HealthyEQUICNCT00032565
EQUIC-SM: Enhancing Quality of Informed Consent
An observational study of Healthy and Informed Consent, run by US Department of Veterans Affairs at 22 sites in United States.
Trial summary
Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthy, Informed Consent
- How many people
- 836 participants
- Where
- 22 sitesUnited States
- Study dates
- Nov 2002to Mar 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients in various VA clinics
Who may be able to join
- Depends on 'parent' study
Who cannot join
None listed.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
VA Maryland Health Care System, Baltimore
Baltimore, Maryland, 21201
VA Medical Center, Birmingham
Birmingham, Alabama, 35233
VA Medical Center, Jamaica Plain Campus
Boston, Massachusetts, 02130
VA Boston Healthcare System, Brockton Campus
Brockton, Massachusetts, 02301
VA Western New York Healthcare System at Buffalo
Buffalo, New York, 14215
VA Medical Center, Cincinnati
Cincinnati, Ohio, 45220
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
Atlanta VA Medical and Rehab Center, Decatur
Decatur, Georgia, 30033
John D. Dingell VA Medical Center, Detroit
Detroit, Michigan, 48201
VA Medical Center, Durham
Durham, North Carolina, 27705
Edward Hines, Jr. VA Hospital
Hines, Illinois, 60141-5000
Michael E. DeBakey VA Medical Center (152)
Houston, Texas, 77030
VA Medical Center, Lexington
Lexington, Kentucky, 40502
VA Medical Center, Loma Linda
Loma Linda, California, 92357
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
Southeast Veterans Healthcare System, New Orleans
New Orleans, Louisiana, 70112
Central Arkansas VHS Eugene J. Towbin Healthcare Ctr, Little Rock
No. Little Rock, Arkansas, 72114-1706
VA Medical Center, Northport
Northport, New York, 11768
VA Palo Alto Health Care System
Palo Alto, California, 94304-1207
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, 23249
VA Connecticut Health Care System (West Haven)
West Haven, Connecticut, 06516
About this study
Official title: CSP #476SM - Enhancing Quality of Informed Consent (EQUIC-SM) Self-Monitoring
Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process.
Read the detailed 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.
- Conditions
- Healthy, Informed Consent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention. Telephone interview. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interview: Telephone based assessment of informed consent
Measured: immediate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2002 (estimated)
- Study startNov 2002
- Primary completionJul 2007
- Study completionMar 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 836 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Philip Lavori, PhD, Study chair, VA Palo Alto Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032565
- Sponsor's protocol ID
- 476SM
- Acronym
- EQUIC
- Status last verified
- Sep 2010
- First submitted
- 27 Mar 2002
- Last updated
- 24 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Lavori PW, Wilt TJ, Sugarman J. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clin Trials. 2007;4(6):638-49. doi: 10.1177/1740774507085144.
PubMed 18042573
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #476SM - Enhancing Quality of Informed Consent (EQUIC-SM) Self-Monitoring
- ClinicalTrials.gov ID
- NCT00032565
- Acronym / sponsor ID
- EQUIC / 476SM
- Conditions
- Healthy, Informed Consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 836 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Nov 2002
- Primary completion
- Jul 2007 (actual)
- Study completion
- Mar 2008 (actual)
- First posted
- 28 Mar 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Patients in 'parent' cooperative studies projects are interviewed about their experiences in the informed consent process.
Detailed 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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –No intervention. Telephone interview. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients in various VA clinics
Key inclusion criteria (1 listed)
- Depends on 'parent' study
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interview: Telephone based assessment of informed consent
Time frame: immediate
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2010.
- Derived from this study: PubMed 18042573Lavori PW, Wilt TJ, Sugarman J. Quality assurance questionnaire for professionals fails to improve the quality of informed consent. Clin Trials. 2007;4(6):638-49. doi: 10.1177/1740774507085144.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Lavori, PhD study chair
VA Palo Alto Health Care System
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy and Informed Consent, run by US Department of Veterans Affairs at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interview: Telephone based assessment of informed consent (time frame: immediate). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00032565, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2010.