The proposed study aims to evaluate a pilot emergency department (ED) digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from acute to chronic low back pain in ED patients discharged with axial acute low back pain (aLBP). The proposed research has significant potential to improve self-efficacy (the confidence in one's ability to manage their condition) which is one of the most potent factors for improved health outcomes.

Investigators:

Principal Investigator: Alexandria Carey (University of Florida, PhD Candidate) Co-Investigator/ Supervisory Chair: Ann Horgas

Supervisory Committee Members:

• Laurie Duckworth
• Hwayoung Cho
• Jason M. Beneciuk Previous Co-Investigator (2022-2024): Angela Starkweather

IRB #: 202301946

Study Site: UF Health Emergency Centers, campuses in Gainesville, Florida

Study Sponsor: University of Florida

Background/Significance: Over 3.4 million acute axial low back pain (aLBP) cases are treated annually in the United States (US) emergency departments (ED). ED patients with aLBP receive varying verbal and written discharge routine care (RC), leading to gaps in patient discharge effectiveness and effective self-management. Ineffective aLBP self-management may increase the risk of transition to chronic low back pain (cLPB), a chief cause of worldwide disability, with associated costs reaching > $60 million annually. This research will address this significant problem by evaluating an ED digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge, and skills, thus reducing the transition from aLBP to cLBP in ED patients discharged with axial aLBP. The proposed research has significant potential to increase self-efficacy, which is one of the most potent mechanisms of behavior change and improved health outcomes. Due to the focus on accessibility and usability, the intervention may reduce discharge disparities in aLBP self-management, especially among patients with low health literacy.

Study Questions: This research will answer the following questions: 1) Will an ED digital pain self-management intervention (EDPSI) focused on improving self-efficacy, knowledge retention, and skills progress patient self-management behaviors and health status?

Primary Objective: Primary Aims 1.1.1 Evaluate the feasibility and acceptability of an ED digital pain self-management intervention (EDPSI) for individuals aged 18 years and older presenting to the ED with acute axial low back pain (aLPB).

• Feasibility will be measured by appropriateness, relevance to the ED population, recruitment, retention, and engagement percentages using the following criteria:

  • Of patients who meet eligibility criteria for the study, >80% will voluntarily consent to participate in the study.
  • Of patients consented to the study, >80% will complete the 1-week follow up measures.
  • Of patients randomized to the intervention group, >70% will attend booster sessions at 2 and 8 weeks.
  • Of patients randomized to the intervention group, >80% will recall the discharge video content during booster sessions at 2 and 8 weeks.

• Acceptability of the intervention will be evaluated using the Preference and Satisfaction Questionnaire (EPSQ) and Patient Satisfaction and Healthcare Utilization Questionnaire (PSHU) post-intervention and the following criteria:

  • Of patients who complete the study, >80% will rate the intervention as "satisfactory" or "highly satisfactory"
  • Of patients who complete the study, >80% would be willing to refer a friend or family member with acute low back pain to the intervention.
  • Of overall patients who complete the study, >80% would be satisfied with study participation and be willing to recommend the study.

1.1.2 Evaluate the preliminary clinical efficacy of the EDPSI on participant's self-management, pain self-efficacy, severity, and interference. Self-management, defined as participant engagement in self-management behaviors and integration into lifestyle by acknowledging confidence and demonstrating knowledge retainment and skills in managing to perform everyday activities while in acute pain. Preliminary clinical efficacy would be assessed using estimates of Minimal Clinically Important Difference (MCID), the smallest change in an outcome that patients perceive as meaningful and indicative of improvement.

• Self-management (self-efficacy, knowledge, and skills) preliminary clinical efficacy (MCID) will be measured using the 13-item Patient Activation Measure (PAM) at 1-week, 6-weeks, and 12-weeks.
• Self-efficacy (confidence) preliminary clinical efficacy (MCID) will be measured using the Pain Self-Efficacy Questionnaire (PSEQ) at 1-week, 6-weeks, and 12-weeks.
• Pain severity and interference preliminary clinical efficacy (MCID) will be measured using the Brief Pain Inventory-Short Form (BPI-SF) at 1-week, 6-weeks, and 12-weeks.

Methods: The proposed phased study will use a two-group pilot randomized controlled trial design to enroll 30 individuals who have been seen in the ED with aLBP. Participants will be randomized into RC or RC + EDPSI and receive follow-up surveys for 12-weeks post-intervention. The intervention group will also receive Booster sessions via Zoom with the principal investigator to assess and reinforce their knowledge retention of techniques and provide return demonstration reinforcement ergonomics and range of motion movements demonstrated, in weeks two and eight.

Outcome Measures: All participants will be followed for 12-weeks assessing self-management and self-efficacy in weeks 1, 6, and 12. Feasibility will be measured by recruitment, enrollment, and retention percentages. Acceptability and education satisfaction will be measured using the Education-Preference and Satisfaction Questionnaire (EPSQ) post-intervention. Self-management sustainment will be measured including PSEQ, PAM, and patient satisfaction and healthcare utilization (PSHU) requesting patient overall satisfaction, additional healthcare utilization, and pain management related to continued back pain or complications post-injury.

Inclusion Criteria:

• Patient subjective chief complaint of acute or subacute axial low back pain, low back injury, mechanical low back pain, non-specific low back pain, back sprain, or back strain Or
• Provider diagnosis of acute axial low back pain
• ICD-10 discharge codes:
• Low back pain, unspecified M54.50
• Pain of lumbar, acute, for less than 3 months; low back strain (S39.012)
• Unspecific injury of lower back, initial encounter (S39.92XA) And
• Are aged 18 years and older
• Can read and consent to participate in the trial
• Can read and speak English
• Can complete study follow-up at prespecified intervals
• Have access to Wi-Fi
• Have access to a phone or other smart device (e.g. a smartphone, tablet, or computer) that would allow receiving of phone calls, text messages, Zoom meetings, or emails

Exclusion Criteria:

• Admission to the hospital
• Disabilities that would inhibit digital intervention learning (medical, psychiatric, traumatic brain injury, concussion, blindness, or deaf)
• Prisoners/Incarcerated

Data Integrity and Oversight: The PI will be responsible for the ethical conduct of the study by all federal, state, and local laws and regulations, institutional policies, and the requirements of the IRB.

Data Management: Subject confidentiality is strictly held in trust by the investigators and study staff. All written informed consent forms will be immediately secured in the locked and secured office of the PI in a locked and secured study-designated cabinet in the College of Nursing Room 2203. Study data collection and instrument administration will be conducted via REDCap, a secure, web-based application designed to support data capture, providing 1) an intuitive interface for validated data entry; 2) audit trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless data downloads to common statistical Packages; and 4) procedures for importing data from external sources. REDCap has built-in measures to protect participants' anonymity.

Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants.