<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03833648</url>
  </required_header>
  <id_info>
    <org_study_id>18-1118</org_study_id>
    <nct_id>NCT03833648</nct_id>
  </id_info>
  <brief_title>UControlPain App (This is the Official IRB Title)</brief_title>
  <official_title>UControlPain App (This is the Official IRB Title)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Colorado, Denver</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      It is estimated that 77% of all Americans own a smartphone and the use of health apps has&#xD;
      doubled in the last two years. Consistent with this development, over half of US smartphone&#xD;
      owners have downloaded a health-related mobile app. While patient engagement is an integral&#xD;
      and well-established component of in-hospital Early Recovery After Surgery (ERAS) programs&#xD;
      that drive improved perioperative outcomes, efforts to support such engagement are often&#xD;
      limited to a patient's hospital stay. The objective of this aim is to empower patients to&#xD;
      control their use of pain medications after surgery in a safe and effective fashion using a&#xD;
      novel and innovative consumer health informatics app: UControlPain. This app will be&#xD;
      leveraged to integrate three critical components of the study into one application: First,&#xD;
      study recruitment and consent documentation. Second, application of the intervention engaging&#xD;
      patients to take control of their pain management after discharge. Lastly, UControlPain will&#xD;
      collect relevant patient outcomes including pain assessments, functional status, and&#xD;
      quantification of opioid and non-opioid analgesic medication intake. Use of the app will&#xD;
      reduce the amount of opioid medication required, while enhancing patient post-operative pain&#xD;
      control by maximizing non-opioid therapy. Subjects will be able to employ flexible non-opioid&#xD;
      therapy with acetaminophen and NSAIDs whenever possible and safe. The rationale is that&#xD;
      testing of such a provider-prescribed consumer health informatics app (UControlPain) will lay&#xD;
      the groundwork to scale this project towards more secure and efficient pain management&#xD;
      practices after surgery on a systems level and beyond. Upon completion, the expectation is to&#xD;
      have developed an effective consumer health informatics app to help patients better manage&#xD;
      their post-surgical pain at home, reduce reliance on opioids, and improve opioid safety&#xD;
      through enhanced storage and disposal behaviors.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prescription opioid overdose has emerged as a leading cause of death in the general&#xD;
      population. Opioid-based therapy represents a corner-stone of post-operative pain management.&#xD;
      With increasing emphasis on robust pain therapy, sales of opioid medications have increased.&#xD;
      Parallel to this rise, opioid-associated deaths have also increased. Over-prescribed opioids&#xD;
      after surgery can create a reservoir of opioids that become available for non-medical use.&#xD;
      Effective strategies to maximize non-opioid pain therapy and to limit such a reservoir are&#xD;
      lacking. Thus, there is an urgent need to individualize post-operative pain therapy and&#xD;
      reduce reliance on opioids.&#xD;
&#xD;
      Preliminary data indicate that postsurgical patients are prescribed combination preparations&#xD;
      (opioid+acetaminophen) in 96% of cases. Opioid+acetaminophen combination products have&#xD;
      received scrutiny from the FDA for causing liver injury from unintentional overdose when&#xD;
      combined with additional over-the-counter (OTC) acetaminophen. If postoperative patients are&#xD;
      prescribed opioid-only products, they can safely use OTC acetaminophen in addition to NSAIDs,&#xD;
      e.g. ibuprofen, in a highly effective fashion. Such an Alternatives to Opioids (ALTO)-based&#xD;
      approach can reduce the need for opioids while ensuring pain control and limiting&#xD;
      opioid-associated side effects. A barrier to utilizing an ALTO-based approach is lack of&#xD;
      patient knowledge on appropriate use and timing of drugs such as acetaminophen, especially&#xD;
      when used in combination with other analgesics. Internet-based applications have been&#xD;
      successfully used for substance use disorder treatment adherence. Importantly, patient-based&#xD;
      interventions to improve adherence are especially effective in the first six weeks, yielding&#xD;
      up to five-fold improvement in compliance. While consumer health informatics applications&#xD;
      have been successfully tested to improve adherence for anti-depressants and diabetic&#xD;
      medications such an approach has not yet been evaluated for perioperative pain therapy. Data&#xD;
      from an ongoing observational study assessing pain outcomes and patient-reported pain&#xD;
      medication intake after hospital discharge support the assumption that effective combinations&#xD;
      of non-opioid pain medications (ALTO) are underutilized.&#xD;
&#xD;
      The study is using an investigator engineered a functioning prototype of a consumer health&#xD;
      informatics app: UControlPain. This study is a randomized controlled pilot trial of this&#xD;
      consumer health informatics app, to test its effect on pain outcomes, analgesic medication&#xD;
      requirements, and patient functional outcomes. For this study, the UControlPain will be&#xD;
      introduced to hospitalized patients after surgery.&#xD;
&#xD;
      Patients will be approached regarding interest in the study prior to hospital discharge. A&#xD;
      trained member of the research team will explain the study to prospective participants. If&#xD;
      the patient is interested in participation the consent will be reviewed with the patient and&#xD;
      the study team will answer any questions the patient may have. Then the study staff will&#xD;
      assist the patient in downloading the UControlPain app. The study patient will be provided&#xD;
      with a hard copy of the consent/HIPAA form.&#xD;
&#xD;
      Demographics and the best contact information will be collected from those enrolled patients&#xD;
      who indicate they are interested in completing the surveys after their hospital discharge.&#xD;
      Patients will be randomized to one of two conditions: 1) usual care versus 2) provision of&#xD;
      the provider-prescribed education/tool part of the consumer health informatics app&#xD;
      (UControlPain) using a random electronic 1:1 allocation scheme. If indicated and approved by&#xD;
      the provider, opioid-only prescriptions will be written for opioid-based analgesia in both&#xD;
      groups. Final dosing decisions and drug choices will remain at the discretion of the treating&#xD;
      provider and nursing staff administering medications. While hospitalized patients will also&#xD;
      be prompted to do a 6-minute walk test and measure the number of steps taken within 24 hours&#xD;
      (if cleared by Physical Therapy to walk without assistance). These functional assessments&#xD;
      will be performed daily while hospitalized and weekly for 4 weeks after discharge.&#xD;
&#xD;
      One week after hospital discharge interested patients with be contacted and asked to complete&#xD;
      the first of four surveys. All communication will be available in English. Patients will be&#xD;
      paid with a $5 gift card or money order equivalent to complete the study assessments within&#xD;
      the app or with an online link.&#xD;
&#xD;
      UControlPain will provide general education on how to properly use ALTO, e.g.,&#xD;
      over-the-counter medications before using opioids in patients where providers have not&#xD;
      identified contraindications to such medications (e.g. acetaminophen and non-steroidal&#xD;
      anti-inflammatory drugs). Other educational information presented in this part of the app&#xD;
      will include information on safe-storage, signs of overdose, and resources for patients who&#xD;
      are concerned about becoming addicted. The survey part of the study consists of a brief&#xD;
      questionnaire asking about pain management following hospital discharge that will be sent out&#xD;
      weekly x 4 starting one week after hospital discharge.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2019</start_date>
  <completion_date type="Actual">April 20, 2020</completion_date>
  <primary_completion_date type="Actual">April 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Single (Participant)</masking>
    <masking_description>Study participants will not know which version of the app they are instructed to install.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Mean Post-Discharge Opioid Intake at 4 weeks post-discharge (total)</measure>
    <time_frame>Four weeks after hospital discharge, as reported on the surveys completed by the patient.</time_frame>
    <description>Milligram morphine equivalent (MME)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-minute Walk Test - Week 1</measure>
    <time_frame>One week after hospital discharge</time_frame>
    <description>Steps taken in a 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute Walk Test - Week 2</measure>
    <time_frame>Two weeks after hospital discharge</time_frame>
    <description>Steps taken in a 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute Walk Test - Week 3</measure>
    <time_frame>Three weeks after hospital discharge</time_frame>
    <description>Steps taken in a 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute Walk Test - Week 4</measure>
    <time_frame>Four weeks after hospital discharge</time_frame>
    <description>Steps taken in a 6-minute walk test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-Hospital Opioid Milligram Morphine Equivalent (MME)</measure>
    <time_frame>24 hours prior to hospital discharge</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Post-Discharge Opioid Dose</measure>
    <time_frame>At the time of discharge</time_frame>
    <description>Mean oral morphine equivalent (MME) post-discharge opioid dose</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 1</measure>
    <time_frame>One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 2</measure>
    <time_frame>Two weeks after hospital discharge, as reported on the Week 2 survey completed one time by the patient.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 3</measure>
    <time_frame>Three weeks after hospital discharge, as reported on the Week 3 survey completed one time by the patient.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Week 4</measure>
    <time_frame>Four weeks after hospital discharge, as reported on the Week 4 survey completed one time by the patient.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 1</measure>
    <time_frame>One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 2</measure>
    <time_frame>Two weeks after hospital discharge, as reported on the Week 2 survey completed one time by the patient.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 3</measure>
    <time_frame>Three weeks after hospital discharge, as reported on the Week 3 survey completed one time by the patient.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Week 4</measure>
    <time_frame>Four weeks after hospital discharge, as reported on the Week 4 survey completed one time by the patient.</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-opioid pain medications taken</measure>
    <time_frame>One week after hospital discharge, as reported on the Week 1 survey completed one time by the patient.</time_frame>
    <description>Mean doses in milligrams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-opioid pain medications taken</measure>
    <time_frame>Two weeks after hospital discharge, as reported on the Week 2 survey completed by the patient.</time_frame>
    <description>Mean doses in milligrams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-opioid pain medications taken</measure>
    <time_frame>Three weeks after hospital discharge, as reported on the Week 3 survey completed by the patient.</time_frame>
    <description>Mean doses in milligrams</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-opioid pain medications taken</measure>
    <time_frame>Four weeks after hospital discharge, as reported on the Week 4 survey completed by the patient.</time_frame>
    <description>Mean doses in milligrams</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Opioid storage and disposal</measure>
    <time_frame>Hospital discharge until 4 weeks after discharge</time_frame>
    <description>Locked vs. un-locked location</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Opioid Use</condition>
  <arm_group>
    <arm_group_label>Arm 1 - Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 - UControl Pain App with Education</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>UControl Pain App with Education</intervention_name>
    <description>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.</description>
    <arm_group_label>Arm 2 - UControl Pain App with Education</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        We will study up to 120 adult surgical patients, with the aim of having usable data from at&#xD;
        least 90 patients.&#xD;
&#xD;
        Inclusion Criteria: 1) Patients ages 18-89 undergoing inpatient surgery at the University&#xD;
        of Colorado Hospital are eligible. 2) Technical capacity and willingness to use and&#xD;
        download the UControlPain app on their personal cell phone.&#xD;
&#xD;
        Exclusion Criteria: 1) Patients under the age of 18 years, 2) Patients returning to&#xD;
        institutional settings (e.g. prison, jail, mental health facility), 3) Pregnant women, 4)&#xD;
        Decisionally challenged patients, 5) Blind or illiterate patients, and 6) Medical&#xD;
        contraindications to use of opioids, acetaminophen, or NSAIDs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Karsten Bartels, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CU Anschutz Medical Campus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Colorado Hospital</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>28189614</PMID>
  </reference>
  <reference>
    <citation>Krebs 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.</citation>
    <PMID>26537656</PMID>
  </reference>
  <reference>
    <citation>Liu 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.</citation>
    <PMID>28492816</PMID>
  </reference>
  <reference>
    <citation>Centers 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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>22048730</PMID>
  </reference>
  <reference>
    <citation>Volkow 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.</citation>
    <PMID>24758595</PMID>
  </reference>
  <reference>
    <citation>Olsen 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.</citation>
    <PMID>16618466</PMID>
  </reference>
  <reference>
    <citation>Calcaterra 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.</citation>
    <PMID>23294765</PMID>
  </reference>
  <reference>
    <citation>Binswanger 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.</citation>
    <PMID>24189594</PMID>
  </reference>
  <reference>
    <citation>Dart 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.</citation>
    <PMID>25587948</PMID>
  </reference>
  <reference>
    <citation>Bartels 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.</citation>
    <PMID>29627407</PMID>
  </reference>
  <reference>
    <citation>Rodgers 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.</citation>
    <PMID>22410178</PMID>
  </reference>
  <reference>
    <citation>Harris 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.</citation>
    <PMID>23682368</PMID>
  </reference>
  <reference>
    <citation>Food and Drug Adminstration. Department of Health and Human Services. Prescription Products Containing Acetaminophen; Actions To Reduce Liver Injury From Unitentional Overdose. Federal Register. 2011;76(10):2691-2697.</citation>
  </reference>
  <reference>
    <citation>Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD010210. doi: 10.1002/14651858.CD010210.pub2.</citation>
    <PMID>23794268</PMID>
  </reference>
  <reference>
    <citation>Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.</citation>
    <PMID>25936786</PMID>
  </reference>
  <reference>
    <citation>Barozzi N, Tett SE. Perceived barriers to paracetamol (acetaminophen) prescribing, especially following rofecoxib withdrawal from the market. Clin Rheumatol. 2009 May;28(5):509-19. doi: 10.1007/s10067-008-1077-8. Epub 2009 Jan 9.</citation>
    <PMID>19132456</PMID>
  </reference>
  <reference>
    <citation>Campbell AN, Nunes EV, Matthews AG, Stitzer M, Miele GM, Polsky D, Turrigiano E, Walters S, McClure EA, Kyle TL, Wahle A, Van Veldhuisen P, Goldman B, Babcock D, Stabile PQ, Winhusen T, Ghitza UE. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014 Jun;171(6):683-90. doi: 10.1176/appi.ajp.2014.13081055. Erratum In: Am J Psychiatry. 2014 Dec 1;171(12):1338.</citation>
    <PMID>24700332</PMID>
  </reference>
  <reference>
    <citation>Sirey JA, Banerjee S, Marino P, Bruce ML, Halkett A, Turnwald M, Chiang C, Liles B, Artis A, Blow F, Kales HC. Adherence to Depression Treatment in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Nov 1;74(11):1129-1135. doi: 10.1001/jamapsychiatry.2017.3047.</citation>
    <PMID>28973066</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>February 5, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03833648
org study id: 18-1118
nct id: NCT03833648
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Other
masking: Single (Participant)
masking description: Study participants will not know which version of the app they are instructed to install.
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.
description: Milligram morphine equivalent (MME)
measure: 6-minute Walk Test - Week 1
time frame: One week after hospital discharge
description: Steps taken in a 6-minute walk test
measure: 6-minute Walk Test - Week 2
time frame: Two weeks after hospital discharge
description: Steps taken in a 6-minute walk test
measure: 6-minute Walk Test - Week 3
time frame: Three weeks after hospital discharge
description: Steps taken in a 6-minute walk test
measure: 6-minute Walk Test - Week 4
time frame: Four weeks after hospital discharge
description: Steps taken in a 6-minute walk test
measure: In-Hospital Opioid Milligram Morphine Equivalent (MME)
time frame: 24 hours prior to hospital discharge
description: 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.
measure: Mean Post-Discharge Opioid Dose
time frame: At the time of discharge
description: Mean oral morphine equivalent (MME) post-discharge opioid dose
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: 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.
measure: 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.
description: Mean doses in milligrams
measure: Non-opioid pain medications taken
time frame: Two weeks after hospital discharge, as reported on the Week 2 survey completed by the patient.
description: Mean doses in milligrams
measure: Non-opioid pain medications taken
time frame: Three weeks after hospital discharge, as reported on the Week 3 survey completed by the patient.
description: Mean doses in milligrams
measure: Non-opioid pain medications taken
time frame: Four weeks after hospital discharge, as reported on the Week 4 survey completed by the patient.
description: Mean doses in milligrams
measure: Opioid storage and disposal
time frame: Hospital discharge until 4 weeks after discharge
description: Locked vs. un-locked location
arm group label: Arm 1 - Usual Care
arm group type: No Intervention
description: 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 group label: Arm 2 - UControl Pain App with Education
arm group type: Experimental
description: 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.
intervention type: Other
intervention name: UControl Pain App with Education
description: 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.
arm group label: Arm 2 - UControl Pain App with Education
criteria: 
gender: All
minimum age: 18 Years
maximum age: 89 Years
healthy volunteers: No
last name: Karsten Bartels, MD, PhD
role: Principal Investigator
affiliation: CU Anschutz Medical Campus
facility: 
country: United States
citation: 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.
PMID: 28189614
citation: Krebs 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.
PMID: 26537656
citation: Liu 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.
PMID: 28492816
citation: Centers 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.
citation: 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.
citation: 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.
citation: 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.
PMID: 22048730
citation: Volkow 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.
PMID: 24758595
citation: Olsen 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.
PMID: 16618466
citation: Calcaterra 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.
PMID: 23294765
citation: Binswanger 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.
PMID: 24189594
citation: Dart 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.
PMID: 25587948
citation: Bartels 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.
PMID: 29627407
citation: Rodgers 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.
PMID: 22410178
citation: Harris 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.
PMID: 23682368
citation: Food and Drug Adminstration. Department of Health and Human Services. Prescription Products Containing Acetaminophen; Actions To Reduce Liver Injury From Unitentional Overdose. Federal Register. 2011;76(10):2691-2697.
citation: Derry CJ, Derry S, Moore RA. Single dose oral ibuprofen plus paracetamol (acetaminophen) for acute postoperative pain. Cochrane Database Syst Rev. 2013 Jun 24;2013(6):CD010210. doi: 10.1002/14651858.CD010210.pub2.
PMID: 23794268
citation: Valentine AR, Carvalho B, Lazo TA, Riley ET. Scheduled acetaminophen with as-needed opioids compared to as-needed acetaminophen plus opioids for post-cesarean pain management. Int J Obstet Anesth. 2015 Aug;24(3):210-6. doi: 10.1016/j.ijoa.2015.03.006. Epub 2015 Mar 23.
PMID: 25936786
citation: Barozzi N, Tett SE. Perceived barriers to paracetamol (acetaminophen) prescribing, especially following rofecoxib withdrawal from the market. Clin Rheumatol. 2009 May;28(5):509-19. doi: 10.1007/s10067-008-1077-8. Epub 2009 Jan 9.
PMID: 19132456
citation: Campbell AN, Nunes EV, Matthews AG, Stitzer M, Miele GM, Polsky D, Turrigiano E, Walters S, McClure EA, Kyle TL, Wahle A, Van Veldhuisen P, Goldman B, Babcock D, Stabile PQ, Winhusen T, Ghitza UE. Internet-delivered treatment for substance abuse: a multisite randomized controlled trial. Am J Psychiatry. 2014 Jun;171(6):683-90. doi: 10.1176/appi.ajp.2014.13081055. Erratum In: Am J Psychiatry. 2014 Dec 1;171(12):1338.
PMID: 24700332
citation: Sirey JA, Banerjee S, Marino P, Bruce ML, Halkett A, Turnwald M, Chiang C, Liles B, Artis A, Blow F, Kales HC. Adherence to Depression Treatment in Primary Care: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Nov 1;74(11):1129-1135. doi: 10.1001/jamapsychiatry.2017.3047.
PMID: 28973066
responsible party type: Sponsor
sharing ipd: No
ipd description: 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.