Digital Behavioral Pain Medicine for Orthopedic Trauma Surgery Patients

NCT03764839 | Completed

• 1 other identifier: 42569
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine the feasibility and preliminary efficacy of a perioperative digital behavioral pain medicine intervention delivered to orthopedic trauma surgery patients (compared to an active control group that receives digital health education). Aim 1: Determine feasibility of and satisfaction, and perceived utility of "My Surgical Success" Hypothesis 1: For My Surgical Success, the investigators anticipate 50% engagement in the study (feasibility). Of those who complete My Surgical Success, the investigators expect 80% satisfaction ratings, and 80% perceived utility of the information learned. Aim 2: Determine group differences in time to post-surgical pain and opioid cessation. Hypothesis 2: "My Surgical Success" participants will evidence quicker time to post-surgical pain and opioid cessation compared to the HE Control Group. Aim 3: Determine group differences in within-subject pain catastrophizing scores (baseline to post-surgery). Hypothesis 3: "My Surgical Success" participants evidence greater reduction in pain catastrophizing (measured with the Pain Catastrophizing Scale; PCS) compared to the HE Control group. Aim 4: Determine group differences in post-surgical psychological correlates (PROMIS Depression, Anxiety, Function, Pain Interference, Sleep Disturbance, Social Isolation, Fatigue, and Pain Intensity). Hypothesis 4: "My Surgical Success" participants will evidence greater post-surgical function and lower pain related interference compared to the HE Control Group. The goal of this research is to advance our understanding regarding the feasibility and effectiveness of "My Surgical Success" (a digital, perioperative behavioral pain medicine treatment) and its impact on post-surgical outcomes.

Conditions

Orthopedic Trauma Surgery Patients

Keywords

pain; treatment; opioid cessation

Outcome Measures

Primary Outcomes (2)

• Participant ratings (0-6) for acceptability, satisfaction, usefulness of the information presented, ease of understanding, and likelihood to use skills learning (for the My Surgical Success group only)

  Participants complete a single time point rating for 5 items listed above. Ratings occur on a 0-6 point scale (e.g., 0=completely useless and 6=Very useful). Percentages will be reported for each item. A higher score indicates better acceptability, satisfaction, usefulness of the information.

  Immediately post-treatment

• Group difference in time to pain and opioid cessation

  This will be measured in days until patients achieve opioid cessation. Fewer days indicate better treatment effects

  This is a survival curve with time being a variable of interest. The examination will occur within the 3-month window after surgery.

Secondary Outcomes (1)

• Group difference in within-subject Pain Catastrophizing Scale (PCS)

  Baseline to 1 month

Other Outcomes (2)

• Group differences in post-surgical Patient Reported Outcomes Measurement Information System (PROMIS) function and PROMIS average pain intensity

  Post-surgical month 1

• Characterize responders to "My Surgical Success" (demographics and psychological correlates)

  Baseline

Study Arms (2)

Active Control Group (Digital Health Education)

NO INTERVENTION

* Demographics survey * Baseline surveys * Participants receive a digital information sheet on nutrition and exercise that are relevant for people recovering from surgery. Participants are encouraged to incorporate healthy lifestyle choices into their daily routines as they recover from surgery Post-surgery: * Pain check-ins (2 times per week) (detailed above) * Patients receive 30 second booster videos at 7, 14, and 21 days after surgery * Follow-up surveys (4, 8, and 12 weeks after surgery)

"My Surgical Success" Treatment Group

EXPERIMENTAL

* Demographics survey * Baseline surveys * Intervention: * 45-minute digital behavioral pain medicine intervention "My Surgical Success" that emphasized cognitive and emotional regulation of pain and downregulation of physiologic arousal. * downloadable app with an audio file * personalized plan that allows learners to incorporate the treatment information * Post-video survey (detailed above) Post-surgery: * Pain check-ins (2 times per week) (detailed above) * Follow-up surveys (4, 8, and 12 weeks after surgery) Intervention: Behavioral: Perioperative Digital Behavioral Pain Medicine "My Surgical Success"

Behavioral: Perioperative Digital Behavioral Pian Medicine "My Surgical Success"

Interventions

Perioperative Digital Behavioral Pian Medicine "My Surgical Success" BEHAVIORAL

The "My Surgical Success" website include 45 minutes of psychoeducation material developed and delivered by Beth Darnall, PhD. Viewers learn basic skills to improve regulation of pain-related distress. Treatment includes an app and a personalized plan for surgical success.

"My Surgical Success" Treatment Group

Eligibility Criteria

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

You may qualify if:

• Age 18-80 years
• Undergoing a scheduled surgery for orthopedic trauma
• Post-surgery up to 7 days
• English fluency
• Ability and willingness to complete electronic study procedures including questionnaires, assessments, and receipt of treatment.

You may not qualify if:

• Any conditions causing inability to complete study procedures (e.g. cognitive ability, mental status, medical status) or lack of access to internet and phone that would prevent participation in study procedures - at the discretion of the staff member.
• long-term opioid use prior to surgery
• Known pregnancy
• Ongoing legal action related to pain or disability claim
• Multiple surgeries and/or infections
• Injury is not fracture related or non-trauma surgery
• Documented history of alcohol abuse

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford Hospital

Palo Alto, California, 94304, United States

Location

Related Publications (1)

• Ziadni MS, You DS, Keane R, Salazar B, Jaros S, Ram J, Roy A, Tanner N, Salmasi V, Gardner M, Darnall BD. "My Surgical Success": Feasibility and Impact of a Single-Session Digital Behavioral Pain Medicine Intervention on Pain Intensity, Pain Catastrophizing, and Time to Opioid Cessation After Orthopedic Trauma Surgery-A Randomized Trial. Anesth Analg. 2022 Aug 1;135(2):394-405. doi: 10.1213/ANE.0000000000006088. Epub 2022 Jul 5.

  PMID: 35696706 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Beth Darnall, PhD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 3, 2018
• First Posted: December 5, 2018
• Study Start: October 5, 2018
• Primary Completion: February 5, 2020
• Study Completion: April 5, 2020
• Last Updated: October 26, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)