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Completed

NCT Number: NCT03991546

Pain and Narcotic Usage After Orthopaedic Surgery

This study aims to 1) observe the course of pain, 2) utilization of opioid pain medication, and 3) possible effect of a behavioral intervention delivered via an automated mobile phone messaging robot in patients undergoing surgical treatment of a traumatic orthopaedic injury.

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Key information

Conditions

Fractures, Closed Acceptance and Commitment Therapy Acute Pain Agnosia Analgesia Analgesics, Opioid Fractures, Bone Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid Use Orthopedics Pain Pain Catastrophizing Pain, Acute Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Text Messaging Wounds and Injuries

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

About this study

Adult patients presenting to a University Hospital Level 1 trauma center indicated for operative fixation of a traumatic upper or lower fracture were considered for the study. A partial Health Insurance Portability and Accountability Act waiver was granted for this investigation to allow research team members to review potential subject's medical record for any condition meeting exclusion criteria. Eligible patients consenting to the study will be assigned a unique study identification number (ID). A master database linking patient ID to patient name and medical record number will be housed on a password protected and encrypted departmental server location, which only research personnel can access.

Participants will complete a basic demographics survey and preoperative/baseline patient reported outcome surveys at enrollment, including the Patient-reported outcomes measurement information system (PROMIS) Pain Intensity 1A short form, PROMIS Pain Intensity 3A short form, PROMIS Pain Interference 8A short form, and PROMIS 8A Emotional Distress-Anxiety 8A short forms. Following completion of these surveys, subjects will be randomized in a 1:1 ratio using a random number generator into one of two study groups. The intervention group will receive mobile messages communicating the behavior intervention following surgery. The control group will not receive the intervention. Subjects will not be blinded to their study group. Participants randomized to the intervention group were subsequently enrolled into the automated mobile messaging protocol and received a confirmation message welcoming them to the study, which was reviewed with them by the research assistant. Subjects were instructed that they were only required to read all messages, no responses were required. No other aspects of patient care including surgical approaches, medications prescribed, or postoperative instructions differ between groups.

After completion of enrollment and assignment of study group, each participant's medical record will be reviewed to obtain the following data that will be recorded in the research study database: Age, Sex, BMI, Medical Comorbidities, Psychological Comorbidities, Substance Abuse History, and presence of preoperative outpatient opioid pain medication utilization.

Subjects in the intervention group will being receiving the mobile messaging intervention the day following surgery. The mobile messaging intervention consists of twice per day mobile messages, morning and evening, starting on postoperative day one and ending on postoperative day 14. Messages communicated to study participants employ the principles of Acceptance and Commitment therapy, otherwise known as ACT, which has been used in the treatment of chronic pain. Prior to discharge, patients will be seen by a research team member to review the opioid pain medication they are prescribed at discharge and instructed to have their pill bottle available to them to provide a pill count at follow-up.

A single instance of follow-up will take place on postoperative day 14. This will occur either in clinic or over the phone with a research team member. At this time, participants will be asked how many tablets of their opioid pain medication they consumed since discharge and to confirm with the amount tablets remaining. Additionally, subjects will fill out a second set of the patient reported outcome surveys completed at enrollment. Collection of these follow-up items marks the end of the subject's participation in the study. No data collection planned following the two week study period.

The study hypothesis is that subjects receiving the behavior intervention delivered via an automated mobile messaging robot would report consuming less opioid pain medication during the study period, and demonstrate better patient reported outcome survey scores than controls at follow-up.

An initial pilot cohort was recruited in order to obtain the data to run the power analysis that determined the population size for the randomized portion of the study. The preliminary study recorded the amount of opioid medication tablets utilized by these patients over a two-week postoperative period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Must have their own personal phone capable of sending and receiving text messages
  • Must be familiar with sending and receiving text messages
  • Must have a traumatic upper or lower extremity fracture
  • Must be indicated for primary operative fixation of their orthopaedic injury

Exclusion criteria

  • Any open orthopaedic injuries
  • Current or previous infection at the injury site
  • Cause of injury is self inflicted non-accidental trauma
  • Active diagnosis of a pain syndrome or chronic condition requiring long-term pain medication usage
  • Indication for fracture temporization using external fixation.
  • Indication for revision surgery for non-union or hardware failure
  • Bilateral upper extremity injuries impeding patient's ability to use a mobile phone
  • Orthopaedic injuries limited to the distal hand and/or foot
  • Preoperative admission to an intensive care unit (ICU)
  • Active cancer diagnosis or history of malignancy receiving treatment within the last 5 years
  • Presence of altered mental status, intellectual disability, or dementia, which impedes a patient from ethically providing consent.
  • Indication for primary arthroplasty treatment of the traumatic injury

Treatment and study plan

Acceptance and Commitment Therapy Delivered via an Automated Mobile Messaging Robot

Behavioral

Mobile messages utilizing the principles of Acceptance and Commitment therapy. These messages were developed in collaboration with a pain psychologist who specializes in treating chronic pain with Acceptance and Commitment therapy. Subjects received twice-daily messages for two weeks following their orthopaedic procedure.

Primary outcomes

  1. Number of opioid pain medication tablets consumed

    Time frame: Measurement of outcome obtained on postoperative day fourteen.

    Amount of outpatient opioid pain medication consumed by participating subjects during the study period. Recorded as tablets consumed allowing for the calculation of morphine milliequivalents. Collected via a pill count in clinic or over the phone.

  2. Change in reported pain intensity score (PROMIS Pain Intensity 1A)

    Time frame: Measurements assessed in person via the standardized forms listed above on the day of surgery (enrollment) and on postoperative day fourteen, in clinic or via telephone.

    Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 1A short form scores collected from all participating subjects.

    PROMIS Pain Intensity 1A short form is a 1 question survey measuring an individual's average pain over the past 7 days. It utilizes a scale of 0 (no pain) to 10 (worst imaginable pain). Higher values represent worse pain outcomes.

    More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net.

  3. Change in reported pain intensity score (PROMIS Pain Intensity 3A)

    Time frame: Measurements assessed in person via the standardized forms listed above on the day of surgery (enrollment) and on postoperative day fourteen, in clinic or via telephone.

    Patient-reported outcomes measurement information system Pain Intensity (PROMIS) 3A short form scores collected from all participating subjects.

    PROMIS Pain Intensity 3A short form is a 3 question survey measuring an individual's pain over the past 7 days. It utilizes a scale of 1 (no pain) to 5 (very severe pain) for all questions. The scores for the 3 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 30.7 to 71.8 for the PROMIS Pain Intensity 3A instrument. Higher t-score values represent worse pain outcomes.

    More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net.

  4. Change in reported pain interference score

    Time frame: Measurements assessed in person via the standardized forms listed above on the day of surgery (enrollment) and on postoperative day fourteen, in clinic or via telephone.

    Patient-reported outcomes measurement information system (PROMIS) Pain Interference 8A short form scores collected from all participating subjects.

    The PROMIS Pain Interference 8A short form is an 8 question survey that measures how much pain has interfered in the respondent's life over the past 7 days. It utilizes a scale of 1 (not at all) to 5 (very much) for all questions. The scores for all 8 questions are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 40.7 to 77.0 for the PROMIS Pain Interference 8A instrument. Higher t-score values represent worse pain interference outcomes.

    More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net.

  5. Change in reported emotional distress (anxiety) score.

    Time frame: Measurements assessed in person via the standardized forms listed above on the day of surgery (enrollment) and on postoperative day fourteen, in clinic or via telephone.

    Patient-reported outcomes measurement information system (PROMIS) Emotional Distress-Anxiety 8A short form scores collected from all participating subjects.

    The PROMIS Emotional Distress-Anxiety 8A short form is an 8 statement survey that measures how much emotional distress, specifically due to anxiety, a respondent has experienced over the past 7 days. It utilizes a scale of 1 (never) to 5 (always) for all the statements. The scores for all 8 statements are summed and then matched to a corresponding t-score for the instrument. The corresponding t-score is the final, reportable score and can range from 37.1 to 83.1 for the PROMIS Emotional Distress-Anxiety 8A instrument. Higher t-score values represent worse anxiety caused emotional distress outcomes.

    More information on this instrument, including a scoring manual, can be found at http://www.healthmeasures.net.

Sponsors and collaborators

Lead sponsor

Christopher Anthony

Other

Collaborators

  • Orthopaedic Trauma Association

Registry information

Official study title

Quantifying Pain and Narcotic Usage Following Orthopedic Surgery Using a Text-Messaging Robot

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Jun 19, 2019
Registry last updated
Sep 4, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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