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Carpal Tunnel SyndromeVIDEONCT06647719

Postoperative Care After Carpal Tunnel Release Using Short Educational Videos

A study testing Educational Videos in people with Carpal Tunnel Syndrome and Patient Satisfaction, run by Carilion Clinic at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Carpal Tunnel Syndrome, Patient Satisfaction
What is being tested?
Educational Videos
Could I receive a placebo?
No, everyone receives an active treatment
How many people
84 participants
Where
1 siteUnited States
Study dates
1 Jun 2022to 31 Dec 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Carilion Clinic Orthopaedic Surgery

    Roanoke, Virginia, 24014

Other trials in United States

About this study

Official title: Patient Directed Care After Carpal Tunnel Release Using Video Integration and Digital Education After Operations (VIDEO)

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.

Read more

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.

Read the detailed description

Carpal tunnel release (CTR) is a commonly performed procedure with predictable outcomes and a low complication rate. Traditionally, patients are scheduled for two postoperative follow-up visits-one at two weeks and another at six weeks. However, these routine visits rarely lead to a change in patient management and often impose logistical and financial burdens on patients, particularly for those living in rural areas who must travel long distances to their healthcare provider's clinic.

This study proposes an alternative postoperative care model for CTR patients that leverages short educational videos and allows patients to manage their recovery more independently. The experimental group in the study will receive three brief (< 60 seconds each) educational videos after surgery. These videos will cover key aspects of postoperative care, including wound management and when to seek medical attention. Unlike the traditional model, patients in this group will not have scheduled in-person or virtual follow-up visits unless they require them. All patients in the experimental group will still have access to their healthcare provider through standard communication channels, such as:

Calling the office for advice or concerns. Sending secure messages through the electronic medical record (EMR) system. Attending urgent in-person visits if necessary. If nonabsorbable sutures are used during surgery, patients in the experimental group will schedule an appointment for suture removal with a nurse at their convenience, usually 10-14 days post-surgery.

The primary goal of the study is to determine whether this patient-directed care model, which utilizes educational videos, can improve patient satisfaction and reduce the use of healthcare resources without compromising care quality or increasing complication rates.

Specific Aim: The study aims to evaluate whether a patient-directed postoperative care program for CTR can:

Improve patient satisfaction. Reduce healthcare resource utilization. Lessen the burden of care (e.g., fewer missed workdays and less time spent on healthcare-related activities).

Maintain comparable patient-reported outcomes, complication rates, and the number of urgent visits as those observed in traditional in-person follow-up care.

Hypotheses:

Patients who receive the educational videos will report higher satisfaction with their care.

These patients will miss fewer days of work and spend less time on health-related activities.

The experimental group will consume fewer healthcare resources (e.g., fewer clinic visits).

Patient-reported outcomes, complication rates, and urgent visits will be similar between the experimental and standard in-person care groups.

Significance: The results of this study have the potential to transform and enhance postoperative care for patients undergoing CTR and other minor surgical procedures. By reducing the need for routine in-person visits, the proposed care model can help alleviate the burden on patients, particularly those from rural areas. Additionally, reducing clinic utilization for straightforward postoperative cases could increase the availability of clinic appointments for more complex cases, thereby improving overall healthcare system efficiency. This patient-directed model could also be expanded to other surgical and nonsurgical conditions, empowering patients to take a more active role in their recovery while maintaining high standards of care.

Being tested
Educational Videos
Keywords
Carpal tunnel release (CTR), Patient-directed care, Educational videos, Minor hand surgery
Medical subject headings
Carpal Tunnel Syndrome, Patient Satisfaction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Educational VideosOther

    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.

Study groups in NCT06647719
Study groupRoleWhat they receive
Standard of CareNo interventionIn-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 ManagementExperimentalPostoperative 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.
Receives: Other: Educational Videos

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 2 and 6 weeks postoperatively

Secondary outcomes (6)
  1. Time Taken Off Work

    Reported by patient or care giver during 2 and 6-week postoperative visits. (hours)

    Measured: Baseline to 6 week follow up

  2. Travel time.

    Time spent traveling to attend postoperative care appointments. (hours)

    Measured: Baseline to 6 week follow up

  3. Number of Unplanned Visits

    The number of visits that were not originally scheduled as a part of standard of care procedures.

    Measured: Baseline to 6 week follow up.

  4. Patient Satisfaction Questionnaire

    Will record patient satisfaction as well as the number of unplanned visits, time taken off of work (hours), and travel time to attend appointments for postoperative care (hours).

    Measured: Baseline to 6 week follow up.

  5. Wound Complications

    Electronic Medical Records review will be performed to determine: Number of wound complications.

    Measured: Baseline to 6 week follow up.

  6. Total In Person Postoperative Visits

    Electronic Medical Records review will be performed to determine: Total number of in person postoperative visits

    Measured: Baseline to 6 week follow up.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Oct 2024
  2. Study start1 Jun 2022
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion31 Dec 2024 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06647719
Sponsor's protocol ID
IRB-21-1469
Acronym
VIDEO
Status last verified
Oct 2024
First submitted
16 Oct 2024
Last updated
18 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Greenfield PT, Manz WJ, DeMaio EL, Duddleston SH, Xerogeanes JW, Scott Maughon T, Spencer CC, Dawes A, Boden SD, Hammond KE, Wagner ER, Gottschalk MB, Daly CA, Pombo MW. Telehealth Can Be Implemented Across a Musculoskeletal Service Line Without Compromising Patient Satisfaction. HSS J. 2021 Feb;17(1):36-45. doi: 10.1177/1556331620977171. Epub 2021 Feb 21.

    PubMed 33967640
  • https://www. pewresearch.org/internet/fact-sheet/social-media/?menuItem=81867c91- 92ad-45b8-a964-a2a894f873ef

  • Kim SH, Koh WU, Rhim JH, Karm MH, Yu HS, Lee BY, Shin JW, Leem JG. Preconsent video-assisted instruction improves the comprehension and satisfaction in elderly patient visiting pain clinic. Korean J Pain. 2012 Oct;25(4):254-7. doi: 10.3344/kjp.2012.25.4.254. Epub 2012 Oct 4.

    PubMed 23091686
  • Denny MC, Vahidy F, Vu KY, Sharrief AZ, Savitz SI. Video-based educational intervention associated with improved stroke literacy, self-efficacy, and patient satisfaction. PLoS One. 2017 Mar 23;12(3):e0171952. doi: 10.1371/journal.pone.0171952. eCollection 2017.

    PubMed 28333925
  • Kim S, Ju MK, Son S, Jun S, Lee SY, Han CS. Development of video-based educational materials for kidney-transplant patients. PLoS One. 2020 Aug 3;15(8):e0236750. doi: 10.1371/journal.pone.0236750. eCollection 2020.

    PubMed 32745145
  • Veldhuijzen G, Klemt-Kropp M, Terhaar Sive Droste JS, van Balkom B, van Esch AAJ, Drenth JPH. Computer-based patient education is non-inferior to nurse counselling prior to colonoscopy: a multicenter randomized controlled trial. Endoscopy. 2021 Mar;53(3):254-263. doi: 10.1055/a-1225-8708. Epub 2020 Nov 5.

    PubMed 32702759
  • Kuba MHM, Izuka BH. One Brace: One Visit: Treatment of Pediatric Distal Radius Buckle Fractures With a Removable Wrist Brace and No Follow-up Visit. J Pediatr Orthop. 2018 Jul;38(6):e338-e342. doi: 10.1097/BPO.0000000000001169.

    PubMed 29529004
  • Gamble D, Jenkins PJ, Edge MJ, Gilmour A, Anthony IC, Nugent M, Rymaszewski LA. Satisfaction and functional outcome with "self-care" for the management of fifth metacarpal fractures. Hand (N Y). 2015 Dec;10(4):607-12. doi: 10.1007/s11552-015-9749-8. Epub 2015 Feb 18.

    PubMed 26568712
  • Vusirikala A, Ensor D, Asokan AK, Lee AJ, Ray R, Tsekes D, Edwin J. Hello, can you hear me? Orthopaedic clinic telephone consultations in the COVID-19 era- a patient and clinician perspective. World J Orthop. 2021 Jan 18;12(1):24-34. doi: 10.5312/wjo.v12.i1.24. eCollection 2021 Jan 18.

    PubMed 33520679
  • Orrange S, Patel A, Mack WJ, Cassetta J. Patient Satisfaction and Trust in Telemedicine During the COVID-19 Pandemic: Retrospective Observational Study. JMIR Hum Factors. 2021 Apr 22;8(2):e28589. doi: 10.2196/28589.

    PubMed 33822736
  • Reider-Demer M, Raja P, Martin N, Schwinger M, Babayan D. Prospective and retrospective study of videoconference telemedicine follow-up after elective neurosurgery: results of a pilot program. Neurosurg Rev. 2018 Apr;41(2):497-501. doi: 10.1007/s10143-017-0878-0. Epub 2017 Jul 22.

    PubMed 28735437
  • Kane LT, Thakar O, Jamgochian G, Lazarus MD, Abboud JA, Namdari S, Horneff JG. The role of telehealth as a platform for postoperative visits following rotator cuff repair: a prospective, randomized controlled trial. J Shoulder Elbow Surg. 2020 Apr;29(4):775-783. doi: 10.1016/j.jse.2019.12.004.

    PubMed 32197766
  • Williams M, Amin A, Getgood A, Hallam P, Chojnowski AJ, Chapman PG. Telephone clinic follow-up following carpal tunnel decompression. J Hand Surg Eur Vol. 2008 Oct;33(5):641-4. doi: 10.1177/1753193408090124. Epub 2008 Jun 25.

    PubMed 18579622
  • Grandizio LC, Mettler AW, Caselli ME, Pavis EJ. Telemedicine After Upper Extremity Surgery: A Prospective Study of Program Implementation. J Hand Surg Am. 2020 Sep;45(9):795-801. doi: 10.1016/j.jhsa.2020.06.002. Epub 2020 Jul 18.

    PubMed 32693989
  • Kummerow Broman K, Roumie CL, Stewart MK, Castellanos JA, Tarpley JL, Dittus RS, Pierce RA. Implementation of a Telephone Postoperative Clinic in an Integrated Health System. J Am Coll Surg. 2016 Oct;223(4):644-51. doi: 10.1016/j.jamcollsurg.2016.07.010. Epub 2016 Aug 18.

    PubMed 27545100

Questions about this trial

What is this clinical trial studying?

A study testing Educational Videos in people with Carpal Tunnel Syndrome and Patient Satisfaction, run by Carilion Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-Reported Outcome Measurement Information System (PROMIS) / Upper Extremity Computer Adaptive Test (UE CAT) / 5-Point Likert Scale (time frame: 2 and 6 weeks postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06647719, which also lists 26 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2024.

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