Health Coaching for Back Pain After Emergency Department Discharge

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Low Back Pain
• Intervention / Treatment: Behavioral: Usual ED Care plus Health Coaching; Behavioral: Usual ED Care plus Education

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
    • Nashville, Tennessee, United States, 37212
      • Tennessee Valley Healthcare System - Nashville VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Usual ED Care plus Health Coaching	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.
Active Comparator: Usual ED Care plus Education	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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)	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

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Investigators: Principal Investigator: Rogelio Coronado, PT, PhD, Vanderbilt University Medical Center; Study Director: Kristin Archer, PhD, DPT, Vanderbilt University Medical Center; Study Director: Sean Collins, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): February 11, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: May 1, 2024
• First Submitted That Met QC Criteria: May 1, 2024
• First Posted (Actual): May 6, 2024

Study Record Updates

• Last Update Posted (Actual): April 28, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Low Back Pain; Socioeconomic Factors; Population Characteristics; Educational Status
• Other Study ID Numbers: 231665

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No