Hysteroscopy SurgeryNCT04614688
Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures
A study testing Patient Education Platform in people with Hysteroscopy Surgery and Informed Consent, run by Unity Health Toronto.
Trial summary
Over the past few decades, there has been a shift in the informed consent process, whereby the focus is centered on patient comprehension, preparedness and satisfaction. When comparing interactive informed consent processes, such as the use of educational pathways, videos, written communication, and the traditional… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysteroscopy Surgery, Informed Consent
- What is being tested?
- Patient Education Platform
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2020to 1 Nov 2021
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women planning on undergoing a hysteroscopy procedure
Who cannot join
- Women NOT planning on undergoing a hysteroscopy procedure
Trial locations and contacts
No sites are listed yet.
About this study
Over the past few decades, there has been a shift in the informed consent process, whereby the focus is centered on patient comprehension, preparedness and satisfaction. When comparing interactive informed consent processes, such as the use of educational pathways, videos, written communication, and the traditional conversational based process, the results are conflicting. Some studies report improved patient comprehension, satisfaction and preparedness with the informed consent interventions, while others found no difference. The purpose of this study is to determine whether the use of a preoperative interactive patient education pathway improves patient comprehension, preparedness and satisfaction prior to undergoing a hysteroscopic procedure.
Read the detailed description
Informed consent is dependent on three criteria; the patient must be competent, relevant information including risks, benefits and alternatives must be clearly communicated, and the acceptance of treatment must be voluntary. The consent process usually occurs in the office setting through physician-led verbal communication. Despite satisfying the three criteria of informed consent, many patients leave the office with an inadequate understanding of the treatment they have consented to.
The purpose of this study is to use an interactive patient education pathway as an adjunct to the informed consent process for patients undergoing hysteroscopy. This will be done using a randomized controlled trial design.
Patients will be randomized to the control group (standard consent process) or the education group (standard consent process augmented by access to an interactive hysteroscopy teaching platform).
All patients will undergo the standard physician-led informed consent process. Patients from both groups will be asked to complete a post-informed consent questionnaire to assess their understanding of their upcoming procedure, preparedness for the procedure, and satisfaction with the informed consent process, be that through the traditional method or the interactive patient education portal.
- Conditions
- Hysteroscopy Surgery, Informed Consent
- Being tested
- Patient Education Platform
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Education PlatformBehavioural
The patient education platform for hysteroscopy surgery is a website platform which has patient education materials regarding hysteroscopy procedures in the format of pictures, videos, and text. Information on this platform includes anatomy of the surgery area, what to expect, reasons for the surgery, ways to prepare for the surgery, and recovering from the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Patient Education Group | Experimental | Patients in this group will undergo the standard physician-led informed consent process and then be provided with an interactive patient education platform for hysteroscopy on a tablet available in the clinic for up to one hour of time. After the patient has explored the patient education platform, they will be given a post-consent survey which will measure their understanding of the surgery, their readiness for the surgery, and their satisfaction with the consent process. Receives: Behavioral: Patient Education Platform |
| Standard Consent Group | No intervention | Patients in this group will undergo the standard physician-led informed consent process only. After they have consented to the surgery, they will be given a post-consent survey which will measure their understanding of the surgery, their readiness for the surgery, and their satisfaction with the consent process. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Comprehension of their Upcoming Surgery
Patient comprehension of their upcoming surgery will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group). The survey will ask the patient to name a benefit, risk, discomfort, and indication of the procedure, as well as a consequence to not having the procedure. One point will be given for each correct answer. Comprehension will be measured using a mean.
Measured: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
Secondary outcomes (2)
Patient Preparedness for their Upcoming Surgery
Patient preparedness for the upcoming surgery will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group). Patients will be asked to indicate how prepared they feel on a 5-point Likert scale with 1 = Very Prepared and 5 = Very Unprepared.
Measured: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
Patient Satisfaction with the Consent Process
Satisfaction with the consent process will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group). Patients will be asked how much time they think was spent on the consent process (vs. actual time spent, measured using a stop watch). Difference between perceived time and actual time will be calculated. Patients will also be asked if certain aspects of the consent process were covered by the doctor during the discussion (e.g. "Was the procedure explained to you?", "Were the risks explained to you?"). Answer options will be "Yes/No". Patients will be asked if they received enough information to make a sound decision and if their questions were answered to their satisfaction. Answer options will be "Yes/No" Patient satisfaction will be determined using frequency counts.
Measured: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2020
- Study start1 Nov 2020 (estimated)
- Primary completion1 Nov 2021 (estimated)
- Study completion1 Nov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hysteroscopy SurgeryStudies of the same condition, open and under way.
- More trials run by Unity Health TorontoThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Unity Health Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eliane Shore, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04614688
- Sponsor's protocol ID
- 20-215
- Status last verified
- Oct 2020
- First submitted
- 19 Oct 2020
- Last updated
- 4 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures
- ClinicalTrials.gov ID
- NCT04614688
- Acronym / sponsor ID
- 20-215
- Conditions
- Hysteroscopy Surgery, Informed Consent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Unity Health TorontoUniversity, hospital or other
- Study start
- 1 Nov 2020 (estimated)
- Primary completion
- 1 Nov 2021 (estimated)
- Study completion
- 1 Nov 2021 (estimated)
- First posted
- 4 Nov 2020 (actual)
- 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.
Over the past few decades, there has been a shift in the informed consent process, whereby the focus is centered on patient comprehension, preparedness and satisfaction. When comparing interactive informed consent processes, such as the use of educational pathways, videos, written communication, and the traditional conversational based process, the results are conflicting. Some studies report improved patient comprehension, satisfaction and preparedness with the informed consent interventions, while others found no difference. The purpose of this study is to determine whether the use of a preoperative interactive patient education pathway improves patient comprehension, preparedness and satisfaction prior to undergoing a hysteroscopic procedure.
Detailed description
Informed consent is dependent on three criteria; the patient must be competent, relevant information including risks, benefits and alternatives must be clearly communicated, and the acceptance of treatment must be voluntary. The consent process usually occurs in the office setting through physician-led verbal communication. Despite satisfying the three criteria of informed consent, many patients leave the office with an inadequate understanding of the treatment they have consented to.
The purpose of this study is to use an interactive patient education pathway as an adjunct to the informed consent process for patients undergoing hysteroscopy. This will be done using a randomized controlled trial design.
Patients will be randomized to the control group (standard consent process) or the education group (standard consent process augmented by access to an interactive hysteroscopy teaching platform).
All patients will undergo the standard physician-led informed consent process. Patients from both groups will be asked to complete a post-informed consent questionnaire to assess their understanding of their upcoming procedure, preparedness for the procedure, and satisfaction with the informed consent process, be that through the traditional method or the interactive patient education portal.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Education Group | Experimental | Behavioral: Patient Education PlatformPatients in this group will undergo the standard physician-led informed consent process and then be provided with an interactive patient education platform for hysteroscopy on a tablet available in the clinic for up to one hour of time. After the patient has explored the patient education platform, they will be given a post-consent survey which will measure their understanding of the surgery, their readiness for the surgery, and their satisfaction with the consent process. |
| Standard Consent Group | No intervention | –Patients in this group will undergo the standard physician-led informed consent process only. After they have consented to the surgery, they will be given a post-consent survey which will measure their understanding of the surgery, their readiness for the surgery, and their satisfaction with the consent process. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Women planning on undergoing a hysteroscopy procedure
Key exclusion criteria (1 listed)
- Women NOT planning on undergoing a hysteroscopy procedure
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 |
|---|---|---|
| Patient Education PlatformThe patient education platform for hysteroscopy surgery is a website platform which has patient education materials regarding hysteroscopy procedures in the format of pictures, videos, and text. Information on this platform includes anatomy of the surgery area, what to expect, reasons for the surgery, ways to prepare for the surgery, and recovering from the surgery. | Behavioural | Patient Education Group |
Primary outcome
Patient Comprehension of their Upcoming Surgery
Time frame: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
Patient comprehension of their upcoming surgery will be measured using a survey given after the patient has consented to their surgery (control group) and after viewing the patient education platform (experimental group). The survey will ask the patient to name a benefit, risk, discomfort, and indication of the procedure, as well as a consequence to not having the procedure. One point will be given for each correct answer. Comprehension will be measured using a mean.
2 secondary outcomes
Patient Preparedness for their Upcoming Surgery
Time frame: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
Patient Satisfaction with the Consent Process
Time frame: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2020.
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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.
Eliane Shore, MD principal investigator
Unity Health Toronto
Questions about this trial
What is this clinical trial studying?
A study testing Patient Education Platform in people with Hysteroscopy Surgery and Informed Consent, run by Unity Health Toronto.
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: status not confirmed, as of the sponsor's last update on 4 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meagan F LaCroix, BSc (416-864-6060 ext. 48119, meagan.lacroix@unityhealth.to), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Comprehension of their Upcoming Surgery (time frame: After (but same day as) the patient has consented to surgery (control group) or after (but same day as) the patient has consented to surgery and explored the patient education platform (experimental group).). 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 4 Nov 2020.