Internet-delivered pain self-management to reduce pain and interference in chronic pancreatitis

Active Project Grant Awarded Last action

Award ID
R01DK137520
Recipient
Awarding agency
Obligated
$3,036,150

Award facts

Completion date 64% complete
Place of performance
Seattle, WA 98101, USA

Award details come from USAspending.gov.

Description

As the agency reported it.

Abstract
Severe abdominal pain is a cardinal symptom of pancreatitis, present in up to 90% of patients with recurrent acute pancreatitis (RAP) and chronic pancreatitis (CP). As pain increases in severity and constancy, IT is associated with significant morbidity including depression and anxiety symptoms, low physical functioning, sleep disturbance, and low quality of life, as well as high economic and societal burden. Painful RAP and CP is most often managed with chronic opioids, which unfortunately have limited efficacy and substantial risk for adverse side effects. This application focuses on addressing this treatment GAP in pain management with a well-established nonpharmacologic intervention. Our team has established efficacy of an internet-delivered cognitive-behavioral therapy (CBT) intervention for chronic pain, and recently adapted IT for pancreatitis pain (the pancreatitis pain course), showing promise for reducing pain and disability in this population. We propose a hybrid effectiveness-implementation design type 1 trial to make rapid translational gains with the primary goal of gathering data on CBT treatment effects on pancreatitis pain and pain interference in individuals with RAP and CP with a secondary goal of gathering implementation data to inform dissemination of the pancreatitis pain course to real-world settings. Our central hypothesis is that the pancreatitis pain course will be effective in reducing pain interference and severity in individuals with painful RAP and CP. Our specific aims are to 1) determine the effectiveness of the pancreatitis pain course in improving pancreatitis pain outcomes, 2) (exploratory) explore the moderating effects of social determinants of health with changes in pain interference and severity following treatment, and 3) identify implementation facilitators, challenges, and solutions for structures and processes that contribute to the seamless integration of the pancreatitis pain course into clinical centers and the community. This study will leverage resources of the chronic pancreatitis, diabetes, and pancreatic cancer (cpdpc) consortium, a niddk-sponsored U01 consortium with recruitment from their nine clinical centers and from self-referral in the community through partnership with the national pancreas foundation. Using a multicenter randomized-controlled pragmatic clinical trial, we will enroll 280 individuals with painful CP into the clinical trial and randomize them to CBT, providing access to the pancreatitis pain course to learn pain self-management skills (e.g., relaxation, activity pacing, goal setting) or education control (access to education website about RAP and CP pain). We will collect patient-reported outcomes at baseline, two months, and six-month follow-up. Relevant stakeholder groups (patients, providers, organizational managers) will participate in a process evaluation to inform future implementation in clinic and community settings. The proposed investigation will significantly advance solutions for nonopioid pain management in CP. If successful, our project will minimize disparities in care, and address a critical need for low-cost, accessible pain self-management for individuals with painful CP.

Transactions

Action Obligated Date
Amendment $697,377
Amendment $706,679
Amendment $726,463
Original award $905,631

Subawards

Subrecipient Amount Awarded
Baylor College Of Medicine As Site PI, Dr. Fisher will assist with patient recruitment and referral. He will serve as the local site champion for the Baylor College of Medicine pancreas… $56,794
Regents Of The University Of Minnesota As Site PI, Dr. Bellin will assist with patient recruitment and referral. She will serve as the local site champion for the University of Minnesota pancreas… $62,197
Trustees Of Indiana University Indiana University, under the guidance of PI, Dr. Evan Fogel, will serve as a subaward on Seattle Children’s Hospital proposal, titled… $55,795
The Leland Stanford Junior University As Site PI, Dr. Park will assist with patient recruitment and referral. He will serve as the local site champion for the Stanford University pancreas center and… $58,308
Cedars-Sinai Medical Center As Site PI, Dr. Pandol will assist with patient recruitment and referral. He will serve as the local site champion for the Cedars-Sinai Medical Center… $62,459
Macquarie University Professor Blake Farran Dear will provide advice, guidance and assistance across all aspects of the project, but will focus on the implementation, use and… $53,094
University Of Florida 1. Obtain IRB approval and any local site-specific committee approval 2. Identify and recruit eligible subjects for the study 3. Complete all study CRFs for… $34,518
Mayo Clinic This clinical trial is to assess the efficacy of Internet delivered pain self-management in patients with painful chronic pancreatitis. For this study, the… $38,786
The Ohio State University Dr. Hart is a Professor of Medicine in the Division of Gastroenterology, Hepatology, and Nutrition. As a coinvestigator, he will serve as the site PI for The… $59,040
The University Of Kentucky Research Foundation As MPI, Dr. Conwell will assist with all aspects of the referral and recruitment process for the study including collaboration with the CPDPC site PIs,… $196,434
University Of Pittsburgh - Of The Commonwealth System Of Higher Education As a Co-Investigator, Dr. Yadav will assist with refining the eligibility criteria, exclusion criteria, screening protocol, and patient recruitment and referral… $115,488
University Of Illinois Dr Ardith Doorenbos will lead the implementation assessment of the grant or Aim 2 activities. This includes overseeing the qualitative interviews, analysis,… $127,060
Show all 12

Quick answers

Who received award R01DK137520?

R01DK137520 was awarded to Seattle Children's Hospital by National Institute of Diabetes and Digestive and Kidney Diseases (National Institutes of Health) on September 1, 2023.

How much is award R01DK137520 worth?

$3,036,150 has been obligated on R01DK137520.

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