Clinical trial NCT03991546: Pain and Narcotic Usage After Orthopaedic Surgery
Official title: Quantifying Pain and Narcotic Usage Following Orthopedic Surgery Using a Text-Messaging Robot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fractures, Closed
Pain, Postoperative
Pain Catastrophizing
Pain, Acute
Analgesia
Opioid Use
Acceptance and Commitment Therapy
Orthopedics
Analgesics, Opioid
Text Messaging
Keywords: Opioid Pain Medication
PROMIS
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Orthopaedic Trauma Association
First posted: 2019-06-19
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study groups. The intervention group and the control group that does not receive the intervention.
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of opioid pain medication tablets consumed
timeFrame: Measurement of outcome obtained on postoperative day fourteen.
measure: Change in reported pain intensity score (PROMIS Pain Intensity 1A)
timeFrame: 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.
measure: Change in reported pain intensity score (PROMIS Pain Intensity 3A)
timeFrame: 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.
measure: Change in reported pain interference score
timeFrame: 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.
measure: Change in reported emotional distress (anxiety) score.
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
Study officials:
affiliation: University of Iowa
name: Christopher A Anthony, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jones J Jr, Southerland W, Catalani B. The Importance of Optimizing Acute Pain in the Orthopedic Trauma Patient. Orthop Clin North Am. 2017 Oct;48(4):445-465. doi: 10.1016/j.ocl.2017.06.003.
citation: Hughes LS, Clark J, Colclough JA, Dale E, McMillan D. Acceptance and Commitment Therapy (ACT) for Chronic Pain: A Systematic Review and Meta-Analyses. Clin J Pain. 2017 Jun;33(6):552-568. doi: 10.1097/AJP.0000000000000425.
citation: Nicholls JL, Azam MA, Burns LC, Englesakis M, Sutherland AM, Weinrib AZ, Katz J, Clarke H. Psychological treatments for the management of postsurgical pain: a systematic review of randomized controlled trials. Patient Relat Outcome Meas. 2018 Jan 19;9:49-64. doi: 10.2147/PROM.S121251. eCollection 2018.
citation: Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.
citation: Dindo L, Zimmerman MB, Hadlandsmyth K, StMarie B, Embree J, Marchman J, Tripp-Reimer T, Rakel B. Acceptance and Commitment Therapy for Prevention of Chronic Postsurgical Pain and Opioid Use in At-Risk Veterans: A Pilot Randomized Controlled Study. J Pain. 2018 Oct;19(10):1211-1221. doi: 10.1016/j.jpain.2018.04.016. Epub 2018 May 17.
citation: Rathbone AL, Prescott J. The Use of Mobile Apps and SMS Messaging as Physical and Mental Health Interventions: Systematic Review. J Med Internet Res. 2017 Aug 24;19(8):e295. doi: 10.2196/jmir.7740.
citation: Tofte JN, Anthony CA, Polgreen PM, Buckwalter JA, Caldwell LS, Fowler TP, Ebinger T, Hanley JM, Dowdle SB, Holte AJ, Arpey NC, Lawler EA. Postoperative care via smartphone following carpal tunnel release. J Telemed Telecare. 2020 May;26(4):223-231. doi: 10.1177/1357633X18807606. Epub 2018 Nov 14.
citation: Anthony CA, Volkmar AJ, Shah AS, Willey M, Karam M, Marsh JL. Communication with Orthopedic Trauma Patients via an Automated Mobile Phone Messaging Robot. Telemed J E Health. 2018 Jul;24(7):504-509. doi: 10.1089/tmj.2017.0188. Epub 2017 Dec 20.
citation: Anthony CA, Lawler EA, Glass NA, McDonald K, Shah AS. Delivery of Patient-Reported Outcome Instruments by Automated Mobile Phone Text Messaging. Hand (N Y). 2017 Nov;12(6):614-621. doi: 10.1177/1558944716672201. Epub 2016 Oct 6.
citation: Day MA, Anthony CA, Bedard NA, Glass NA, Clark CR, Callaghan JJ, Noiseux NO. Increasing Perioperative Communication With Automated Mobile Phone Messaging in Total Joint Arthroplasty. J Arthroplasty. 2018 Jan;33(1):19-24. doi: 10.1016/j.arth.2017.08.046. Epub 2017 Sep 19.
citation: Anthony CA, Lawler EA, Ward CM, Lin IC, Shah AS. Use of an Automated Mobile Phone Messaging Robot in Postoperative Patient Monitoring. Telemed J E Health. 2018 Jan;24(1):61-66. doi: 10.1089/tmj.2017.0055. Epub 2017 Jun 16.
citation: Anthony CA, Polgreen LA, Chounramany J, Foster ED, Goerdt CJ, Miller ML, Suneja M, Segre AM, Carter BL, Polgreen PM. Outpatient blood pressure monitoring using bi-directional text messaging. J Am Soc Hypertens. 2015 May;9(5):375-81. doi: 10.1016/j.jash.2015.01.008. Epub 2015 Jan 21.
citation: Anthony CA, Peterson AR. Utilization of a text-messaging robot to assess intraday variation in concussion symptom severity scores. Clin J Sport Med. 2015 Mar;25(2):149-52. doi: 10.1097/JSM.0000000000000115.
citation: Anthony CA, Rojas EO, Keffala V, Glass NA, Shah AS, Miller BJ, Hogue M, Willey MC, Karam M, Marsh JL. Acceptance and Commitment Therapy Delivered via a Mobile Phone Messaging Robot to Decrease Postoperative Opioid Use in Patients With Orthopedic Trauma: Randomized Controlled Trial. J Med Internet Res. 2020 Jul 29;22(7):e17750. doi: 10.2196/17750.