Opioid UseNCT03833648
UControlPain App (This is the Official IRB Title)
A study of Opioid Use, run by University of Colorado, Denver at 1 site in United States.
Trial summary
It is estimated that 77% of all Americans own a smartphone and the use of health apps has doubled in the last two years. Consistent with this development, over half of US smartphone owners have downloaded a health-related mobile app. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Opioid Use
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2019to 20 Apr 2020
- 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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
We will study up to 120 adult surgical patients, with the aim of having usable data from at least 90 patients.
Inclusion Criteria: 1) Patients ages 18-89 undergoing inpatient surgery at the University of Colorado Hospital are eligible. 2) Technical capacity and willingness to use and download the UControlPain app on their personal cell phone.
Exclusion Criteria: 1) Patients under the age of 18 years, 2) Patients returning to institutional settings (e.g. prison, jail, mental health facility), 3) Pregnant women, 4) Decisionally challenged patients, 5) Blind or illiterate patients, and 6) Medical contraindications to use of opioids, acetaminophen, or NSAIDs.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Hospital
Aurora, Colorado, 80045
About this study
It is estimated that 77% of all Americans own a smartphone and the use of health apps has doubled in the last two years. Consistent with this development, over half of US smartphone owners have downloaded a health-related mobile app. While patient engagement is an integral and well-established component of in-hospital Early Recovery After Surgery (ERAS) programs that drive improved perioperative outcomes, efforts to support such engagement are often limited to a patient's hospital stay. The objective of this aim is to empower patients to control their use of pain medications after surgery in a safe and effective fashion using a novel and innovative consumer health informatics app: UControlPain. This app will be leveraged to integrate three critical components of the study into one application: First, study recruitment and consent documentation. Second, application of the intervention engaging patients to take control of their pain management after discharge. Lastly, UControlPain will collect relevant patient outcomes including pain assessments, functional status, and quantification of opioid and non-opioid analgesic medication intake. Use of the app will reduce the amount of opioid medication required, while enhancing patient post-operative pain control by maximizing non-opioid therapy. Subjects will be able to employ flexible non-opioid therapy with acetaminophen and NSAIDs whenever possible and safe. The rationale is that testing of such a provider-prescribed consumer health informatics app (UControlPain) will lay the groundwork to scale this project towards more secure and efficient pain management practices after surgery on a systems level and beyond. Upon completion, the expectation is to have developed an effective consumer health informatics app to help patients better manage their post-surgical pain at home, reduce reliance on opioids, and improve opioid safety through enhanced storage and disposal behaviors.
Read the detailed description
Prescription opioid overdose has emerged as a leading cause of death in the general population. Opioid-based therapy represents a corner-stone of post-operative pain management. With increasing emphasis on robust pain therapy, sales of opioid medications have increased. Parallel to this rise, opioid-associated deaths have also increased. Over-prescribed opioids after surgery can create a reservoir of opioids that become available for non-medical use. Effective strategies to maximize non-opioid pain therapy and to limit such a reservoir are lacking. Thus, there is an urgent need to individualize post-operative pain therapy and reduce reliance on opioids.
Preliminary data indicate that postsurgical patients are prescribed combination preparations (opioid+acetaminophen) in 96% of cases. Opioid+acetaminophen combination products have received scrutiny from the FDA for causing liver injury from unintentional overdose when combined with additional over-the-counter (OTC) acetaminophen. If postoperative patients are prescribed opioid-only products, they can safely use OTC acetaminophen in addition to NSAIDs, e.g. ibuprofen, in a highly effective fashion. Such an Alternatives to Opioids (ALTO)-based approach can reduce the need for opioids while ensuring pain control and limiting opioid-associated side effects. A barrier to utilizing an ALTO-based approach is lack of patient knowledge on appropriate use and timing of drugs such as acetaminophen, especially when used in combination with other analgesics. Internet-based applications have been successfully used for substance use disorder treatment adherence. Importantly, patient-based interventions to improve adherence are especially effective in the first six weeks, yielding up to five-fold improvement in compliance. While consumer health informatics applications have been successfully tested to improve adherence for anti-depressants and diabetic medications such an approach has not yet been evaluated for perioperative pain therapy. Data from an ongoing observational study assessing pain outcomes and patient-reported pain medication intake after hospital discharge support the assumption that effective combinations of non-opioid pain medications (ALTO) are underutilized.
The study is using an investigator engineered a functioning prototype of a consumer health informatics app: UControlPain. This study is a randomized controlled pilot trial of this consumer health informatics app, to test its effect on pain outcomes, analgesic medication requirements, and patient functional outcomes. For this study, the UControlPain will be introduced to hospitalized patients after surgery.
Patients will be approached regarding interest in the study prior to hospital discharge. A trained member of the research team will explain the study to prospective participants. If the patient is interested in participation the consent will be reviewed with the patient and the study team will answer any questions the patient may have. Then the study staff will assist the patient in downloading the UControlPain app. The study patient will be provided with a hard copy of the consent/HIPAA form.
Demographics and the best contact information will be collected from those enrolled patients who indicate they are interested in completing the surveys after their hospital discharge. Patients will be randomized to one of two conditions: 1) usual care versus 2) provision of the provider-prescribed education/tool part of the consumer health informatics app (UControlPain) using a random electronic 1:1 allocation scheme. If indicated and approved by the provider, opioid-only prescriptions will be written for opioid-based analgesia in both groups. Final dosing decisions and drug choices will remain at the discretion of the treating provider and nursing staff administering medications. While hospitalized patients will also be prompted to do a 6-minute walk test and measure the number of steps taken within 24 hours (if cleared by Physical Therapy to walk without assistance). These functional assessments will be performed daily while hospitalized and weekly for 4 weeks after discharge.
One week after hospital discharge interested patients with be contacted and asked to complete the first of four surveys. All communication will be available in English. Patients will be paid with a $5 gift card or money order equivalent to complete the study assessments within the app or with an online link.
UControlPain will provide general education on how to properly use ALTO, e.g., over-the-counter medications before using opioids in patients where providers have not identified contraindications to such medications (e.g. acetaminophen and non-steroidal anti-inflammatory drugs). Other educational information presented in this part of the app will include information on safe-storage, signs of overdose, and resources for patients who are concerned about becoming addicted. The survey part of the study consists of a brief questionnaire asking about pain management following hospital discharge that will be sent out weekly x 4 starting one week after hospital discharge.
- Conditions
- Opioid Use
- Being tested
- UControl Pain App with Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UControl Pain App with EducationOther
The intervention will include educational information on pain management, e.g., using acetaminophen and NSAIDs to manage pain, as well as information on addiction and safe storage of medications.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Usual Care | No intervention | No intervention, patients will receive treatment as usual. Patients will download the UControl Pain app on their personal cell phones and will complete the four study surveys via the app or via REDCap. |
| Arm 2 - UControl Pain App with Education | Experimental | Patients will install the UControl Pain app on their personal cell phones. The app will include educational information about pain management, e.g., using acetaminophen and NSAIDs for pain, as well as information on addiction and safe storage of medications. Subjects will also complete the four study surveys via the app or via REDCap. Receives: Other: UControl Pain App with Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Post-Discharge Opioid Intake at 4 weeks post-discharge (total)
Milligram morphine equivalent (MME)
Measured: Four weeks after hospital discharge, as reported on the surveys completed by the patient.
Secondary outcomes (18)
6-minute Walk Test - Week 1
Steps taken in a 6-minute walk test
Measured: One week after hospital discharge
6-minute Walk Test - Week 2
Steps taken in a 6-minute walk test
Measured: Two weeks after hospital discharge
6-minute Walk Test - Week 3
Steps taken in a 6-minute walk test
Measured: Three weeks after hospital discharge
6-minute Walk Test - Week 4
Steps taken in a 6-minute walk test
Measured: Four weeks after hospital discharge
In-Hospital Opioid Milligram Morphine Equivalent (MME)
Total MME of all in-hospital opioid medications prescribed in the 24 hours prior to hospital discharge as recorded in the electronic medical record (EMR) for each patient.
Measured: 24 hours prior to hospital discharge
Mean Post-Discharge Opioid Dose
Mean oral morphine equivalent (MME) post-discharge opioid dose
Measured: At the time of discharge
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 1
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score as reported on the Week 1 study survey. The Scale consists of 8 questions; each question in the Scale has five response options ranging in value from one to five, e.g., Not at all (1), A little bit (2), Somewhat (3), Quite a bit (4), Very much (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40, with a lower score indicating a better outcome/less pain interference. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 2
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score as reported on the Week 2 study survey. The Scale consists of 8 questions; each question in the Scale has five response options ranging in value from one to five, e.g., Not at all (1), A little bit (2), Somewhat (3), Quite a bit (4), Very much (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40, with a lower score indicating a better outcome/less pain interference. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: Two weeks after hospital discharge, as reported on the Week 2 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 3
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score as reported on the Week 3 study survey. The Scale consists of 8 questions; each question in the Scale has five response options ranging in value from one to five, e.g., Not at all (1), A little bit (2), Somewhat (3), Quite a bit (4), Very much (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40, with a lower score indicating a better outcome/less pain interference. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: Three weeks after hospital discharge, as reported on the Week 3 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 4
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Score as reported on the Week 4 study survey. The Scale consists of 8 questions; each question in the Scale has five response options ranging in value from one to five, e.g., Not at all (1), A little bit (2), Somewhat (3), Quite a bit (4), Very much (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 8; the highest possible raw score is 40, with a lower score indicating a better outcome/less pain interference. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: Four weeks after hospital discharge, as reported on the Week 4 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 1
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score as reported on the Week 1 study survey. The Scale consists of 3 questions; each question in the Scale has five response options ranging in value from one to five, e.g., No pain (1), Mild (2), Moderate (3), Severe (4), Very Severe (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15, with a lower score indicating a better outcome/less pain intensity. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 2
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score as reported on the Week 2 study survey. The Scale consists of 3 questions; each question in the Scale has five response options ranging in value from one to five, e.g., No pain (1), Mild (2), Moderate (3), Severe (4), Very Severe (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15, with a lower score indicating a better outcome/less pain intensity. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: Two weeks after hospital discharge, as reported on the Week 2 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 3
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score as reported on the Week 3 study survey. The Scale consists of 3 questions; each question in the Scale has five response options ranging in value from one to five, e.g., No pain (1), Mild (2), Moderate (3), Severe (4), Very Severe (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15, with a lower score indicating a better outcome/less pain intensity. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: Three weeks after hospital discharge, as reported on the Week 3 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 4
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Score as reported on the Week 4 study survey. The Scale consists of 3 questions; each question in the Scale has five response options ranging in value from one to five, e.g., No pain (1), Mild (2), Moderate (3), Severe (4), Very Severe (5). To find the total raw score sum the values of the response to each question. The lowest possible raw score is 3; the highest possible raw score is 15, with a lower score indicating a better outcome/less pain intensity. Raw scores are then translated into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10.
Measured: Four weeks after hospital discharge, as reported on the Week 4 survey completed one time by the patient.
Non-opioid pain medications taken
Mean doses in milligrams
Measured: One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.
Non-opioid pain medications taken
Mean doses in milligrams
Measured: Two weeks after hospital discharge, as reported on the Week 2 survey completed by the patient.
Non-opioid pain medications taken
Mean doses in milligrams
Measured: Three weeks after hospital discharge, as reported on the Week 3 survey completed by the patient.
Non-opioid pain medications taken
Mean doses in milligrams
Measured: Four weeks after hospital discharge, as reported on the Week 4 survey completed by the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2019
- Study start19 Jun 2019
- Primary completion20 Apr 2020
- Study completion20 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)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 Colorado, DenverThe 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to one of two conditions: 1) usual care versus 2) provision of the provider-prescribed education/tool part of the consumer health informatics app (UControlPain) using a random electronic 1:1 allocation scheme.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karsten Bartels, MD, PhD, Principal investigator, CU Anschutz Medical Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03833648
- Sponsor's protocol ID
- 18-1118
- Status last verified
- Sep 2021
- First submitted
- 5 Feb 2019
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared. Aggregate data may be shared with other researchers as required by some journals or as requested by qualified investigators as determined by the study PI. However, the names and any other personal health information that identifies research subjects will always be kept confidential and will not be shared.
Publications
Milani RV, Franklin NC. The Role of Technology in Healthy Living Medicine. Prog Cardiovasc Dis. 2017 Mar-Apr;59(5):487-491. doi: 10.1016/j.pcad.2017.02.001. Epub 2017 Feb 11.
PubMed 28189614Krebs P, Duncan DT. Health App Use Among US Mobile Phone Owners: A National Survey. JMIR Mhealth Uhealth. 2015 Nov 4;3(4):e101. doi: 10.2196/mhealth.4924.
PubMed 26537656Liu VX, Rosas E, Hwang J, Cain E, Foss-Durant A, Clopp M, Huang M, Lee DC, Mustille A, Kipnis P, Parodi S. Enhanced Recovery After Surgery Program Implementation in 2 Surgical Populations in an Integrated Health Care Delivery System. JAMA Surg. 2017 Jul 19;152(7):e171032. doi: 10.1001/jamasurg.2017.1032. Epub 2017 Jul 19.
PubMed 28492816Centers for Disease Control and Prevention. Prescription Drug Overdose: Understanding the Epidemic. http://www.cdc.gov/drugoverdose/data/index.html Accessed last on 09/28/2017.
Centers for Disease Control and Prevention. Leading Causes of Death. http://www.cdc.gov/injury/wisqars/leading_causes_death.html Accessed last on 09/27/2017.
Acute Pain Management: Operative or Medical Procedures and Trauma. Agency for Healthcare Research and Quality (AHCPR). 1992; http://archive.ahrq.gov/clinic/medtep/acute.htm. Accessed 12/11/2014.
Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.
PubMed 22048730Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies--tackling the opioid-overdose epidemic. N Engl J Med. 2014 May 29;370(22):2063-6. doi: 10.1056/NEJMp1402780. Epub 2014 Apr 23. No abstract available.
PubMed 24758595Olsen Y, Daumit GL, Ford DE. Opioid prescriptions by U.S. primary care physicians from 1992 to 2001. J Pain. 2006 Apr;7(4):225-35. doi: 10.1016/j.jpain.2005.11.006.
PubMed 16618466Calcaterra S, Glanz J, Binswanger IA. National trends in pharmaceutical opioid related overdose deaths compared to other substance related overdose deaths: 1999-2009. Drug Alcohol Depend. 2013 Aug 1;131(3):263-70. doi: 10.1016/j.drugalcdep.2012.11.018. Epub 2013 Jan 5.
PubMed 23294765Binswanger IA, Blatchford PJ, Mueller SR, Stern MF. Mortality after prison release: opioid overdose and other causes of death, risk factors, and time trends from 1999 to 2009. Ann Intern Med. 2013 Nov 5;159(9):592-600. doi: 10.7326/0003-4819-159-9-201311050-00005.
PubMed 24189594Dart RC, Surratt HL, Cicero TJ, Parrino MW, Severtson SG, Bucher-Bartelson B, Green JL. Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med. 2015 Jan 15;372(3):241-8. doi: 10.1056/NEJMsa1406143.
PubMed 25587948Bartels K, Fernandez-Bustamante A, McWilliams SK, Hopfer CJ, Mikulich-Gilbertson SK. Long-term opioid use after inpatient surgery - A retrospective cohort study. Drug Alcohol Depend. 2018 Jun 1;187:61-65. doi: 10.1016/j.drugalcdep.2018.02.013. Epub 2018 Mar 27.
PubMed 29627407Rodgers J, Cunningham K, Fitzgerald K, Finnerty E. Opioid consumption following outpatient upper extremity surgery. J Hand Surg Am. 2012 Apr;37(4):645-50. doi: 10.1016/j.jhsa.2012.01.035. Epub 2012 Mar 10.
PubMed 22410178Harris K, Curtis J, Larsen B, Calder S, Duffy K, Bowen G, Hadley M, Tristani-Firouzi P. Opioid pain medication use after dermatologic surgery: a prospective observational study of 212 dermatologic surgery patients. JAMA Dermatol. 2013 Mar;149(3):317-21. doi: 10.1001/jamadermatol.2013.1871.
PubMed 23682368
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UControlPain App (This is the Official IRB Title)
- ClinicalTrials.gov ID
- NCT03833648
- Acronym / sponsor ID
- 18-1118
- Conditions
- Opioid Use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Study start
- 19 Jun 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 20 Apr 2020 (actual)
- First posted
- 7 Feb 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.
It is estimated that 77% of all Americans own a smartphone and the use of health apps has doubled in the last two years. Consistent with this development, over half of US smartphone owners have downloaded a health-related mobile app. While patient engagement is an integral and well-established component of in-hospital Early Recovery After Surgery (ERAS) programs that drive improved perioperative outcomes, efforts to support such engagement are often limited to a patient's hospital stay. The objective of this aim is to empower patients to control their use of pain medications after surgery in a safe and effective fashion using a novel and innovative consumer health informatics app: UControlPain. This app will be leveraged to integrate three critical components of the study into one application: First, study recruitment and consent documentation. Second, application of the intervention engaging patients to take control of their pain management after discharge. Lastly, UControlPain will collect relevant patient outcomes including pain assessments, functional status, and quantification of opioid and non-opioid analgesic medication intake. Use of the app will reduce the amount of opioid medication required, while enhancing patient post-operative pain control by maximizing non-opioid therapy. Subjects will be able to employ flexible non-opioid therapy with acetaminophen and NSAIDs whenever possible and safe. The rationale is that testing of such a provider-prescribed consumer health informatics app (UControlPain) will lay the groundwork to scale this project towards more secure and efficient pain management practices after surgery on a systems level and beyond. Upon completion, the expectation is to have developed an effective consumer health informatics app to help patients better manage their post-surgical pain at home, reduce reliance on opioids, and improve opioid safety through enhanced storage and disposal behaviors.
Detailed description
Prescription opioid overdose has emerged as a leading cause of death in the general population. Opioid-based therapy represents a corner-stone of post-operative pain management. With increasing emphasis on robust pain therapy, sales of opioid medications have increased. Parallel to this rise, opioid-associated deaths have also increased. Over-prescribed opioids after surgery can create a reservoir of opioids that become available for non-medical use. Effective strategies to maximize non-opioid pain therapy and to limit such a reservoir are lacking. Thus, there is an urgent need to individualize post-operative pain therapy and reduce reliance on opioids.
Preliminary data indicate that postsurgical patients are prescribed combination preparations (opioid+acetaminophen) in 96% of cases. Opioid+acetaminophen combination products have received scrutiny from the FDA for causing liver injury from unintentional overdose when combined with additional over-the-counter (OTC) acetaminophen. If postoperative patients are prescribed opioid-only products, they can safely use OTC acetaminophen in addition to NSAIDs, e.g. ibuprofen, in a highly effective fashion. Such an Alternatives to Opioids (ALTO)-based approach can reduce the need for opioids while ensuring pain control and limiting opioid-associated side effects. A barrier to utilizing an ALTO-based approach is lack of patient knowledge on appropriate use and timing of drugs such as acetaminophen, especially when used in combination with other analgesics. Internet-based applications have been successfully used for substance use disorder treatment adherence. Importantly, patient-based interventions to improve adherence are especially effective in the first six weeks, yielding up to five-fold improvement in compliance. While consumer health informatics applications have been successfully tested to improve adherence for anti-depressants and diabetic medications such an approach has not yet been evaluated for perioperative pain therapy. Data from an ongoing observational study assessing pain outcomes and patient-reported pain medication intake after hospital discharge support the assumption that effective combinations of non-opioid pain medications (ALTO) are underutilized.
The study is using an investigator engineered a functioning prototype of a consumer health informatics app: UControlPain. This study is a randomized controlled pilot trial of this consumer health informatics app, to test its effect on pain outcomes, analgesic medication requirements, and patient functional outcomes. For this study, the UControlPain will be introduced to hospitalized patients after surgery.
Patients will be approached regarding interest in the study prior to hospital discharge. A trained member of the research team will explain the study to prospective participants. If the patient is interested in participation the consent will be reviewed with the patient and the study team will answer any questions the patient may have. Then the study staff will assist the patient in downloading the UControlPain app. The study patient will be provided with a hard copy of the consent/HIPAA form.
Demographics and the best contact information will be collected from those enrolled patients who indicate they are interested in completing the surveys after their hospital discharge. Patients will be randomized to one of two conditions: 1) usual care versus 2) provision of the provider-prescribed education/tool part of the consumer health informatics app (UControlPain) using a random electronic 1:1 allocation scheme. If indicated and approved by the provider, opioid-only prescriptions will be written for opioid-based analgesia in both groups. Final dosing decisions and drug choices will remain at the discretion of the treating provider and nursing staff administering medications. While hospitalized patients will also be prompted to do a 6-minute walk test and measure the number of steps taken within 24 hours (if cleared by Physical Therapy to walk without assistance). These functional assessments will be performed daily while hospitalized and weekly for 4 weeks after discharge.
One week after hospital discharge interested patients with be contacted and asked to complete the first of four surveys. All communication will be available in English. Patients will be paid with a $5 gift card or money order equivalent to complete the study assessments within the app or with an online link.
UControlPain will provide general education on how to properly use ALTO, e.g., over-the-counter medications before using opioids in patients where providers have not identified contraindications to such medications (e.g. acetaminophen and non-steroidal anti-inflammatory drugs). Other educational information presented in this part of the app will include information on safe-storage, signs of overdose, and resources for patients who are concerned about becoming addicted. The survey part of the study consists of a brief questionnaire asking about pain management following hospital discharge that will be sent out weekly x 4 starting one week after hospital discharge.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be randomized to one of two conditions: 1) usual care versus 2) provision of the provider-prescribed education/tool part of the consumer health informatics app (UControlPain) using a random electronic 1:1 allocation scheme.
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Usual Care | No intervention | –No intervention, patients will receive treatment as usual. Patients will download the UControl Pain app on their personal cell phones and will complete the four study surveys via the app or via REDCap. |
| Arm 2 - UControl Pain App with Education | Experimental | Other: UControl Pain App with EducationPatients will install the UControl Pain app on their personal cell phones. The app will include educational information about pain management, e.g., using acetaminophen and NSAIDs for pain, as well as information on addiction and safe storage of medications. Subjects will also complete the four study surveys via the app or via REDCap. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| UControl Pain App with EducationThe intervention will include educational information on pain management, e.g., using acetaminophen and NSAIDs to manage pain, as well as information on addiction and safe storage of medications. | Other | Arm 2 - UControl Pain App with Education |
Primary outcome
Mean Post-Discharge Opioid Intake at 4 weeks post-discharge (total)
Time frame: Four weeks after hospital discharge, as reported on the surveys completed by the patient.
Milligram morphine equivalent (MME)
18 secondary outcomes
6-minute Walk Test - Week 1
Time frame: One week after hospital discharge
6-minute Walk Test - Week 2
Time frame: Two weeks after hospital discharge
6-minute Walk Test - Week 3
Time frame: Three weeks after hospital discharge
6-minute Walk Test - Week 4
Time frame: Four weeks after hospital discharge
In-Hospital Opioid Milligram Morphine Equivalent (MME)
Time frame: 24 hours prior to hospital discharge
Mean Post-Discharge Opioid Dose
Time frame: At the time of discharge
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 1
Time frame: One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 2
Time frame: Two weeks after hospital discharge, as reported on the Week 2 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 3
Time frame: Three weeks after hospital discharge, as reported on the Week 3 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 4
Time frame: Four weeks after hospital discharge, as reported on the Week 4 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 1
Time frame: One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 2
Time frame: Two weeks after hospital discharge, as reported on the Week 2 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 3
Time frame: Three weeks after hospital discharge, as reported on the Week 3 survey completed one time by the patient.
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 4
Time frame: Four weeks after hospital discharge, as reported on the Week 4 survey completed one time by the patient.
Non-opioid pain medications taken
Time frame: One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.
Non-opioid pain medications taken
Time frame: Two weeks after hospital discharge, as reported on the Week 2 survey completed by the patient.
Non-opioid pain medications taken
Time frame: Three weeks after hospital discharge, as reported on the Week 3 survey completed by the patient.
Non-opioid pain medications taken
Time frame: Four weeks after hospital discharge, as reported on the Week 4 survey completed by the patient.
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 30 Sep 2021.
- Background: PubMed 28189614Milani RV, Franklin NC. The Role of Technology in Healthy Living Medicine. Prog Cardiovasc Dis. 2017 Mar-Apr;59(5):487-491. doi: 10.1016/j.pcad.2017.02.001. Epub 2017 Feb 11.
- Background: PubMed 26537656Krebs P, Duncan DT. Health App Use Among US Mobile Phone Owners: A National Survey. JMIR Mhealth Uhealth. 2015 Nov 4;3(4):e101. doi: 10.2196/mhealth.4924.
- Background: PubMed 28492816Liu VX, Rosas E, Hwang J, Cain E, Foss-Durant A, Clopp M, Huang M, Lee DC, Mustille A, Kipnis P, Parodi S. Enhanced Recovery After Surgery Program Implementation in 2 Surgical Populations in an Integrated Health Care Delivery System. JAMA Surg. 2017 Jul 19;152(7):e171032. doi: 10.1001/jamasurg.2017.1032. Epub 2017 Jul 19.
- BackgroundCenters for Disease Control and Prevention. Prescription Drug Overdose: Understanding the Epidemic. http://www.cdc.gov/drugoverdose/data/index.html Accessed last on 09/28/2017.
- BackgroundCenters for Disease Control and Prevention. Leading Causes of Death. http://www.cdc.gov/injury/wisqars/leading_causes_death.html Accessed last on 09/27/2017.
- BackgroundAcute Pain Management: Operative or Medical Procedures and Trauma. Agency for Healthcare Research and Quality (AHCPR). 1992; http://archive.ahrq.gov/clinic/medtep/acute.htm. Accessed 12/11/2014.
- Background: PubMed 22048730Centers for Disease Control and Prevention (CDC). Vital signs: overdoses of prescription opioid pain relievers---United States, 1999--2008. MMWR Morb Mortal Wkly Rep. 2011 Nov 4;60(43):1487-92.
- Background: PubMed 24758595Volkow ND, Frieden TR, Hyde PS, Cha SS. Medication-assisted therapies--tackling the opioid-overdose epidemic. N Engl J Med. 2014 May 29;370(22):2063-6. doi: 10.1056/NEJMp1402780. Epub 2014 Apr 23. No abstract available.
- Background: PubMed 16618466Olsen Y, Daumit GL, Ford DE. Opioid prescriptions by U.S. primary care physicians from 1992 to 2001. J Pain. 2006 Apr;7(4):225-35. doi: 10.1016/j.jpain.2005.11.006.
- Background: PubMed 23294765Calcaterra S, Glanz J, Binswanger IA. National trends in pharmaceutical opioid related overdose deaths compared to other substance related overdose deaths: 1999-2009. Drug Alcohol Depend. 2013 Aug 1;131(3):263-70. doi: 10.1016/j.drugalcdep.2012.11.018. Epub 2013 Jan 5.
- Background: PubMed 24189594Binswanger IA, Blatchford PJ, Mueller SR, Stern MF. Mortality after prison release: opioid overdose and other causes of death, risk factors, and time trends from 1999 to 2009. Ann Intern Med. 2013 Nov 5;159(9):592-600. doi: 10.7326/0003-4819-159-9-201311050-00005.
- Background: PubMed 25587948Dart RC, Surratt HL, Cicero TJ, Parrino MW, Severtson SG, Bucher-Bartelson B, Green JL. Trends in opioid analgesic abuse and mortality in the United States. N Engl J Med. 2015 Jan 15;372(3):241-8. doi: 10.1056/NEJMsa1406143.
- Individual participant dataSharing planned: No. No individual participant data will be shared. Aggregate data may be shared with other researchers as required by some journals or as requested by qualified investigators as determined by the study PI. However, the names and any other personal health information that identifies research subjects will always be kept confidential and will not be shared.
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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 principal investigator
CU Anschutz Medical Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Opioid Use, run by University of Colorado, Denver 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?
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 30 Sep 2021. 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?
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?
Mean Post-Discharge Opioid Intake at 4 weeks post-discharge (total) (time frame: Four weeks after hospital discharge, as reported on the surveys completed by the patient.). 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 NCT03833648, which also lists 21 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 30 Sep 2021.