|
EQUIC-SM Clinical Trials Information presented on Clinical Trials Search is not intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD on EQUIC-SM conditions. Clinical Trials Search.org is a site committed to listing clinical research studies in human subjects. EQUIC-SM Clinical research trials and EQUIC-SM health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like EQUIC-SM. EQUIC-SM Clinical Trials and other clinical trials allow for volunteers to have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes there is a cost for a EQUIC-SM clinical trial. Subjects oftentimes recieve the most effective healthcare possible for their EQUIC-SM condition. Hazards are a reality, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "E" Clinical Trials Conditions > EQUIC-SM  EQUIC-SM
EQUIC-SM
For Condition: Informed consent
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process.
Details: 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.
Eligibility:
Study Type: Observational, Screening, Cross-Sectional, Convenience Sample, Prospective Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: Depends on 'parent' study
Total Enrollment: 1800
Location and Contact Information:
Depart. of Veterans Affairs (#494) (SM) *Recruiting*
Cincinnati, Ohio, 45219
United States
Recruiting Dewleen Baker 513-475-6387
VA Palo Alto Health Care System (Umbrella) *Recruiting*
Palo Alto, California, 94304
United States
Recruiting Philip Lavori 650-493-5000
Duke University Medical Center (SM) *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Jeremy Sugarman 919-681-4650
Boston VA Medical Center (EQUIC SM HOST #453) *Recruiting*
Boston, Massachusetts, 02130
United States
Recruiting James Kaufman 617-232-9500
Boston VA Medical Center (CSP #494 EQUIC SM) *Recruiting*
Boston, Massachusetts, 02130
United States
Recruiting Susan Orsillo 617-232-9500
Mineapolis VA Medical Center (CSP #499) (SM) *Recruiting*
Minneapolis, Minnesota, 55417
United States
Recruiting Timothy Wilt 612-725-2158
Northport VA Medical Center (CSP #719B) (SM) *Recruiting*
Northport, New York, 11768
United States
Recruiting Shing-shing Yeh 631-261-4400
Atlanta VA Medical Center, EQUIC SM (#494 PTSD) *Recruiting*
Decatur, Georgia, 30033
United States
Recruiting Shirley Quarles 404-728-7608
Boston VAMC (CSP #499 SELECT) (SM) *Recruiting*
Boston, Massachusetts, 02130
United States
Recruiting Mary Brophy 617-232-9500
John D. Dingell Detroit VA Medical Center HOST SM) *Recruiting*
Detroit, Michigan, 48201
United States
Recruiting Daoud Abu-Hamdan 313-576-33451
University of Pennsylvania (SM) *Recruiting*
Philadelphia, Pennsylvania, 19104
United States
Recruiting David Casarett 215-898-2583
West Palm Beach VA Medical Center (CSP #453) (SM) *Recruiting*
West Palm Beach, Florida, 33410
United States
Recruiting David Cohen 561-882-8134
Northport VA Medical Center (CSP #499) (SM) *Recruiting*
Northport, New York, 11768
United States
Recruiting Shing-shing Yeh 631-261-4400
Edward Hines Jr. VA Medical Center (CSP #719B) (SM) *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Nirmala Bhoopalam 708-202-7010
New Orleans VAMC (CSP #494 EQUIC SM) *Recruiting*
New Orleans, Louisiana, 70112
United States
Recruiting Madeline Uddo 504-568-0811
Cincinnati VA Medical Center (CSP #494 EQUIC SM) *Recruiting*
Cincinnati, Ohio, 45220
United States
Recruiting Dewleen Baker 513-475-6387
Dallas VAMC (CS #494 PTSD in Women) (SM) *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Alina Suris 214-857-0334
Boston VA Medical Center (#719B EQUIC SM) *Recruiting*
Boston, Massachusetts, 02130
United States
Recruiting Mary Brophy 617-232-9500
Northport VA Medical Center (CSP #453) (SM) *Recruiting*
Northport, New York, 11768
United States
Recruiting Troy Dixon 631-261-4400
Portland VAMC (EQUIC SM) #494 PTSD *Recruiting*
Portland, Oregon, 97201
United States
Recruiting Irene Powch 503-220-8262
Edward Hines Jr. Medical Center (CSP #499) (SM) *Recruiting*
Hines, Illinois, 60141
United States
Recruiting Nirmala Bhoopalam 708-202-7010
Loma Linda VA Medical Center (EQUIC SM #499) *Recruiting*
Loma Linda, California, 92357
United States
Recruiting Lynetta Skortez 909-422-3200
Additional Information:
Study ID Numbers: 476SM;
Study Start Date: November 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032565
Other Informed Consent Studies:
1. Enhancing Quality of Informed Consent (EQUIC-DP) Developmental Phase
2. EQUIC-SM
Related Studies:
Other Informed consent Clinical Trials
Other Texas Clinical Trials
Other Dallas Clinical Trials
EQUIC-SM
|
|
|
|
|
|
|
|
