Opioid UseNCT04039191
SMS Education for Post-operative Pain
A study testing SMS education and SMS survey in people with Opioid Use and Pain, Postoperative, run by Cedars-Sinai Medical Center at 1 site in United States.
Trial summary
The purpose the research is to assess whether or not postoperative education and awareness about pain and opioid use through SMS text messages will reduce overall opioid utilization after common outpatient surgeries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Opioid Use, Pain, Postoperative
- What is being tested?
- SMS education and SMS survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2019to 30 Jul 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients aged ≥18 who are undergoing outpatient surgery (admission <23hrs) where opioids are typically prescribed
Who cannot join
- Non-English speaking patients.
- No access to cellphone.
- Admission beyond 24 hours.
Trial locations and contacts
1 site in 1 country.
United States1 site
Cedars Sinai Medical Center
Los Angeles, California, 90048
About this study
Official title: Short Messaging Service (SMS) Education for Post-operative Pain
The purpose the research is to assess whether or not postoperative education and awareness about pain and opioid use through SMS text messages will reduce overall opioid utilization after common outpatient surgeries.
Read the detailed description
1.0 BACKGROUND, RATIONALE Since the turn of the century, opioid prescriptions and opioid-related overdose deaths in the United States has been on the rise, and is seen as the main cause of the consecutive decrease in life expectancy seen in 2015-2016. This epidemic has been declared a Public Health Emergency by the Department of Health and Human Services (HHS), with approximately 115 people dying daily from opioid-related drug overdoses nationwide. Over 40% of these overdoses are associated with prescription opioid abuse.
While non-medical opioid use is seen most commonly in those aged 15-24, accidental opioid overdose rates are highest in the those aged 45-54, an age group in which the medical use of opioids is most common. For many adults, their first medical exposure to opioids is following a surgical procedure. New persistent opioid use has been identified following both minor and major surgical procedures in 5.9% to 6.5% of patients, and was associated with behavioral and pain disorders rather than surgical pain itself. Furthermore, prolonged opioid use beyond 5 days, and even more so when the prescription exceeds 10 days, has been associated with an increased probability of continued long term opioid use.
Better pain management strategies and better research are key strategies the HHS have identified to combat the growing opioid epidemic. Current prescription patterns in the US are highly variable, although initiatives have been put into place to develop evidence based guidelines. Prescription opioid use has previously been linked to improved patient satisfaction with care, and in a study of primary care providers, those physicians who were incentivized by patient satisfaction scores reported an increased impact of these scores on their opioid prescribing practices. However, multiple studies have revealed no correlation between patient satisfaction scores and the amount of postoperative opioids prescribed.
A systematic review of studies describing opioid oversupply after surgery reported that 67-92% of patients reported unused opioids with few storing or disposing of excessive pills in an appropriate manner. Multiple studies have looked at interventions on the provider side, in order to minimize opioid prescriptions and thus minimize the availability of excess opioids that may facilitate opioid dependence and diversion into the community. While there has been an almost universal reduction in opioids prescribed, fewer studies have demonstrated a reduction in actual opioids taken by the patient.
Hill et al identified in 642 patients undergoing 5 common outpatient procedures a wide variation in the number of opioid pills prescribed and identified an ideal number of opioid pills per procedure that would adequate treat postoperative pain in the majority of patients, a number that was typically less than 50% of what was historically prescribed. The same group then presented their findings at their institution and recommended prescribers to encourage patients to use nonopioid analgesics. They found that following this education, there was a significant reduction in number of opioid pills prescribed across all procedures and also a decrease in the mean number of pills taken by patients following inguinal hernia and partial mastectomy with sentinel lymph node biopsy (SLNB) patients.
Howard et al reported a decrease in median amount of opioids prescribed for laparoscopic cholecystectomy from 250mg to 75mg following the development and education of physicians on evidence based prescribing guidelines. This was associated with no increase in the frequency of refill requests and a median postoperative opioid use reduction from 30mg to 20mg without a change in pain score. Similar results were seen in a group of oncology patients undergoing breast and melanoma procedures.
Several studies have also incorporated preoperative patient education about expected postoperative recovery and pain management strategies. However, most of these studies have been retrospectively performed in the context of quality improvement projects, with the comparison of preinterventional and postinterventional cohorts of patients.
Shindo et al in a retrospective cohort study of patients undergoing thyroid and parathyroid surgery reported a significant decrease in the amount of opioids prescribed following an intervention including preoperative patient counselling regarding pain management, the use of multimodality nonopioid pain management and the education of nurses and physicians. Prabhu et al took a shared decision-making approach to opioid prescribing utilizing a tablet computer based decision aid and found that patients who participated chose a 50% decreased in the number of opioids prescribed postoperatively.
Holman et al performed a retrospective cohort study on orthopedic trauma patients and found that patients who were instructed at the time of index procedure that they would receive prescription opioids for a maximum of 6 weeks were significantly more likely to have stopped using opioids by that time, although this effect was lost at 12 weeks.
Prospective studies evaluating the effects of these interventions have been fewer. Hartford et al developed a 4-pronged opioid intervention involving the implementation of patient education, healthcare provider education, intraoperative and postoperative multimodal analgesia with opioid reduction strategies in patients undergoing laparoscopic cholecystectomy or open hernia repair and evaluated their results prospectively. They found no difference in patient reported average postoperative pain scores but improvements in patient reported pain control. They also found a decrease in the number of opioids prescribed by the provider and ultimately filled by the patient.
Sugai et al randomized patients who underwent outpatient aesthetic surgery to preoperative education on how the body responds to pain and the side effects of opioids. Compared with patients who did not receive education in whom 100% filled their opioid prescription, they found that 90% of patients who received education declined a postoperative opioid prescription. Furthermore, patients in the control group had significantly greater postoperative average pain scores and a significantly longer duration of pain.
Alter et al performed a prospective randomized controlled trial of patients undergoing carpal tunnel release surgery and found that patients randomized to formal preoperative opioid counseling had reduced postoperative opioid consumption compared with patients without counselling (1.4 vs 4.2 opioid pills).
While preoperative patient education is undoubtedly useful, there is also an opportunity to monitor patients postoperatively and provide real-time feedback and reinforcement about pain management strategies and appropriate opioid use. The investigators have previously assessed real-time postoperative pain and opioid use in patients undergoing thyroid and parathyroid surgery utilizing a novel SMS survey (Chen et al, unpublished data). Overall response rate was >80% and the investigators were able to identify risk factors for patients who had prolonged opioid use, beyond what was expected after thyroid and parathyroid surgery. Although no intervention was performed in this study, it could potentially help identify patients in whom closer follow-up and earlier intervention might be beneficial.
The investigators theorize that real-time feedback and education about appropriate opioid use postoperatively may lead to a reduction in actual opioids consumed by the patient. The investigators propose a prospective randomized controlled trial to evaluate this in patients undergoing elective outpatient surgery.
- Conditions
- Opioid Use, Pain, Postoperative
- Being tested
- SMS education, SMS survey
- Keywords
- SMS, Education, Opioid Use, Pain, postoperative
- Medical subject headings
- Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SMS educationBehavioural
Patients will receive additional educational SMS messages post-operatively
SMS surveyBehavioural
Patients will receive survey questions about post-operative pain and opioid use but no education
| Study group | Role | What they receive |
|---|---|---|
| SMS survey | Placebo comparator | Subject to receive SMS survey. Receives: Behavioral: SMS survey |
| SMS survey with education | Active comparator | Subject to receive SMS survey with education. Receives: Behavioral: SMS education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of opioid pills consumed
Number of opioid pills consumed
Measured: 10 days post-op
Secondary outcomes (1)
Post-operative pain scores
Pain score will be utilizing a numeric pain rating scale (0-10) where 0 corresponds to no pain and 10 to worst pain.
Total pain score will be reported as well as total scaled pain score which is total pain score divided by response rate.
Measured: 10 days post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2019
- Study start9 Dec 2019
- Primary completion30 Jun 2023
- Study completion30 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cedars-Sinai Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yufei Chen, Cedars-Sinai Medical Center
- Investigators
- Yufei Chen, MD, Principal investigator, Cedars-Sinai Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04039191
- Sponsor's protocol ID
- IIT2019-CHEN-SMS
- Status last verified
- Nov 2023
- First submitted
- 29 Jul 2019
- Last updated
- 2 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Lee WG, Amersi FF, Jain M, Cunneen SA, Burch M, Phillips E, Chen Y. Real-Time Pain Control Education After Outpatient General Surgery: A Randomized Controlled Trial. J Surg Res. 2025 Jan;305:118-125. doi: 10.1016/j.jss.2024.10.053. Epub 2024 Dec 12.
PubMed 39671759
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Messaging Service (SMS) Education for Post-operative Pain
- ClinicalTrials.gov ID
- NCT04039191
- Acronym / sponsor ID
- IIT2019-CHEN-SMS
- Conditions
- Opioid Use, Pain, Postoperative
- Keywords
- SMS, Education, Opioid Use, Pain, postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Cedars-Sinai Medical CenterUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Jul 2023 (actual)
- First posted
- 31 Jul 2019 (actual)
- 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 the research is to assess whether or not postoperative education and awareness about pain and opioid use through SMS text messages will reduce overall opioid utilization after common outpatient surgeries.
Detailed description
1.0 BACKGROUND, RATIONALE Since the turn of the century, opioid prescriptions and opioid-related overdose deaths in the United States has been on the rise, and is seen as the main cause of the consecutive decrease in life expectancy seen in 2015-2016. This epidemic has been declared a Public Health Emergency by the Department of Health and Human Services (HHS), with approximately 115 people dying daily from opioid-related drug overdoses nationwide. Over 40% of these overdoses are associated with prescription opioid abuse.
While non-medical opioid use is seen most commonly in those aged 15-24, accidental opioid overdose rates are highest in the those aged 45-54, an age group in which the medical use of opioids is most common. For many adults, their first medical exposure to opioids is following a surgical procedure. New persistent opioid use has been identified following both minor and major surgical procedures in 5.9% to 6.5% of patients, and was associated with behavioral and pain disorders rather than surgical pain itself. Furthermore, prolonged opioid use beyond 5 days, and even more so when the prescription exceeds 10 days, has been associated with an increased probability of continued long term opioid use.
Better pain management strategies and better research are key strategies the HHS have identified to combat the growing opioid epidemic. Current prescription patterns in the US are highly variable, although initiatives have been put into place to develop evidence based guidelines. Prescription opioid use has previously been linked to improved patient satisfaction with care, and in a study of primary care providers, those physicians who were incentivized by patient satisfaction scores reported an increased impact of these scores on their opioid prescribing practices. However, multiple studies have revealed no correlation between patient satisfaction scores and the amount of postoperative opioids prescribed.
A systematic review of studies describing opioid oversupply after surgery reported that 67-92% of patients reported unused opioids with few storing or disposing of excessive pills in an appropriate manner. Multiple studies have looked at interventions on the provider side, in order to minimize opioid prescriptions and thus minimize the availability of excess opioids that may facilitate opioid dependence and diversion into the community. While there has been an almost universal reduction in opioids prescribed, fewer studies have demonstrated a reduction in actual opioids taken by the patient.
Hill et al identified in 642 patients undergoing 5 common outpatient procedures a wide variation in the number of opioid pills prescribed and identified an ideal number of opioid pills per procedure that would adequate treat postoperative pain in the majority of patients, a number that was typically less than 50% of what was historically prescribed. The same group then presented their findings at their institution and recommended prescribers to encourage patients to use nonopioid analgesics. They found that following this education, there was a significant reduction in number of opioid pills prescribed across all procedures and also a decrease in the mean number of pills taken by patients following inguinal hernia and partial mastectomy with sentinel lymph node biopsy (SLNB) patients.
Howard et al reported a decrease in median amount of opioids prescribed for laparoscopic cholecystectomy from 250mg to 75mg following the development and education of physicians on evidence based prescribing guidelines. This was associated with no increase in the frequency of refill requests and a median postoperative opioid use reduction from 30mg to 20mg without a change in pain score. Similar results were seen in a group of oncology patients undergoing breast and melanoma procedures.
Several studies have also incorporated preoperative patient education about expected postoperative recovery and pain management strategies. However, most of these studies have been retrospectively performed in the context of quality improvement projects, with the comparison of preinterventional and postinterventional cohorts of patients.
Shindo et al in a retrospective cohort study of patients undergoing thyroid and parathyroid surgery reported a significant decrease in the amount of opioids prescribed following an intervention including preoperative patient counselling regarding pain management, the use of multimodality nonopioid pain management and the education of nurses and physicians. Prabhu et al took a shared decision-making approach to opioid prescribing utilizing a tablet computer based decision aid and found that patients who participated chose a 50% decreased in the number of opioids prescribed postoperatively.
Holman et al performed a retrospective cohort study on orthopedic trauma patients and found that patients who were instructed at the time of index procedure that they would receive prescription opioids for a maximum of 6 weeks were significantly more likely to have stopped using opioids by that time, although this effect was lost at 12 weeks.
Prospective studies evaluating the effects of these interventions have been fewer. Hartford et al developed a 4-pronged opioid intervention involving the implementation of patient education, healthcare provider education, intraoperative and postoperative multimodal analgesia with opioid reduction strategies in patients undergoing laparoscopic cholecystectomy or open hernia repair and evaluated their results prospectively. They found no difference in patient reported average postoperative pain scores but improvements in patient reported pain control. They also found a decrease in the number of opioids prescribed by the provider and ultimately filled by the patient.
Sugai et al randomized patients who underwent outpatient aesthetic surgery to preoperative education on how the body responds to pain and the side effects of opioids. Compared with patients who did not receive education in whom 100% filled their opioid prescription, they found that 90% of patients who received education declined a postoperative opioid prescription. Furthermore, patients in the control group had significantly greater postoperative average pain scores and a significantly longer duration of pain.
Alter et al performed a prospective randomized controlled trial of patients undergoing carpal tunnel release surgery and found that patients randomized to formal preoperative opioid counseling had reduced postoperative opioid consumption compared with patients without counselling (1.4 vs 4.2 opioid pills).
While preoperative patient education is undoubtedly useful, there is also an opportunity to monitor patients postoperatively and provide real-time feedback and reinforcement about pain management strategies and appropriate opioid use. The investigators have previously assessed real-time postoperative pain and opioid use in patients undergoing thyroid and parathyroid surgery utilizing a novel SMS survey (Chen et al, unpublished data). Overall response rate was >80% and the investigators were able to identify risk factors for patients who had prolonged opioid use, beyond what was expected after thyroid and parathyroid surgery. Although no intervention was performed in this study, it could potentially help identify patients in whom closer follow-up and earlier intervention might be beneficial.
The investigators theorize that real-time feedback and education about appropriate opioid use postoperatively may lead to a reduction in actual opioids consumed by the patient. The investigators propose a prospective randomized controlled trial to evaluate this in patients undergoing elective outpatient surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SMS survey | Placebo comparator | Behavioral: SMS surveySubject to receive SMS survey. |
| SMS survey with education | Active comparator | Behavioral: SMS educationSubject to receive SMS survey with education. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients aged ≥18 who are undergoing outpatient surgery (admission <23hrs) where opioids are typically prescribed
Key exclusion criteria (3 listed)
- Non-English speaking patients.
- No access to cellphone.
- Admission beyond 24 hours.
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 |
|---|---|---|
| SMS educationPatients will receive additional educational SMS messages post-operatively | Behavioural | SMS survey with education |
| SMS surveyPatients will receive survey questions about post-operative pain and opioid use but no education | Behavioural | SMS survey |
Primary outcome
Number of opioid pills consumed
Time frame: 10 days post-op
Number of opioid pills consumed
1 secondary outcome
Post-operative pain scores
Time frame: 10 days post-op
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 2 Nov 2023.
- Derived from this study: PubMed 39671759Lee WG, Amersi FF, Jain M, Cunneen SA, Burch M, Phillips E, Chen Y. Real-Time Pain Control Education After Outpatient General Surgery: A Randomized Controlled Trial. J Surg Res. 2025 Jan;305:118-125. doi: 10.1016/j.jss.2024.10.053. Epub 2024 Dec 12.
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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.
Yufei Chen, MD principal investigator
Cedars-Sinai 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 SMS education and SMS survey in people with Opioid Use and Pain, Postoperative, run by Cedars-Sinai 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 1 inclusion and 3 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 2 Nov 2023. 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?
Number of opioid pills consumed (time frame: 10 days post-op). 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 NCT04039191, which also lists 1 linked publication.
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 2 Nov 2023.