EQUIC-CC: Enhancing Quality of Informed Consent - Customized Consent
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|ClinicalTrials.gov Identifier: NCT00032539|
Recruitment Status : Completed
First Posted : March 28, 2002
Last Update Posted : March 16, 2012
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||240 participants|
|Official Title:||CSP #476CC - Enhancing Quality of Informed Consent (EQUIC-CC) Customized Consent|
|Study Start Date :||April 1999|
|Actual Primary Completion Date :||April 1999|
|Actual Study Completion Date :||April 1999|
- improve method of disclosing information to patients in the informed consent process [ Time Frame: post-randomization ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032539
|United States, California|
|VA Palo Alto Health Care System|
|Palo Alto, California, United States, 94304-1290|
|Stanford, California, United States, 94305|
|United States, North Carolina|
|VA Medical Center, Durham|
|Durham, North Carolina, United States, 27705|
|United States, Pennsylvania|
|VA Medical Center, Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Study Chair:||Philip Lavori, PhD||Stanford University|