Clinical trial NCT03764839: Digital Behavioral Pain Medicine for Orthopedic Trauma Surgery Patients
Official title: "My Surgical Success": A Randomized Controlled Trial of a Perioperative Digital Behavioral Pain Medicine Treatment Tested in Orthopedic Trauma Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthopedic Trauma Surgery Patients
Keywords: pain
treatment
opioid cessation
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 141
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: Patients are identified by their orthopedic surgeon or study personnel immediately prior to surgery or during their stay on the inpatient post-surgical recovery unit. Beyond recruitment, the entire study is conducted remotely with no in-person contact with study staff. After enrollment, study staff follow-up with patients by phone, text or email (depending on patient preference); informed consent is obtained online.

All participants are asked to provide baseline demographic information, as well as self-reported measures assessing mood, pain, cognitive and emotional responses to pain, catastrophizing, and medications. All measures are administered via a secure, HIPAA compliant, online system (REDCap).

Participants are then randomized to receive one of two digital treatments: a behavioral pain medicine intervention ("My Surgical Success") or to a health education (HE Control). Participants who have been randomized to the HE control group receive online text information about health and nutrition, and are oriented that the information is relevant for improving recovery from surgery. The digital behavioral pain medicine intervention emphasizes treatment content that targets cognitive and emotional regulation in the context of pain. "My Surgical Success" includes three brief psychoeducational video learning modules, a downloadable app with an audio file, and a downloadable PDF Personalized Plan for Success. After participants in the "My Surgical Success" group view the online treatment videos, they complete questions regarding their satisfaction with the video content, perceived usefulness of information, and likelihood to use the skills learned. All participants are tracked twice per week post-surgically to assess pain and opioid use. Data are captured for the duration of the study (12 weeks) or until patients reach opioid cessation (four consecutive surveys indicating zero opioid use). Psychosocial data are collected post-surgically at weeks 4, 8, and 12.

Post-treatment questions:

Participants in the "My Surgical Success" group are asked to rate questions about the about the video content in regards to its understandability, relevance, usefulness, their overall satisfaction, how likely they are to use the information learned.

Following surgery, all participants fill out online brief pain check-ins (2 times per week) to assess pain and medication use. Daily measures continue until the participant reports 4 consecutive reports of zero opiate use. Until reaching this endpoint, pain check-ins are collected for 12 weeks (the duration of the study).

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: 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)
timeFrame: Immediately post-treatment
measure: Group difference in time to pain and opioid cessation
timeFrame: 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:
measure: Group difference in within-subject Pain Catastrophizing Scale (PCS)
timeFrame: Baseline to 1 month
Other outcomes:
measure: Group differences in post-surgical Patient Reported Outcomes Measurement Information System (PROMIS) function and PROMIS average pain intensity
timeFrame: Post-surgical month 1
measure: Characterize responders to "My Surgical Success" (demographics and psychological correlates)
timeFrame: Baseline
Locations:
city: Palo Alto
country: United States
facility: Stanford Hospital
state: California
Study officials:
affiliation: Stanford University
name: Beth Darnall, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.