Clinical trial NCT06400602: Health Coaching for Back Pain After Emergency Department Discharge
Official title: Integrative Health Coaching for Back Pain: An Emergency Department-to-Home Recovery Model
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Low Back Pain
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - study enrollment
timeFrame: Baseline
measure: Feasibility - study retention
timeFrame: 3 and 6 months after ED discharge
measure: Feasibility - session attendance
timeFrame: 3 months after ED discharge
measure: Feasibility - Feasibility of Intervention Measure (FIM)
timeFrame: 3 months after ED discharge
measure: Acceptability - Acceptability of Intervention Measure (AIM)
timeFrame: 3 months after ED discharge
measure: Acceptability - Intervention Appropriateness Measure (IAM)
timeFrame: 3 months after ED discharge
measure: Perceptions of intervention
timeFrame: 3 months after ED discharge
Secondary outcomes:
measure: Disability - Oswestry Disability Index
timeFrame: Baseline, 3 months after ED discharge, 6 months after ED discharge
measure: Physical Function - Patient-Reported Outcomes Measurement Information System (PROMIS)
timeFrame: Baseline, 3 months after ED discharge, 6 months after ED discharge
measure: Pain Interference - Patient-Reported Outcomes Measurement Information System
timeFrame: Baseline, 3 months after ED discharge, 6 months after ED discharge
measure: Pain Intensity - Patient-Reported Outcomes Measurement Information System
timeFrame: Baseline, 3 months after ED discharge, 6 months after ED discharge
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Valley Healthcare System - Nashville VA Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Rogelio Coronado, PT, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vanderbilt University Medical Center
name: Kristin Archer, PhD, DPT
role: STUDY_DIRECTOR
affiliation: Vanderbilt University Medical Center
name: Sean Collins, MD
role: STUDY_DIRECTOR
References: