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This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.
Opioid use disorder is a national health emergency. Opioid prescribing practices to treat post-operative pain have contributed to the problem. This study seeks to explore the effects of changing pre-operative education & increasing patient input regarding post-operative receipt of opioids. The study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. Women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. The investigators will monitor both post-operative opioid consumption and return to physical activity. The investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. Our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Centered pre-op education | Experimental | Patient centered pre-operative education and patient centered post-operative care. |
|
| Routine Pre-op education | Active Comparator | Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient centered pre-op education | Behavioral | To implement a patient centered education intervention to evaluate post-op narcotic use. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use at Approximately Two Weeks Post-op | Morphine milligram equivalents at the two weeks post-op | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Opioid Use at Approximately Six to Eight Weeks Post-op | Morphine milligram equivalents at the six to eight weeks post-op | 6-8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yuko Komesu, MD | University of New Mexico | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UNMH Women's Care Clinic | Albuquerque | New Mexico | 87112 | United States | ||
| UNM Sandoval Regional Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37428883 | Derived | Serna-Gallegos TR, Komesu YM, Dunivan GC, Meriwether KV, Ninivaggio CS, Petersen TR, Jeppson PC. Randomized Trial on Expectations and Pain Control Advancement in Surgery: The REPAIR Study. Urogynecology (Phila). 2024 Jan 1;30(1):7-16. doi: 10.1097/SPV.0000000000001387. Epub 2023 Jun 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Patient Centered Pre-op Education | Patient centered pre-operative education and patient centered post-operative care. Patient centered pre-op education: To implement a patient centered education intervention to evaluate post-op narcotic use. |
| FG001 | Routine Pre-op Education |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 17, 2023 |
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| routine preop education | Behavioral | To implement routine patient education intervention to evaluate post-op narcotic use. |
|
| Rio Rancho |
| New Mexico |
| 87144 |
| United States |
Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics routine preop education: To implement routine patient education intervention to evaluate post-op narcotic use. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Patient Centered Pre-op Education | Patient centered pre-operative education and patient centered post-operative care. Patient centered pre-op education: To implement a patient centered education intervention to evaluate post-op narcotic use. |
| BG001 | Routine Pre-op Education | Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics routine preop education: To implement routine patient education intervention to evaluate post-op narcotic use. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opioid Use at Approximately Two Weeks Post-op | Morphine milligram equivalents at the two weeks post-op | Posted | Median | Inter-Quartile Range | MME | 2 weeks |
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| |||||||||||||||||||||||||||||
| Secondary | Opioid Use at Approximately Six to Eight Weeks Post-op | Morphine milligram equivalents at the six to eight weeks post-op | Posted | Median | Inter-Quartile Range | MME | 6-8 weeks |
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Enrollment of patient until 8 weeks post-operatively for each patient.
All adverse events were collected routinely.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patient Centered Pre-op Education | Patient centered pre-operative education and patient centered post-operative care. Patient centered pre-op education: To implement a patient centered education intervention to evaluate post-op narcotic use. | 0 | 86 | 0 | 86 | 0 | 86 |
| EG001 | Routine Pre-op Education | Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics routine preop education: To implement routine patient education intervention to evaluate post-op narcotic use. | 0 | 88 | 0 | 88 | 0 | 88 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cassandra Darley | University of New Mexico Health Sciences Center | 505-967-8428 | cjdarley@salud.unm.edu |
| Feb 7, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D001519 | Behavior |
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| >=65 years |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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