Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032539
Status:
COMPLETED
Last Update Posted:
2012-03-16
First Post:
2002-03-27
Brief Title:
EQUIC-CC Enhancing Quality of Informed Consent - Customized Consent
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 476CC - Enhancing Quality of Informed Consent EQUIC-CC Customized Consent
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Patients in parent cooperative study projects are interviewed about their experiences in the informed consent process
Detailed Description:
Intervention 1 Cognitive stratification obtained by a test of cognitive ability followed by a tailored IC process 2 Pre-recruitment video a patient-activation video designed to prevent several common misconceptions 3 Provide prospective research volunteers with a sense of the purpose and methods of controlled research and 4 Evaluation of the informed consent process using the Brief Informed Consent Evaluation Protocol BICEP developed in EQUIC-DP
Primary Hypothesis The validity of informed consent can be improved as measured by an independent interview of patients BICEP by at least one of three interventions described above
Primary Outcomes The quality of the informed consent process as measured by the BICEP Brief Informed Consent Evaluation Protocol The BICEP also offers a method to certify informed consent in routine use
Study Abstract Customized Consent will develop and test an innovative supplemental method of disclosing information to patients in the informed consent process This disclosure strategy is intended to increase patients understanding and satisfaction with the consent process This study has two goals
to evaluate the effectiveness of an intervention to improve comprehension during informed consent and
to identify those patients for whom this intervention is most effective
The primary goal of EQUIC-CC is to determine whether an intervention added to usual procedures for obtaining informed consent is able to improve comprehension The second goal of EQUIC-CC is to identify those patients for whom an augmented consent intervention is most effective as well as to determine which subgroups of patients if any are most likely to benefit from visual information added to the usual disclosure phase of obtaining informed consent
Primary Hypothesis The validity of informed consent can be improved as measured by an independent interview of patients BICEP by at least one of three interventions described above
Primary Outcomes The quality of the informed consent process as measured by the BICEP Brief Informed Consent Evaluation Protocol The BICEP also offers a method to certify informed consent in routine use
Study Abstract Customized Consent will develop and test an innovative supplemental method of disclosing information to patients in the informed consent process This disclosure strategy is intended to increase patients understanding and satisfaction with the consent process This study has two goals
to evaluate the effectiveness of an intervention to improve comprehension during informed consent and
to identify those patients for whom this intervention is most effective
The primary goal of EQUIC-CC is to determine whether an intervention added to usual procedures for obtaining informed consent is able to improve comprehension The second goal of EQUIC-CC is to identify those patients for whom an augmented consent intervention is most effective as well as to determine which subgroups of patients if any are most likely to benefit from visual information added to the usual disclosure phase of obtaining informed consent
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None