Low Back Pain
Conditions
Brief summary
The goal of this two-group randomized trial is to determine the feasibility and acceptability of a remotely-delivered health coaching intervention offered in conjunction with usual care for patients with an acute exacerbation of chronic low back pain who present to the emergency department (ED). The main questions this feasibility trial aims to answer are: * Is our health coaching intervention and randomized trial methodology feasible to conduct? * Is our health coaching intervention acceptable to participants and ED providers? Participants will be randomized to one of two groups (usual ED care plus health coaching or usual ED care plus education) and complete outcome assessments at 3 and 6 months after ED discharge. Participants and ED providers will also complete an interview.
Detailed description
This study is a two-group randomized feasibility trial of usual ED care plus either remote health coaching or remote education in patients with acute exacerbation of chronic low back pain presenting to the ED. We hypothesize that our health coaching intervention and randomized trial methodology will be feasible and that our health coaching intervention will be acceptable to participants and ED providers. Forty participants will be randomized (20 per group), with 36 (90%) retained in the trial up to 6 months follow-up. Eligible patients presenting to the ED with a chief complaint of acute exacerbation of chronic low back pain will be randomized. Patients will be enrolled during or shortly after their ED visit, asked to complete a baseline questionnaire, and then randomized. Randomized participants will receive 8 calls from either a health coach or education provider, and be asked to complete assessments at 3 and 6 months after ED discharge. Interviews will be conducted with randomized participants and 15 ED providers asking about their experience with the intervention.
Interventions
BEHAVIORALUsual ED Care plus Health Coaching
Patients will participate in eight remotely-delivered sessions of health coaching after ED discharge. Patients will receive usual care during their ED visit.
BEHAVIORALUsual ED Care plus Education
Patients will participate in eight remotely-delivered sessions of education after ED discharge. Patients will receive usual care during their ED visit.
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Chief complaint of musculoskeletal LBP 2. Meets NIH-supported chronic LBP criterion (e.g., pain greater than 3 months that has resulted in pain on at least half the days in the past 6 months) 3. Age 18 years of age or older 4. English-speaking
Exclusion criteria
1. Requires hospitalization for an acute medical condition or active comorbidity 2. In the opinion of the investigator has a severe psychiatric or behavioral diagnosis or substance use disorder that would interfere with the ability to perform the intervention and complete follow-up 3. Involved in litigation related to the LBP condition
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility - study enrollment | Baseline | Percentage of eligible patients enrolled into study |
| Feasibility - study retention | 3 and 6 months after ED discharge | Percentage of enrolled participants who complete assessments |
| Feasibility - session attendance | 3 months after ED discharge | Median and range of sessions attended |
| Feasibility - Feasibility of Intervention Measure (FIM) | 3 months after ED discharge | 4-item questionnaire assessing feasibility of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater feasibility. |
| Acceptability - Acceptability of Intervention Measure (AIM) | 3 months after ED discharge | 4-item questionnaire assessing acceptability of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater acceptability. |
| Acceptability - Intervention Appropriateness Measure (IAM) | 3 months after ED discharge | 4-item questionnaire assessing appropriateness of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater appropriateness. |
| Perceptions of intervention | 3 months after ED discharge | Perceptions of intervention as assessed through an interview |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disability - Oswestry Disability Index | Baseline, 3 months after ED discharge, 6 months after ED discharge | 10-item questionnaire assessing back-related disability. Scores range from 0 to 100, with higher scores indicating higher disability. |
| Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS) | Baseline, 3 months after ED discharge, 6 months after ED discharge | 4-item PROMIS questionnaire assessing physical function. Scores are reported as t-scores, with higher scores indicating higher physical function. |
| Pain Interference - Patient-Reported Outcomes Measurement Information System | Baseline, 3 months after ED discharge, 6 months after ED discharge | 4-item PROMIS questionnaire assessing pain interference. Scores are reported as t-scores, with higher scores indicating higher pain interference. |
| Pain Intensity - Patient-Reported Outcomes Measurement Information System | Baseline, 3 months after ED discharge, 6 months after ED discharge | Single item question assessing level of pain intensity. Scores range from 0 to 10, with higher scores indicating higher pain intensity. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRogelio Coronado, PT, PhD
Vanderbilt University Medical Center
STUDY_DIRECTORKristin Archer, PhD, DPT
Vanderbilt University Medical Center
STUDY_DIRECTORSean Collins, MD
Vanderbilt University Medical Center
Outcome results
None listed