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A Cluster-Randomized Trial of the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) Protocol for Acute Low Back Pain

Award Number: R01HS027426
ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY
OPDIV: AHRQ
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/30/2020
PERIOD OF PERFORMANCE END DATE: 07/31/2026

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A Cluster-Randomized Trial of the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) Protocol for Acute Low Back Pain - PROJECT SUMMARY Low back pain represents a significant health care burden in the United States and accounts for nearly four million emergency department (ED) visits per year. In nearly two thirds of these visits, an opioid medication is administered or prescribed, making low back pain the most common reason for which opioids are prescribed. Despite this aggressive medication-based approach, patient outcomes after an ED visit for back pain remain poor: after three months, nearly half of all patients report persistent functional impairment, and one in five patients report continued opioid use. Additionally, low back pain continues to be a major driver of unnecessary diagnostic imaging. Nearly one in three ED visits for low back pain results in a plain radiograph, despite multiple professional society guidelines advising against routine imaging. ED-initiated physical therapy (ED-PT) is a promising new resource to improve patient care for low back pain. A growing number of EDs now have dedicated physical therapists that can be consulted to evaluate and treat patients through a combination of education, anticipatory guidance, and early mobilization and exercise. Our preliminary data indicate that patients receiving ED-PT, compared to usual care, report more rapid functional improvement, use fewer opioids, and receive less diagnostic imaging. However, these observational data are limited by biases in treatment selection due to physician discretion in which patients receive ED-PT, as well as other measured and unmeasured confounders. To more rigorously evaluate the efficacy of ED-PT for acute low back pain, we propose (Aim 1) to develop a revised model of ED-PT in which the physical therapist is “embedded” within the primary ED treatment team to evaluate all patients with acute low back pain early in the overall treatment course: the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) protocol. We will then (Aim 2) conduct a physician-randomized trial of NEED-PT versus usual care (i.e., no physical therapy) in ED patients with acute low back pain, comparing a primary outcome of patient-reported functioning and a secondary outcome of opioid use at the primary endpoint of three months. Finally, we will (Aim 3) compare diagnostic imaging utilization among ED back pain visits receiving NEED-PT versus usual care. We hypothesize that patients receiving NEED-PT will experience greater improvement in functioning and lower use of opioids, and that ED visits with NEED-PT will utilize less diagnostic imaging. The findings generated from this research have the potential to meaningfully mitigate the current reliance on opioids for low back pain. As such, we believe this proposal is both timely and responsive to the ARHQ Special Emphasis Notice on Health Services Research to Address the Opioids Crisis (NOT-HS-18-015).


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2025 ( Subtotal = $0 )
2025	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	5/20/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $265,590 )
2024	2024	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Research on Healthcare Costs, Quality and Outcomes	000	5	5/31/2024	NON-COMPETING CONTINUATION	$265,590
														Subtotal = $265,590

Issue Date FY: 2023 ( Subtotal = $492,778 )
2023	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Research on Healthcare Costs, Quality and Outcomes	001	4	6/30/2023	SUPPLEMENT FOR EXPANSION	$100,000
2023	2023	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Research on Healthcare Costs, Quality and Outcomes	000	4	6/28/2023	NON-COMPETING CONTINUATION	$392,778
														Subtotal = $492,778

Issue Date FY: 2022 ( Subtotal = $395,122 )
2022	2022	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Research on Healthcare Costs, Quality and Outcomes	000	3	6/27/2022	NON-COMPETING CONTINUATION	$395,122
														Subtotal = $395,122

Issue Date FY: 2021 ( Subtotal = $394,766 )
2021	2021	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Research on Healthcare Costs, Quality and Outcomes	000	2	7/13/2021	NON-COMPETING CONTINUATION	$394,766
														Subtotal = $394,766

Issue Date FY: 2020 ( Subtotal = $395,776 )
2020	2020	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Research on Healthcare Costs, Quality and Outcomes	001	1	9/25/2020	NEW	$0
2020	2020	NORTHWESTERN UNIVERSITY	633 CLARK ST	EVANSTON	IL	60208	COOK	USA	Research on Healthcare Costs, Quality and Outcomes	000	1	9/17/2020	NEW	$395,776
														Subtotal = $395,776

Grand Total All Awards = $1,944,032

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A Cluster-Randomized Trial of the Northwestern Embedded Emergency Department Physical Therapy (NEED-PT) Protocol for Acute Low Back Pain

Award Number: R01HS027426

ORGANIZATION: AGENCY FOR HEALTH CARE RESEARCH AND QUALITY

OPDIV: AHRQ

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/30/2020

PERIOD OF PERFORMANCE END DATE: 07/31/2026

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