Informed ConsentPhase 2NCT02541799
Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
A Phase 2 study testing Audio-visual telemedicine in people with Informed Consent, run by University of Iowa at 1 site in United States.
Trial summary
The investigators hypothesis is that patient comprehension of telemedicine-enabled research informed consent is not inferior to standard face-to-face research informed consent. The procotol will involve a prospective, randomized control trial to test the effectiveness of a telemedicine medium in obtaining research… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Informed Consent
- What is being tested?
- Audio-visual telemedicine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Sep 2015
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- any adult patient presenting to the emergency department, and expected to be admitted to the hospital.
Who cannot join
- prisoners
- pregnant patients
- non-English speaking patients
- unable to provide informed consent based on mental status.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
About this study
The investigators hypothesis is that patient comprehension of telemedicine-enabled research informed consent is not inferior to standard face-to-face research informed consent.
The procotol will involve a prospective, randomized control trial to test the effectiveness of a telemedicine medium in obtaining research informed consent. Within a single emergency department, the investigators will conduct a simple, low risk randomized trial (single does of oral chlorhexideine to prevent hospital acquired pneumonia among adult patients with expected hospital admission). Prior to being approached for informed consent, potential participants will be randomized in a 1:1 allocation ratio to standard face-to-face consent vs. consent provided by audio-visual telemedicine. After standard clinical care, potential participants will be approached according to their allocation. Comprehension of research informed consent will be the primary outcome, and will be measured using the modified Quality of Informed Consent (QuIC) instrument.
- Conditions
- Informed Consent
- Being tested
- Audio-visual telemedicine, Standard care
- Keywords
- informed consent, telemedicine, research methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio-visual telemedicineProcedure or surgery
Participants in an emergency department will have their care delivered using telemedicine, then they will be approached for a study by a study investigator using the same telemedicine link
Standard careProcedure or surgery
Participants in an emergency department will have their care delivered in person, then they will be approached by a study investigator face-to-face.
| Study group | Role | What they receive |
|---|---|---|
| Telemedicine | Experimental | Participants allocated to this arm will be approached the using a telemedicine medium to discuss study participation. The consent form will be administered while the investigator is on a telemedicine link. Receives: Procedure: Audio-visual telemedicine |
| Standard Care | Active comparator | Participants allocated to this arm will be approached in standard fashion where the investigator approaches the patient face to face. The consent form will be administered while the investigator is in the participant's room. Receives: Procedure: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comprehension of research informed consent
Comprehension of research informed consent will be assessed within 30 minutes of approaching participants for study inclusion. The QuIC will be used to assess comprehension of the elements of research informed consent.
Measured: Immediately
Secondary outcomes (1)
Consent rate
Rate of consenting for a low-risk clinical trial in the emergency department, depending on how research participation was solicited.
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Informed ConsentStudies of the same condition, open and under way.
- More trials run by University of IowaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohr, Nicholas M, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02541799
- Sponsor's protocol ID
- 201504742
- Status last verified
- Oct 2015
- First submitted
- 2 Sep 2015
- Last updated
- 6 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
- ClinicalTrials.gov ID
- NCT02541799
- Acronym / sponsor ID
- 201504742
- Conditions
- Informed Consent
- Keywords
- informed consent, telemedicine, research methods
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 4 Sep 2015 (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.
The investigators hypothesis is that patient comprehension of telemedicine-enabled research informed consent is not inferior to standard face-to-face research informed consent.
The procotol will involve a prospective, randomized control trial to test the effectiveness of a telemedicine medium in obtaining research informed consent. Within a single emergency department, the investigators will conduct a simple, low risk randomized trial (single does of oral chlorhexideine to prevent hospital acquired pneumonia among adult patients with expected hospital admission). Prior to being approached for informed consent, potential participants will be randomized in a 1:1 allocation ratio to standard face-to-face consent vs. consent provided by audio-visual telemedicine. After standard clinical care, potential participants will be approached according to their allocation. Comprehension of research informed consent will be the primary outcome, and will be measured using the modified Quality of Informed Consent (QuIC) instrument.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Telemedicine | Experimental | Procedure: Audio-visual telemedicineParticipants allocated to this arm will be approached the using a telemedicine medium to discuss study participation. The consent form will be administered while the investigator is on a telemedicine link. |
| Standard Care | Active comparator | Procedure: Standard careParticipants allocated to this arm will be approached in standard fashion where the investigator approaches the patient face to face. The consent form will be administered while the investigator is in the participant's room. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any adult patient presenting to the emergency department, and expected to be admitted to the hospital.
Key exclusion criteria (4 listed)
- prisoners
- pregnant patients
- non-English speaking patients
- unable to provide informed consent based on mental status.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio-visual telemedicineParticipants in an emergency department will have their care delivered using telemedicine, then they will be approached for a study by a study investigator using the same telemedicine link | Procedure or surgery | Telemedicine |
| Standard careParticipants in an emergency department will have their care delivered in person, then they will be approached by a study investigator face-to-face. | Procedure or surgery | Standard Care |
Primary outcome
Comprehension of research informed consent
Time frame: Immediately
Comprehension of research informed consent will be assessed within 30 minutes of approaching participants for study inclusion. The QuIC will be used to assess comprehension of the elements of research informed consent.
1 secondary outcome
Consent rate
Time frame: Immediately
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 6 Oct 2015.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Audio-visual telemedicine in people with Informed Consent, run by University of Iowa at 1 site 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 4 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 6 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Comprehension of research informed consent (time frame: Immediately). 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 6 Oct 2015.