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Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain

Award Number: UH3AT011265
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: COOPERATIVE AGREEMENT
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/21/2020
PERIOD OF PERFORMANCE END DATE: 08/31/2026

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Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain - Nearly 100 people die every day from a prescription opioid overdose in the United States (US). Over-reliance on opioids for these with chronic pain is one of the factors that led to this crisis. Pain, both acute and chronic, that is so severe that it requires opioids to attempt to keep to tolerable levels, is a constant companion to the 100,000 people in the United States, mostly of African or Hispanic background, and millions more worldwide living with sickle cell disease (SCD). Pain is SCD’s hallmark symptom, and the leading cause for almost 200,000 annual emergency department (ED) admissions, and is the leading cause of hospitalization, with estimated annual health care costs in the US of $2.4 billion. We will conduct a hybrid type 1 effectiveness implementation trial to assess the effectiveness of acupuncture and guided relaxation on 360 people with SCD while observing and gathering information on implementation in three health systems: University of Illinois Hospital & Health Sciences System, University of Florida Health, and Duke University Health Systems. Each serves a large population with SCD, uses EPIC as their electronic health record, and has a Clinical and Translational Science Award (CTSA), which will help speed the translation of discovery into improved patient care. UG3 1-year Planning Phase: Year 1 comprises milestone-driven planning to prepare the three health systems for the subsequent pragmatic clinical trial (UH3). During the UH3 Implementation Phase, our 3-arm, 3- site randomized controlled trial will follow a quantitative SMART design. A pragmatic trial that evaluates adaptive interventions where our guided relaxation and acupuncture interventions responds to patients’ characteristics and evolving pain status. We rely on the Consolidated Framework for Implementation Research (CFIR) to plan, execute, and evaluate associated implementation processes. The use of complementary and integrative (CIH) therapies by those with SCD to reduce pain, opioid use, and enable themselves to better cope with their pain is well known, but there are few studies that evaluate the effectiveness of these therapies, and none that also evaluates the implementation across multiple health care systems and patient populations as this study will.


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	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD AVE M/C 551	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	000	5	3/12/2025	NON-COMPETING CONTINUATION	$0
2025	2024	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD AVE M/C 551	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	001	5	8/28/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,584,065 )
2024	2024	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD AVE M/C 551	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	002	5	9/2/2024	NON-COMPETING CONTINUATION	$1,584,065
2024	2023	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD AVE M/C 551	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	001	4	2/15/2024	NON-COMPETING CONTINUATION	$0
2024	2023	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD AVE M/C 551	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	000	4	11/6/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,584,065

Issue Date FY: 2023 ( Subtotal = $1,582,439 )
2023	2023	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD AVE M/C 551	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	002	4	9/5/2023	NON-COMPETING CONTINUATION	$1,582,439
2023	2022	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD AVE M/C 551	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	001	3	5/12/2023	NON-COMPETING CONTINUATION	$0
2023	2022	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD RM 520	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	000	3	10/17/2022	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,582,439

Issue Date FY: 2022 ( Subtotal = $1,625,677 )
2022	2022	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD RM 520	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	003	3	9/8/2022	NON-COMPETING CONTINUATION	$1,573,843
2022	2021	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD RM 520	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	002	2	4/21/2022	EXTENSION WITH OR WITHOUT FUNDS	$1,932
2022	2021	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD RM 520	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	000	2	11/10/2021	EXTENSION WITH OR WITHOUT FUNDS	$0
2022	2021	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD RM 520	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	001	2	1/10/2022	EXTENSION WITH OR WITHOUT FUNDS	$49,901
														Subtotal = $1,625,677

Issue Date FY: 2021 ( Subtotal = $1,612,143 )
2021	2021	UNIVERSITY OF ILLINOIS	809 S MARSHFIELD RM 520	CHICAGO	IL	60612	COOK	USA	Research and Training in Complementary and Integrative Health	000	2	9/22/2021	EXTENSION WITH OR WITHOUT FUNDS	$1,612,143
														Subtotal = $1,612,143

Grand Total All Awards = $6,404,324

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Hybrid Effectiveness-Implementation Trial of Guided Relaxation and Acupuncture for Chronic Sickle Cell Disease Pain

Award Number: UH3AT011265

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: COOPERATIVE AGREEMENT

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

PERIOD OF PERFORMANCE START DATE: 09/21/2020

PERIOD OF PERFORMANCE END DATE: 08/31/2026

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