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

April 8, 2024 updated by: Alexandria Carey, University of Florida

Feasibility and Acceptability of an Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes: A Pilot Randomized Controlled Trial

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Shand's Adult Emergency Department, campus 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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32608
        • UF Health Shand's Adult Emergency Department
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
The intervention group will receive Emergency Department Digital Pain Self-Management Intervention (EDPSI) + routine discharge care (RC).
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
Active Comparator: Control Group
The control group will receive routine discharge care (RC).
Other: Routine Discharge Care
Routine Discharge Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improving Self-Management Health Outcomes
Time Frame: 1-week
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Alexandria A Carey, MSN, MBA, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 15, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

April 8, 2024

First Submitted That Met QC Criteria

April 8, 2024

First Posted (Actual)

April 11, 2024

Study Record Updates

Last Update Posted (Actual)

April 11, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301946

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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