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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032539
First received: March 27, 2002
Last updated: March 14, 2012
Last verified: March 2012
  Purpose

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


Condition
Healthy

Study Type: Observational
Study Design: Observational Model: Case-Crossover
Time Perspective: Retrospective
Official Title: CSP #476CC - Enhancing Quality of Informed Consent (EQUIC-CC) Customized Consent

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • improve method of disclosing information to patients in the informed consent process [ Time Frame: post-randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: April 1999
Study Completion Date: April 1999
Primary Completion Date: April 1999 (Final data collection date for primary outcome measure)

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.

  Eligibility

Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Chair: Philip Lavori, PhD Stanford University
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032539     History of Changes
Other Study ID Numbers: 476CC
Study First Received: March 27, 2002
Last Updated: March 14, 2012
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Informed Consent

ClinicalTrials.gov processed this record on August 27, 2014