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

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.

Study Overview

• Status: Terminated
• Conditions: Surgery; Linear Closure
• Intervention / Treatment: Behavioral: Video Discharge Instructions; Behavioral: Telecommunication Reminders; Behavioral: Standard of Care

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 Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • University Hospitals at Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

● Non-fluent English speakers

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Up to 8 weeks after discharge

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Up to 8 weeks after discharge

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2017
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): June 21, 2019

Study Registration Dates

• First Submitted: November 18, 2016
• First Submitted That Met QC Criteria: November 18, 2016
• First Posted (Estimate): November 22, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 21, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: surgery; video discharge instructions
• Other Study ID Numbers: CASE1616

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No