NCT02970435

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 22, 2016

Completed
8 months until next milestone

Study Start

First participant enrolled

July 12, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 21, 2019

Completed
Last Updated

January 25, 2021

Status Verified

January 1, 2021

Enrollment Period

10 months

First QC Date

November 18, 2016

Last Update Submit

January 21, 2021

Conditions

Keywords

surgeryvideo discharge instructions

Outcome Measures

Primary Outcomes (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

    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 Outcomes (4)

  • Difference in knowledge of discharge instructions in intervention group versus control group

    Up to 8 weeks after discharge

  • Difference in confidence in intervention group versus control group

    Up to 8 weeks after discharge

  • Difference in satisfaction in intervention group versus control group

    Up to 8 weeks after discharge

  • Difference in self reported anxiety levels in intervention group versus control group

    Up to 8 weeks after discharge

Study Arms (2)

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.

Behavioral: Video Discharge InstructionsBehavioral: Telecommunication RemindersBehavioral: 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

Behavioral: Standard of Care

Interventions

The video discharge instructions, will be provided to the patient at the time of surgical procedure.

Video Discharge Instructions

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

Video Discharge Instructions

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

Verbal and Written Discharge InstructionsVideo Discharge Instructions

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • ● Non-fluent English speakers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Jeremy Bordeaux, MD

    University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2016

First Posted

November 22, 2016

Study Start

July 12, 2017

Primary Completion

May 1, 2018

Study Completion

June 21, 2019

Last Updated

January 25, 2021

Record last verified: 2021-01

Locations