EQUIC-SM: Enhancing Quality of Informed Consent

Healthy Clinical Trial

— EQUIC  

Official title:

CSP #476SM - Enhancing Quality of Informed Consent (EQUIC-SM) Self-Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00032565
• Other study ID #: 476SM
• Status: Completed
• Phase: N/A
• First received: March 27, 2002
• Last updated: September 22, 2010
• Start date: November 2002
• Est. completion date: March 2008

Study information

• Verified date: September 2010
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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

Description:

Intervention: Self-Monitoring Questionnaire (a questionnaire relating to the process of IC self-administered by study coordinators) and evaluation of the informed consent process using the Brief Informed Consent Evaluation Protocol (BICEP) developed during the EQUIC-DP phase.

Primary Hypothesis: We hypothesize that by focusing attention on what may have become a routinized process, the quality of the IC encounter will be enhanced. We will evaluate the success of this intervention by having the patient-subject complete a telephone questionnaire, the BICEP (Brief Informed Consent Evaluation Protocol), after the IC process is completed.

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: Enhancing the Quality of Informed Consent Self-Monitoring (EQUIC-SM) is one component of a VA Cooperative Studies Program-wide initiative on informed consent (EQUIC). Its objective is the field testing and iterative improvement of one intervention in the informed consent (IC) process, self monitoring. Self-monitoring involves having the person obtaining IC complete a Self-Monitoring Questionnaire, or SMQ after the IC encounter with a patient-subject being recruited for a participating study. We conceive of the SMQ as an activation device which prompts the person obtaining IC to monitor how he/she conducts the IC encounter. RESEARCH DESIGN: EQUIC-SM will be conducted in conjunction with participating clinical trials of the VA CSP at multiple VAs throughout the country. Patient-subjects will be recruited from among participants in these parent studies. Parent studies will be randomized to SM protocol or to control sites.

METHODOLOGY: Patient-subjects will be informed about EQUIC-SM at the time that they are first presented with information about the parent study. The person obtaining consent will use a scripted description of EQUIC-SM. If the subject agrees, verbal consent for EQUIC-SM will be obtained. The same parent study informed consent process will be used for both the SM protocol and control arms of EQUIC-SM; however in the SM protocol arm, the person obtaining consent will complete the SMQ after the IC process. In both arms, patient-subjects will be asked to complete the BICEP interview after the parent study IC process is completed. FINDINGS: Investigators will use the results of EQUIC-SM to assess the value of the self-monitoring technique in improving the quality of informed consent. The premise is that focusing the attention of the person obtaining informed consent on the IC process will enhance the quality of the IC encounter, and thus of the informed consent obtained.

SIGNIFICANCE: Practitioners of clinical trials have a responsibility to ensure that patients participation in research be informed and voluntary. This responsibility implies that we should strive continuously to improve the effectiveness of methods for informing prospective research volunteers about experimental studies, thereby enhancing the protection of their interests. If the self-monitoring technique tested in EQUIC-SM proves to enhance the quality of informed consent, this technique may be adapted for wider use in conducting clinical trials, thus representing an important step towards this goal.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 836
• Est. completion date: March 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

Depends on 'parent' study

Exclusion Criteria:

Study Design

Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Healthy
• Informed Consent

Locations

Country	Name	City	State
United States	VA Maryland Health Care System, Baltimore	Baltimore	Maryland
United States	VA Medical Center, Birmingham	Birmingham	Alabama
United States	VA Medical Center, Jamaica Plain Campus	Boston	Massachusetts
United States	VA Boston Healthcare System, Brockton Campus	Brockton	Massachusetts
United States	VA Western New York Healthcare System at Buffalo	Buffalo	New York
United States	VA Medical Center, Cincinnati	Cincinnati	Ohio
United States	VA North Texas Health Care System, Dallas	Dallas	Texas
United States	Atlanta VA Medical and Rehab Center, Decatur	Decatur	Georgia
United States	John D. Dingell VA Medical Center, Detroit	Detroit	Michigan
United States	VA Medical Center, Durham	Durham	North Carolina
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois
United States	Michael E. DeBakey VA Medical Center (152)	Houston	Texas
United States	VA Medical Center, Lexington	Lexington	Kentucky
United States	VA Medical Center, Loma Linda	Loma Linda	California
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota
United States	Southeast Veterans Healthcare System, New Orleans	New Orleans	Louisiana
United States	Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock	No. Little Rock	Arkansas
United States	VA Medical Center, Northport	Northport	New York
United States	VA Palo Alto Health Care System	Palo Alto	California
United States	VA Medical Center, Philadelphia	Philadelphia	Pennsylvania
United States	Hunter Holmes McGuire VA Medical Center	Richmond	Virginia
United States	VA Connecticut Health Care System (West Haven)	West Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interview: Telephone based assessment of informed consent		immediate	No