Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes
NCT ID: NCT06360341
Last Updated: 2025-06-27
Study Results
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Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2024-04-15
2024-10-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Intervention Group
The intervention group will receive Emergency Department Digital Pain Self-Management Intervention (EDPSI) + routine discharge care (RC).
Emergency Department Digital Pain Self-Management Intervention (EDPSI)
The EDPSI is a developed supplemental digital video for patients presenting to the emergency department with acute low back pain (aLBP). The content consists of self-management approaches for diverse adult patient preferences including biopsychosocial contributors to pain and clinical practice guidelines to self-management options. Highlights of the discharge instructions summary include follow-up with provider, red flag warnings, and medication safety. Actor demonstration of ergonomics and range of motion movements provide application of Physical Therapy (PT)-based preventative strategies. Combination therapies including PT counseling, complementary alternative medicine (acupuncture, massage, yoga, or Pilates), and use of and safety with ice or heat thermal therapies. Active participation, stress management, and involvement of support systems are addressed.
Routine Discharge Care
Routine Discharge Care
Control Group
The control group will receive routine discharge care (RC).
Routine Discharge Care
Routine Discharge Care
Interventions
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Emergency Department Digital Pain Self-Management Intervention (EDPSI)
The EDPSI is a developed supplemental digital video for patients presenting to the emergency department with acute low back pain (aLBP). The content consists of self-management approaches for diverse adult patient preferences including biopsychosocial contributors to pain and clinical practice guidelines to self-management options. Highlights of the discharge instructions summary include follow-up with provider, red flag warnings, and medication safety. Actor demonstration of ergonomics and range of motion movements provide application of Physical Therapy (PT)-based preventative strategies. Combination therapies including PT counseling, complementary alternative medicine (acupuncture, massage, yoga, or Pilates), and use of and safety with ice or heat thermal therapies. Active participation, stress management, and involvement of support systems are addressed.
Routine Discharge Care
Routine Discharge Care
Eligibility Criteria
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Inclusion Criteria
* 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
* Disabilities that would inhibit digital intervention learning (medical, psychiatric, traumatic brain injury, concussion, blindness, or deaf)
* Prisoners/Incarcerated
18 Years
ALL
No
Sponsors
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University of Florida
OTHER
Responsible Party
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Principal Investigators
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Alexandria A Carey, MSN, MBA
Role: PRINCIPAL_INVESTIGATOR
University of Florida
Locations
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UF Health Emergency Centers
Gainesville, Florida, United States
Countries
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References
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Related Links
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Pain self-efficacy questionnaire (PSEQ).
FastStats - emergency department visits. Centers for Disease Control and Prevention.
Understanding statistical power and significance testing - an interactive visualization.
Back safety - statpearls - NCBI bookshelf.
Emmi Educational Videos. Yale Health.
Other Identifiers
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202301946
Identifier Type: -
Identifier Source: org_study_id
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