Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
836 participants
OBSERVATIONAL
2002-11-30
2008-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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 he/she 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
No intervention. Telephone interview.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
US Department of Veterans Affairs
FED
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Department of Veterans Affairs
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Philip Lavori, PhD
Role: STUDY_CHAIR
VA Palo Alto Health Care System
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VA Medical Center, Birmingham
Birmingham, Alabama, United States
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, United States
VA Medical Center, Loma Linda
Loma Linda, California, United States
VA Palo Alto Health Care System
Palo Alto, California, United States
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, United States
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States
VA Medical Center, Lexington
Lexington, Kentucky, United States
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, United States
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, United States
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, United States
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, United States
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, United States
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States
VA Medical Center, Northport
Northport, New York, United States
VA Medical Center, Durham
Durham, North Carolina, United States
VA Medical Center, Cincinnati
Cincinnati, Ohio, United States
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, United States
VA North Texas Health Care System, Dallas
Dallas, Texas, United States
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Lavori PW, Wilt TJ, Sugarman J. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clin Trials. 2007;4(6):638-49. doi: 10.1177/1740774507085144.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
476SM
Identifier Type: -
Identifier Source: org_study_id