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

Condition
Informed Consent

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: 1) to evaluate the effectiveness of an intervention to improve comprehension during informed consent, and 2) 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.

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Depends on 'parent' study

California
      VA Palo Alto Health Care System (Umbrella), Palo Alto,  California,  94304,  United States; Recruiting
North Carolina
      Duke University Medical Center (CC), Durham,  North Carolina,  27710,  United States; Recruiting
Pennsylvania
      University of Pennsylvania (CC), Philadelphia,  Pennsylvania,  19104,  United States; Recruiting

Study ID Numbers:  476CC
Record last reviewed:  August 2004
Record first received:  March 27, 2002
ClinicalTrials.gov Identifier:  NCT00032539
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-09