Anterior Cruciate Ligament InjuriesSOARNCT04225468
Safe Options for ACL Recovery
A study testing ACL Opioid Exposure Reduction Program in people with Anterior Cruciate Ligament Injuries and Opioid Use, run by Karen Derefinko, PhD at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injuries, Opioid Use
- What is being tested?
- ACL Opioid Exposure Reduction Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2020to 3 Jun 2022
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Under 12 years of age
- Contraindication to opioids
- Unable to understand intervention material in English
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Tennessee Health Science Center
Memphis, Tennessee, 38163
About this study
Official title: Safe Options for ACL Recovery: An Opioid Exposure Reduction Program for Anterior Cruciate Ligament Surgery Patients
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.
Read the 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.
- Conditions
- Anterior Cruciate Ligament Injuries, Opioid Use
- Being tested
- ACL Opioid Exposure Reduction Program
- Keywords
- prevention, opioid exposure, exposure reduction
- Medical subject headings
- Anterior Cruciate Ligament Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ACL Opioid Exposure Reduction ProgramBehavioural
Also called ACL-OERP
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.
| Study group | Role | What they receive |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | No intervention will be administered. |
| Opioid Exposure Reduction Program 1 (OERP1) | Experimental | Participants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery. Receives: Behavioral: ACL Opioid Exposure Reduction Program |
| Opioid Exposure Reduction Program 2 (OERP2) | Experimental | 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. Receives: Behavioral: ACL Opioid Exposure Reduction Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine milligram equivalents administered
Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts
Measured: Assessed at 30 days post surgery
Secondary outcomes (1)
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.
Measured: Assessed at baseline and 7-days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start12 Feb 2020
- Primary completion3 Jun 2022
- Study completion3 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Cruciate Ligament InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karen Derefinko, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of Memphis, Campbell Clinic
- Responsible party
- Sponsor-investigator, Karen Derefinko, PhD, University of Tennessee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225468
- Sponsor's protocol ID
- 19-07075-XP
- Acronym
- SOAR
- Status last verified
- Oct 2022
- First submitted
- 7 Jan 2020
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Options for ACL Recovery: An Opioid Exposure Reduction Program for Anterior Cruciate Ligament Surgery Patients
- ClinicalTrials.gov ID
- NCT04225468
- Acronym / sponsor ID
- SOAR / 19-07075-XP
- Conditions
- Anterior Cruciate Ligament Injuries, Opioid Use
- Keywords
- prevention, opioid exposure, exposure reduction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Karen Derefinko, PhDUniversity, hospital or other
- Collaborators
- University of Memphis, Campbell Clinic
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 3 Jun 2022 (actual)
- Study completion
- 3 Jun 2022 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment As Usual (TAU) | No intervention | –No intervention will be administered. |
| Opioid Exposure Reduction Program 1 (OERP1) | Experimental | Behavioral: ACL Opioid Exposure Reduction ProgramParticipants will engage in a brief, educational intervention at their pre-surgery appointment approximately 2-3 weeks before ACL reconstruction surgery. |
| Opioid Exposure Reduction Program 2 (OERP2) | Experimental | Behavioral: ACL Opioid Exposure Reduction ProgramParticipants 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- Under 12 years of age
- Contraindication to opioids
- Unable to understand intervention material in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ACL Opioid Exposure Reduction ProgramAlso: ACL-OERPSubjects 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. | Behavioural | Opioid Exposure Reduction Program 1 (OERP1), Opioid Exposure Reduction Program 2 (OERP2) |
Primary outcome
Total morphine milligram equivalents administered
Time frame: Assessed at 30 days post surgery
Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts
1 secondary outcome
Knowledge of safe opioid use
Time frame: Assessed at baseline and 7-days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- UTHSC main websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ACL Opioid Exposure Reduction Program in people with Anterior Cruciate Ligament Injuries and Opioid Use, run by Karen Derefinko, PhD 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 2 inclusion and 3 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: finished, as of the sponsor's last update on 2 Nov 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Total morphine milligram equivalents administered (time frame: Assessed at 30 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Nov 2022.