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Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care

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ClinicalTrials.gov Identifier: NCT02970435
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : April 23, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Linear Closure Surgery Behavioral: Video Discharge Instructions Behavioral: Telecommunication Reminders Behavioral: Standard of Care Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 628 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluating the Impact of Video Discharge Instructions for Mohs Surgery Post-Operative Care
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: After Surgery

Arm Intervention/treatment
Experimental: Video Discharge Instructions
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.
Behavioral: Video Discharge Instructions
The video discharge instructions, will be provided to the patient at the time of surgical procedure.

Behavioral: Telecommunication Reminders
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

Behavioral: Standard of Care
Standard of Care: verbal and written discharge instructions for patients after surgery

Active Comparator: Verbal and Written Discharge Instructions
Nursing and medical staff will provide verbal and written discharge instructions as is standard of care post surgery
Behavioral: Standard of Care
Standard of Care: verbal and written discharge instructions for patients after surgery




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Difference in knowledge of discharge instructions in intervention group versus control group [ Time Frame: Up to 8 weeks after discharge ]
    Answers to survey questions investigating knowledge of discharge instruction will be compared between the control and intervention groups.

  2. Difference in confidence in intervention group versus control group [ Time Frame: Up to 8 weeks after discharge ]
    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.

  3. Difference in satisfaction in intervention group versus control group [ Time Frame: Up to 8 weeks after discharge ]
    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.

  4. Difference in self reported anxiety levels in intervention group versus control group [ Time Frame: Up to 8 weeks after discharge ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who underwent a linear closure on the face at UH Mohs clinic
  • Fluent English speakers

Exclusion Criteria:

● Non-fluent English speakers


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02970435


Contacts
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Contact: Jeremy Bordeaux, MD 216-844-8200 jeremy.bordeauz@uhhospitals.org

Locations
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United States, Ohio
University Hospitals at Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Jeremy Bordeaux, MD    216-844-8200    Jeremy.Bordeaux@uhhospitals.org   
Principal Investigator: Jeremy Bordeaux, MD         
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Jeremy Bordeaux, MD University Hospitals at Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02970435     History of Changes
Other Study ID Numbers: CASE1616
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
surgery
video discharge instructions