- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01546194
A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
Illinois
-
Evanston, Illinois, Forenede Stater, 60201
- NorthShore University HealthSystem
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
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).
Tidsramme: First postoperative day
|
Subjects will reply using a 11-point scale from 0=strongly disagree to 10=strongly agree.
|
First postoperative day
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- EH09-533
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .