Health Coaching for Back Pain After Emergency Department Discharge

NCT06400602 | Active Not Recruiting

• 1 other identifier: 231665
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (4)

• Disability - Oswestry Disability Index

  Baseline, 3 months after ED discharge, 6 months after ED discharge

• Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS)

  Baseline, 3 months after ED discharge, 6 months after ED discharge

• Pain Interference - Patient-Reported Outcomes Measurement Information System

  Baseline, 3 months after ED discharge, 6 months after ED discharge

• Pain Intensity - Patient-Reported Outcomes Measurement Information System

  Baseline, 3 months after ED discharge, 6 months after ED discharge

Study Arms (2)

Usual ED Care plus Health Coaching

EXPERIMENTAL

Behavioral: Usual ED Care plus Health Coaching

Usual ED Care plus Education

ACTIVE COMPARATOR

Behavioral: Usual ED Care plus Education

Interventions

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.

Usual ED Care plus Health Coaching

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.

Usual ED Care plus Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chief complaint of musculoskeletal LBP
• 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)
• Age 18 years of age or older
• English-speaking

You may not qualify if:

• Requires hospitalization for an acute medical condition or active comorbidity
• 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
• Involved in litigation related to the LBP condition

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (2)

Tennessee Valley Healthcare System - Nashville VA Medical Center

Nashville, Tennessee, 37212, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor

Study Record Dates

• First Submitted: May 1, 2024
• First Posted: May 6, 2024
• Study Start: May 6, 2024
• Primary Completion: February 11, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)