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

• ClinicalTrials.gov Identifier: NCT02970435
• Recruitment Status: Terminated
• First Posted: November 22, 2016
• Last Update Posted: January 25, 2021
• Sponsor: Case Comprehensive Cancer Center
• Information provided by (Responsible Party): Case Comprehensive Cancer Center

Study Description

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 14 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
• Actual Primary Completion Date: May 1, 2018
• Actual Study Completion Date: June 21, 2019

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

United States, Ohio

University Hospitals at Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States, 44106-5065

Sponsors and Collaborators

Case Comprehensive Cancer Center

Investigators

• Principal Investigator: Jeremy Bordeaux, MD; University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

More Information

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT02970435
• Other Study ID Numbers: CASE1616
• First Posted: November 22, 2016
• Last Update Posted: January 25, 2021
• Last Verified: January 2021

• 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