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Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Function and Quality of Life in Veterans

Award Number: UH3AT009765
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: 01/01/2024
PERIOD OF PERFORMANCE END DATE: 12/31/2025

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Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Function and Quality of Life in Veterans - ABSTRACT The overarching goal of this NIH/DoD/VA Pain Management Collaboratory project, wHOPE (Whole Health Options for Pain Education) is to generate evidence for the VA Whole Health model in addressing chronic pain in a national sample of veterans across six geographically distinct VA healthcare systems. Specifically, we will evaluate a Whole Health Team (WHT), including a medical provider with training in integrative medicine, a CIH provider (e.g., yoga instructor, acupuncturist, nutritionist) and a Whole Health coach that collaborates with patients to develop a Personalized Health Plan, emphasizing non-pharmacological approaches to pain management. Specific Aim 1 is to determine whether a Whole Health Team approach is superior to Primary Care Group Education (PC-GE, modified group Cognitive Behavioral Therapy for Chronic Pain), and whether both are superior to VA Usual Primary Care (UPC) in decreasing pain interference in veterans with moderate to severe chronic pain (primary outcome). Secondary outcomes include changes in pain severity, quality of life, non-pharmacological therapies, use of pain medications (including opioids), and mental health symptoms in trial participants across the three study arms. To collect patient-reported outcomes, masked telephone assessments will be conducted at baseline, 3, 6, 9, and 12 months. Aim 2 is to conduct a process evaluation of the two active interventions (WHT and PC-GE) and a budget impact analysis that includes costs to implement the two active interventions and control (UPC) to inform the development of an implementation toolkit for scaling and dissemination. Eligible participants are veterans reporting moderate to severe chronic pain present every day or nearly every day for ≥ 6 months. The total sample size for the population is based on our main study aim/hypothesis and is N=765. This breaks down to n=341 in each of the active interventions (WHT and PC-GE) and n=83 in the control (UPC). Results of this UG3/UH3 Pain Management Collaboratory project will contribute to the overall mission of the NIH/DoD/VA initiative to build national-level infrastructure that supports non-pharmacologic pain management in veterans and military service personnel. As the study has been conducted during the COVID-19 pandemic, Aim 3 will use a nationwide cohort of veterans from the entire VA system to investigate the differential impact of the COVID pandemic on racial/ethnic minority, women, and rural Veterans’ use of Whole Health and CIH services for chronic pain management.


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	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST # 151	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	001	6	11/25/2024	SUPPLEMENT FOR EXPANSION	$0
2025	2023	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST # 151	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	000	6	11/22/2024	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2024 ( Subtotal = $1,206,104 )
2024	2024	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST # 151	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	000	6	12/26/2023	SUPPLEMENT FOR EXPANSION	$1,206,104
														Subtotal = $1,206,104

Issue Date FY: 2023 ( Subtotal = $1,298,416 )
2023	2023	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	002	6	4/18/2023	NON-COMPETING CONTINUATION	$0
2023	2023	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	001	6	3/24/2023	NON-COMPETING CONTINUATION	$64,920
2023	2023	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	000	6	1/24/2023	NON-COMPETING CONTINUATION	$1,233,496
2023	2023	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	003	6	6/2/2023	NON-COMPETING CONTINUATION	$0
														Subtotal = $1,298,416

Issue Date FY: 2022 ( Subtotal = $1,356,992 )
2022	2022	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	000	5	12/1/2021	NON-COMPETING CONTINUATION	$1,221,293
2022	2022	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	002	5	7/21/2022	NON-COMPETING CONTINUATION	$0
2022	2022	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	001	5	6/9/2022	NON-COMPETING CONTINUATION	$135,699
														Subtotal = $1,356,992

Issue Date FY: 2021 ( Subtotal = $1,404,594 )
2021	2021	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	001	4	2/10/2021	NON-COMPETING CONTINUATION	$140,460
2021	2021	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	002	4	7/9/2021	NON-COMPETING CONTINUATION	$0
2021	2021	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	000	4	1/22/2021	NON-COMPETING CONTINUATION	$1,264,134
														Subtotal = $1,404,594

Issue Date FY: 2020 ( Subtotal = $1,746,813 )
2020	2020	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	004	3	8/20/2020	SUPPLEMENT FOR EXPANSION	$142,563
2020	2020	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	002	3	7/17/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
2020	2020	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	000	3	1/28/2020	EXTENSION WITH OR WITHOUT FUNDS	$1,504,944
2020	2020	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	003	3	8/3/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
2020	2020	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	001	3	5/4/2020	EXTENSION WITH OR WITHOUT FUNDS	$99,306
2020	2020	NORTHERN CALIFORNIA INSTITUTE FOR RESEARCH AND EDUCATION, INC.	4150 CLEMENT ST 151 NC	SAN FRANCISCO	CA	94121	SAN FRANCISCO	USA	Research and Training in Complementary and Integrative Health	005	3	9/11/2020	EXTENSION WITH OR WITHOUT FUNDS	$0
														Subtotal = $1,746,813

Grand Total All Awards = $7,012,919

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Implementation of a Pragmatic Trial of Whole Health Team vs. Primary Care Group Education to Promote Non-Pharmacological Strategies to Improve Pain, Function and Quality of Life in Veterans

Award Number: UH3AT009765

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: 01/01/2024

PERIOD OF PERFORMANCE END DATE: 12/31/2025

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