Impact of Early ADL Education on Outcomes Post DRF ORIF

Impact of Early Multimodal ADL Education on Outcomes Post Distal Radius Fracture Open Reduction Internal Fixation Surgery

This study is a randomized controlled trial (RCT). This RCT which will study the effect of performing daily activities early after a distal radius fracture being treated with surgical intervention of open reduction and internal fixation. This study will have two groups. The experimental group will watch a video and be given a handout on how to perform daily activities with the hand of the injured wrist while recovering from surgery and postoperative instructions. The control group will watch a video on wound care and be given a handout on postoperative instructions. Outcome measures will be taken at initial evaluation between 1-2 weeks post surgery, at 5-7 weeks post surgery, at 8-10 weeks, and at 12-14 weeks. Outcome measures will include the Michigan Wrist Evaluation, Visual Analog Pain Scale, Tampa Scale of Kinesiophobia-11 Scale, finger mobility testing, grip and pinch strength, and the 9 hole peg test to test fine motor coordination. Outcome measure scores will be compared between groups using a t-test statistical test. Outcome measure scores will also be tested within groups using a paired t-test.

Study Overview

• Status: Not yet recruiting
• Conditions: Distal Radius Fractures
• Intervention / Treatment: Behavioral: ADL/Postoperative Instruction; Behavioral: Postoperative Instruction

Detailed Description

1. The surgeon will recruit patients who have had surgery for a distal radius fracture with open reduction and internal fixation and have met inclusion and exclusion criteria utilizing a recruitment statement.
2. If the patient is interested in participating in the study, the surgeon will obtain informed consent and email a copy of the informed consent form to the patient.
3. Once informed consent is obtained, the surgeon will ask the front desk to give him an envelop which will include a letter with either the word control or experimental group on it.
4. Once the surgeon reads the letter, the subject will receive either the standard of care video and handout (control) or the intervention video and handout (experimental).
5. If the subject receives the intervention then the surgeon will play the intervention video in the office and review with the subject the educational handout. The handout will be given to the subject to take home which includes a QR code to the educational video.

If the subject is in the control group then the surgeon will play the standard of care (postoperative care) video in the office and review with the subject the postoperative care handout. The handout will be given to the subject to take home which includes a QR code to the video.

The following data collection procedures will occur with the subjects

The surgeon will collect data from all subjects at 1-2 weeks post surgery and data collection will include: age, gender, race, hand dominance, side injured, fracture severity, workers comp status, comorbidities, smoker status, work status, and household assistance. The hand surgeon will also collect data from the subjects on their current level of function, pain, and fear of moving their injured limb.

At 5-7 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion.

At 8-10 weeks the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination.

At 12-14 the surgeon will collect data from all subjects on their current level of function, pain, fear of moving their injured limb. The surgeon will also measure finger motion, grip, pinch strength and fine motor coordination.

All subjects will be followed for 14 weeks. If the patient receives a referral for hand therapy it will be noted in the record. It will also be noted in the record if subject experiences any complication such as median nerve compression, tendonitis, or complex regional pain syndrome.

The outcome measures that will be used with both the control and experimental groups and at each time point that the data will be collected. All outcome measures will be uploaded onto RedCap. Subjects will use a tablet to fill out all questionnaires (Michigan Hand Evaluation, Visual Analog Scale, Tampa Scale of Kinesiophobia-11) while in the office or forms will be emailed through RedCap and scores will be uploaded into the RedCap database. All clinical tests (grip and pinch testing, distance from distal palmar crease, 9 hole peg test) will be recorded in RedCap. Demographic information will either be collected on the tablet in RedCap.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Sarah Doerrer, PhD; Phone Number: 757-651-5110; Email: sdoerrer56@gwu.edu

Study Locations

• United States
  • Virginia
    • Washington, Virginia, United States, 22204
      • Medical Facilities Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

English Speaking DRF treated with ORIF Individuals 18 years of age or older 2 weeks or less post ORIF for DRF

Exclusion Criteria:

Individuals with pre-existing neurological coniditons affecting the upper limb Individuals with congnitive deficits that would limit the ability to correctly report information on outcome measures Individuals with psychological deficits which would limit the ability to correctly report information on outcome measures Individuals with multiple injuries to the affected upper limb Individuals with multiple injuries to both upper limbs Prior distal radius fracture involving the same wrist Individuals receiving hand therapy for another injury at enrollment into study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADL/Postoperative Instruction; Participants in the experimental group will watch a video instructing them on early ADL participation after DRF fracture treated by ORIF and postoperative care. Participants in the experimental group will also receive a handout on ADL participation and postoperative care with a QR code to the video.	Behavioral: ADL/Postoperative Instruction; This is an education video which includes demonstration of simple ADL tasks that the participant can do at home after surgery. Handout includes the same information and a QR code to watch the video.; Behavioral: Postoperative Instruction; This is an education video that only includes the postoperative instructions. Handout includes the same information and a QR code to watch the video.
Active Comparator: Postoperative Instruction; Participants in the control group will watch a video instructing them on postoperative care. Participants in the control group will receive a handout on postoperative care with a QR code to the video.	Behavioral: Postoperative Instruction; This is an education video that only includes the postoperative instructions. Handout includes the same information and a QR code to watch the video.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Michigan Hand Questionnaire	Patient reported outcome measure for function	baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale	patient reported outcome measure for pain intensity	baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Tampa Scale of Kinesiophobia	patient reported outcome measure for fear of movement	baseline, 5-7 weeks, 8-10 weeks, 12-14 weeks
Range of Motion of digits	distance from digits to distal palmar crease in cm	5-7 weeks, 8-10 weeks, 12-14 weeks
Grip and Pinch Strength	Jamar grip gauge testing and pinchmeter gauge testing for strength	8-10 weeks, 12-14 weeks
9 hole peg test	fine motor coordination/sensorimotor test	8-10 weeks, 12-14 weeks

Collaborators and Investigators

• Sponsor: George Washington University

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Activities of Daily Living; Postsurgical Patient Education
• Additional Relevant MeSH Terms: Fractures, Bone; Wounds and Injuries; Arm Injuries; Forearm Injuries; Wrist Injuries; Radius Fractures; Wrist Fractures
• Other Study ID Numbers: NCR235402

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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