Opioid Reduction Program for Total Knee Replacement Patients (TKR ORP)

In the context of prescribed opioids, research suggests that increased exposure is associated with long-term opioid use. Orthopedic surgeries are associated with the prescribing of more opioid narcotics than any other surgical specialty, particularly for Total Knee Replacement surgery, which is associated with severe post-operative pain. The proposed project is a randomized clinical trial to explore the efficacy of our Total Knee Replacement Opioid Reduction Program (ORP) vs. Treatment As Usual (TAU) in the reduction of opioid use following total knee replacement surgery.

Study Overview

• Status: Completed
• Conditions: Knee Injuries; Opioid Use; Knee Injuries and Disorders
• Intervention / Treatment: Behavioral: Opioid Reduction Program

Detailed Description

The purpose of the study is to build upon our existing research to: (1) explore the efficacy of a disseminable Opioid Reduction Program (ORP) to reduce long-term use of prescribed opioids following TKR surgery, (2) assess whether lower opioid use following surgery is related to better functional recovery, and (3) model opioid use trajectories following TKR surgery (i.e., MMEs/week for 12 weeks), which will allow us to examine the factors that characterize at-risk groups.

There will be one control arm (Treatment as Usual or TAU) and one experimental arm (Opioid Reduction Program or ORP). The experimental arm will receive the intervention material twice. The first session is pre-surgery, and the second session is a shortened "booster" session approximately 2-weeks post-op.

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Memphis, Tennessee, United States, 38163
      • University of Tennessee Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years or older.
• Presenting for a total knee replacement (TKR) surgery at Campbell Clinic which will result in an opioid prescription.
• Access to a telephone.
• Able to consent in English.

Exclusion Criteria:

• Under the age of 18.
• Contraindications to use of opioid medication.
• No access to a telephone.
• Unable to understand consent materials in English.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Treatment As Usual (TAU); No intervention will be administered.
Experimental: Opioid Reduction Program; Participants will engage in a brief, educational intervention pre-surgery and a brief booster session 2 weeks post-surgery.	Behavioral: Opioid Reduction Program; Subjects will engage in a brief, educational session which includes information about the appropriate use of opioid pain medication, exposure and tolerance, the definition of misuse and opioid-related harms, how to wean off medication, alternative pain management strategies, and appropriate disposal of leftover medication.; Other Names: TKR-ORP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Opioid pills (dose and type) prescribed by Campbell Clinic.	transcribed from medical record at Campbell Clinic	12-weeks post-op.
Opioid pills prescribed outside of Campbell Clinic.	assessed via scan of prescription drug monitoring database for Tennessee	12-weeks post-op.
Opioid pill count questionnaire.	self-report from participant of how many opioids are left in the bottle at the 12 week assessment	12-weeks post-op.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
KOOS Jr.	There are 3 domains scored from the 7-item measure: Stiffness (1 item), assessed on a 1-5 scale from None to Extreme; Pain (4 items), assessed on a 1-5 scale from None to Extreme; Function, daily living (2 items), assessed on a 1-5 scale from None to Extreme	12-weeks post-op.

Collaborators and Investigators

• Sponsor: University of Tennessee
• Collaborators: Campbell Clinic
• Investigators: Principal Investigator: Karen Derefinko, PhD, University of Tennessee

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): May 25, 2022
• Study Completion (Actual): May 25, 2022

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 7, 2022
• First Posted (Actual): June 10, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Opioid; Prevention; Knee Arthroplasty; Total Knee Replacement; Analgesics, Opioid; Knee Injuries
• Additional Relevant MeSH Terms: Leg Injuries; Wounds and Injuries; Knee Injuries; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: 21-08206-XP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: It is anticipated that a cleaned data set of study-specific data will be provided within two years following the termination of the study for the data archive and this data set would be made public. Confidentiality of individual participants would be maintained with all releases of data. The final study analytical database would be processed according to HIPAA definitions for public data sharing. Documentation would be provided along with the data sharing file that includes but is not limited to: data dictionary, data codebook, valid variable ranges (where provided), the protocol, procedure and operational manuals, intervention manual or programs and any electronic versions of any paper forms that were used in data collection.
• IPD Sharing Time Frame: 2 years after data collection ends
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

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