Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes

Acute Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06360341
• Other study ID #: 202301946
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2024
• Est. completion date: January 1, 2025

Study information

• Verified date: May 2024
• Source: University of Florida
• Contact: Alexandria A Carey, MSN, MBA
• Phone: 6616071702
• Email: alexandria.carey[@]ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain
• Back Pain
• Emergencies
• Low Back Pain
• Low Back Pain, Mechanical

Intervention

Behavioral:
• 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.

Other:
• Routine Discharge Care
Routine Discharge Care

Locations

Country	Name	City	State
United States	UF Health Emergency Centers	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

References & Publications (30)

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* Note: There are 30 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improving Self-Management Health Outcomes	Self-management (measuring self-efficacy, knowledge, and skills) will be assessed using the short 13-item Patient Activation Measure (PAM) and self-efficacy will be assessed using the Pain Self-Efficacy Questionnaire (PSEQ).	1-week

External Links

•   Back safety - statpearls - NCBI bookshelf.
•   Emmi Educational Videos. Yale Health.
•   FastStats - emergency department visits. Centers for Disease Control and Prevention.
•   Improving the emergency department discharge process: Environmental scan report.
•   Pain self-efficacy questionnaire (PSEQ).
•   Understanding statistical power and significance testing - an interactive visualization.