Pain and Narcotic Usage After Orthopaedic Surgery

NCT03991546 | Completed

• 1 other identifier: 201412701
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (5)

• Number of opioid pain medication tablets consumed

  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.

  Measurement of outcome obtained on postoperative day fourteen.

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

  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.

  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.

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

  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.

  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.

• Change in reported pain interference score

  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.

  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.

• Change in reported emotional distress (anxiety) score.

  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.

  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.

Study Arms (2)

Acceptance and Commitment Therapy

EXPERIMENTAL

Subjects randomizing into this arm received the study intervention that consisted of twice-daily, AM and PM, text messages starting on postoperative day one and ending on postoperative day fourteen. Subjects were only required to read these messages, which utilized the principles of Acceptance and Commitment therapy.

Behavioral: Acceptance and Commitment Therapy Delivered via an Automated Mobile Messaging Robot

Control group

NO INTERVENTION

Subjects randomizing into this arm did not receive the text message study intervention.

Interventions

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.

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Christopher Anthony: lead
• Orthopaedic Trauma Association: collaborator

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (14)

• 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.

  PMID: 28870305 BACKGROUND

• 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.

  PMID: 27479642 BACKGROUND

• 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.

  PMID: 29403322 BACKGROUND

• 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.

  PMID: 27993338 BACKGROUND

• 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.

  PMID: 29777950 BACKGROUND

• 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.

  PMID: 28838887 BACKGROUND

• 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.

  PMID: 30428766 BACKGROUND

• 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.

  PMID: 29261036 BACKGROUND

• 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.

  PMID: 29091492 BACKGROUND

• 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.

  PMID: 29017803 BACKGROUND

• 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.

  PMID: 28622079 BACKGROUND

• 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.

  PMID: 25771023 BACKGROUND

• 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.

  PMID: 24905538 BACKGROUND

• 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.

  PMID: 32723723 DERIVED

MeSH Terms

Conditions

Fractures, Closed; Pain, Postoperative; Acute Pain; Agnosia

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Christopher A Anthony, MD

  University of Iowa

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopaedic Surgery Graduate Medical Education Resident 5

Model Details: Two study groups. The intervention group and the control group that does not receive the intervention.

Study Record Dates

• First Submitted: June 17, 2019
• First Posted: June 19, 2019
• Study Start: June 3, 2016
• Primary Completion: June 17, 2019
• Study Completion: June 17, 2019
• Last Updated: September 4, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)