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Safe Options for ACL Recovery (SOAR)

Primary Purpose

Anterior Cruciate Ligament Injuries, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ACL Opioid Exposure Reduction Program
Sponsored by
Karen Derefinko, PhD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anterior Cruciate Ligament Injuries focused on measuring prevention, opioid exposure, exposure reduction

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Presenting for a pre-operatory appointment at the study site for ACL reconstruction with patellar tendon autograft surgery.
  • Be able to return to the clinic at least one time within the first 10 days post-op.

Exclusion Criteria:

  • Under 12 years of age
  • Contraindication to opioids
  • Unable to understand intervention material in English

Sites / Locations

  • University of Tennessee Health Science Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Treatment As Usual (TAU)

Opioid Exposure Reduction Program 1 (OERP1)

Opioid Exposure Reduction Program 2 (OERP2)

Arm Description

No intervention will be administered.

Participants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery.

Participants will engage in the same intervention as OERP1, but those in OERP2 will also receive a 5-minute "booster" intervention session 3 days after surgery.

Outcomes

Primary Outcome Measures

Total morphine milligram equivalents administered
Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts

Secondary Outcome Measures

Knowledge of safe opioid use
Change in pre and post test scores of a knowledge test of topics covered in the intervention including tolerance, weaning off opioids, safe disposal methods, and alternative pain management strategies.

Full Information

First Posted
January 7, 2020
Last Updated
October 31, 2022
Sponsor
Karen Derefinko, PhD
Collaborators
University of Memphis, Campbell Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04225468
Brief Title
Safe Options for ACL Recovery
Acronym
SOAR
Official Title
Safe Options for ACL Recovery: An Opioid Exposure Reduction Program for Anterior Cruciate Ligament Surgery Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
February 12, 2020 (Actual)
Primary Completion Date
June 3, 2022 (Actual)
Study Completion Date
June 3, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Karen Derefinko, PhD
Collaborators
University of Memphis, Campbell Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the proposed work is to test a brief opioid exposure reduction program (ACL-OERP) designed to improve health literacy about opioid use following surgeries. This intervention is specifically designed to be used with patients (or for patients under 18, the patient and caregiver) undergoing Anterior Cruciate Ligament (ACL) reconstruction, a painful surgery that is often followed by at least 7 days of opioid medication.
Detailed Description
The goal of this study is to test whether the ACL-OERP intervention (vs. a treatment as usual [TAU] comparison) improves knowledge of (1) risks associated with opioid self-administration (development of tolerance, dangers of concomitant sedative use, taking as prescribed for safety), (2) expected pain following ACL reconstruction, (3) accurate pain assessment, (4) and weaning from opioid to non-narcotic analgesics. There will be one control arm (TAU) and two intervention arms, both of which are experimental. Both will receive the ACL-OERP before surgery, and the second arm will also receive a "booster" intervention session of the intervention 3 days after surgery. In addition, investigators wish to compare the amount of opioid self-administered in the intervention groups (vs. TAU comparison) to assess whether this knowledge reduces self-administration of opioid. The project will also examine whether the implementation of the booster intervention session in the third arm improves these outcomes compared to the other intervention arm.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anterior Cruciate Ligament Injuries, Opioid Use
Keywords
prevention, opioid exposure, exposure reduction

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment As Usual (TAU)
Arm Type
No Intervention
Arm Description
No intervention will be administered.
Arm Title
Opioid Exposure Reduction Program 1 (OERP1)
Arm Type
Experimental
Arm Description
Participants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery.
Arm Title
Opioid Exposure Reduction Program 2 (OERP2)
Arm Type
Experimental
Arm Description
Participants will engage in the same intervention as OERP1, but those in OERP2 will also receive a 5-minute "booster" intervention session 3 days after surgery.
Intervention Type
Behavioral
Intervention Name(s)
ACL Opioid Exposure Reduction Program
Other Intervention Name(s)
ACL-OERP
Intervention Description
Subjects will engage in a brief, educational 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.
Primary Outcome Measure Information:
Title
Total morphine milligram equivalents administered
Description
Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts
Time Frame
Assessed at 30 days post surgery
Secondary Outcome Measure Information:
Title
Knowledge of safe opioid use
Description
Change in pre and post test scores of a knowledge test of topics covered in the intervention including tolerance, weaning off opioids, safe disposal methods, and alternative pain management strategies.
Time Frame
Assessed at baseline and 7-days post surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Presenting for a pre-operatory appointment at the study site for ACL reconstruction with patellar tendon autograft surgery. Be able to return to the clinic at least one time within the first 10 days post-op. Exclusion Criteria: Under 12 years of age Contraindication to opioids Unable to understand intervention material in English
Facility Information:
Facility Name
University of Tennessee Health Science Center
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Links:
URL
https://uthsc.edu
Description
UTHSC main website

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Safe Options for ACL Recovery

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