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Toolkit for Optimal Recovery after Orthopedic Injury; A multi-site feasibility study to prevent persistent pain and disability

Award Number: R01AT010462
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

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PROJECT SUMMARY Using the NCCIH U01 mechanism, we aim to establish benchmarks to allow for successful implementation of a future scientifically rigorous multi-site hybrid efficacy-effectiveness trial (UG3/UH3 mechanism) of the live video, individual mind body program Toolkit for Optimal Recovery after Injury (TOR) versus a minimally enhanced usual care control (MEUC) delivered to individual patients with acute orthopedic musculoskeletal injuries at risk for chronic pain and disability. Our pilot feasibility trial at the Massachusetts General Hospital (MGH) Level 1 Trauma Clinic provided evidence for feasibility, acceptability, signal of improvement after TOR participation, and allowed us to identify limitations and barriers to recruitment and study implementations, which informed the current proposal. The multi-site feasibility study will be conducted at 3 geographically diverse Level 1 trauma centers: MGH (MA), Dell Medical School (TX), Lexington (KY). First, using elements of Proctors’ Implementation Outcomes Framework we will conduct focus groups with orthopedic surgeons and staff at each site to understand barriers and facilitators to psychological care and study referrals/procedures and develop training materials to bypass these barriers and ensure integration of study procedures within each site (aim 1). Next, we will conduct a feasibility multi-site randomized controlled trial of the TOR against UC (60 patients/site; 30/arm; 50 completers) targeting a priori set benchmarks. Our team is uniquely positioned for this U01, with a psychologist (Vranceanu; overall PI) and orthopedic surgeon (Ring; Dell site PI) with over 12 years’ collaboration. The PI and statistician have extensive expertise in intervention development, feasibility testing, clinical trials, and live video intervention delivery. We recruited an implementation science expert with prior experience working in orthopedic surgery. There is excitement and support from each of the Orthopedic Trauma Units, and we recruited orthopedic surgeons passionate about psychosocial care to serve as champions at each site. We hope to enhance the care of orthopedic trauma patients through a low burden mind body program (TOR) focused on optimizing recovery and preventing chronic pain and disability. This early focus on study implementation will bolster the rigor of the subsequent UG3/UH3 trial as well as inform future TOR implementation, should this be supported by efficacy data.


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: 2023 ( Subtotal = $768,504 )
2023	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	002	4	9/15/2023	SUPPLEMENT FOR EXPANSION	$29,938
2023	2023	THE GENERAL HOSPITAL CORPORATION	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	001	4	5/18/2023	NON-COMPETING CONTINUATION	$738,566
2023	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	000	3	12/5/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $768,504

Issue Date FY: 2022 ( Subtotal = $841,311 )
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	003	3	8/24/2022	SUPPLEMENT FOR EXPANSION	$99,892
2022	2022	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	002	3	5/16/2022	NON-COMPETING CONTINUATION	$741,419
2022	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	000	2	12/15/2021	NON-COMPETING CONTINUATION	$0
2022	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	001	2	1/12/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $841,311

Issue Date FY: 2021 ( Subtotal = $746,002 )
2021	2021	MASSACHUSETTS GENERAL HOSPITAL, THE	55 FRUIT ST	BOSTON	MA	02114	SUFFOLK	USA	Research and Training in Complementary and Integrative Health	000	2	5/11/2021	NON-COMPETING CONTINUATION	$746,002
														Subtotal = $746,002

Grand Total All Awards = $2,355,817

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Toolkit for Optimal Recovery after Orthopedic Injury; A multi-site feasibility study to prevent persistent pain and disability

Award Number: R01AT010462

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

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