Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01AT012367 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| University of Utah | OTHER |
| Northwestern Lake Forest Hospital | OTHER |
| Northwestern Memorial Hospital |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Embedded Emergency Department Physical Therapy | Experimental | 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. |
|
| Usual Care | Other | Usual care treatment for low back pain presenting in the emergency department (ED). Usual care consists of any ED testing or treatment not involving an ED physical therapist in accordance with the treating physician's usual and customary practice. This could include diagnostic imaging, patient education and resources, and administration and/or prescribing of analgesic medications. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Embedded Emergency Department Physical Therapy | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal participant surveys (effectiveness): missing data rate for the Patient-Reported Outcome Measurement Information System (PROMIS)-Pain Interference (PI) assessment. | Rate of missing data for assessments administered between baseline and 12 months. Variable type: binary / proportion. | 12 months |
| Longitudinal participant surveys (effectiveness): screening-to-enrollment ratio | Number of participants who enter screening compared to the number of participants who enroll in the study. Variable type: binary / proportion. | Baseline |
| Longitudinal participant surveys (effectiveness): participant retention rate defined as completion of at least one follow-up survey. | Ratio of participants enrolled to the number who complete at least one follow-up survey. | 12 months. |
| Electronic Health Record (EHR) extraction (implementation): adoption of Emergency Department (ED) physical therapy | 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. | Baseline |
| Electronic Health Record (EHR) extraction (implementation): fidelity of Emergency Department (ED) physical therapy | 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. | Baseline |
| Clinician surveys before and after implementation of the intervention (implementation): Normalisation Measure Development Questionnaire (NoMAD) questionnaire scores |
| Measure | Description | Time Frame |
|---|---|---|
| Longitudinal participant surveys (effectiveness): a sum of the missing data rate for the remaining Participant Reported Outcomes (PROs) combined. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Participant and clinician focus groups (implementation) | These data will be collected and analyzed qualitatively. | 1-6 months before the first participant enrolls and 1-6 months after the study closes to follow-up. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Howard Kim, MD, MS | Contact | 312-926-0591 | howard.kim@northwestern.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Memorial Hospital | Recruiting | Chicago | Illinois | 60611 | United States |
Scientific data and metadata will be archived into Northwestern University Libraries' institutional repository, Arch (https://arch.library.northwestern.edu/). Northwestern University faculty, students, and staff with a current NetID are allowed unlimited storage, file uploads, and hosting for their scientific work.
Scientific data will be made available at the end of the award period or at the time of the corresponding publication, in the case of any publications that pre-date the award end date. Datasets resulting from this work will remain available in the repository in perpetuity or until deaccessioned at the discretion of the repository. Should the funding or organizational imperatives of the Northwestern University Libraries change, the Libraries will strive to provide at least one year notice, and devote resources to support the transition to another host institution and/or returning the data to the data producers.
Scientific data will be made available at the end of the award period or at the time of the corresponding publication, in the case of any publications that pre-date the award end date. Datasets resulting from this work will remain available in the repository in perpetuity or until deaccessioned at the discretion of the repository.
Access to scientific data and metadata will not be controlled after archiving. Arch is an open access repository that is focused on digital data archiving and unmediated public access to research results.
Not provided
Not provided
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D004630 | Emergencies |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
Not provided
Not provided
| OTHER |
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.
Not provided
Not provided
Not provided
Not provided
|
| Usual Care | Other | Standard-of-care treatment for low back pain presenting in the emergency department |
|
1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. Variable type: continuous. |
| 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. |
| 12 months |
| Electronic Health Record (EHR) extraction (effectiveness): rate of subsequent health care encounters. | Variable type: count, may be considered binary / proportion | 12 months |
| Electronic Health Record (EHR) extraction (effectiveness): rate of opioid prescribing | Variable type: count, may be considered binary / proportion | 12 months |
| Electronic Health Record (EHR) extraction (effectiveness): rate of advanced diagnostic imaging | Variable type: count, may be considered binary / proportion | 12 months |
| 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. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome. | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. |
| 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. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome. | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. |
| 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. Variable type: continuous. Minimum value is 4, Maximum value is 20. Higher scores = higher agreement with outcome. | 1-6 months prior to opening study to accrual and 1-6 months after the last participant enrolls at the site. |
| University of Utah | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |