Linear ClosureNCT02970435
Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care
A study testing Video Discharge Instructions and Telecommunication Reminders in people with Linear Closure and Surgery, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial summary
The purpose of this research is to look at how educational videos provided by doctors might affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs surgery care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Linear Closure, Surgery
- What is being tested?
- Video Discharge Instructions and Telecommunication Reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jul 2017to 21 Jun 2019
- 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
- Patients who underwent a linear closure on the face at UH Mohs clinic
- Fluent English speakers
Who cannot join
- ● Non-fluent English speakers
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals at Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Cleveland, Ohio, 44106-5065
About this study
The purpose of this research is to look at how educational videos provided by doctors might affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs surgery care. Patients will be randomized to either: 1) a group that receives educational videos in addition to standard-of-care written and verbal instructions or 2) a group that receives only standard-of-care written and verbal instructions.
Read the detailed description
The Primary Objective of this study is to determine if video discharge instructions, when added to standard of care written and verbal instructions, lead to a decrease in unnecessary phone calls from patients in a Mohs dermatology clinic.
The Secondary Objectives of this study are to determine if video discharge instructions, when added to standard of care written and verbal instructions, help to improve patients' satisfaction with education materials provided by the clinic, improve patients' knowledge of post-operative management, improve patients' confidence in taking care of their suture site post-operatively, and reduce post-operative anxiety about their suture site.
This study will be a randomized controlled trial in which the impact of video discharge instructions on patient calls, anxiety, and confidence will be evaluated. Patients will be randomized using a permuted block model generated through SAS.
- Conditions
- Linear Closure, Surgery
- Being tested
- Video Discharge Instructions, Telecommunication Reminders, Standard of Care
- Keywords
- surgery, video discharge instructions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video Discharge InstructionsBehavioural
The video discharge instructions, will be provided to the patient at the time of surgical procedure.
Telecommunication RemindersBehavioural
Telecommunication reminders including text messages, email, or phone calls to remind participants how to access the video discharge instruction up to three times before follow-up
Standard of CareBehavioural
Standard of Care: verbal and written discharge instructions for patients after surgery
| Study group | Role | What they receive |
|---|---|---|
| Video Discharge Instructions | Experimental | These videos contain the same instructions that a patient receives via the standard-of-care verbal and written discharge instructions. These instructions will be delivered by the same nursing and medical staff that also regularly provides verbal and written discharge instructions to patients. There will be no difference in the content between the standard-of-care verbal and written instructions and the video discharge instructions. Patients in this group will receive telecommunication reminders on how to access discharge videos. Receives: Behavioral: Video Discharge Instructions; Behavioral: Telecommunication Reminders; Behavioral: Standard of Care |
| Verbal and Written Discharge Instructions | Active comparator | Nursing and medical staff will provide verbal and written discharge instructions as is standard of care post surgery Receives: Behavioral: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of patients in the intervention group who call the clinic compared to percentage of patients in the control group who call the clinic
Researchers will record when each participant calls the clinic. The number of people who call in the intervention group will be compared to the number of people who call in the control group. This will give an efficacy measure of the video discharge instructions
Measured: Up to 8 weeks after discharge
Secondary outcomes (4)
Difference in knowledge of discharge instructions in intervention group versus control group
Answers to survey questions investigating knowledge of discharge instruction will be compared between the control and intervention groups.
Measured: Up to 8 weeks after discharge
Difference in confidence in intervention group versus control group
A survey investigating confidence about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.
Measured: Up to 8 weeks after discharge
Difference in satisfaction in intervention group versus control group
A survey investigating patient satisfaction about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.
Measured: Up to 8 weeks after discharge
Difference in self reported anxiety levels in intervention group versus control group
A survey investigating anxiety about Mohs surgery post-operative care will be used in this study. This survey will be quantified using the Likert scale.
Measured: Up to 8 weeks after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2016 (estimated)
- Study start12 Jul 2017
- Primary completion1 May 2018
- Study completion21 Jun 2019
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Linear ClosureStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Bordeaux, MD, Principal investigator, University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970435
- Sponsor's protocol ID
- CASE1616
- Status last verified
- Jan 2021
- First submitted
- 18 Nov 2016
- Last updated
- 25 Jan 2021
- 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 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care
- ClinicalTrials.gov ID
- NCT02970435
- Acronym / sponsor ID
- CASE1616
- Conditions
- Linear Closure, Surgery
- Keywords
- surgery, video discharge instructions
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 12 Jul 2017 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 21 Jun 2019 (actual)
- First posted
- 22 Nov 2016 (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 purpose of this research is to look at how educational videos provided by doctors might affect patients knowledge, satisfaction, confidence, and anxiety with post-operative Mohs surgery care. Patients will be randomized to either: 1) a group that receives educational videos in addition to standard-of-care written and verbal instructions or 2) a group that receives only standard-of-care written and verbal instructions.
Detailed description
The Primary Objective of this study is to determine if video discharge instructions, when added to standard of care written and verbal instructions, lead to a decrease in unnecessary phone calls from patients in a Mohs dermatology clinic.
The Secondary Objectives of this study are to determine if video discharge instructions, when added to standard of care written and verbal instructions, help to improve patients' satisfaction with education materials provided by the clinic, improve patients' knowledge of post-operative management, improve patients' confidence in taking care of their suture site post-operatively, and reduce post-operative anxiety about their suture site.
This study will be a randomized controlled trial in which the impact of video discharge instructions on patient calls, anxiety, and confidence will be evaluated. Patients will be randomized using a permuted block model generated through SAS.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Discharge Instructions | Experimental | Behavioral: Video Discharge Instructions, Behavioral: Telecommunication Reminders, Behavioral: Standard of CareThese videos contain the same instructions that a patient receives via the standard-of-care verbal and written discharge instructions. These instructions will be delivered by the same nursing and medical staff that also regularly provides verbal and written discharge instructions to patients. There will be no difference in the content between the standard-of-care verbal and written instructions and the video discharge instructions. Patients in this group will receive telecommunication reminders on how to access discharge videos. |
| Verbal and Written Discharge Instructions | Active comparator | Behavioral: Standard of CareNursing and medical staff will provide verbal and written discharge instructions as is standard of care post surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who underwent a linear closure on the face at UH Mohs clinic
- Fluent English speakers
Key exclusion criteria (1 listed)
- ● Non-fluent English speakers
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 |
|---|---|---|
| Video Discharge InstructionsThe video discharge instructions, will be provided to the patient at the time of surgical procedure. | Behavioural | Video Discharge Instructions |
| Telecommunication RemindersTelecommunication reminders including text messages, email, or phone calls to remind participants how to access the video discharge instruction up to three times before follow-up | Behavioural | Video Discharge Instructions |
| Standard of CareStandard of Care: verbal and written discharge instructions for patients after surgery | Behavioural | Verbal and Written Discharge Instructions, Video Discharge Instructions |
Primary outcome
Ratio of patients in the intervention group who call the clinic compared to percentage of patients in the control group who call the clinic
Time frame: Up to 8 weeks after discharge
Researchers will record when each participant calls the clinic. The number of people who call in the intervention group will be compared to the number of people who call in the control group. This will give an efficacy measure of the video discharge instructions
4 secondary outcomes
Difference in knowledge of discharge instructions in intervention group versus control group
Time frame: Up to 8 weeks after discharge
Difference in confidence in intervention group versus control group
Time frame: Up to 8 weeks after discharge
Difference in satisfaction in intervention group versus control group
Time frame: Up to 8 weeks after discharge
Difference in self reported anxiety levels in intervention group versus control group
Time frame: Up to 8 weeks after discharge
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2021.
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.
Jeremy Bordeaux, MD principal investigator
University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Discharge Instructions and Telecommunication Reminders in people with Linear Closure and Surgery, run by Case Comprehensive Cancer Center 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 2 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: stopped early, as of the sponsor's last update on 25 Jan 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 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 was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
Ratio of patients in the intervention group who call the clinic compared to percentage of patients in the control group who call the clinic (time frame: Up to 8 weeks after discharge). 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 25 Jan 2021; AzTrials last refreshed its copy on 7 Nov 2026.