Ignite Creation Date:
2024-05-05 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00032565
Status:
COMPLETED
Last Update Posted:
2010-09-24
First Post:
2002-03-27
Brief Title:
EQUIC-SM Enhancing Quality of Informed Consent
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 476SM - Enhancing Quality of Informed Consent EQUIC-SM Self-Monitoring
Status:
COMPLETED
Status Verified Date:
2010-09
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:
EQUIC
Brief Summary:
Patients in parent cooperative studies projects are interviewed about their experiences in the informed consent process
Detailed Description:
Intervention Self-Monitoring Questionnaire a questionnaire relating to the process of IC self-administered by study coordinators and evaluation of the informed consent process using the Brief Informed Consent Evaluation Protocol BICEP developed during the EQUIC-DP phase
Primary Hypothesis We hypothesize that by focusing attention on what may have become a routinized process the quality of the IC encounter will be enhanced We will evaluate the success of this intervention by having the patient-subject complete a telephone questionnaire the BICEP Brief Informed Consent Evaluation Protocol after the IC process is completed
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 Enhancing the Quality of Informed Consent Self-Monitoring EQUIC-SM is one component of a VA Cooperative Studies Program-wide initiative on informed consent EQUIC Its objective is the field testing and iterative improvement of one intervention in the informed consent IC process self monitoring Self-monitoring involves having the person obtaining IC complete a Self-Monitoring Questionnaire or SMQ after the IC encounter with a patient-subject being recruited for a participating study We conceive of the SMQ as an activation device which prompts the person obtaining IC to monitor how heshe conducts the IC encounter RESEARCH DESIGN EQUIC-SM will be conducted in conjunction with participating clinical trials of the VA CSP at multiple VAs throughout the country Patient-subjects will be recruited from among participants in these parent studies Parent studies will be randomized to SM protocol or to control sites
METHODOLOGY Patient-subjects will be informed about EQUIC-SM at the time that they are first presented with information about the parent study The person obtaining consent will use a scripted description of EQUIC-SM If the subject agrees verbal consent for EQUIC-SM will be obtained The same parent study informed consent process will be used for both the SM protocol and control arms of EQUIC-SM however in the SM protocol arm the person obtaining consent will complete the SMQ after the IC process In both arms patient-subjects will be asked to complete the BICEP interview after the parent study IC process is completed FINDINGS Investigators will use the results of EQUIC-SM to assess the value of the self-monitoring technique in improving the quality of informed consent The premise is that focusing the attention of the person obtaining informed consent on the IC process will enhance the quality of the IC encounter and thus of the informed consent obtained
SIGNIFICANCE Practitioners of clinical trials have a responsibility to ensure that patients participation in research be informed and voluntary This responsibility implies that we should strive continuously to improve the effectiveness of methods for informing prospective research volunteers about experimental studies thereby enhancing the protection of their interests If the self-monitoring technique tested in EQUIC-SM proves to enhance the quality of informed consent this technique may be adapted for wider use in conducting clinical trials thus representing an important step towards this goal
Primary Hypothesis We hypothesize that by focusing attention on what may have become a routinized process the quality of the IC encounter will be enhanced We will evaluate the success of this intervention by having the patient-subject complete a telephone questionnaire the BICEP Brief Informed Consent Evaluation Protocol after the IC process is completed
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 Enhancing the Quality of Informed Consent Self-Monitoring EQUIC-SM is one component of a VA Cooperative Studies Program-wide initiative on informed consent EQUIC Its objective is the field testing and iterative improvement of one intervention in the informed consent IC process self monitoring Self-monitoring involves having the person obtaining IC complete a Self-Monitoring Questionnaire or SMQ after the IC encounter with a patient-subject being recruited for a participating study We conceive of the SMQ as an activation device which prompts the person obtaining IC to monitor how heshe conducts the IC encounter RESEARCH DESIGN EQUIC-SM will be conducted in conjunction with participating clinical trials of the VA CSP at multiple VAs throughout the country Patient-subjects will be recruited from among participants in these parent studies Parent studies will be randomized to SM protocol or to control sites
METHODOLOGY Patient-subjects will be informed about EQUIC-SM at the time that they are first presented with information about the parent study The person obtaining consent will use a scripted description of EQUIC-SM If the subject agrees verbal consent for EQUIC-SM will be obtained The same parent study informed consent process will be used for both the SM protocol and control arms of EQUIC-SM however in the SM protocol arm the person obtaining consent will complete the SMQ after the IC process In both arms patient-subjects will be asked to complete the BICEP interview after the parent study IC process is completed FINDINGS Investigators will use the results of EQUIC-SM to assess the value of the self-monitoring technique in improving the quality of informed consent The premise is that focusing the attention of the person obtaining informed consent on the IC process will enhance the quality of the IC encounter and thus of the informed consent obtained
SIGNIFICANCE Practitioners of clinical trials have a responsibility to ensure that patients participation in research be informed and voluntary This responsibility implies that we should strive continuously to improve the effectiveness of methods for informing prospective research volunteers about experimental studies thereby enhancing the protection of their interests If the self-monitoring technique tested in EQUIC-SM proves to enhance the quality of informed consent this technique may be adapted for wider use in conducting clinical trials thus representing an important step towards this goal
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