EQUIC-CC: Enhancing Quality of Informed Consent - Customized Consent

NCT ID: NCT00032539

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 240 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1999-04-30
• Study Completion Date: 1999-04-30

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.

Conditions

Healthy

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: RETROSPECTIVE

Study Groups

1

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Depends on 'parent' study

Exclusion Criteria

• Depends on 'parent' study

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philip Lavori, PhD

Role: STUDY_CHAIR

Stanford University

Locations

VA Palo Alto Health Care System

Palo Alto, California, United States

Stanford University

Stanford, California, United States

VA Medical Center, Durham

Durham, North Carolina, United States

VA Medical Center, Philadelphia

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

476CC

Identifier Type: -

Identifier Source: org_study_id