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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
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
Patients in 'parent' cooperative study projects are interviewed about their experiences in the informed consent process.

Condition or disease
Healthy

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.


Study Type : Observational
Estimated Enrollment : 240 participants
Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: CSP #476CC - Enhancing Quality of Informed Consent (EQUIC-CC) Customized Consent
Study Start Date : April 1999
Primary Completion Date : April 1999
Study Completion Date : April 1999

Group/Cohort
1



Primary Outcome Measures :
  1. improve method of disclosing information to patients in the informed consent process [ Time Frame: post-randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Veterans in selected clinical trials conducted by VA
Criteria

Inclusion Criteria:

Inclusion Criteria:

  • Depends on 'parent' study

Exclusion Criteria:

Exclusion Criteria:

  • Depends on 'parent' study

Information from the National Library of Medicine

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


Locations
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1290
Stanford University
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
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Study Chair: Philip Lavori, PhD Stanford University

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00032539     History of Changes
Other Study ID Numbers: 476CC
First Posted: March 28, 2002    Key Record Dates
Last Update Posted: March 16, 2012
Last Verified: March 2012

Keywords provided by VA Office of Research and Development:
Informed Consent