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| Name | Class |
|---|---|
| Baylor University | OTHER |
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The purpose of this project is to assess the impact of an educational video on the use of prescription opioid medication during a 6-month period following spine surgery. Subjects will be recruited from the pool of patients coming in for the pre-operative appointment prior to spine surgery. Patients that consent and enroll will be randomized to receive either a brief educational video at this appointment or usual care. Patients will be followed after surgery weekly for the first month, and then again at 6 months to determine their prescription opioid medication utilization patterns. Prescription data will also be pulled from electronic medical records.
After consenting, meeting inclusion criteria, and enrollment, all participants will complete several standard self-report questionnaires related to medical history, social demographic, and psychosocial variables that are related to low back pain, and often used in clinics that manage patients with low back pain. They will then be randomized to either receive the education, or only usual care (which is the typical information the surgeon provides the patient verbally during the pre-operative appointment). All patients will receive the usual care education from their surgeon.
Education Group:
The educational video is a white board style patient-centric video. The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer on-acute pain. It also discusses some of the dangers of long-term opioid usage.
All Subjects:
All subjects will receive the usual care education that is typically given by their surgeon. That will be left up to the discretion of each surgeon.
All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted, and then again at 6 months to ask history of prescription opioid utilization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Educational Video | Experimental | Evidence-based video: Best Advice for People Taking Opioid Medication |
|
| Usual Care | No Intervention | Usual care education provided at time of pre-operative appointment. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational Video | Behavioral | The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Opioid Medication Prescriptions | Number of prescriptions within 12 months after surgery | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI) | The ODI and NDI are 10-item scales with higher numbers indicating greater disability. Each item has 6 possible questions (0-5), which are then summed and multiplied to provide a % score out of 100%. The ODI focused on low back pain and the NDI on neck pain. As values are on the same scale, they were entered as one outcome since we included both neck and low back pain patients. Patients undergoing cervical spine surgery filled out the NDI (Neck Disability Index) and patients undergoing lumbar spine surgery filled out the ODI (Oswestry Disability Index) |
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Inclusion Criteria:
Exclusion Criteria:
a. Known aversion or allergy that would prevent the patient from taking any opioid based pain medication
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| Name | Affiliation | Role |
|---|---|---|
| Daniel Rhon, DPT, DSc | Brooke Army Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brooke Army Medical Center | San Antonio | Texas | 78234 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22786449 | Background | Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, Brown KR, Bruel BM, Bryce DA, Burks PA, Burton AW, Calodney AK, Caraway DL, Cash KA, Christo PJ, Damron KS, Datta S, Deer TR, Diwan S, Eriator I, Falco FJ, Fellows B, Geffert S, Gharibo CG, Glaser SE, Grider JS, Hameed H, Hameed M, Hansen H, Harned ME, Hayek SM, Helm S 2nd, Hirsch JA, Janata JW, Kaye AD, Kaye AM, Kloth DS, Koyyalagunta D, Lee M, Malla Y, Manchikanti KN, McManus CD, Pampati V, Parr AT, Pasupuleti R, Patel VB, Sehgal N, Silverman SM, Singh V, Smith HS, Snook LT, Solanki DR, Tracy DH, Vallejo R, Wargo BW; American Society of Interventional Pain Physicians. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2--guidance. Pain Physician. 2012 Jul;15(3 Suppl):S67-116. | |
| 16700278 |
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Any data sharing must first go through a Data Sharing Agreement approved by the Defense Health Agency.
Available for 1 year
US Defense Health Agency data sharing agreement application approved
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| ID | Title | Description |
|---|---|---|
| FG000 | Educational Video | Evidence-based video: Best Advice for People Taking Opioid Medication Educational Video: The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long. |
| FG001 | Usual Care | Usual care education provided at time of pre-operative appointment. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Educational Video | Evidence-based video: Best Advice for People Taking Opioid Medication Educational Video: The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Opioid Medication Prescriptions | Number of prescriptions within 12 months after surgery | Posted | Mean | 95% Confidence Interval | prescriptions count | 12 months |
|
6 months
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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 | Educational Video | Evidence-based video: Best Advice for People Taking Opioid Medication Educational Video: The content of the education focus on providing a historical perspective for opioid prescription from the time when the risk of dependence was highly underestimated. The video discusses the current evidence for the effect of opioid medications in non-cancer non-acute pain. It also discusses some of the dangers of long-term opioid usage. The video is 11 and ½ minutes long. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| death | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Dan Rhon | Brooke Army Medical Center | 210-916-3303 | daniel.i.rhon.ctr@mail.mil |
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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 | May 4, 2018 | Nov 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D009293 | Opioid-Related Disorders |
| D019547 | Neck Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
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|
|
| 6 months |
| Numeric Pain Rating Scale (NPRS) | A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess pain intensity. | 6 months |
| Background |
| Trescot AM, Boswell MV, Atluri SL, Hansen HC, Deer TR, Abdi S, Jasper JF, Singh V, Jordan AE, Johnson BW, Cicala RS, Dunbar EE, Helm S 2nd, Varley KG, Suchdev PK, Swicegood JR, Calodney AK, Ogoke BA, Minore WS, Manchikanti L. Opioid guidelines in the management of chronic non-cancer pain. Pain Physician. 2006 Jan;9(1):1-39. |
| 25281256 | Background | Devin CJ, Lee DS, Armaghani SJ, Bible J, Shau DN, Martin PR, Ehrenfeld JM. Approach to pain management in chronic opioid users undergoing orthopaedic surgery. J Am Acad Orthop Surg. 2014 Oct;22(10):614-22. doi: 10.5435/JAAOS-22-10-614. |
| 18027538 | Background | Walid MS, Hyer L, Ajjan M, Barth AC, Robinson JS Jr. Prevalence of opioid dependence in spine surgery patients and correlation with length of stay. J Opioid Manag. 2007 May-Jun;3(3):127-8, 130-2. doi: 10.5055/jom.2007.0050. |
| 17227935 | Background | Martell BA, O'Connor PG, Kerns RD, Becker WC, Morales KH, Kosten TR, Fiellin DA. Systematic review: opioid treatment for chronic back pain: prevalence, efficacy, and association with addiction. Ann Intern Med. 2007 Jan 16;146(2):116-27. doi: 10.7326/0003-4819-146-2-200701160-00006. |
| 17636781 | Background | Deshpande A, Furlan A, Mailis-Gagnon A, Atlas S, Turk D. Opioids for chronic low-back pain. Cochrane Database Syst Rev. 2007 Jul 18;(3):CD004959. doi: 10.1002/14651858.CD004959.pub3. |
| 24897746 | Background | Lee D, Armaghani S, Archer KR, Bible J, Shau D, Kay H, Zhang C, McGirt MJ, Devin C. Preoperative Opioid Use as a Predictor of Adverse Postoperative Self-Reported Outcomes in Patients Undergoing Spine Surgery. J Bone Joint Surg Am. 2014 Jun 4;96(11):e89. doi: 10.2106/JBJS.M.00865. Epub 2014 Jun 4. |
| 19187891 | Background | Chou R, Ballantyne JC, Fanciullo GJ, Fine PG, Miaskowski C. Research gaps on use of opioids for chronic noncancer pain: findings from a review of the evidence for an American Pain Society and American Academy of Pain Medicine clinical practice guideline. J Pain. 2009 Feb;10(2):147-59. doi: 10.1016/j.jpain.2008.10.007. |
| 35130200 | Result | Rhon DI, Greenlee TA, Mayhew R, Boyer C, Laugesen M, Roth J, Dowd TC, Gill NW. Engaging Education About Risks of Opioid Use With Patients Before Elective Surgery of the Lower Extremity Did Not Reduce Postoperative Opioid Utilization: A Randomized Controlled Trial. J Am Acad Orthop Surg. 2022 Apr 1;30(7):e649-e657. doi: 10.5435/JAAOS-D-21-00603. |
| BG001 | Usual Care | Usual care education provided at time of pre-operative appointment. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Modified Oswestry Disability Index (ODI) or Neck Disability Index (NDI) | The ODI and NDI are 10-item scales with higher numbers indicating greater disability. Each item has 6 possible questions (0-5), which are then summed and multiplied to provide a % score out of 100%. The ODI focused on low back pain and the NDI on neck pain. As values are on the same scale, they were entered as one outcome since we included both neck and low back pain patients. Patients undergoing cervical spine surgery filled out the NDI (Neck Disability Index) and patients undergoing lumbar spine surgery filled out the ODI (Oswestry Disability Index) | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 6 months |
|
|
|
| Secondary | Numeric Pain Rating Scale (NPRS) | A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess pain intensity. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | 6 months |
|
|
|
| 0 |
| 60 |
| 0 |
| 60 |
| 0 |
| 60 |
| EG001 | Usual Care | Usual care education provided at time of pre-operative appointment. | 0 | 60 | 0 | 60 | 0 | 60 |
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| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |