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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02970435
Other study ID # CASE1616
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date July 12, 2017
Est. completion date June 21, 2019

Study information

Verified date January 2021
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 14
Est. completion date June 21, 2019
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Video Discharge Instructions
The video discharge instructions, will be provided to the patient at the time of surgical procedure.
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
Standard of Care
Standard of Care: verbal and written discharge instructions for patients after surgery

Locations

Country Name City State
United States University Hospitals at Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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