TKR ORP: Opioid Reduction Program for Total Knee Replacement Patients

Sponsor

University of Tennessee (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05414942

Collaborator

Campbell Clinic (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

8.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Injuries Knee Injuries and Disorders Opioid Use	Behavioral: Opioid Reduction Program	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

85 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Opioid Reduction Program for Total Knee Replacement Patients

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Jun 1, 2022

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

KOOS Jr. [12-weeks post-op.]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.