Patient SatisfactionNCT04048538
Preoperative Patient Education Via Animated Videos to Improve Patient Satisfaction and Reduce Complications in Head and Neck Surgery
A study testing Precare in people with Patient Satisfaction and Surgery, run by Jewish General Hospital at 1 site in Canada.
Trial summary
This randomized control trial will compare traditional patient education methods (pamphlets, clinical visits) to the implementation of an innovated patient education platform. The purpose of the project is to determine whether the use of this animation based patient education platform prior to undergoing surgery will… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Patient Satisfaction, Surgery
- What is being tested?
- Precare
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2019to 30 Jan 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals having any of the following surgical procedure at the Jewish General Hospital over the next 12 months: head and neck cancer resection with or without reconstruction, excision of parotid lesion, thyroidectomy, parathyroidectomy, laryngectomy, or trans-oral robotic resection.
Who cannot join
- Individuals who are undergoing a surgical procedure not included in the ones listed above, or those who are having revision surgery or have previously had surgery in the otolaryngology, head and neck surgery department.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Patient Education Via Animated Videos to Improve Patient Satisfaction and Reduce Complications in Head and Neck Surgery: a Randomized Controlled Study
This randomized control trial will compare traditional patient education methods (pamphlets, clinical visits) to the implementation of an innovated patient education platform. The purpose of the project is to determine whether the use of this animation based patient education platform prior to undergoing surgery will lead to improved patient satisfaction and quality of life.
Read the detailed description
Hypothesis/Study question:
Does the implementation of an animation based patient education platform prior to undergoing surgery lead to improved patient satisfaction and quality of life?
Study objectives:
Help address patient gaps in understanding, reduce learning barriers in order for patients to make informed decisions, improve behaviors, and better partner with their health providers to attain optimal health outcomes
Methodology / Study design:
Patients will receive access to the patient education platform during the clinical visit in which they receive their diagnosis, and will be asked if they wish to enroll in the study consisting of completing questionnaires before and after their surgical procedure. Questions will inquire on levels of anxiety, patient satisfaction, knowledge retention, and platform feedback.
- Conditions
- Patient Satisfaction, Surgery
- Being tested
- Precare, usual standard of care
- Keywords
- patient education, surgical education, multimedia, animation, guide
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrecareOther
an innovative patient education platform using animated videos created by using up-to-date evidence-based informaiton
usual standard of careOther
individuals will receive treatment as per the usual standard of care
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | Individuals who will receive access to the animated multimedia platform prior to their surgical procedure. Receives: Other: Precare |
| Control Arm | Active comparator | Individuals who will not receive access to the animated patient platform, and instead will receive the usual standard of care. Receives: Other: usual standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Satisfaction
analyzed using patient questionnaire responses
Measured: 1 month post-operative
Secondary outcomes (1)
Post-operative complication rate
analyzed using hospital data
Measured: 1 month post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2019
- Study start1 Sep 2019
- Primary completion30 Dec 2020
- Study completion30 Jan 2021
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 Patient SatisfactionStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sena Turkdogan, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04048538
- Sponsor's protocol ID
- Precare
- Status last verified
- Oct 2021
- First submitted
- 6 Aug 2019
- Last updated
- 18 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Turkdogan S, Roy CF, Chartier G, Payne R, Mlynarek A, Forest VI, Hier M. Effect of Perioperative Patient Education via Animated Videos in Patients Undergoing Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Feb 1;148(2):173-179. doi: 10.1001/jamaoto.2021.3765.
PubMed 34967863
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Patient Education Via Animated Videos to Improve Patient Satisfaction and Reduce Complications in Head and Neck Surgery: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04048538
- Acronym / sponsor ID
- Precare
- Conditions
- Patient Satisfaction, Surgery
- Keywords
- patient education, surgical education, multimedia, animation, guide
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Jan 2021 (actual)
- First posted
- 7 Aug 2019 (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.
This randomized control trial will compare traditional patient education methods (pamphlets, clinical visits) to the implementation of an innovated patient education platform. The purpose of the project is to determine whether the use of this animation based patient education platform prior to undergoing surgery will lead to improved patient satisfaction and quality of life.
Detailed description
Hypothesis/Study question:
Does the implementation of an animation based patient education platform prior to undergoing surgery lead to improved patient satisfaction and quality of life?
Study objectives:
Help address patient gaps in understanding, reduce learning barriers in order for patients to make informed decisions, improve behaviors, and better partner with their health providers to attain optimal health outcomes
Methodology / Study design:
Patients will receive access to the patient education platform during the clinical visit in which they receive their diagnosis, and will be asked if they wish to enroll in the study consisting of completing questionnaires before and after their surgical procedure. Questions will inquire on levels of anxiety, patient satisfaction, knowledge retention, and platform feedback.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Other: PrecareIndividuals who will receive access to the animated multimedia platform prior to their surgical procedure. |
| Control Arm | Active comparator | Other: usual standard of careIndividuals who will not receive access to the animated patient platform, and instead will receive the usual standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals having any of the following surgical procedure at the Jewish General Hospital over the next 12 months: head and neck cancer resection with or without reconstruction, excision of parotid lesion, thyroidectomy, parathyroidectomy, laryngectomy, or trans-oral robotic resection.
Key exclusion criteria (1 listed)
- Individuals who are undergoing a surgical procedure not included in the ones listed above, or those who are having revision surgery or have previously had surgery in the otolaryngology, head and neck surgery department.
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 |
|---|---|---|
| Precarean innovative patient education platform using animated videos created by using up-to-date evidence-based informaiton | Other | Treatment Arm |
| usual standard of careindividuals will receive treatment as per the usual standard of care | Other | Control Arm |
Primary outcome
Patient Satisfaction
Time frame: 1 month post-operative
analyzed using patient questionnaire responses
1 secondary outcome
Post-operative complication rate
Time frame: 1 month post-operative
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 18 Oct 2021.
- Derived from this study: PubMed 34967863Turkdogan S, Roy CF, Chartier G, Payne R, Mlynarek A, Forest VI, Hier M. Effect of Perioperative Patient Education via Animated Videos in Patients Undergoing Head and Neck Surgery: A Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2022 Feb 1;148(2):173-179. doi: 10.1001/jamaoto.2021.3765.
- Individual participant dataSharing planned: No
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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 study testing Precare in people with Patient Satisfaction and Surgery, run by Jewish General Hospital at 1 site in Canada.
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 18 Oct 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 Canada. 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?
Patient Satisfaction (time frame: 1 month post-operative). 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 NCT04048538, 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 18 Oct 2021.