Low Back Pain
Conditions
Keywords
Low back pain, Physical therapy, FEED-PT, Feasibility, Emergency department
Brief summary
This is a multi-site feasibility trial of an embedded emergency department (ED) physical therapy care model for low back pain at two EDs in the Northwestern Medicine and University of Utah Health systems. The study intervention (embedded ED physical therapy) is a reconceptualization of the traditional outpatient physical therapy care model in which we place a physical therapist directly in the ED to initiate timely care for patients with low back pain; we previously evaluated this intervention in a single center randomized trial. This multi-site feasibility trial will be comprised of 9 months of active intervention and 12 months of longitudinal data collection. The two sites will be parallel randomized 1:1 to receive either the embedded ED physical therapy condition (intervention, n=1) or usual care (control, n=1) via simple randomization. This trial focuses on feasibility outcomes - such as our ability to enroll participants, deliver the intervention with fidelity, and collect longitudinal patient-reported outcome data and electronic health record data - but a future multi-site full-scale trial will focus on the outcomes of pain-interference and opioid use.
Detailed description
After a 12-month milestone-driven planning and preparation phase, we will conduct a 21-month randomized feasibility clinical trial of the embedded ED physical therapy intervention at the Northwestern Medicine and University of Utah health systems, comprised of 9 months of active intervention and 12 months of longitudinal data collection. Two hospital EDs (Northwestern Memorial Hospital, University of Utah Hospital) will be randomized to receive either the embedded ED physical therapist intervention (treatment, n=1) or usual care (control, n=1). Following completion of the feasibility trial, the control site will receive the intervention as per standard waitlist procedures for randomized trials. A third hospital ED (Northwestern Lake Forest Hospital) will not participate in randomization or participant enrollment but will contribute baseline electronic health record data to assist in feasibility assessments for a future full-scale trial.
Interventions
We place a physical therapist directly in the emergency department to initiate timely care for patients with low back pain rather than waiting on an outpatient referral to physical therapy, which can often take weeks to accomplish, if ever at all. The actual techniques and approaches used by the embedded ED physical therapist in this study (e.g., exercises, maneuvers, coaching) are standard-of-care and do not involve investigational interventions, devices, or drugs.
OTHERUsual Care
Standard-of-care treatment for low back pain presenting in the emergency department
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Utah
Northwestern Lake Forest Hospital
Northwestern Memorial Hospital
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two hospital EDs (Northwestern Memorial Hospital, University of Utah Hospital) will be randomized to receive either the embedded ED physical therapist intervention (treatment, n=1) or usual care (control, n=1). Following completion of the feasibility trial, the control site will receive the intervention as per standard waitlist procedures for randomized trials. A third hospital ED (Northwestern Lake Forest Hospital) will not participate in randomization or participant enrollment but will contribute electronic health record data to assist in feasibility assessments for a future full-scale trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Emergency Department (ED) visit with primary diagnosis related to low back pain * ED visit occurring at an ED site participating in randomization (Northwestern Memorial Hospital, University of Utah Hospital) * ED visit check-in time during the hours of 8am-8pm * Current episode of low back pain less than or equal to 30 days, defined as pain between the 12th rib and buttocks * Age greater than or equal to 18 years; there is no age maximum * English or Spanish-speaking
Exclusion criteria
* Red flag symptoms indicating a life or limb-threatening process * Currently in police custody * Unable to consent * Known pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician surveys before and after implementation of the intervention (implementation): Normalisation Measure Development Questionnaire (NoMAD) questionnaire scores | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. |
| Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment. | 12 months | Rate of missing data for assessments administered between baseline and 12 months. Variable type: binary / proportion. |
| Longitudinal participant surveys (effectiveness): screening-to-enrollment ratio | Baseline | Number of participants who enter screening compared to the number of participants who enroll in the study. Variable type: binary / proportion. |
| Longitudinal participant surveys (effectiveness): participant retention rate defined as completion of at least one follow-up survey. | 12 months. | Ratio of participants enrolled to the number who complete at least one follow-up survey. |
| Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy | Baseline | Adoption is defined as the number of potentially eligible low back pain ED visits have a documented order for a physical therapy evaluation. Cross-sectional at the level of site/Emergency Department during the trial. Variable type: Proportion. |
| Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy | Baseline | Fidelity is defined as the number of low back pain ED visits that have a structured research note documenting use of the protocol. Cross-sectional at the level of site/Emergency Department (ED) during the trial. Variable type: proportion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinician surveys before and after implementation of the intervention (implementation): Intervention Appropriateness Measure (IAM) | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome. |
| Clinician surveys before and after implementation of the intervention (implementation): Feasibility of Intervention measure (FIM). | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome. |
| Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined. | 12 months | Missing data rate for each PRO will not be analyzed separately, but will be combined into one measurement as one outcome. PROs: modified Oswestry Disability Index (ODI), four-item Pain Catastrophizing Score, four item Pain Self-Efficacy Questionnaire, Global Rating of Change, Numeric Pain Rating Scale, additional healthcare utilization (e.g., physical therapy, ED, doctor's office), and a medication use survey. |
| Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters. | 12 months | Variable type: count, may be considered binary / proportion |
| Electronic Health Record (EHR) extraction (effectiveness): rate of opioid prescribing | 12 months | Variable type: count, may be considered binary / proportion |
| Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging | 12 months | Variable type: count, may be considered binary / proportion |
| Clinician surveys before and after implementation of the intervention (implementation): Acceptability of Intervention Measure (AIM) | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Participant and clinician focus groups (implementation) | 1-6 months before the first participant enrolls and 1-6 months after the study closes to follow-up. | These data will be collected and analyzed qualitatively. |
Countries
United States
Contacts
Primary ContactHoward Kim, MD, MS
Outcome results
None listed