Pain and Narcotic Usage After Orthopaedic Surgery
Condition: Fractures, Closed; Pain, Postoperative; Pain Catastrophizing; Pain, Acute; Analgesia; Opioid Use; Acceptance and Commitment Therapy; Orthopedics; Analgesics, Opioid; Text Messaging
MeSH terms: Pain, Postoperative; Acute Pain; Fractures, Closed
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Acceptance and Commitment Therapy Delivered via an Automated Mobile Messaging Robot
Intervention type(s): Behavioral
Intervention description(s): 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two study groups. The intervention group and the control group that does not receive the intervention.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Opioid Pain Medication; PROMIS