Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase

This study has been completed.
Sponsor:
Information provided by:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032552
First received: March 27, 2002
Last updated: March 23, 2010
Last verified: March 2010
  Purpose

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


Condition
Informed Consent

Study Type: Observational
Official Title: CSP #476DP - Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • measuring the process and outcome if informed consent [ Time Frame: immediately during patient interview ] [ Designated as safety issue: No ]

Enrollment: 632
Study Start Date: April 1999
Study Completion Date: February 2006
Primary Completion Date: February 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Intervention: Immediately after giving informed consent for the parent study and before randomization, research subjects will be asked for consent to participate in EQUIC-DP.

The parent-study staff will provide the research subject with privacy and place a call to the coordinating center. Staff (at the EQUIC coordinating center), who will be administering the Brief Informed Consent Evaluation Protocol (BICEP) to the research subject, will introduce themselves. Then, the subject will be interviewed using a BICEP structured assessment questionnaire of approximately 12-20 open ended questions, aimed at determining the success and validity of the informed consent process of the parent study. The results of the interviews will be used to fine-tune and adjust both the process of assessing informed consent in this manner as well as the questionnaire itself.

Primary Hypothesis: Enhancing the Quality of Informed Consent Development Phase (EQUIC-DP) is a pilot and instrument-development study that will be used as the base for a VA Cooperative Studies Program-wide initiative on informed consent, called EQUIC (Enhancing the Quality of Informed Consent). EQUIC-DP has as its primary aim the field testing and iterative improvement of a method for measuring the success of an informed consent encounter with a patient-subject.

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: Practitioners of clinical trials have a responsibility to ensure that patients participation in research is informed and voluntary. This implies that we should continuously strive to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the likelihood that their interests are respected. Innovations in informed consent should be tested in realistic contexts (i.e., in clinical trials) and when appropriate with randomization at the first opportunity. In this proposed project we take efforts to improve the quality of informed consent, based on experimentation with informed consent in ongoing clinical trials in the VA Cooperative Studies Program. The CSP is uniquely situated to serve as a testing ground for informed consent, not only because of concerns for enhancing consent for human experimentation, but also because of the centralized coordination of wide variety of clinical studies representing an extraordinary range of patient capacities and vulnerabilities. Moreover, such an effort is a special responsibility of the VA given the profound trust placed in the research enterprise by veterans.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Veterans

Criteria

Inclusion Criteria:

Depends on 'parent' study

Exclusion Criteria:

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032552

Locations
United States, Alabama
VA Medical Center, Birmingham
Birmingham, Alabama, United States, 35233
United States, California
VA Palo Alto Health Care System
Palo Alto, California, United States, 94304-1207
United States, Florida
MIMA Century Research Assoc. (CSP #424) (DP)
Melbourne, Florida, United States, 32901
West Palm Beach VA Medical Center
West Palm Beach, Florida, United States, 33410
United States, Illinois
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States, 60141-5000
United States, Indiana
Richard Roudebush VA Medical Center, Indianapolis
Indianapolis, Indiana, United States, 46202-2884
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113
United States, Minnesota
VA Medical Center, Minneapolis
Minneapolis, Minnesota, United States, 55417
Mayo Clinic Rochester (CSP #424) (DP)
Rochester, Minnesota, United States, 55905
United States, Missouri
VA Medical Center, St Louis
St Louis, Missouri, United States, 63106
United States, Nevada
VA Sierra Nevada Health Care System
Reno, Nevada, United States, 89502
United States, New York
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States, 14215
New York Harbor HCS
New York, New York, United States, 10010
VA Medical Center, Northport
Northport, New York, United States, 11768
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
United States, Texas
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, United States, 77030
United States, Washington
VA Puget Sound Health Care System, Seattle
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Investigators
Study Chair: Philip Lavori, PhD VA Palo Alto Health Care System
  More Information

No publications provided

Responsible Party: Lavori, Philip - Study Chair, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032552     History of Changes
Other Study ID Numbers: 476DP
Study First Received: March 27, 2002
Last Updated: March 23, 2010
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on April 16, 2014