The primary objective of this study is: To evaluate and improve patient recruitment procedures and follow-up methods. The secondary objectives are: (1) To determine the response rate before and after the introduction of optimized patient recruitment…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Brandwonden
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter will be the response rate in the patient group
contacted using the normal recruitment strategy and in the patient group
contacted using the optimized recruitment strategy. Response rates will be
calculated for both the total groups and for subgroups of patients, as far as
possible.
Secondary outcome
Secundary paramters are:
- Data on socio demographic (age, gender, education, ethnicity) and burn
characteristics (etiology, setting (home, work, else), firework (yes/no), body
region, extent of the burn), and comorbidity
- Both generic and burn specific quality of life
- Data on post-traumatic stress symptoms will be assessed using the Impact of
Event Scale
- Data on patients extramural medical costs and indirect costs (productivity
loss, absenteeism) will be collected 2 and 6 months post injury, using a
questionnaire *Costs and medical consumption*
Background summary
Rationale: Data on epidemiology, outcomes and costs of burn injuries presenting
at emergency department (ED)s are scarce. Dutch data on the epidemiology of
burn injures presenting at EDs can be derived from the Injury Surveillance
System (LIS), but provide limited information, and generalizability is not
established for patients with burns. Furthermore, to our knowledge, no studies
exist into the quality of life (QOL) after burns treated at an ED and data on
medical or societal costs after burns treated at an ED are scarce. No studies
exist which incorporate all three study domains.
In previous studies conducted on quality of life (QOL) after specialized burn
care in both pediatric and adult populations and QOL after injury in general
presenting at an ED, questionnaires proved to be feasible, however, response
rates were low (37-43%). In studies using (postal) questionnaires, the response
rate is crucial for the efficiency of the study. A low response rate will
require to address more patients and could even result in an insufficient
sample size. In this pilot study, emphasis will be put on the evaluation and
optimization of patient recruitment procedures and follow-up methods. By
optimizing the recruitment strategy and to compare this strategy to the
standard recruitment strategy we aim to demonstrate an increase in response of
patients. In addition, it is unclear whether specific high risk groups of burn
patients, for instance patents with lower socio-economic status are present in
the selected study region, and if so whether response rates differ between high
risk groups, for burn injuries. As a next step, we aim to conduct a larger
study to evaluate the epidemiology, quality of life and costs of burn injuries
presenting at all EDs within Network Emergency Care Brabant (NAZB, formerly
known as Trauma Centre Brabant), using the knowledge from this pilot study.
Study objective
The primary objective of this study is: To evaluate and improve patient
recruitment procedures and follow-up methods. The secondary objectives are: (1)
To determine the response rate before and after the introduction of optimized
patient recruitment procedures and follow-up, (2) To examine to what extent
high risk groups are represented among patients with burn-related injuries
attending to one of the two EDs and among the group of respondents, (3) To
obtain first insights into the epidemiology, quality of life and costs of burn
injuries presenting at EDs.
Study design
In a prospective follow-up study, all patients with burn-related injuries
attending two larger EDs from trauma region Brabant during 3 months will be
included. The follow-up period will be 6 months as patients will receive
questionnaires after 2 and 6 months after the first ED visit. Patients
attending the ED in the first month will be approached using the standard
recruitment strategy and patients attending the ED in the other months will be
approached using the optimized recruitment strategy. The EDs at Amphia hospital
(Breda) and St. Elisabeth hospital (Tilburg) will participate in this study.
Study burden and risks
The risks and inconvenience of participation are kept as low as possible. There
are no medical interventions involved in the study as outcomes will be assessed
using questionnaires. The time to complete the questionnaires depends on the
age group and time of assessments, and will vary between 15 min (assessment
after 2 months) and 25 minutes (assessment after 6 months). Moreover, special
questionnaires will be given to minors and data on post-traumatic stress
symptoms will only be assessed in adults using the Impact of Event Scale.
Maasstadweg 21
Rotterdam 3079 DZ
NL
Maasstadweg 21
Rotterdam 3079 DZ
NL
Listed location countries
Age
Inclusion criteria
All patients with burn-related injuries attending one of the two EDs from the trauma region Brabant between 1st of November 2013 and 1st of February 2014 (3 months).
Exclusion criteria
Patients who provide incomplete contact information will be excluded from the study.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
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CCMO | NL46438.008.13 |