Knee Injuries and DisordersOpiateLEONCT02997644
Impact of Different Educational Approaches on Post-operative Opiate Utilization After Elective Lower Extremity Surgery
A study testing Video Education in people with Knee Injuries and Disorders and Hip Injuries and Disorders, run by Brooke Army Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of post-operative opioid use after two different educational interventions. The investigators will compare changes in pain, disability and sleep between groups 6 months after elective lower extremity surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Knee Injuries and Disorders, Hip Injuries and Disorders, Opiate Addiction
- What is being tested?
- Video Education
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 1 Sep 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any Tricare-eligible patient scheduled for a pre-operative surgery appointment for an elective orthopaedic surgery of the hip, knee, or foot/ankle at SAMMC.
- The surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
- Between the age of 18 - 65 years
- Read and speak English well enough to understand the education, provide informed consent and follow study instructions (the surgeon, investigators, or research assistants will make this determination. Any patient that needs an interpreter will not be allowed to enroll).
Who cannot join
- Known aversion or allergy that would prevent the patient from taking any opioid-based pain medication (any contraindications to using opioids)
- History of prior surgery to the same location.
Trial locations and contacts
1 site in 1 country.
United States1 site
Brooke Army Medical Center
San Antonio, Texas, 78234
About this study
Official title: The Effect of an Educational Pain Approach Before Elective Lower-extremity Surgery on 6-month Post-operative Use of Opioid Medication: A Randomized Clinical Trial
The purpose of this study is to evaluate the use of post-operative opioid use after two different educational interventions. The investigators will compare changes in pain, disability and sleep between groups 6 months after elective lower extremity surgery.
Read the detailed description
Hypothesis: The primary hypothesis is that the educational intervention provided prior to the surgery and prior to the prescription, will result in a greater understanding and awareness of the deleterious effects of long-term use of opioid based medications, and in turn reduce utilization post-operatively in the long-term (6 months).
Specific Aim 1: Evaluate prescription opioid medication use for the 6-month period after surgery in subjects that received the education compared to those that received usual care education.
Specific Aim 2: Compare the changes in self-reported outcome measures (pain, disability, and sleep) between groups over the 6-month period after surgery.
Specific Aim 3: Describe the sociodemographic factors and healthcare utilization in enrolled subjects for the 12 months leading up to a surgical procedure. Identify factors that could account for differences in opioid medication utilization, and any potential interaction effect between intervention, opioid use, and clinical outcomes following surgery.
Study Procedures/Research Interventions:
Subjects will be randomized to either receive usual care only or usual care plus the education video. Usual care is defined as typical information the surgeon would otherwise provide the patient before surgery. All patients will receive the usual care education from their surgeon.
Randomization:
Subjects will then be randomized into one of two arms (Group I = Educational Video, Group II= Usual Care Only). The method of group assignment will be sequentially numbered opaque sealed envelopes (SNOSE). To minimize the risk of predicting the treatment assignment of the next eligible patient, randomization will be performed in permuted blocks of two or four with random variation of the blocking number.
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. The screening and enrollment should take no more than 5-10 minutes, and then the filling out of self-report questionnaires should take approximately 5-7 minutes. Subjects in the group that is randomized to the education will take an additional 11 minutes to view the educational content.
All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted (phone call, email, and text message - depending on what they consented to).
At the 1-month and 6-month time points they will be asked to fill out the additional clinical outcomes measures detailed below. These can be done in person with a visit to the clinic or over the telephone.
Sample Size Estimation. Collection of healthcare utilization will occur in 100% of the subjects as no follow-up is required, and therefore no opportunities to collect data from a follow-up visit will be lost. A sample of 120 subjects should allow us to determine significant differences between groups, based on a moderate effect size of 0.6.
- Being tested
- Video Education, Usual Care Group
- Keywords
- patient education, orthopaedic surgery, post-surgical pain, chronic opioid use
- Medical subject headings
- Knee Injuries, Disease, Hip Injuries, Opioid-Related Disorders, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video EducationBehavioural
The content of the education focuses 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 consent, enrollment, and video education will take about 20-30 minutes for patients in this group, and occur at the end of their preoperative visit. The patient will watch the video on a portable Tablet computer.
Usual Care GroupBehavioural
Patients that are randomized to usual care will only receive the regular instructions about opioid usage they typically receive from their surgeon.
| Study group | Role | What they receive |
|---|---|---|
| Video Education | Experimental | Video education delivered on a tablet computer Receives: Behavioral: Video Education |
| Usual Care Group | Placebo comparator | Regular information about opioid usage they typically receive from their surgeon. Receives: Behavioral: Usual Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opiate Prescriptions
Total opiate prescriptions
Measured: 6 months
Secondary outcomes (2)
Numeric Pain Rating Scale
A 0-10 numeric pain rating scale ('0' indicating no pain, and '10' worst imaginable pain) will be used to assess LBP intensity. Numeric pain scales are known to have excellent test-retest reliability.
Measured: baseline, 1 month, 6 months
PROMIS-29
The Patient Reported Outcomes Measurement Information Systems (PROMIS) 29-item short form (version 2) to assess disability. The PROMIS 29-item short form efficiently assesses several outcomes important to patients with a neuromusculoskeletal injury, including pain intensity and interference, sleep disturbance, anxiety, depression, fatigue, and social role participation using items developed with rigorous methodology and patient input. The PROMIS-29 scores have been found valid for patients with orthopedic injuries, with minimum clinically important change thresholds of 2-4 points for most scales. It has also been used to successfully measure psychosocial resiliency in patients with disability.
Measured: baseline, 1 month, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2016 (estimated)
- Study startJun 2016
- Primary completion30 Apr 2019
- Study completion1 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Knee Injuries and DisordersStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Dan Rhon, Brooke Army Medical Center
- Investigators
- Daniel Rhon, DSc, Principal investigator, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02997644
- Sponsor's protocol ID
- C.2016.142d
- Acronym
- OpiateLEO
- Status last verified
- Jan 2020
- First submitted
- 6 Dec 2016
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data sharing must go through a Data Sharing Agreement via the Defense Health Agency
Publications
French MT, McGeary KA, Chitwood DD, McCoy CB. Chronic illicit drug use, health services utilization and the cost of medical care. Soc Sci Med. 2000 Jun;50(12):1703-13. doi: 10.1016/s0277-9536(99)00411-6.
PubMed 10798326Songer TJ, LaPorte RE. Disabilities due to injury in the military. Am J Prev Med. 2000 Apr;18(3 Suppl):33-40. doi: 10.1016/s0749-3797(00)00107-0.
PubMed 10736539Vanderlip ER, Sullivan MD, Edlund MJ, Martin BC, Fortney J, Austen M, Williams JS, Hudson T. National study of discontinuation of long-term opioid therapy among veterans. Pain. 2014 Dec;155(12):2673-2679. doi: 10.1016/j.pain.2014.09.034. Epub 2014 Sep 30.
PubMed 25277462Toblin RL, Quartana PJ, Riviere LA, Walper KC, Hoge CW. Chronic pain and opioid use in US soldiers after combat deployment. JAMA Intern Med. 2014 Aug;174(8):1400-1. doi: 10.1001/jamainternmed.2014.2726. No abstract available.
PubMed 24978399Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy in military veterans. Anesth Analg. 2014 Aug;119(2):454-459. doi: 10.1213/ANE.0000000000000292.
PubMed 24977636Dobscha SK, Morasco BJ, Duckart JP, Macey T, Deyo RA. Correlates of prescription opioid initiation and long-term opioid use in veterans with persistent pain. Clin J Pain. 2013 Feb;29(2):102-8. doi: 10.1097/AJP.0b013e3182490bdb.
PubMed 23269280Rhon 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.
PubMed 35130200
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Educational Pain Approach Before Elective Lower-extremity Surgery on 6-month Post-operative Use of Opioid Medication: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02997644
- Acronym / sponsor ID
- OpiateLEO / C.2016.142d
- Keywords
- patient education, orthopaedic surgery, post-surgical pain, chronic opioid use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- Jun 2016 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 1 Sep 2019 (actual)
- First posted
- 20 Dec 2016 (estimated)
- 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 this study is to evaluate the use of post-operative opioid use after two different educational interventions. The investigators will compare changes in pain, disability and sleep between groups 6 months after elective lower extremity surgery.
Detailed description
Hypothesis: The primary hypothesis is that the educational intervention provided prior to the surgery and prior to the prescription, will result in a greater understanding and awareness of the deleterious effects of long-term use of opioid based medications, and in turn reduce utilization post-operatively in the long-term (6 months).
Specific Aim 1: Evaluate prescription opioid medication use for the 6-month period after surgery in subjects that received the education compared to those that received usual care education.
Specific Aim 2: Compare the changes in self-reported outcome measures (pain, disability, and sleep) between groups over the 6-month period after surgery.
Specific Aim 3: Describe the sociodemographic factors and healthcare utilization in enrolled subjects for the 12 months leading up to a surgical procedure. Identify factors that could account for differences in opioid medication utilization, and any potential interaction effect between intervention, opioid use, and clinical outcomes following surgery.
Study Procedures/Research Interventions:
Subjects will be randomized to either receive usual care only or usual care plus the education video. Usual care is defined as typical information the surgeon would otherwise provide the patient before surgery. All patients will receive the usual care education from their surgeon.
Randomization:
Subjects will then be randomized into one of two arms (Group I = Educational Video, Group II= Usual Care Only). The method of group assignment will be sequentially numbered opaque sealed envelopes (SNOSE). To minimize the risk of predicting the treatment assignment of the next eligible patient, randomization will be performed in permuted blocks of two or four with random variation of the blocking number.
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. The screening and enrollment should take no more than 5-10 minutes, and then the filling out of self-report questionnaires should take approximately 5-7 minutes. Subjects in the group that is randomized to the education will take an additional 11 minutes to view the educational content.
All patients will proceed with the surgical procedure as planned. Each week during the 1-month period after the surgery, patients will be contacted (phone call, email, and text message - depending on what they consented to).
At the 1-month and 6-month time points they will be asked to fill out the additional clinical outcomes measures detailed below. These can be done in person with a visit to the clinic or over the telephone.
Sample Size Estimation. Collection of healthcare utilization will occur in 100% of the subjects as no follow-up is required, and therefore no opportunities to collect data from a follow-up visit will be lost. A sample of 120 subjects should allow us to determine significant differences between groups, based on a moderate effect size of 0.6.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Video Education | Experimental | Behavioral: Video EducationVideo education delivered on a tablet computer |
| Usual Care Group | Placebo comparator | Behavioral: Usual Care GroupRegular information about opioid usage they typically receive from their surgeon. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Any Tricare-eligible patient scheduled for a pre-operative surgery appointment for an elective orthopaedic surgery of the hip, knee, or foot/ankle at SAMMC.
- The surgery is taking place for a condition that has been ongoing for 6 months or longer (chronic)
- Between the age of 18 - 65 years
- Read and speak English well enough to understand the education, provide informed consent and follow study instructions (the surgeon, investigators, or research assistants will make this determination. Any patient that needs an interpreter will not be allowed to enroll).
Key exclusion criteria (2 listed)
- Known aversion or allergy that would prevent the patient from taking any opioid-based pain medication (any contraindications to using opioids)
- History of prior surgery to the same location.
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 |
|---|---|---|
| Video EducationThe content of the education focuses 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 consent, enrollment, and video education will take about 20-30 minutes for patients in this group, and occur at the end of their preoperative visit. The patient will watch the video on a portable Tablet computer. | Behavioural | Video Education |
| Usual Care GroupPatients that are randomized to usual care will only receive the regular instructions about opioid usage they typically receive from their surgeon. | Behavioural | Usual Care Group |
Primary outcome
Opiate Prescriptions
Time frame: 6 months
Total opiate prescriptions
2 secondary outcomes
Numeric Pain Rating Scale
Time frame: baseline, 1 month, 6 months
PROMIS-29
Time frame: baseline, 1 month, 6 months
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 18 Jan 2020.
- Background: PubMed 10798326French MT, McGeary KA, Chitwood DD, McCoy CB. Chronic illicit drug use, health services utilization and the cost of medical care. Soc Sci Med. 2000 Jun;50(12):1703-13. doi: 10.1016/s0277-9536(99)00411-6.
- Background: PubMed 10736539Songer TJ, LaPorte RE. Disabilities due to injury in the military. Am J Prev Med. 2000 Apr;18(3 Suppl):33-40. doi: 10.1016/s0749-3797(00)00107-0.
- Background: PubMed 25277462Vanderlip ER, Sullivan MD, Edlund MJ, Martin BC, Fortney J, Austen M, Williams JS, Hudson T. National study of discontinuation of long-term opioid therapy among veterans. Pain. 2014 Dec;155(12):2673-2679. doi: 10.1016/j.pain.2014.09.034. Epub 2014 Sep 30.
- Background: PubMed 24978399Toblin RL, Quartana PJ, Riviere LA, Walper KC, Hoge CW. Chronic pain and opioid use in US soldiers after combat deployment. JAMA Intern Med. 2014 Aug;174(8):1400-1. doi: 10.1001/jamainternmed.2014.2726. No abstract available.
- Background: PubMed 24977636Rozet I, Nishio I, Robbertze R, Rotter D, Chansky H, Hernandez AV. Prolonged opioid use after knee arthroscopy in military veterans. Anesth Analg. 2014 Aug;119(2):454-459. doi: 10.1213/ANE.0000000000000292.
- Background: PubMed 23269280Dobscha SK, Morasco BJ, Duckart JP, Macey T, Deyo RA. Correlates of prescription opioid initiation and long-term opioid use in veterans with persistent pain. Clin J Pain. 2013 Feb;29(2):102-8. doi: 10.1097/AJP.0b013e3182490bdb.
- Derived from this study: PubMed 35130200Rhon 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.
- Individual participant dataSharing planned: Yes. Data sharing must go through a Data Sharing Agreement via the Defense Health Agency
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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.
Daniel Rhon, DSc principal investigator
Brooke Army Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video Education in people with Knee Injuries and Disorders and Hip Injuries and Disorders, run by Brooke Army Medical Center 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 4 inclusion and 2 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 18 Jan 2020. 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. Some participants in this study may receive a placebo. 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?
Opiate Prescriptions (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02997644, which also lists 7 linked publications.
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 18 Jan 2020.