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| ID | Type | Description | Link |
|---|---|---|---|
| 1K23AR080224-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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The goal of this clinical trial is to develop an pharmacist-led preoperative opioid taper intervention for patients undergoing total knee or hip replacement who are on chronic opioids before their surgery. The main questions it aims to answer are:
Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pharmacist-led opioid taper intervention | Experimental | The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period. Participants will meet with a clinical pharmacist, who will provide some basic education on pain and opioids, and will propose an opioid taper schedule. The pharmacist will then follow-up with the participant by phone each week until surgery to assess progress and adjust the taper as necessary. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| opioid taper | Behavioral | The participant will attempt to taper their opioid dose by ~50% during the 4-6 week preoperative period |
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| Measure | Description | Time Frame |
|---|---|---|
| Acceptability | Mixed-methods assessment of the intervention by participants. Participants will provide qualitative feedback at multiple points during and after the intervention, and will quantitatively rate satisfaction at the end of the study. These results will be analyzed jointly to determine acceptability. | From enrollment until approximately 2 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Study Recruitment Rate | In order to assess feasibility of the taper intervention, we will track the proportion of participants who are offered enrollment that ultimately enroll (will be measured separately for those offered enrollment in person and those who are mailed information about the study) | From enrollment until approximately 2 weeks after surgery |
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Inclusion Criteria:
Exclusion Criteria:
Taking opioid medications that include:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kevin R Riggs, MD | Contact | 205-934-0778 | kriggs@uabmc.edu | |
| Shakristal Williams | Contact | 205-934-2304 | shakristalwilliams@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kevin R Riggs, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Hospital-Highlands | Recruiting | Birmingham | Alabama | 35205 | United States |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Study Retention Rate | In order to assess feasibility of the taper intervention, we will track the proportion of enrolled participants who complete the final study visit. | From enrollment until approximately 2 weeks after surgery |
| Taper Efficacy | change in opioid dose from enrollment through surgery | From enrollment until the time of surgery |
| Perioperative Pain | pain scores throughout the perioperative period | From enrollment until approximately 2 weeks after surgery |