None listed
Conditions
Brief summary
Our experience with cold calling patients to obtain followup data on their satisfaction with pain management is that some patients were upset by the unexpected cold call. We hypothesized, therefore, that this upset may affect the way that patients respond to the subjective question of satisfaction. We undertook a clinical trial where patients were randomized to consent to participate either in the emergency department or at the start of the cold call. The purpose of the study was to determine if the timing and context of informed consent would confound (impact upon) subjective study endpoints.
Interventions
Patients enrolled will be randomised to be consented for follow up either while they are in the emergency department or at the time of the follow up telephone call (48 hours post emergency department discharge). Those consented in the emergency department will have the study explained by a final year medical student. They will be given an information form and allowed to ask any questions. Verbal consent will be obtained and documented. Those not consented in the emergency department will not kno
Patients enrolled will be randomised to be consented for follow up either while they are in the emergency department or at the time of the follow up telephone call (48 hours post emergency department discharge). Those consented in the emergency department will have the study explained by a final year medical student. They will be given an information form and allowed to ask any questions. Verbal consent will be obtained and documented. Those not consented in the emergency department will not know of the study until they receive the follow up call. At that time, the student will give an explanation of the study, answer any questions and obtain verbal consent before proceeding. Neither patient group will be aware that they were randomised to consent in the ED or at follow up. Both techniques could be considered standards of care and knowledge of the randomisation has the potential to introduce response bias into the data - something that could compromise the study's findings. The approving ethics committee was happy with this approach. The total time commitment for each participant is expected to be approximately 5 minutes (including explanation of the study and consent.
Sponsors
Austin Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Age 18 years or more • Moderate or severe pain (triage pain score 4 or more on a scale of 0-10)
Exclusion criteria
• Refusal to participate (in the ED or at follow up) • Significant illness/pain rendering pain scoring inappropriate • Inability to communicate a pain score (significant disability or cognitive impairment, severe illness, poor English) • Inability to follow up the patient (e.g. no telephone)
Outcome results
None listed