- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01546194
A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Patients participating in approved, minimal risk clinical research projects will be approached by the study investigators. Consent for clinical research will be obtained on the day of surgery in the ambulatory surgery unit. In addition, some patients will be contacted by telephone on the day prior to surgery to be informed that they will be approached about participation in a research project. If patients agree to participate in the clinical trial, they will be provided with a self-addressed envelope containing the survey and a brief cover letter. The research team member will explain the purpose of the survey (to determine patients' attitudes towards research consent on the day of surgery). Subjects will be requested to complete the survey within a week of the surgical procedure. Two days after surgery, the research team will provide a follow-up call to determine if there are any questions about completing the survey. Although patient names will not be identified on the survey packet, all surveys will be coded with the subjects study number for subsequent analysis.
Questions are designed to investigate six areas of potential concern relating to informed consent; comprehension, situation (privacy/time), obligation (pressure) motivation, compunction (regrets), and satisfaction. Subjects will reply using a 5-point scale from 1=strongly disagree to 5=strongly agree.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Illinois
-
Evanston, Illinois, Förenta staterna, 60201
- NorthShore University HealthSystem
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Patients participating in approved, minimal risk clinical research projects will be approached by the study investigators
Exclusion Criteria:
- Inability to speak English
- Refusal to participate in the clinical research projects
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
---|---|
Morning consent
Consent process consisting of information only provided on the morning of surgery
|
A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
|
Phone call and morning consent
Consent process consisting of information provided on the morning of surgery.
In addition, a phone call on the day prior to surgery will be provided to subjects explaining that they will be approached about participation in a clinical research project
|
A phone call on the day before surgery will be provided to subjects explaining the nature of the clinical trial
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Overall Patient Satisfaction With the Same-day Consent Process-total Number of Questions Answered With a Score of 0 to 10 (on a 11-point Scale From 0=Strongly Disagree to 10=Strongly Agree).
Tidsram: First postoperative day
|
Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.
|
First postoperative day
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- EH09-533
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