting/ emergency management. Higher Scores mean better knowledge retention.
Measured: 6 weeks and 6 months
The difference in the self-efficacy scores of course participants versus controls at 6 weeks and 6 month follow-up
Self-Efficacy - Tracheostomy Tubes: A self-efficacy survey that is content relevant for tracheostomy tubes has been developed based on Bandura's framework 24. The survey consists of 16 items assessing the registrants' perceived capability to perform each aspect of care on a likert scale with a 0-100 response interval. Higher Scores mean more self-efficacy.
Measured: 6 weeks and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2020
- Study start15 Nov 2017
- Primary completion30 Sep 2019
- Study completion30 Sep 2019
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 Evaluation of HomeCare RN Respiratory EducationStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reshma Amin, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04559932
- Sponsor's protocol ID
- 1000057879
- Status last verified
- Nov 2023
- First submitted
- 27 Aug 2020
- Last updated
- 27 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shi JY, Orkin J, Walsh CM, Chu S, Keilty K, McKay S, Mocanu C, Qazi A, Ambreen M, Amin R. Pediatric Chronic Tracheostomy Care: An Evaluation of an Innovative Competency-Based Education Program for Community Health Care Providers. Front Pediatr. 2022 May 31;10:885405. doi: 10.3389/fped.2022.885405. eCollection 2022.
PubMed 35757113
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paediatric Chronic Tracheostomy Care: An Evaluation of an Innovative Competency-based Education Program for Community Health Care Providers
- ClinicalTrials.gov ID
- NCT04559932
- Acronym / sponsor ID
- 1000057879
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 15 Nov 2017 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 23 Sep 2020 (actual)
- 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.
This project will evaluate a new course developed for nurses that provide care to children with breathing technology including breathing tubes and home breathing machines. The investigators plan to assess the nurses' knowledge and comfort of their ability to care for these medical technologies prior to the course as well as their ability to retain their knowledge 6 weeks and 6 months after course completion.
Detailed description
A structured program evaluation considering a hierarchy of outcomes is essential to determine whether the tracheostomy module is associated with improved knowledge and skills for CHPs (community health providers). This investigators proposed study is guided by the evaluation of knowledge acquisition and self-efficacy as a theoretical framework 24. CHPs' sense of self-efficacy or perceived capability in caring for this population is important to foster to potentially mitigate significant morbidity and mortality, while ultimately striving for safe, high-quality clinical care for these medically complex children.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Tracheostomy Training CourseThe knowledge and self-efficacy pre-tests will be completed at the start of the course and the post-test will be completed after the course at the end of the day. Study participants will complete tests independently using paper and pencil. Six weeks and six months post course completion, the knowledge and self-efficacy tests will be completed using REDcap (Research Electronic Data Capture), a secure web application for building and managing online surveys and databases or via telephone as per participant preference. Study participants will be sent a link to complete the tests online for the subsequent study visits. Study participants will receive 2 reminder emails (1 week apart) and 1 reminder phone call after the email reminders (if applicable) to complete the tests. Monthly telephone calls by the RA will be made to review the HCP experience logs. |
| Control | No intervention | –Study participants in the control arm will be offered complementary attendance in the Health Tech Junior enterostomy and vascular access competency based training course while awaiting their session. This is being done to minimize the potential confound of generalized improvements in self-efficacy that may occur as a result of participating in an 8 hour learning opportunity at SickKids. The control group will also complete the tracheostomy course during session 3 and 4 but this will occur outside the window of data collection for the study procedures. Data collection intervals as described above for the intervention group will be followed for the control group. |
Who may qualify
- Ages
- Up to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Course registrants for the competency-based tracheostomy education course from VHA Home Healthcare agency
- Consent to study participation
- English speaking
Key exclusion criteria (1 listed)
- Previously attended the competency-based tracheostomy course at SickKids
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 |
|---|---|---|
| Tracheostomy Training CourseA standardized competency-based education tracheostomy module has been developed by the investigator group in collaboration with Respiratory Medicine, Complex Care, Respiratory Therapy, Nursing Education, Family Advisory Network and the Learning Institute at SickKids. Instructional methods for the full module are based on principles of adult learning and evidence from the procedure education literature and include the use of interactive, small-group teaching, hands-on simulation-based learning stations with relevant equipment as well as a formal assessment of knowledge and skills using simulation. Pre-learning packages are sent to course attendees at the time of registration to facilitate higher level discussions on the day of the course. While investigators have rigorously developed the curriculum and evaluation measures, the course outcomes remain unknown. | Other | Intervention |
Primary outcome
The difference in the immediate knowledge retention scores of tracheostomy course participants versus controls at 6 week follow-up
Time frame: 6 weeks
Knowledge Assessment - Tracheostomy Tubes: Multiple choice question (MCQ) tests have been developed by clinical experts. These tests focus on the important knowledge required to care for a child with a tracheostomy tube. Major themes include: i) clinical assessment; ii) safety; iii) general care; iv) troubleshooting/ emergency management. Higher Scores mean better knowledge retention.
2 secondary outcomes
The difference in the sustained knowledge retention scores of course participants versus controls at 6 month follow-up
Time frame: 6 weeks and 6 months
The difference in the self-efficacy scores of course participants versus controls at 6 weeks and 6 month follow-up
Time frame: 6 weeks and 6 months
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 27 Nov 2023.
- Derived from this study: PubMed 35757113Shi JY, Orkin J, Walsh CM, Chu S, Keilty K, McKay S, Mocanu C, Qazi A, Ambreen M, Amin R. Pediatric Chronic Tracheostomy Care: An Evaluation of an Innovative Competency-Based Education Program for Community Health Care Providers. Front Pediatr. 2022 May 31;10:885405. doi: 10.3389/fped.2022.885405. eCollection 2022.
- Individual participant dataSharing planned: No
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 Tracheostomy Training Course in people with Evaluation of HomeCare RN Respiratory Education, run by The Hospital for Sick Children 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 3 inclusion and 1 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 27 Nov 2023. 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?
The difference in the immediate knowledge retention scores of tracheostomy course participants versus controls at 6 week follow-up (time frame: 6 weeks). 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 NCT04559932, 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 27 Nov 2023.