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A Decentralized Trial of Evidence-Based Pain Care in Rural Communities

Award Number: R01AT013631
ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2026
PERIOD OF PERFORMANCE END DATE: 07/31/2029

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A Decentralized Trial of Evidence-Based Pain Care in Rural Communities - PROJECT SUMMARY Chronic pain imposes tremendous burden on society, with disproportionate impact on rural communities. Evidence-based, mind and body interventions for persons with chronic pain involve nonpharmacologic care often provided by physical therapists (PTs). Nonpharmacologic mind-body EBIs are underutilized, and often un- available, in rural communities with profound consequences including greater risk for disability, work loss and opioid use. Social determinants of health create unique challenges for EBI delivery in rural communities. Rural residents tend to have less healthcare access, lower income, less education attainment, etc. Persons of Hispanic/Latino ethnicity are a growing part of rural communities, increasing the need for culturally-congruent care. COVID showed the potential of telehealth to expand access to evidence-based care, while also raising many questions for rural residents. An array of digital health technologies hold promise to increase the reach and impact of telehealth, but have not been developed or studied in partnership with rural communities. The overall goal of the Better Pain Care with Telehealth & Technology (BP-2) trial is to better leverage digital health strategies to improve pain management in rural communities. BP-2 is a hybrid II effectiveness-implemen- tation trial that uses a study-within-a-trial design to efficiently address two research gaps; 1) how to best leverage digital health to provide mind-body pain EBIs using TH; and 2) how to reach persons in rural communities to connect to a mind-body pain EBI. BP-2 is a fully de-centralized trial, a key design consideration for increasing participation of rural healthcare settings and residents. We will partner with Federally Qualified Health Centers and two large health systems to identify persons with chronic musculoskeletal pain via electronic health records and randomize them to different text messaging (TM) strategies to reach and connect them to a PT-led telehealth EBI. Four TM strategies will test factorial combinations of two factors; 1) TM content (personalized or not), and 2) TM cadence (weekly or early density). In the second randomization persons who connect to the telehealth EBI and enroll are randomized to a delivery strategy; 1) TH, or 2) TH with app-based remote monitoring (TH+). The BP-2 study will use this design to test 3 specific aims; 1) determine differences in delivery strategies for telehealth EBI (TH vs/ TH+) for rural residents, 2) determine differences in reach among TM strategies to connect rural residents to a pain EBI, and 3) explore mind-body pain EBI implementation outcomes with rural residents using mixed methods. BP-2 addresses critical research gaps on how to use digital health to reach patients, and optimize the effectiveness evidence-based, nonpharmacologic, mind-body interventions.


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: 2026 ( Subtotal = $2,126,986 )
2026	2026	UNIVERSITY OF UTAH	201 PRESIDENTS CIR	SALT LAKE CITY	UT	84112	SALT LAKE	USA	The National Institute of Neurological Disorders and Stroke (NINDS) Helping to End Addiction Long-term® (HEAL) Initiative	000	1	8/18/2026	NEW	$2,126,986
														Subtotal = $2,126,986

Grand Total All Awards = $2,126,986

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A Decentralized Trial of Evidence-Based Pain Care in Rural Communities

Award Number: R01AT013631

ORGANIZATION: CENTER FOR DRUG EVALUATION AND RESEARCH, NIH

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2026

PERIOD OF PERFORMANCE END DATE: 07/31/2029

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