HealthyNCT00032539
EQUIC-CC: Enhancing Quality of Informed Consent - Customized Consent
An observational study of Healthy, run by US Department of Veterans Affairs at 4 sites in United States.
Trial summary
Patients in 'parent' cooperative study 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
- How many people
- 240 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 1999to Apr 1999
- 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: Veterans in selected clinical trials conducted by VA
Who may be able to join
- Depends on 'parent' study
Who cannot join
- Depends on 'parent' study
Trial locations and contacts
4 sites in 1 country.
United States4 sites
VA Medical Center, Durham
Durham, North Carolina, 27705
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
VA Medical Center, Philadelphia
Philadelphia, Pennsylvania, 19104
Stanford University
Stanford, California, 94305
About this study
Official title: CSP #476CC - Enhancing Quality of Informed Consent (EQUIC-CC) Customized Consent
Patients in 'parent' cooperative study projects are interviewed about their experiences in the informed consent process.
Read the 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.
- Conditions
- Healthy
- Keywords
- 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 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
improve method of disclosing information to patients in the informed consent process
Measured: post-randomization
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 startApr 1999
- Primary completionApr 1999
- Study completionApr 1999
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Philip Lavori, PhD, Study chair, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032539
- Sponsor's protocol ID
- 476CC
- Status last verified
- Mar 2012
- First submitted
- 27 Mar 2002
- Last updated
- 16 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #476CC - Enhancing Quality of Informed Consent (EQUIC-CC) Customized Consent
- ClinicalTrials.gov ID
- NCT00032539
- Acronym / sponsor ID
- 476CC
- Conditions
- Healthy
- Keywords
- Informed Consent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 1999
- Primary completion
- Apr 1999 (actual)
- Study completion
- Apr 1999 (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 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.
Study design
- Observational model
- Case crossover
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Veterans in selected clinical trials conducted by VA
Key inclusion criteria (1 listed)
- Depends on 'parent' study
Key exclusion criteria (1 listed)
- Depends on 'parent' study
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
improve method of disclosing information to patients in the informed consent process
Time frame: post-randomization
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 16 Mar 2012.
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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
Stanford University
4 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, run by US Department of Veterans Affairs at 4 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 1 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 16 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
improve method of disclosing information to patients in the informed consent process (time frame: post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2012.