Communication tools for parents of children presenting to the Emergency Department with croup

ISRCTN	ISRCTN39642997
DOI	https://doi.org/10.1186/ISRCTN39642997
Protocol serial number	N/A
Sponsor	University of Alberta (Canada) - Department of Paediatrics
Funder	University of Alberta (Canada) - Department of Paediatrics

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

Aberhart Centre One, Room 8213
11402 University Avenue
Edmonton
T6G 2J3
Canada

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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(s)	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.
Key secondary outcome measure(s)	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
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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