DHA Research and Development Science that Delivers · DHA Research and Development Science that...

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DHA Research and DevelopmentScience that Delivers

Dr. Sean BiggerstaffActing Deputy Assistant Director

Defense Health Agency, Research & Development Directorate

Presentation to:Association of Military Surgeons of the United States (AMSUS)

National Harbor, MD

December 3, 2019

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Disclosures

• Presenter has no conflicts of interest to disclose.

• The views expressed in this presentation are those of the authors and do not necessarily represent the official policy or position of the Department of Defense, Defense Health Agency, or any other U.S. government agency. This work was prepared as part of official duties as U.S. Government employees and, therefore, is defined as U.S. Government work under Title 17 U.S.C.§101. Per Title 17 U.S.C.§105, copyright protection is not available for any work of the U.S. Government.

December 3, 2019 "Medically Ready Force...Ready Medical Force" 2

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Objectives

1. Describe how the DHP Research & Development supports the mission of a ready medical force.

2. Understand the Defense Health Program and how research is executed and funded.

3. Translation and transition of research into products.


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DHA Director’s Priorities Aligned to the DHA Strategy Map

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GreatOutcomes

Ready Medical

Force

Satisfied Patients

Fulfilled Staff

1 2 3 4

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Supporting the Enterprise Learning Health System

"Medically Ready Force...Ready Medical Force" 5

Diagram: Kaiser Permanente Washington Health Research Institute*University of Michigan Medical School, Learning Health System Definition

To drive operational efficiencies to align research capabilities to support the enterprise Learning Health System and solve problems faced by the warfighter and beneficiaries. We are an enabler for innovative improvements in patient outcomes and the delivery of care.

Continuously self-study and adapt using data and analytics to generate knowledge, engage stakeholders and implement behavior change to transform practice.*

Support data-driven decision making by using quantitative research to inform changes in treatment and care to improve outcomes.

Disseminate knowledge throughout the system, proliferating standardized, repeatable and proven practices that elevate clinical quality and support readiness.

December 3, 2019

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Science That Delivers


Front (Left) EndIdentify and provide insight into gaps in research areas and clinical practice.

Back (Right) EndTranslate research results into practical/ clinical knowledge, products, and policy recommendations. Disseminate that information.

Middle (Books)In partnership with the government, academia, and industry we populate

the “bookshelf” by engaging in research and/or clinical investigations.

S&T Studies &

Analysis

Clin

ical Inve

stigation

s

CoEs Ad

vance

dD

eve

lop

me

nt

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DHA R&D (J-9) Organization

Mission: Lead the discovery, development, and delivery of enhanced pathways to military health and readiness

Vision: To bridge the future of military health and readiness


Deputy Assistant Director Research and Development

(J-9)

Vision Center of

Excellence

Psychological Health Center of Excellence

Defense & Veterans Brain

Injury Center

Hearing Center of

Excellence

Information

Management

Prevention & Surveillance

Clinical Care & Rehabilitation

Research

National Museum of Health and Medicine

Research Program

Administration

Office of the Director

Administration &

Operations

Performance &

Analytics

Primary Care

Behavioral Health

Clinical Care

Research

PH Promotion

Operations

Clinical Affairs

Research

Education

Support

Collections

Engagements &

Exhibitions

Chief of Staff

Research Portfolio

Oversight Management

Interagency Partnership,

Coordination & Outreach

Research Regulatory Oversight Office

Information

Management & Informatics

Education, Training, Modelling & Simulations

Rehabilitation & Reintegration

Clinical Care

Research & Surveillance

Business Support Office

Communications

Knowledge Translation

& Partnerships

Clinical Investigations

Program & Health Services Research

Federal Research Coordination & Support

R&D Decision Support

Strategy Development

Deputy Director

Human Research

Protection Program

Research Integrated

Product Team

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Delivering Materiel & Knowledge Products


Knowledge Products

• Assessment Tool

• Military Acute Concussion Evaluation 2 (MACE 2): Incorporatess current state-of-the-science TBI information, including vestibular-ocular-motor screening. Ref: DoDI 6490.11 - DoD Policy Guidance for Management of Mild Traumatic Brain Injury/Concussion in the Deployed Setting

• Clinical Recommendations - Suites of tools (normally Clinical recommendation, brochure or fact sheet, and reference cards)

• Eye and Vision Care Following Blast Exposure and/or Possible TBI

Ref: VHA Notice 2017-35 – Recession of VHA Directive 2008-065, Performance of TBI Specific Ocular Health and Visual Functioning Examinations for Polytrauma Rehabilitation Center Patients (25APR2017)

Materiel Products

• Endovascular Hemostasis (REBOA): Used in patients that are rapidly bleeding. In addition to the 14 military lives saved in combat, there have now been a documented 200 civilian lives saved by REBOA.

• KeraStat® Burn Gel: Used at all points of care as a wound dressing for partial thickness burns and other partial thickness wounds. Will increase readiness, reduce disability and care costs, and improve quality of life.

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Research and Research Funding

• RDT&E funding: Big “R” Science and Technology (Budget activity 6.1 to 6.3): Basic Science, Applied

Science, and Advanced Technology Development

Advanced Development (Budget activity 6.4 – 6.7): Advanced Component Development, Systems Development and Demonstration, RDT&E Management, Operational System Development

• Operations and Maintenance funding: Little “r” Studies and analysis

Clinical Investigations Program

GME

Quality and Process Improvement


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History of the DHP RDT&E programUnderstand the Defense Health Program and how research is executed and funded.


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Management Hierarchy and Roles


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Defense Health Program RDT&E


DHP RDT&E

Army

R&D funding structure addressing highest-priority needs across the MHS

Air Force Navy USUAdvanced

Developers

Research, Development, &

Directed RequirementsNamed Programs Named Programs Named Programs

Joint Program

Committees

Strategic Guidance

Capability Documents

Executive Direction

Named Programs

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DHP Research Investment Areas


Photos courtesy of DoD

Medical Simulation & Information

Sciences

•Medical Modelling & Simulations

Military Infectious Diseases

•Bacterial

•Parasitic

•Viral

Military Operational

Medicine

•Injury Prevention & Reduction

•Psychological Health & Resilience

•Physiological Health

•Environmental Health & Protection

Combat Casualty Care

•Neurotrauma & Traumatic Brain Injury

•Hemorrhage Control & Resuscitation

•Forward Surgical

•Photonics & Light-Based Innovation for Severe Injury

Radiation Health Effects

•Post-Exposure mitigation of radiation injury

•Protection & Prevention

•Mechanism of Radiation Injury

•Develop Biodosimetry tools

Aeromedical

•Physiological Episodes “Hypoxia”

•Medevac/ En-Route Care

Clinical & Rehabilitative

Medicine

•Neuromusculo-skeletal Injury Rehabilitation

•Military Cancer

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Execution Managers


• Uniformed Services University of the Health Sciences

• Army Medical Research & Development Command

• Office of Naval Research

• Navy Bureau of Medicine and Surgery

• Combatant Commands (E.g. United States Special Operations Command)

DHA Research and Development Directorate manages and executes the DHP RDT&E Science and Technology appropriation through Execution Managers:

• Air Force 711th Human Performance Wing

• Air Force 59th Science & Technology Squadron

• Air Force Office of Scientific Research

• Congressionally Directed Medical Research Program

• Academia

• Industry

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Research Planning & Execution Process

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State of Science/Research

Analyses

Research Gap Identification

Strategic Planning

Research Prioritization

Research Implementation

Plan

Review and Analysis

Portfolio Analysis

Transition of Materiel

Solutions to End-Users & Adv. Development

Dissemination of Knowledge

Solutions & CPGs to End-Users

Scientific Review

Programmatic Review

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Studies and Analyses

• Post-Traumatic Brain Injury visual dysfunctions study. Clinical techniques resulted in implementation of better measures in patients care, in research and clinical training.


Psychological Health

Traumatic Brain Injury

Hearing

Vision

• New evidence briefs on: Crisis Response for Suicidality; Lethal Means Safety for Suicidality; and Seeking Safety for PTSD with Comorbid Substance Use Disorder.

• Systematic reviews identify and promote evidence-based practices for PH. In-progress reports include: Transcranial Magnetic Stimulation (TMS) for Adults with PTSD; Adjustment Disorder Predictors and Prognosis; and Differential Mental Health Treatment Dropout Rates among Military Personnel.

• FY07 NDAA Sec. 721 15-year Longitudinal Study on traumatic brain injury incurred by members of the Armed Forces in Operation Iraqi Freedom and Operation Enduring Freedom.

• Deputy Secretary of Defense Comprehensive Strategy and Action Plan for Warfighter Brain Health Initiative’s Research Line of Effort and the FY18 NDAA Sec. 734 Longitudinal Study’s Health & Performance Line of Inquiry for blast pressure exposure of members of the Armed Forces.

• Military studies to assess functional communication performance with hearing profiles to help hearing health professionals communicate hearing readiness to Combatant Commands.

• Study to determine how factors such as age, gender, pay grade, job role, and the accession audiogram impact the progression of hearing loss. Results will refine DoD accession standards.

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Way Ahead for Clinical Investigations Program and Human Research Protections Program

• Starting 1 October 2019, on a rolling basis, the DHA began assuming HRPP oversight for the 34 MTFs conducting human subjects research

• A single submission process and template to capture all required information for each review

• All necessary reviews are completed concurrently in one system

• Improve submission process through user feedback

• Reduce compliance issues

• Increase in researcher satisfaction

• Reduce the number of status update requests from researchers


Human Research

Protections Program

Clinical Investigations

Program

• Centralized DHA program office: Joint manning of the program office; Consolidated program funding

• Centralized administration of CIP research

• Database of CIP research being conducted; utilize Institutional Review Board (IRB) technology for data capture

Consolidated performance metrics

Annual research priority setting review that meets DHA, Services, Joint Staff research & training priorities

Coordinated PPBE and contract activities

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Health Services Research

Supports the transition and transformation of the Military Health System to a data driven organization capable of providing innovative, quality care informed through rigorous research


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J-9 Knowledge Implementation Capability


Current State: On average, it takes more than a decade before important research and medical breakthroughs are accepted and practiced in a hospital or clinic.

Approach: Apply sustainable dissemination, implementation, and evaluation best practices to efficiently and effectively move research resulting in knowledge products into practice.

Ideal State: Standardized process for translation of knowledge products across the enterprise, a reduced “bench to battlefield” time, optimized provision of care, and maximized return on research investment.

Best Practices• Dissemination (e.g., market research, social media content, infographics)• Implementation (e.g., trainings/webinars, facilitation, train the trainer)• Evaluation (e.g., SMART objectives, focus groups, surveys, logic models)

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VA’s Rapid Response to the Opioid Crisis


Results

• Participating providers had naloxone co-prescription rates 7x higher than providers who did not

• 800 opioid overdose reversals

• 205,100 veterans received naloxone

Academic Detailing

Evidence-based

information

Peer outreach

Direct one-on-one

instruction

To combat the opioid crisis, the VA developed the Opioid Overdose Education and Naloxone Distribution (OEND) Program.

References:• Bounthavong, M., Harvey, M. A., Wells, D. L., Popish, S. J., Himstreet, J., Oliva, E. M., ... & Christopher, M. L. (2017). Trends in naloxone

prescriptions prescribed after implementation of a National Academic Detailing Service in the Veterans Health Administration: A preliminary analysis. Journal of the American Pharmacists Association, 57(2), S68-S72.

• “VA equips 200,000 Veterans with lifesaving naloxone” (https://www.va.gov/opa/pressrel/pressrelease.cfm?id=5349)

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MHS Adaptation


• J-9 coordinated with the Defense & Veterans Center for Integrative Pain Management (DVCIPM) to stand up an OEND program tailored to the MHS environment

• J-9 and DVCIPM designed a phase-based approach to pilot and scale the OEND program using a train the trainer model

MHS Challenges:• Frequent transitions of providers

and program staff• Large community with varying

policies and capabilities• Expectation that policy drives

change

*Elevated Risk defined as having a Risk Index for Overdose or Serious Opioid-Induced Respiratory Depression (RIOSORD) > 32

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Questions?

"Medically Ready Force...Ready Medical Force" 22December 3, 2019

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