Funded Projects

NOFO Title: Administrative Supplements to Existing NIH Grants and Cooperative Agreements (Parent Admin Supp Clinical Trial Optional)
NOFO Number: PA-18-591
Summary:

African American adults are less likely to receive analgesics, particularly opioids. Research in the pediatric surgical population is limited, but the pattern of disparate use of opioids appears consistent with adults. Furthermore, adolescent access to prescribed opioids has increased, both through physician prescribing and misuse of medications prescribed to family members or friends. This study will explore the interrelated impacts of policy, clinical need, and sociodemographic factors by combining Medicaid claims and electronic health record data with findings from a statewide opioid policy inventory. We will focus on discharge prescribing of opioids in three high-volume pediatric surgical procedures: tonsillectomy/adenoidectomy, supracondylar fracture, and appendectomy. We aim to 1) determine the extent of racial disparities in postoperative discharge opioid prescribing since the 2011 onset of enhanced opioid prescription reduction activities and 2) develop an expanded model to assess the linkage between differential opioid use for pediatric postoperative pain and opioid use-related outcomes.

NOFO Title: Implementation Science Research to Improve Dental, Oral and Craniofacial Health (U01)
NOFO Number: RFA-DE-18-001
Summary:

The primary objective of this project is to de-implement the use of opioid analgesics for the management of postoperative pain following dental extractions and to implement effective alternative pain management. We propose a cluster-randomized trial designin which dental practitioners are randomly assigned to one of three conditions: 1) standard practice as a control condition; 2) a clinical decision support (CDS) tool that will extract patient history and interface with the state prescription drug monitoring program to provide personalized recommendations for analgesic prescribing and offer language for discussing non-opioid pain management; 3) an enhanced version of the CDS (CDS-E) that will also include information regarding optimal, evidence-based non-opioid pain management delivered to the patient both before and following the dental extraction visit. We will examine opioid and non-opioid prescribing data from the electronic health record across study arms as well as other provider- and patient-focused outcomes using mixed methods.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Reduce Stigma in Pain Management and Opioid Use Disorder (OUD) and Treatment
NOFO Number: NOT-OD-20-101
Summary:

Medications have proven to be effective for treating opioid use disorder (OUD). Increasing accessibility to buprenorphine provides an opportunity for many with OUD to benefit from its proven effectiveness. Adherence to medication-based treatments however is low, in part because of the stigma associated with use of this and other effective drugs and as such, leads to inadequate treatment and poor outcomes. This study aims to understand the effects of stigma on patient engagement, retention, and outcomes of buprenorphine treatment. Knowledge drawn from the HIV Stigma Theory and tools developed to reduce HIV associated stigma will be used to assess OUD stigma and to develop interventions to reduce it in the context of buprenorphine treatment. The study findings may provide resources to address stigma and thus maximize treatment adherence among those affected by OUD.

NOFO Title: Data Coordinating Center for the NICHD Cooperative Multicenter Maternal Fetal Medicine Units Research Network (U10)
NOFO Number: RFA-HD-13-014
Summary:

Cesarean deliveries are the most commonly performed surgical procedure in the United States. Opioids are almost universally used for post-cesarean analgesia management. Studies suggest that most women are prescribed more tablets at discharge than needed. These often go unused, providing an important reservoir contributing to the opioid crisis. Physicians struggle to prescribe and dose postoperative opioids appropriately while tackling the real needs of acute pain from surgery. Without literature to guide obstetric providers on appropriate amounts of opioids to prescribe upon discharge, actual prescription amounts nationally vary widely by up to 65 tablets. To improve post-cesarean opioid prescribing practices without compromising pain management, the study will test an individualized, patient-empowered approach for pain management and opioid prescription quantity. This is a noninferiority randomized trial of 5,500 women with a cesarean delivery who will be randomized prior to discharge.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed)
NOFO Number: NOT-NS-21-048
Summary:

Identifying optimal chronic low back pain treatments on a patient-specific basis is an important and unresolved challenge. Tailoring interventions according to patient movement characteristics is one option. This research is characterizing patients based on spinal motion during functional tasks and daily activities and will use artificial intelligence to objectively characterize motions of the spine during both clinical assessments and day-to-day life. During clinical assessments, participants will be asked to perform functional tasks while wearing motion sensors. Data collected from the sensors will be used to identify tasks of interest, such as activities of daily living and aberrant/painful motions. An artificial intelligence approach will then interpret data collected continuously during assessment in patients’ homes over a 7-day testing period. Ultimately, this data could be used to help clinicians tailor treatments that are responsive to a patient’s real-world functional impairments.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Promote Training in Clinical Research on Pain (Admin Supp ? Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-044
Summary:

There are numerous non-pharmacological interventions for chronic low back pain, yet no treatment is invariably effective for all. Understanding patient characteristics that predict differential responses to these non-pharmacological interventions will allow for tailored treatments to maximize positive patient impact. This supplement supports a training experience for an individual in clinical pain research, including exploring differential response to psychotherapeutic interventions. The aim of the project is to provide an extensive systematic literature review examining baseline phenotypic factors that predict differential responsiveness to the some of the most commonly used psychotherapeutic interventions for chronic low back pain.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

Chronic overlapping pain conditions represent up to half of all chronic pain cases and can be more debilitating than other forms of chronic pain. These conditions include but are not limited to the following: temporomandibular disorders, fibromyalgia, irritable bowel syndrome, vulvodynia, interstitial cystitis/painful bladder syndrome, painful endometriosis, chronic tension type headache, migraine headache, chronic low back pain, and chronic fatigue syndrome. Common neurobiological mechanisms have been suspected to account for the overlap between these conditions, but until recently it has been difficult to efficiently classify each condition within individual patients. A digital classification tool for clinicians has been developed for this purpose, but access to the tool remains limited. Here we propose converting this chronic overlapping pain conditions classification tool into a common web-based application format.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

The University of California, San Francisco, as part of the Back Pain Consortium (BACPAC) Research Program, has established a Core Center for Patient-centric Mechanistic Phenotyping in Chronic Low Back Pain (REACH). The main goal of REACH is to define different subtypes (phenotypes) of chronic low back pain as well as to identify underlying pain mechanisms that can lead to effective, personalized treatments for patients across all population subgroups. To achieve this goal, REACH is, or will be, participating in several clinical trials, and it is imperative that the patients participating in these trials reflect the diversity of the U.S. population. Therefore, this project seeks to adapt methods that have successfully improved minority participation in other settings as well as to develop and deploy digital strategies that can promote recruitment and engagement of patients from marginalized populations.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Support Career Enhancement Related to Clinical Research on Pain (Admin Supp – Clinical Trial Not Allowed) 
NOFO Number: NOT-NS-21-048
Summary:

The Acute to Chronic Pain Signatures (A2CPS) Program aims to identify combinations of biomarkers that predict susceptibility or resilience to the development of chronic pain. This career enhancement award will help a promising postdoctoral trainee gain access to tools and develop skills needed to pursue a career in clinical pain research. The research involves conducting collaborative multi-site cohort studies and analyzing A2CPS data to determine if a combination of metabolic and psychosocial biomarkers can be used to explain pre-surgery differences in pain, function, and disability in patients with severe knee osteoarthritis.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

There is a clear public health imperative to improve the care and outcomes of people who experience severe acute and chronic pain. The Early Phase Pain Investigation Clinical Network (EPPIC-Net) is charged with conducting deep phenotyping and biomarker studies for specific pain conditions – and with conducting high-quality phase II clinical trials to test novel non-opioid pain treatments with academic and industry partners. This research will extend EPPIC-Net’s current portfolio to develop novel and efficient data-analytic methodologies for complex medical data, such as those that are expected to be generated by the clinical trials conducted by EPPIC-Net.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for Administrative Supplements to Promote Training in Clinical Research on Pain (Admin Supp ? Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-044
Summary:

Exacerbation of health disparities has emerged during the COVID 19 pandemic and highlighted the recognition that minority underrepresentation in clinical research may contribute to racial disparities in health outcomes. In clinical trials related to pain, disparities in trial patient inclusion are documented by white patients often being overrepresented. Mitigating these disparities is an area in which an early-career pain investigator training and contributions may have lasting benefits. The pandemic also drove rapid expansion of telehealth for pain management without knowledge of how social and demographic factors affect utilization patterns of this care delivery model. This supplement supports research to examine the extent to which disparities exist in access to and outcomes of telehealth in socially marginalized pain patients. Findings will be applied to enrich the diversity in clinical trial populations for phase 2 safety trials performed in the HEAL EPPIC Network.

NOFO Title: HEAL Initiative: Notice of Special Interest (NOSI) regarding the Availability of Administrative Supplements to Support Strategies to Increase Participant Diversity, Inclusion and Engagement in Clinical Studies
NOFO Number: NOT-NS-21-025
Summary:

A main goal of the NIH HEAL Initiative and the Early Phase Pain Intervention Clinical Network (EPPIC-Net) is to improve non-opioid pain management. This award will leverage the resources at one of EPPIC-Net’s Specialized Clinical Centers by implementing and evaluating strategies to improve the engagement, recruitment, and retention of individuals from underserved racial/ethnic minority populations to participate in EPPIC-Net clinical trials. Since environmental, cultural, and genetic factors may account for observed differences in pain responses between racial and ethnic groups, enrollment of a diverse sample in pain research is crucial to obtain a complete understanding of the effectiveness of any proposed pain therapeutic intervention. The success of these activities will be evaluated, and a toolkit will be created to define best practices that can be by other EPPIC-Net sites and additional trials.

NOFO Title: Notice of Special Interest to Encourage Eligible NIH HEAL Initiative Awardees to Apply for PA-20-222: Research Supplements to Promote Diversity in Health-Related Research (Admin Supp - Clinical Trial Not Allowed)
NOFO Number: NOT-NS-20-107
Summary:

A significant gap exists in understanding of the barriers blocking access to specialized care for children of color who experience headaches, as well as to understand and appreciate the impact of undertreatment on a child’s functional ability and quality of life. Long-term, this research aims to understand these barriers to care and test interventions to remedy disparities. As the first step, this project's primary objective is to identify socioeconomic and clinical factors that lead children experiencing headache to seek care in an emergency department in lieu of outpatient neurology care. The results of this research will help to inform efforts to reduce the negative effects of emergency department overuse in this population and guide them to potentially more appropriate outpatient care.