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| Name | Class |
|---|---|
| University of Memphis | OTHER |
| Campbell Clinic | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ACL Opioid Exposure Reduction Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine milligram equivalents administered | Cumulative morphine milligram equivalents self-administered following surgery; based upon pill counts | Assessed at 30 days post surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Assessed at baseline and 7-days post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Tennessee Health Science Center | Memphis | Tennessee | 38163 | United States |
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| Label | URL |
|---|---|
| UTHSC main website | View source |
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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.
2 years after data collection ends
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| ID | Term |
|---|---|
| D000070598 | Anterior Cruciate Ligament Injuries |
| ID | Term |
|---|---|
| D007718 | Knee Injuries |
| D007869 | Leg Injuries |
| D014947 | Wounds and Injuries |
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