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Assessing the Safety and Effectiveness of Opioid Tapering in Large Health Systems

Award Number: R01DA047537
ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 03/15/2019
PERIOD OF PERFORMANCE END DATE: 12/31/2023

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Assessing the Safety and Effectiveness of Opioid Tapering in Large Health Systems - PROJECT ABSTRACT The United States is amidst a rapidly evolving opioid epidemic, with more than 200,000 deaths from opioid pain reliever overdoses since 1999. In 2016, the Centers for Disease Control and Prevention issued guidelines on the management of opioid therapy in chronic pain. These guidelines emphasized tapering opioids among individuals prescribed high-dose opioid therapy or with other overdose risk factors. While physicians are increasingly reducing or discontinuing (tapering) patients prescribed chronic opioid therapy, evidence to support the effectiveness and safety of tapering practices is lacking. While tapering opioids represents a reasonable approach to reduce the risk of overdose, there are also concerns that tapering opioids may lead to increased pain and withdrawal, prompting some individuals to seek illicit opioids such as heroin, paradoxically increasing their risk for overdose. The overall goal of this project is to conduct a longitudinal cohort study to determine the effectiveness and safety of opioid tapering in large health systems. We will leverage a data system (Pathways to Opioid Safety Datalink [POSD]) that contains linked data on more than 2.5 million people in rural and urban areas in Colorado and Wisconsin. Using the POSD data system, we will examine opioid tapering practices in a cohort of approximately 48,000 patients prescribed chronic opioid therapy from 2012 to 2020. We will employ novel analytic techniques to identify distinct tapering practices, such as gradual dose reduction, rapid dose reduction, dose discontinuation followed by re-initiation, and sustained dose discontinuation. We will then determine which patient and provider factors and behaviors are associated with opioid tapering. In the cohort, effectiveness and safety will be examined by comparing clinically important outcomes across tapering practices. Outcomes will include overdose, suicide, opioid use disorder, and health care utilization for pain and withdrawal. Lastly, we will develop and apply novel methods to minimize bias from loss to follow-up and misclassification of exposure and outcomes, including quantitative bias analysis, probabilistic bias analysis, and propensity scores. Our findings will have the potential to influence national clinical guidelines on opioid management. Our proposed research approach also represents a new paradigm for how to rigorously assess important opioid prescribing and substance use outcomes using complex health services 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: 2024 ( Subtotal = -$6,364 )
2024	2022	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Drug Use and Addiction Research Programs	000	4	4/2/2024	NON-COMPETING CONTINUATION	-$6,364
														Subtotal = -$6,364

Issue Date FY: 2022 ( Subtotal = $708,769 )
2022	2022	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Drug Use and Addiction Research Programs	000	4	12/10/2021	NON-COMPETING CONTINUATION	$637,892
2022	2022	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Drug Use and Addiction Research Programs	001	4	3/18/2022	NON-COMPETING CONTINUATION	$70,877
														Subtotal = $708,769

Issue Date FY: 2021 ( Subtotal = $705,123 )
2021	2021	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Drug Use and Addiction Research Programs	002	3	2/22/2021	NON-COMPETING CONTINUATION	$54,196
2021	2021	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Drug Use and Addiction Research Programs	001	3	12/9/2020	SUPPLEMENT FOR EXPANSION	$163,172
2021	2021	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Drug Use and Addiction Research Programs	000	3	12/4/2020	NON-COMPETING CONTINUATION	$487,755
														Subtotal = $705,123

Issue Date FY: 2020 ( Subtotal = $549,946 )
2020	2020	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Drug Use and Addiction Research Programs	000	2	1/27/2020	NON-COMPETING CONTINUATION	$549,946
														Subtotal = $549,946

Issue Date FY: 2019 ( Subtotal = $588,255 )
2019	2019	KAISER FOUNDATION HOSPITALS	1800 HARRISON ST FL 16	OAKLAND	CA	94612	ALAMEDA	USA	Drug Use and Addiction Research Programs	000	1	3/8/2019	NEW	$588,255
														Subtotal = $588,255

Grand Total All Awards = $2,545,729

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Assessing the Safety and Effectiveness of Opioid Tapering in Large Health Systems

Award Number: R01DA047537

ORGANIZATION: NATIONAL INSTITUTE ON DRUG ABUSE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 03/15/2019

PERIOD OF PERFORMANCE END DATE: 12/31/2023

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