Feasibility and Acceptability of an Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes: A Pilot Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Improving Self-Management Health Outcomes
Study Overview
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: Ann Horgas
Supervisory Committee Members:
- Laurie Duckworth
- Hwayoung Cho
- Jason M. Beneciuk Previous Co-Investigator (2022-2024): Angela Starkweather
IRB #: 202301946
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Randomization to RC or Intervention group will not be masked to the Principal Investigator (PI), co-PI, or to participants.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Intervention Group
The intervention group will receive Emergency Department Digital Pain Self-Management Intervention (EDPSI) + routine discharge care (RC).
Intervention: Emergency Department Digital Pain Self-Management Intervention (EDPSI) (Behavioral)
Intervention Group
The intervention group will receive Emergency Department Digital Pain Self-Management Intervention (EDPSI) + routine discharge care (RC).
Intervention: Routine Discharge Care (Other)
Control Group
The control group will receive routine discharge care (RC).
Intervention: Routine Discharge Care (Other)
Outcomes
Primary Outcomes
Improving Self-Management Health Outcomes
Time Frame: 12-weeks
Feasibility and Acceptability of the pilot study will assess recruitment, retention, engagement, satisfaction, and willingness to recommend. Acceptability and intervention satisfaction will be assessed using the Education Preference and Satisfaction Questionnaire (EPSQ) and study satisfaction and recommendation using the Patient Satisfaction and Healthcare Utilization Questionnaire (PSHU). Preliminary Clinical Efficacy will be assessed for self-management, self-efficacy, pain severity and interference. Self-management will be assessed using the short 13-item Patient Activation Measure (PAM), self-efficacy using the Pain Self-Efficacy Questionnaire (PSEQ), pain severity and interference using the Brief Pain Inventory Short-Form (BPI-SF). Preliminary clinical efficacy of the EDPSI for adults with aLBP will be evaluated using estimates of Minimal Clinically Important Difference (MCID), the smallest change in an outcome that patients perceive as meaningful and indicative of improvement.
Secondary Outcomes
No secondary outcomes reported