NCT06647719

Brief Summary

The goal of this clinical trial is to learn if a patient-directed postoperative care program, using short educational videos, can improve patient satisfaction and reduce healthcare resource utilization in patients undergoing carpal tunnel release (CTR). The main questions it aims to answer are: Will patients in the video-based care program be more satisfied with their postoperative care? Will this approach reduce healthcare resource use and the burden on patients without increasing complication rates? Researchers will compare the video-based patient-directed care group to the standard in-person follow-up group to see if patient satisfaction and resource use differ while maintaining similar outcomes and complication rates. Participants will: Watch three short educational videos (\< 60 seconds each) on postoperative care. Schedule a suture removal appointment with a nurse at their convenience if needed. Continue to have access to their provider through traditional methods such as phone, EMR, or urgent in-person visits.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Start

First participant enrolled

June 1, 2022

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

October 16, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

October 18, 2024

Status Verified

October 1, 2024

Enrollment Period

2.4 years

First QC Date

October 16, 2024

Last Update Submit

October 16, 2024

Conditions

Keywords

Carpal tunnel release (CTR)Patient-directed careEducational videosMinor hand surgery

Outcome Measures

Primary Outcomes (1)

  • Patient-Reported Outcome Measurement Information System (PROMIS) / Upper Extremity Computer Adaptive Test (UE CAT) / 5-Point Likert Scale

    All patient reported outcome measures will be reported at 2 and 6 weeks postoperatively. All responses will be recorded within the study's REDCap data base.

    2 and 6 weeks postoperatively

Secondary Outcomes (6)

  • Time Taken Off Work

    Baseline to 6 week follow up

  • Travel time.

    Baseline to 6 week follow up

  • Number of Unplanned Visits

    Baseline to 6 week follow up.

  • Patient Satisfaction Questionnaire

    Baseline to 6 week follow up.

  • Wound Complications

    Baseline to 6 week follow up.

  • +1 more secondary outcomes

Study Arms (2)

Standard of Care

NO INTERVENTION

In-person group will be followed with standard -of-care postoperative clinic visits with a hand \& upper extremity orthopaedic surgeon at Carilion Clinic Institute for Orthopaedics and Neurosciences at 2 weeks and 6 weeks from date of service.

Video Management

EXPERIMENTAL

Postoperative education will be provided with 3 short videos that will be accessible to patients on all social media platforms and through MyChart with no scheduled in person postoperative visits. Patients will have a one time visit with either nurse or orthopaedic technician for suture removal 10-14 days from surgery if the participant has nonabsorbable sutures placed during surgery.

Other: Educational Videos

Interventions

Subjects in the experimental group will be provided with 3 links to videos to be watched after CTR surgery. These videos will be available through YouTube, Twitter, Facebook, Instagram, TikTok, or MyChart. Videos will be available to watch multiple times at the subjects choice.

Video Management

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing either endoscopic (CPT 29848) or open CTR (CPT 64721)
  • Access to a smartphone, tablet, or computer to view educational videos
  • Access to internet to download or view postoperative education videos
  • Age 18 or older

You may not qualify if:

  • Patients undergoing any additional procedures
  • Worker's compensation status
  • Revision procedures
  • Patients unable to utilize technology to view videos or follow instructions
  • Patients with no access to internet
  • Inability to provide informed consent for the study
  • Patients unable to speak English fluently

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Carilion Clinic Orthopaedic Surgery

Roanoke, Virginia, 24014, United States

Location

Related Publications (26)

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    PMID: 28333925BACKGROUND
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    PMID: 32745145BACKGROUND
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    PMID: 32702759BACKGROUND
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    PMID: 29529004BACKGROUND
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    PMID: 26568712BACKGROUND
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    PMID: 33520679BACKGROUND
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    PMID: 33822736BACKGROUND
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    PMID: 28735437BACKGROUND
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    PMID: 32197766BACKGROUND
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    PMID: 18579622BACKGROUND
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    PMID: 32693989BACKGROUND
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    PMID: 27545100BACKGROUND
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    PMID: 32459409BACKGROUND
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    BACKGROUND
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    PMID: 32951916BACKGROUND
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    PMID: 32235192BACKGROUND
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    PMID: 32220506BACKGROUND
  • Tofte JN, Anthony CA, Polgreen PM, Buckwalter JA, Caldwell LS, Fowler TP, Ebinger T, Hanley JM, Dowdle SB, Holte AJ, Arpey NC, Lawler EA. Postoperative care via smartphone following carpal tunnel release. J Telemed Telecare. 2020 May;26(4):223-231. doi: 10.1177/1357633X18807606. Epub 2018 Nov 14.

    PMID: 30428766BACKGROUND
  • Zhang D, Blazar P, Earp BE. Rates of Complications and Secondary Surgeries of Mini-Open Carpal Tunnel Release. Hand (N Y). 2019 Jul;14(4):471-476. doi: 10.1177/1558944718765226. Epub 2018 Mar 20.

    PMID: 29557679BACKGROUND
  • Matsis R, Chou J, Clode N. Outcome of carpal tunnel decompression with pre-surgical diagnosis determined on general practitioner assessment and nerve conduction study. J Clin Orthop Trauma. 2020 Sep 6;13:15-18. doi: 10.1016/j.jcot.2020.08.028. eCollection 2021 Feb.

    PMID: 33717870BACKGROUND
  • Sun Cao P, Loewenstein SN, Timsina LR, Adkinson JM. The Association of Insurance Status and Complications After Carpal Tunnel Release. Hand (N Y). 2023 Mar;18(2):192-197. doi: 10.1177/1558944721990818. Epub 2021 Feb 25.

    PMID: 33631982BACKGROUND
  • Fajardo M, Kim SH, Szabo RM. Incidence of carpal tunnel release: trends and implications within the United States ambulatory care setting. J Hand Surg Am. 2012 Aug;37(8):1599-605. doi: 10.1016/j.jhsa.2012.04.035. Epub 2012 Jun 23.

    PMID: 22727925BACKGROUND
  • Luckhaupt SE, Dahlhamer JM, Ward BW, Sweeney MH, Sestito JP, Calvert GM. Prevalence and work-relatedness of carpal tunnel syndrome in the working population, United States, 2010 National Health Interview Survey. Am J Ind Med. 2013 Jun;56(6):615-24. doi: 10.1002/ajim.22048. Epub 2012 Apr 11.

    PMID: 22495886BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel SyndromePatient Satisfaction

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and InjuriesTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Cesar Bravo, M.D.

    Carilion Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Orthopedic Hand and Upper Extremity Surgeon

Study Record Dates

First Submitted

October 16, 2024

First Posted

October 18, 2024

Study Start

June 1, 2022

Primary Completion

October 31, 2024

Study Completion

December 31, 2024

Last Updated

October 18, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations