Communication tools for parents of children presenting to the Emergency Department with croup
| ISRCTN | ISRCTN39642997 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39642997 |
| Secondary identifying numbers | N/A |
- Submission date
- 04/10/2007
- Registration date
- 16/10/2007
- Last edited
- 11/11/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Terry Klassen
Scientific
Scientific
Aberhart Centre One, Room 8213
11402 University Avenue
Edmonton
T6G 2J3
Canada
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Quality of life |
| Scientific title | |
| Study acronym | CCT (Croup Communication Tools) Study |
| Study objectives | Stories, delivered through printed and illustrated story booklets, versus standard information sheets distributed in the Emergency Department (ED), will produce different results in terms of: 1. Parental anxiety, knowledge, satisfaction, and decisional regret 2. Healthcare utilisation patterns, and 3. Costs Please note that as of 05/09/2008, the anticipated end date of this trial was extended to 31st March 2009 to create more time to recruit the full sample size. The previous anticipated end date was 31st March 2008. |
| Ethics approval(s) | Approved by University of Alberta Health Research Ethics Board on the 14th September 2007 (ref: B-110607). |
| Health condition(s) or problem(s) studied | Acute obstructive laryngitis (croup) |
| Intervention | Patients are randomly assigned to one of the following: 1. Experimental intervention is three booklets that integrate stories, as told by parents of children with croup attending the ED, with evidence regarding the epidemiology and treatment of the condition. These will be given when they are recruited and randomised at the beginning of their ED visit. They will be able to take the information home and refer to it at their convenience. Parents will be interviewed when they are recruited to the study (baseline), on discharge from the ED, one day post-ED discharge and three days post-ED discharge. For patients who still have symptoms at day three, the parents will be interviewed every two days until the symptoms resolve or until 9 days post-discharge. A convenience sample of 30 parents randomised to the story group will be asked to participate in an in-depth qualitative interview approximately 2 weeks after the ED visit. All parents will be interviewed at 1 year post-ED visit 2. Control intervention is a standard patient information sheet on croup |
| Intervention type | Other |
| Primary outcome measure | Parental anxiety measured using the State-Trait Anxiety Inventory (STAI-S, Form Y). Anxiety will be measured at baseline, discharge from ED, one day post-discharge, and when child is symptom free. |
| Secondary outcome measures | 1. Event impact 2. Parental knowledge, measured at day 3 post-discharge, 1 year post-discharge 3. Parental satisfaction with ED visit, measured at day 1 post-discharge 4. Decisional regret, measured at day 1 post-discharge 5. Incidence of return for medical care, measured at day 1, day 3 and every two days thereafter until child is symptom-free or until day 9 post-discharge 6. Healthcare utilisation patterns, measured at day 1, day 3 and every two days thereafter until child is symptom-free or until day 9 post-discharge, 1 year post-discharge 7. Costs, measured at day 1, day 3 and every two days thereafter until child is symptom-free or until day 9 post-discharge, 1 year post-discharge |
| Overall study start date | 15/10/2007 |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 420 |
| Key inclusion criteria | 1. Parents of children with a clinical diagnosis of croup 2. Parents must also meet the following criteria: 2.1. Have a telephone and be willing to be contacted for follow-up interviews 2.2. Fluent in English 2.3. Provide informed consent 2.4. No prior visit to an ED during this episode of the disease 2.5. No prior visit to an ED for another episode of croup during the study period |
| Key exclusion criteria | Parents will be excluded if: 1. Stridor is due to another cause (e.g., bacterial tracheitis, presence of a supraglottic foreign body) 2. Parent has previously been included in the study |
| Date of first enrolment | 15/10/2007 |
| Date of final enrolment | 31/03/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
Aberhart Centre One, Room 8213
Edmonton
T6G 2J3
Canada
T6G 2J3
Canada
Sponsor information
University of Alberta (Canada) - Department of Paediatrics
University/education
University/education
Aberhart Centre One
11402 University Avenue
Edmonton
T6G 2J3
Canada
| Website | http://www.ualberta.ca/ |
|---|---|
"ROR" |
https://ror.org/0160cpw27 |
Funders
Funder type
University/education
University of Alberta (Canada) - Department of Paediatrics
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/10/2013 | Yes | No |
