Opioid UseEQUIPPEDNCT05221866
Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
A study testing Empowering Patient to Steer Their Pain Management After Surgery and Provider-facing Prescription Aid in people with Opioid Use and Opioid Dependence, run by University of Nebraska at 1 site in United States.
Trial summary
Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. Read more about this study
- Who is it for?
- Ages 19 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use, Opioid Dependence, Opioid Misuse
- What is being tested?
- Empowering Patient to Steer Their Pain Management After Surgery and Provider-facing Prescription Aid
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 711 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 10 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 19-89 years old
- Access to a smartphone (iOS or Android)
- Inpatient surgery requiring at least over-night hospitalization and anticipated discharge to home
Who cannot join
- Re-hospitalization within 30 days
- Pregnant
- Unable to read the English language
- Discharge to a post-acute care facility
- Contraindications to opioids, acetaminophen, or NSAIDs
- Long-term opioid therapy (AHRQ definition - opioid use on most days >3 months) prior to surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Nebraska Medical Center
Omaha, Nebraska, 68198
About this study
Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. The proposed study seeks to test a provider-facing decision support tool and a participant-facing smartphone app to reduce the amount of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery. Adult participants with smart phones having had inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home will be randomized to one of the two groups. Study measurements will include self-reported cumulative amounts of opioids taken after discharge, non-opioid analgesic taken, prescribed post-discharge opioid doses in morphine milligram equivalents (MME), pain intensity and pain interference scores (PROMIS), need for additional opioid prescriptions within one-month post-discharge, as well as any self-reported disposal of leftover medications.
Read the detailed description
Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, participants will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components). Randomization will be implemented via REDCap by the study coordinators. Further, information on which type of app was installed will not be shared with providers or participants.
During the second half of the trial, a provider-facing electronic decision support tool will be activated. This will create a 2:2 design to test the provider-facing tool. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.
- Being tested
- Empowering Patient to Steer Their Pain Management After Surgery, Provider-facing Prescription Aid
- Medical subject headings
- Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowering Patient to Steer Their Pain Management After SurgeryBehavioural
Participants will be randomized to receive the consumer health informatics app (UControlPain) versus an app with only data collection function (no educational components) in an intent-to-treat design. Randomization will be implemented via REDCap by the study coordinators so that all investigators will remain blind to group assignment. Further, information on which type of app was installed will not be shared with providers or participants.
Provider-facing Prescription AidBehavioural
Providers will be given information to inform a participant-centered post-discharge pain management plan. This tool will be activated once half the subjects are enrolled. Participants will be masked when the provider-facing tool is turned on.
| Study group | Role | What they receive |
|---|---|---|
| UControlPain App With Only Data Collection Function (Control) | No intervention | UControlPain App with only data collection function. No provider-facing prescription intervention. |
| UControlPain Educational App Only | Active comparator | UControlPain app with education components. No provider-facing prescription intervention. Receives: Behavioral: Empowering Patient to Steer Their Pain Management After Surgery |
| UControlPain App and Provider Facing Tool | Active comparator | UControlPain app with education components and provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated. Receives: Behavioral: Empowering Patient to Steer Their Pain Management After Surgery; Behavioral: Provider-facing Prescription Aid |
| Provider Facing Tool Only | Active comparator | UControlPain App with only data collection function. Provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated. Receives: Behavioral: Provider-facing Prescription Aid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative Weekly Opioid Intake After Discharge
Opioids reported as taken will be recorded by type of opioid, units, and total amount taken within the first 28 days after hospital discharge. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).
Measured: Baseline (discharge), weekly for four weeks
Secondary outcomes (5)
Pain Assessment-Pain Intensity
The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to measure pain intensity, with higher scores indicating more intense pain. The PROMIS was assessed four times after discharge, once per week for 28 days, and averaged. On the PROMIS 4-item scale pain intensity scores, higher scores indicate higher pain intensity. All PROMIS scores are analyzed as standardized T-scores [mean=50, standard deviation (SD) =10].
Measured: Weekly for four weeks after discharge
Pain Assessment-Pain Interference
The Patient-Reported Outcomes Measurement Information System (PROMIS) was used to measure pain interference, with higher scores indicating more intense pain. The PROMIS was assessed four times after discharge, once per week for 28 days, and averaged. On the PROMIS 4-item scale pain interference scores, higher scores indicate higher pain interference. All PROMIS scores are analyzed as standardized T-scores [mean=50, standard deviation (SD) =10].
Measured: Weekly for four weeks after discharge
Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge
Opioids prescribed on the day of discharge will be recorded by type of opioid, unit dispensed, and total amount dispensed. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).
Measured: Baseline (discharge)
Number of Participants With Opioids Prescribed From "Day of Discharge + 1" Until 28 Days After Discharge
Discovered by medical record review. This measure will account for opioids prescribed to patients because they run out prematurely. We will calculate opioid prescriptions from "day of discharge +1" until 28 days after discharge.
Measured: Baseline (discharge) +1 day until day 28, up to 27 days total
Number of Participants Who Disposed of Opioids
Number of participants who reported their disposal of any leftover opioids is recorded. This is reported on the weekly surveys done in 28 days post-discharge.
Measured: Baseline (discharge), weekly for four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start2 May 2022
- Primary completion10 Dec 2023
- Study completion10 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (91)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- 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
- Factorial
- Model description
- The participant-facing app will be trialed prior to and after implementation of a provider-facing prescription intervention using a 2x2 design. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 711 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Sponsor
- Investigators
- Karsten Bartels, MD, PhD, MBA, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221866
- Sponsor's protocol ID
- 0724-21-FB
- Acronym
- EQUIPPED
- Status last verified
- Jun 2025
- First submitted
- 26 Oct 2021
- Last updated
- 1 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Guy GP Jr, Zhang K, Bohm MK, Losby J, Lewis B, Young R, Murphy LB, Dowell D. Vital Signs: Changes in Opioid Prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017 Jul 7;66(26):697-704. doi: 10.15585/mmwr.mm6626a4.
PubMed 28683056Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1.
PubMed 30605448Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017 Nov 1;152(11):1066-1071. doi: 10.1001/jamasurg.2017.0831.
PubMed 28768328Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
PubMed 26824844Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
PubMed 28594763Nooromid MJ, Blay E Jr, Holl JL, Bilimoria KY, Johnson JK, Eskandari MK, Stulberg JJ. Discharge prescription patterns of opioid and nonopioid analgesics after common surgical procedures. Pain Rep. 2018 Feb 6;3(1):e637. doi: 10.1097/PR9.0000000000000637. eCollection 2018 Jan.
PubMed 29430565Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
PubMed 27429023Howard R, Waljee J, Brummett C, Englesbe M, Lee J. Reduction in Opioid Prescribing Through Evidence-Based Prescribing Guidelines. JAMA Surg. 2018 Mar 1;153(3):285-287. doi: 10.1001/jamasurg.2017.4436.
PubMed 29214318Khorfan R, Shallcross ML, Yu B, Sanchez N, Parilla S, Coughlin JM, Johnson JK, Bilimoria KY, Stulberg JJ. Preoperative patient education and patient preparedness are associated with less postoperative use of opioids. Surgery. 2020 May;167(5):852-858. doi: 10.1016/j.surg.2020.01.002. Epub 2020 Feb 20.
PubMed 32087946Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
PubMed 28594762Frieden TR, Houry D. Reducing the Risks of Relief--The CDC Opioid-Prescribing Guideline. N Engl J Med. 2016 Apr 21;374(16):1501-4. doi: 10.1056/NEJMp1515917. Epub 2016 Mar 15. No abstract available.
PubMed 26977701Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
PubMed 22786464Heyward J, Olson L, Sharfstein JM, Stuart EA, Lurie P, Alexander GC. Evaluation of the Extended-Release/Long-Acting Opioid Prescribing Risk Evaluation and Mitigation Strategy Program by the US Food and Drug Administration: A Review. JAMA Intern Med. 2020 Feb 1;180(2):301-309. doi: 10.1001/jamainternmed.2019.5459.
PubMed 31886822Chen EY, Marcantonio A, Tornetta P 3rd. Correlation Between 24-Hour Predischarge Opioid Use and Amount of Opioids Prescribed at Hospital Discharge. JAMA Surg. 2018 Feb 21;153(2):e174859. doi: 10.1001/jamasurg.2017.4859. Epub 2018 Feb 21.
PubMed 29238810Carrico JA, Mahoney K, Raymond KM, McWilliams SK, Mayes LM, Mikulich-Gilbertson SK, Bartels K. Predicting Opioid Use Following Discharge After Cesarean Delivery. Ann Fam Med. 2020 Mar;18(2):118-126. doi: 10.1370/afm.2493.
PubMed 32152015
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency And Quality In Post-Surgical Pain Therapy After Discharge
- ClinicalTrials.gov ID
- NCT05221866
- Acronym / sponsor ID
- EQUIPPED / 0724-21-FB
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 711 participants (actual)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- 2 May 2022 (actual)
- Primary completion
- 10 Dec 2023 (actual)
- Study completion
- 10 Dec 2023 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Posted 1 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following inpatient surgery, more than 80% of patients are prescribed opioids for use after discharge, yet up to 90% of patients report leftover opioids, and only 16% maximize non-opioid therapy. The proposed study seeks to test a provider-facing decision support tool and a participant-facing smartphone app to reduce the amount of opioids prescribed and taken following discharge, while ensuring effective treatment of pain after surgery. Adult participants with smart phones having had inpatient surgery requiring at least over-night hospitalization with anticipated discharge to home will be randomized to one of the two groups. Study measurements will include self-reported cumulative amounts of opioids taken after discharge, non-opioid analgesic taken, prescribed post-discharge opioid doses in morphine milligram equivalents (MME), pain intensity and pain interference scores (PROMIS), need for additional opioid prescriptions within one-month post-discharge, as well as any self-reported disposal of leftover medications.
Detailed description
Prior to discharge from the hospital, patients will be approached regarding interest in the study with an introductory letter that describes the content and purpose of the study. Following informed consent, participants will be randomized to receive the consumer health informatics app (UControlPain) versus provision of an app with only data collection function (no educational components). Randomization will be implemented via REDCap by the study coordinators. Further, information on which type of app was installed will not be shared with providers or participants.
During the second half of the trial, a provider-facing electronic decision support tool will be activated. This will create a 2:2 design to test the provider-facing tool. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (investigator)
- Number of arms
- 4
- Model description
- The participant-facing app will be trialed prior to and after implementation of a provider-facing prescription intervention using a 2x2 design. Four arms will be described: the UControlPain App with Only data collection, the UControlPain Educational app only, the UControlPain App and provider-facing tool, and the UControlPain App with only data collection function and provider-facing tool. Once half of the subjects are enrolled, the provider-facing tool will be turned on.
| Arm | Type | Receives |
|---|---|---|
| UControlPain App With Only Data Collection Function (Control) | No intervention | –UControlPain App with only data collection function. No provider-facing prescription intervention. |
| UControlPain Educational App Only | Active comparator | Behavioral: Empowering Patient to Steer Their Pain Management After SurgeryUControlPain app with education components. No provider-facing prescription intervention. |
| UControlPain App and Provider Facing Tool | Active comparator | Behavioral: Empowering Patient to Steer Their Pain Management After Surgery, Behavioral: Provider-facing Prescription AidUControlPain app with education components and provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated. |
| Provider Facing Tool Only | Active comparator | Behavioral: Provider-facing Prescription AidUControlPain App with only data collection function. Provider-facing prescription intervention. Once half of the subjects are enrolled, the provider-facing tool will be turned on. Participants will be masked to when the provider-facing tool is activated. |
Who may qualify
- Ages
- 19 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 19-89 years old
- Access to a smartphone (iOS or Android)
- Inpatient surgery requiring at least over-night hospitalization and anticipated discharge to home
Key exclusion criteria (6 listed)
- Re-hospitalization within 30 days
- Pregnant
- Unable to read the English language
- Discharge to a post-acute care facility
- Contraindications to opioids, acetaminophen, or NSAIDs
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 |
|---|---|---|
| Empowering Patient to Steer Their Pain Management After SurgeryParticipants will be randomized to receive the consumer health informatics app (UControlPain) versus an app with only data collection function (no educational components) in an intent-to-treat design. Randomization will be implemented via REDCap by the study coordinators so that all investigators will remain blind to group assignment. Further, information on which type of app was installed will not be shared with providers or participants. | Behavioural | UControlPain App and Provider Facing Tool, UControlPain Educational App Only |
| Provider-facing Prescription AidProviders will be given information to inform a participant-centered post-discharge pain management plan. This tool will be activated once half the subjects are enrolled. Participants will be masked when the provider-facing tool is turned on. | Behavioural | Provider Facing Tool Only, UControlPain App and Provider Facing Tool |
Primary outcome
Cumulative Weekly Opioid Intake After Discharge
Time frame: Baseline (discharge), weekly for four weeks
Opioids reported as taken will be recorded by type of opioid, units, and total amount taken within the first 28 days after hospital discharge. To account for different opioid potencies, the cumulative dose of opioids will be expressed in milligram morphine equivalents (MME).
5 secondary outcomes
Pain Assessment-Pain Intensity
Time frame: Weekly for four weeks after discharge
Pain Assessment-Pain Interference
Time frame: Weekly for four weeks after discharge
Opioid Prescription Amount in Morphine Milligram Equivalents on Day of Discharge
Time frame: Baseline (discharge)
Number of Participants With Opioids Prescribed From "Day of Discharge + 1" Until 28 Days After Discharge
Time frame: Baseline (discharge) +1 day until day 28, up to 27 days total
Number of Participants Who Disposed of Opioids
Time frame: Baseline (discharge), weekly for four weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28683056Guy GP Jr, Zhang K, Bohm MK, Losby J, Lewis B, Young R, Murphy LB, Dowell D. Vital Signs: Changes in Opioid Prescribing in the United States, 2006-2015. MMWR Morb Mortal Wkly Rep. 2017 Jul 7;66(26):697-704. doi: 10.15585/mmwr.mm6626a4.
- Background: PubMed 30605448Scholl L, Seth P, Kariisa M, Wilson N, Baldwin G. Drug and Opioid-Involved Overdose Deaths - United States, 2013-2017. MMWR Morb Mortal Wkly Rep. 2018 Jan 4;67(5152):1419-1427. doi: 10.15585/mmwr.mm675152e1.
- Background: PubMed 28768328Bicket MC, Long JJ, Pronovost PJ, Alexander GC, Wu CL. Prescription Opioid Analgesics Commonly Unused After Surgery: A Systematic Review. JAMA Surg. 2017 Nov 1;152(11):1066-1071. doi: 10.1001/jamasurg.2017.0831.
- Background: PubMed 26824844Bartels K, Mayes LM, Dingmann C, Bullard KJ, Hopfer CJ, Binswanger IA. Opioid Use and Storage Patterns by Patients after Hospital Discharge following Surgery. PLoS One. 2016 Jan 29;11(1):e0147972. doi: 10.1371/journal.pone.0147972. eCollection 2016.
- Background: PubMed 28594763Bateman BT, Cole NM, Maeda A, Burns SM, Houle TT, Huybrechts KF, Clancy CR, Hopp SB, Ecker JL, Ende H, Grewe K, Raposo Corradini B, Schoenfeld RE, Sankar K, Day LJ, Harris L, Booth JL, Flood P, Bauer ME, Tsen LC, Landau R, Leffert LR. Patterns of Opioid Prescription and Use After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):29-35. doi: 10.1097/AOG.0000000000002093.
- Background: PubMed 29430565Nooromid MJ, Blay E Jr, Holl JL, Bilimoria KY, Johnson JK, Eskandari MK, Stulberg JJ. Discharge prescription patterns of opioid and nonopioid analgesics after common surgical procedures. Pain Rep. 2018 Feb 6;3(1):e637. doi: 10.1097/PR9.0000000000000637. eCollection 2018 Jan.
- Background: PubMed 27429023Waljee JF, Li L, Brummett CM, Englesbe MJ. Iatrogenic Opioid Dependence in the United States: Are Surgeons the Gatekeepers? Ann Surg. 2017 Apr;265(4):728-730. doi: 10.1097/SLA.0000000000001904. No abstract available.
- Background: PubMed 29214318Howard R, Waljee J, Brummett C, Englesbe M, Lee J. Reduction in Opioid Prescribing Through Evidence-Based Prescribing Guidelines. JAMA Surg. 2018 Mar 1;153(3):285-287. doi: 10.1001/jamasurg.2017.4436.
- Background: PubMed 32087946Khorfan R, Shallcross ML, Yu B, Sanchez N, Parilla S, Coughlin JM, Johnson JK, Bilimoria KY, Stulberg JJ. Preoperative patient education and patient preparedness are associated with less postoperative use of opioids. Surgery. 2020 May;167(5):852-858. doi: 10.1016/j.surg.2020.01.002. Epub 2020 Feb 20.
- Background: PubMed 28594762Prabhu M, McQuaid-Hanson E, Hopp S, Burns SM, Leffert LR, Landau R, Lauffenburger JC, Choudhry NK, Kaimal A, Bateman BT. A Shared Decision-Making Intervention to Guide Opioid Prescribing After Cesarean Delivery. Obstet Gynecol. 2017 Jul;130(1):42-46. doi: 10.1097/AOG.0000000000002094.
- Background: PubMed 26977701Frieden TR, Houry D. Reducing the Risks of Relief--The CDC Opioid-Prescribing Guideline. N Engl J Med. 2016 Apr 21;374(16):1501-4. doi: 10.1056/NEJMp1515917. Epub 2016 Mar 15. No abstract available.
- Background: PubMed 22786464Manchikanti L, Helm S 2nd, Fellows B, Janata JW, Pampati V, Grider JS, Boswell MV. Opioid epidemic in the United States. Pain Physician. 2012 Jul;15(3 Suppl):ES9-38.
- Individual participant dataSharing planned: No
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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.
Karsten Bartels, MD, PhD, MBA principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowering Patient to Steer Their Pain Management After Surgery and Provider-facing Prescription Aid in people with Opioid Use and Opioid Dependence, run by University of Nebraska 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 3 inclusion and 6 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 1 Jul 2025. 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. 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?
Yes. Results are posted in the registry (first posted 1 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cumulative Weekly Opioid Intake After Discharge (time frame: Baseline (discharge), weekly for four weeks). 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 NCT05221866, which also lists 91 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 1 Jul 2025.