CataractNCT04975126
Computer-based Tutorial as Supportive Means to Enhance the Informed Consent Process for Cataract Surgery
A study testing CatInfo tool in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
Trial summary
To assess whether a computer-based tutorial as supportive means enhances quality and efficiency of the informed consent process for cataract surgery focussing on the patients' attitude before and after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- CatInfo tool
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteAustria
- Study dates
- 9 Apr 2015to 27 Mar 2017
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cataract
- Age 18 and older
- First eye to be operated
- No previous ophthalmic surgery
- written informed consent to participation in the study
Who cannot join
- Visual acuity of less than 0.1 Snellen in the worse eye
- Severe hearing loss
- Inability to use touch screen device (e.g. severe tremor, etc.)
Trial locations and contacts
1 site in 1 country.
Austria1 site
Vienna Institute for Research in Ocular Surgery (VIROS)
Vienna, 1140
About this study
Official title: Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery: an Exploratory Study
To assess whether a computer-based tutorial as supportive means enhances quality and efficiency of the informed consent process for cataract surgery focussing on the patients' attitude before and after surgery.
Read the detailed description
Informing the patient and obtaining informed consent is one of the major duties physicians perform before starting a medical treatment. The requirements concerning the informed consent process are high. The amount of information needed to be explained to the patient is growing, as procedures get more complex and the number of treatment options increase.
The CatInfo tool is a computer-based tutorial about cataract and cataract surgery run on a handheld device with headphones and presented in an audio-visual fashion. The patient gives feedback after each chapter using a traffic light system to ensure that the content has been understood (green - content understood, ready to continue; yellow - questions that require discussion with the physician and red - repetition of the module required). A printout that summarizes what the patient has selected after each chapter immediately tells the physician which topics have been poorly understood or were unclear.
It has been shown in a randomized triple-masked study that patients using the CatInfo tool were significantly better informed than patients only having a face-to-face interview. Satisfaction with the tool was high. This present study has the goal to assess the patients' attitude before and after surgery using validated questionnaires (decisional conflict scale, decision regret scale) as well as knowledge. Patients scheduled for their first eye cataract surgery are randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using the interactive CatInfo tool (study group). Scores between the groups are compared.
- Conditions
- Cataract
- Being tested
- CatInfo tool
- Keywords
- Cataract surgery, informed consent process, patient education
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CatInfo toolOther
Presentation about cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| CatInfo tool + Face-to-face discussion with physician | Experimental | audio-visual presentation (CatInfo tool) before face-to-face informed-consent discussion with the physician Receives: Other: CatInfo tool |
| Face-to-face discussion with physician only | No intervention | face-to-face informed-consent discussion with the physician only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decisional conflict scale score
To assess the decisional confidence after the face-to-face informed consent discussion patients are asked to complete the decisional conflict scale questionnaire. In this study it is calculated as decisional confidence, where 0 represents the lowest decisional confidence and 100 the highest.
Measured: Day of pre-assessment visit (1 week before surgery)
Decision regret scale score
One month after surgery the patients' satisfaction with their decision is evaluated with the decision regret scale (DRS) questionnaire via telephone interview. A score of 0 means no regret, a score of 100 high regret.
Measured: 1 month after surgery
Number of correctly answered questions assessing knowledge
To assess the knowledge concerning cataract surgery patients are asked to complete a multiple-choice questionnaire concerning cataract surgery. The number of correctly answered questions are summed up. The scale ranges from a minimum of 0 points to a maximum of 19 points. The more points the better the patient's knowledge about cataract and cataract surgery.
Measured: Day of pre-assessment visit (1 week before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start9 Apr 2015
- Primary completion27 Mar 2017
- Study completion27 Mar 2017
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 CataractStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vienna Institute for Research in Ocular Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prim. Prof. Dr. Oliver Findl, MBA, Vienna Institute for Research in Ocular Surgery
- Investigators
- Oliver Findl, MD, MBA, Principal investigator, Vienna Institute for Research in Ocular surgery (VIROS), Vienna, Austria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04975126
- Sponsor's protocol ID
- CatInfo
- Status last verified
- Jul 2021
- First submitted
- 14 Jul 2021
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ullrich M, Findl O, Kefer K, Doller B, Varsits R, Hienert J, Hirnschall N. An evaluation of the efficacy of a supplemental computer-based tutorial to enhance the informed consent process for cataract surgery: an exploratory randomized clinical study. BMC Ophthalmol. 2022 Nov 11;22(1):430. doi: 10.1186/s12886-022-02652-z.
PubMed 36368980
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Tutorial as Supportive Means to Enhance Quality and Efficiency of the Informed Consent Process for Cataract Surgery: an Exploratory Study
- ClinicalTrials.gov ID
- NCT04975126
- Acronym / sponsor ID
- CatInfo
- Conditions
- Cataract
- Keywords
- Cataract surgery, informed consent process, patient education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Vienna Institute for Research in Ocular SurgeryUniversity, hospital or other
- Study start
- 9 Apr 2015 (actual)
- Primary completion
- 27 Mar 2017 (actual)
- Study completion
- 27 Mar 2017 (actual)
- First posted
- 23 Jul 2021 (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.
To assess whether a computer-based tutorial as supportive means enhances quality and efficiency of the informed consent process for cataract surgery focussing on the patients' attitude before and after surgery.
Detailed description
Informing the patient and obtaining informed consent is one of the major duties physicians perform before starting a medical treatment. The requirements concerning the informed consent process are high. The amount of information needed to be explained to the patient is growing, as procedures get more complex and the number of treatment options increase.
The CatInfo tool is a computer-based tutorial about cataract and cataract surgery run on a handheld device with headphones and presented in an audio-visual fashion. The patient gives feedback after each chapter using a traffic light system to ensure that the content has been understood (green - content understood, ready to continue; yellow - questions that require discussion with the physician and red - repetition of the module required). A printout that summarizes what the patient has selected after each chapter immediately tells the physician which topics have been poorly understood or were unclear.
It has been shown in a randomized triple-masked study that patients using the CatInfo tool were significantly better informed than patients only having a face-to-face interview. Satisfaction with the tool was high. This present study has the goal to assess the patients' attitude before and after surgery using validated questionnaires (decisional conflict scale, decision regret scale) as well as knowledge. Patients scheduled for their first eye cataract surgery are randomly allocated to two groups, receiving standard face-to-face informed consent (control group) or additionally using the interactive CatInfo tool (study group). Scores between the groups are compared.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CatInfo tool + Face-to-face discussion with physician | Experimental | Other: CatInfo toolaudio-visual presentation (CatInfo tool) before face-to-face informed-consent discussion with the physician |
| Face-to-face discussion with physician only | No intervention | –face-to-face informed-consent discussion with the physician only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Cataract
- Age 18 and older
- First eye to be operated
- No previous ophthalmic surgery
- written informed consent to participation in the study
Key exclusion criteria (3 listed)
- Visual acuity of less than 0.1 Snellen in the worse eye
- Severe hearing loss
- Inability to use touch screen device (e.g. severe tremor, etc.)
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 |
|---|---|---|
| CatInfo toolPresentation about cataract surgery | Other | CatInfo tool + Face-to-face discussion with physician |
Primary outcome
Decisional conflict scale score
Time frame: Day of pre-assessment visit (1 week before surgery)
To assess the decisional confidence after the face-to-face informed consent discussion patients are asked to complete the decisional conflict scale questionnaire. In this study it is calculated as decisional confidence, where 0 represents the lowest decisional confidence and 100 the highest.
Decision regret scale score
Time frame: 1 month after surgery
One month after surgery the patients' satisfaction with their decision is evaluated with the decision regret scale (DRS) questionnaire via telephone interview. A score of 0 means no regret, a score of 100 high regret.
Number of correctly answered questions assessing knowledge
Time frame: Day of pre-assessment visit (1 week before surgery)
To assess the knowledge concerning cataract surgery patients are asked to complete a multiple-choice questionnaire concerning cataract surgery. The number of correctly answered questions are summed up. The scale ranges from a minimum of 0 points to a maximum of 19 points. The more points the better the patient's knowledge about cataract and cataract surgery.
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 23 Jul 2021.
- Derived from this study: PubMed 36368980Ullrich M, Findl O, Kefer K, Doller B, Varsits R, Hienert J, Hirnschall N. An evaluation of the efficacy of a supplemental computer-based tutorial to enhance the informed consent process for cataract surgery: an exploratory randomized clinical study. BMC Ophthalmol. 2022 Nov 11;22(1):430. doi: 10.1186/s12886-022-02652-z.
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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.
Oliver Findl, MD, MBA principal investigator
Vienna Institute for Research in Ocular surgery (VIROS), Vienna, Austria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CatInfo tool in people with Cataract, run by Vienna Institute for Research in Ocular Surgery at 1 site in Austria.
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 5 inclusion and 3 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 23 Jul 2021. 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 Austria. 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?
Decisional conflict scale score (time frame: Day of pre-assessment visit (1 week before surgery)). The study lists 3 primary outcomes in all. 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 NCT04975126, 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 23 Jul 2021.