Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual ED Care plus Health Coaching | Experimental |
| |
| Usual ED Care plus Education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual ED Care plus Health Coaching | Behavioral | Patients will participate in eight remotely-delivered sessions of health coaching after ED discharge. Patients will receive usual care during their ED visit. |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility - study enrollment | Percentage of eligible patients enrolled into study | Baseline |
| Feasibility - study retention | Percentage of enrolled participants who complete assessments | 3 and 6 months after ED discharge |
| Feasibility - session attendance | Median and range of sessions attended | 3 months after ED discharge |
| Feasibility - Feasibility of Intervention Measure (FIM) | 4-item questionnaire assessing feasibility of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater feasibility. | 3 months after ED discharge |
| Acceptability - Acceptability of Intervention Measure (AIM) | 4-item questionnaire assessing acceptability of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater acceptability. | 3 months after ED discharge |
| Acceptability - Intervention Appropriateness Measure (IAM) | 4-item questionnaire assessing appropriateness of an intervention. Averaged scores range from 1 to 5, with higher scores indicating greater appropriateness. | 3 months after ED discharge |
| Perceptions of intervention | Perceptions of intervention as assessed through an interview | 3 months after ED discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Disability - Oswestry Disability Index | 10-item questionnaire assessing back-related disability. Scores range from 0 to 100, with higher scores indicating higher disability. | Baseline, 3 months after ED discharge, 6 months after ED discharge |
| Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Rogelio Coronado, PT, PhD | Vanderbilt University Medical Center | Principal Investigator |
| Kristin Archer, PhD, DPT | Vanderbilt University Medical Center | Study Director |
| Sean Collins, MD | Vanderbilt University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tennessee Valley Healthcare System - Nashville VA Medical Center | Nashville | Tennessee | 37212 | United States | ||
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Usual ED Care plus Education | Behavioral | Patients will participate in eight remotely-delivered sessions of education after ED discharge. Patients will receive usual care during their ED visit. |
|
4-item PROMIS questionnaire assessing physical function. Scores are reported as t-scores, with higher scores indicating higher physical function. |
| Baseline, 3 months after ED discharge, 6 months after ED discharge |
| Pain Interference - Patient-Reported Outcomes Measurement Information System | 4-item PROMIS questionnaire assessing pain interference. Scores are reported as t-scores, with higher scores indicating higher pain interference. | Baseline, 3 months after ED discharge, 6 months after ED discharge |
| Pain Intensity - Patient-Reported Outcomes Measurement Information System | Single item question assessing level of pain intensity. Scores range from 0 to 10, with higher scores indicating higher pain intensity. | Baseline, 3 months after ED discharge, 6 months after ED discharge |
| Vanderbilt University Medical Center |
| Nashville |
| Tennessee |
| 37232 |
| United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |