HEAL Initiative: Coordinated Pain Care in Health Care Systems Research Program – Coordinating Center (U24 Clinical Trial Not Allowed)

July 29, 2022 by dld5dt@virginia.edu

Purpose:

The purpose of this FOA is to solicit applications for a Coordinating Center to provide leadership for the HEAL Coordinated Approaches to Pain Care in Health Care Systems Program. The Coordinating Center will 1) work collaboratively with each Project team supported through the Collaboratory program, including their partnering health care system (HCS), to develop, test, and implement the proposed Projects while providing technical, design, and coordination support; 2) provide centralized resources (e.g., electronic health records expertise, study design and statistical expertise for implementation trials, bioethics and regulatory expertise) for coordination and integration of the research effort across all projects; and 3) centralize the engagement of patients, care providers, health care systems, payors, and policy makers to inform the activities of the program of research, with a particular focus on HCS with less historical involvement in research studies. The Coordinating Center also will serve as the central administrative resource for the activities of the Coordinated Approaches to Pain Care Program.

Background:

The HEAL Coordinated Approaches to Pain Care in Health Care Systems Research Program

The overall goal of the HEAL Coordinated Approaches to Pain Care in Health Care Systems Research Program is to provide additional evidence to enhance the ability of health care delivery organizations to implement coordinated and personalized care to manage complex pain conditions.

The biopsychosocial model of pain highlights the need for coordinated and personalized care to manage complex pain conditions. Pain care is too often delivered as single modality through one setting, providing inadequate pain management, and resulting in poor outcomes. Coordinated personalized care should optimize use of effective medications, procedures, physical function and/or psychological therapies, patient self-management strategies, and complementary approaches to manage pain. The care plan should be centered on patient goals and can be achieved by leveraging existing HCS resources delivered though a coordinated approach and supported by payor policies and guidelines. An integrated (AHRQ) coordinated care approach would provide support for primary care providers to interact with related care teams to enhance evidence-based coordinated care through referral to specialty care as needed. A comprehensive (AHRQ) coordinated care approach would provide appropriate components of coordinated pain care in a specialty clinic or rehabilitation setting in consultation with primary care.

This program will have two main components:

A Coordinating Center (CC) solicited by this funding opportunity announcement (FOA) that will: 1) provide leadership for the program and further develop, adapt, and adopt technical and policy guidelines and best practices for the efficient conduct of research on coordinated models of pain care; 2) work collaboratively with each team supported through the HEAL Coordinated Approaches to Pain Care Program by providing technical, design, and coordination support for the trials; and 3) identify and disseminate the best strategies for engaging health care systems as research partners to implement coordinated pain care programs. The Coordinating Center also will serve as the central administrative resource for organizing the activities of the Coordinated Approaches to Pain Care Program.

The coordinating center will:

• Establish a steering committee to oversee the awarded Individual Implementation Research Projects.

• Create a consortium to coordinate and integrate research across all study teams.

• Establish working groups led by experts from the CC and populated by representatives from each research project to enhance study designs, optimize patient engagement, provide biostatistical expertise, assist with creating plans and testing use of data from the electronic health records, facilitate interactions with the health care systems, address bioethics and regulatory issues of the trials, and inform augmentation of electronic health record data to capture patient reported outcomes if appropriate.

• Support centralized resources across all studies: e.g., patient/community engagement strategies; assist individual teams with their efforts to diversify and retain the research workforce and patient population; data collection, sharing, and harmonization of common measures; and engagement with payers, policy makers, and health care systems.

Individual Implementation Research Projects (5 to 6), will be awarded through a related funding announcement RFA-NS-22-053, to a variety of HCSs where coordinated care does not exist or has limited uptake by patients. The goal of the research projects is to rigorously assess and embed implementation strategiesfor evidenced based coordinated care approaches into partner HCS, one with research resources and one with limited research resources and expertise The collective goal of this program is to answer the question of how best to deliver effective coordinated pain care in a variety of HCS in accord with their available resources for health care delivery.

HCSs of interest include:

  • Private or Nonprofit HCSs with infrastructure and resources for delivery and coverage of coordinated care components through specialty care centers to provide comprehensive care.
  • Private or Nonprofit HCSs with coverage for services provided in part through primary care and in part through referral to other specialty services within the HCS for integrated care.
  • Public HCSs with capability for delivery of services in part through primary care and in part through referrals to other specialty services for integrated care (e.g., FQHCs)
  • Disability programs for patients with work related injury or on short-term disability receive coverage for medical services that may be done via primary care and referrals or a coordinated pain care program in specialty setting.

Research areas of interest include:

  • Research studies to evaluate the effectiveness of implementation strategies to embed evidence-based approaches for coordinated pain care (integrated or comprehensive care) into a HCS.
  • Evaluation of strategies that enhance, increase the uptake of, or access to existing coordinated care pain programs for underserved populations.
  • Trials to assess and embed innovative approaches to optimize existing coordinated pain care models in an HCS: e.g., improve access to coordinated care, expand available services, enhance stakeholder engagement in developing care plans, or extend community partnerships.
  • Hybrid trials which test the effectiveness of different models of coordinated pain care AND implementation of the effective models.

Essential items for the Coordinated Approaches to Pain Care Program Implementation Research Projects:

  • A proposed coordinated care approach that includes at a minimum a multidisciplinary set of treatments, including as appropriate medication management program, psychological approaches and physical interventions. Additional interventions such as, but not limited to, procedures and complementary interventions may be included.
  • Partnership between two HCS, one with research resources and expertise and one which has little or no history of not participation in research.
    • It is anticipated that the Projects will be performed with high volume electronically supported integrated HCS to establish efficiencies. The HCS partnership must facilitate access to all data sources relevant to the project.
  • Utilization of rigorous methods and study design for an implementation trial.
  • An implementation plan for embedding evidence-based models of coordinated pain care. A plan for service coverage within the HCS (leverage proposed CMS rule change for codes and coverage of comprehensive or integrated pain care programs).
  • Inclusion of patients, providers, payors and policy makers as stakeholders in study strategic planning, design, implementation, and evaluation.
  • A plan for sustainability of the pain care model in the participating HCSs after study completion.
  • A plan to address the NIH inlcusion policies.
  • A plan to integrate  primary care and specialty care.
  • A plan for collaboration across awarded projects and contribution to the coordinating center activities.
  • Inclusion of primary care providers in either a comprehensive or integrated care strategy to deliver coordinated care.

  • Priority will be given to projects that address scientific questions to improve the care of NIH-designated populations that experience health disparities.

  • Inclusion of stakeholders: At minimum the following: Primary care providers, specialty pain care providers, patients, payors, and policy makers.
  • A strategy to coordinate pain care planning, service delivery, and outcomes assessment between primary care and existing specialty pain care services within each of the partner HCS.
  • .Research strategy to implement the evidence-based care model into partner HCS
  • Plans to retain successful study practices beyond the duration of the award.

It is anticipated that the Research Projects will be performed with high volume electronically supported integrated HCS to establish efficiencies. The HCS partnership must facilitate access to all data sources relevant to the project. Research Project awards will  utilize a phased award UG3/UH3 mechanism, with a one-year planning (UG3) and an up to four-year implementation (UH3) phase.

Background:

Open Date (Earliest Submission Date): October 04, 2022
Letter of Intent Due Date(s): 30 days prior to application due date.
Applications Due: November 04, 2022

URL for more information:

https://grants.nih.gov/grants/guide/rfa-files/RFA-NS-22-065.html

Filed Under: Funding Opportunities