Health Coaching for Back Pain After Emergency Department Discharge

Low Back Pain Clinical Trial

Official title:

Integrative Health Coaching for Back Pain: An Emergency Department-to-Home Recovery Model

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06400602
• Other study ID #: 231665
• Status: Recruiting
• Phase: N/A
• Start date: May 6, 2024
• Est. completion date: September 2025

Study information

• Verified date: May 2024
• Source: Vanderbilt University Medical Center
• Contact: Amanda Priest
• Phone: 615-421-8336
• Email: amanda.priest[@]vumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: September 2025
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Emergencies
• Low Back Pain

Intervention

Behavioral:
• Usual 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.
• Usual 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility - study enrollment	Percentage of eligible patients enrolled into study	Baseline
Primary	Feasibility - study retention	Percentage of enrolled participants who complete assessments	3 and 6 months after ED discharge
Primary	Feasibility - session attendance	Median and range of sessions attended	3 months after ED discharge
Primary	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
Primary	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
Primary	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
Primary	Perceptions of intervention	Perceptions of intervention as assessed through an interview	3 months after ED discharge
Secondary	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
Secondary	Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS)	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
Secondary	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
Secondary	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