Clinical trial NCT00032539: EQUIC-CC: Enhancing Quality of Informed Consent - Customized Consent
Official title: CSP #476CC - Enhancing Quality of Informed Consent (EQUIC-CC) Customized Consent
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Informed Consent
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2002-03-28
Enrollment: 240
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Veterans in selected clinical trials conducted by VA

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.

Eligibility criteria: Inclusion Criteria:

Inclusion Criteria:

* Depends on 'parent' study

Exclusion Criteria:

Exclusion Criteria:

* Depends on 'parent' study

Primary outcomes:
measure: improve method of disclosing information to patients in the informed consent process
timeFrame: post-randomization
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Durham
country: United States
facility: VA Medical Center, Durham
state: North Carolina
city: Philadelphia
country: United States
facility: VA Medical Center, Philadelphia
state: Pennsylvania
Study officials:
affiliation: Stanford University
name: Philip Lavori, PhD
role: STUDY_CHAIR
References: