Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06360341
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2024-04-08
Brief Title:
Emergency Department Digital Pain Self-Management Intervention to Improve Acute Low Back Pain Outcomes
Sponsor:
University of Florida
Organization:
University of Florida
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ones 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
BackgroundSignificance Over 34 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 111 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
112 Evaluate the effects of the EDPSI on participants 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
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
BackgroundSignificance Over 34 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 111 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
112 Evaluate the effects of the EDPSI on participants 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None