Digital Behavioral Pain Medicine for Orthopedic Trauma Surgery Patients



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - Any
Updated:12/8/2018
Start Date:October 5, 2018
End Date:October 5, 2019
Contact:Maisa Ziadni, PhD
Email:mziadni@stanford.edu
Phone:6507365494

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"My Surgical Success": A Randomized Controlled Trial of a Perioperative Digital Behavioral Pain Medicine Treatment Tested in Orthopedic Trauma Patients

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.

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).

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
We found this trial at
1
site
Palo Alto, California 94305
Phone: 650-723-8386
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mi
from
Palo Alto, CA
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