Clinical trial NCT06360341: Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes
Official title: Feasibility and Acceptability of an Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain, Mechanical
Acute Pain
Keywords: Pilot Randomized Controlled Trial
Digital Pain Self-Management Intervention
Improving Health Outcomes
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2024-04-11
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Individuals in the pilot randomized controlled trial (RCT) intervention will be randomized to either the intervention or routine discharge care (RC) using REDCap randomizer and assigned to RC or Emergency Department Digital Pain Self-Management Intervention (EDPSI) + RC.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Investigators:

Principal Investigator: Alexandria Carey (University of Florida, PhD Candidate) Co-Investigator/ Supervisory Chair: Angela Starkweather, Primary (University of Florida, Director, PhD Program)

Supervisory Committee Members:

* Ann Horgas
* Hwayoung Cho
* Jason M. Beneciuk

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 recruitment, enrollment, and retention percentages using the following criteria:

  * Of patients identified in the ED with a discharge diagnosis of acute low back pain, \>50% will fit within the operational definition of acute low back pain as stated in the research protocol.
  * 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.
* Acceptability of the intervention will be evaluated using the Preference and Satisfaction Questionnaire (EPSQ) 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.

1.1.2 Evaluate the effects of the EDPSI on participant's pain self-efficacy and 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.

* Self-efficacy (confidence) effects will be measured using the Pain Self-Efficacy Questionnaire (PSEQ) at 1-week.
* Self-management (self-efficacy, knowledge, and skills) effects will be measured using the short 13-item Patient Activation Measure (PAM) at 1-week.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Improving Self-Management Health Outcomes
timeFrame: 1-week
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Emergency Centers
state: Florida
Study officials:
affiliation: University of Florida
name: Alexandria A Carey, MSN, MBA
role: PRINCIPAL_INVESTIGATOR
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