FHST #1-2020: Why-How the Veterans Affairs (VA) Should Adopt Digital Therapy Applications + A BONUS - Fed. Health Sys.Thought Leadership (FHST) Series

Purpose

Veterans with Substance Abuse Disorder (SUD) deserve access to effective, convenient, and innovative treatment options to produce superior outcomes. The purpose of this article is to illustrate why and how the Veterans Affairs (VA) should adopt Digital Therapy (DTx) applications for veterans with substance abuse disorder (SUD). The article will use an innovative FDA approved application (APP) to support Cognitive Behavior Therapy (CBT) as an example.

A BONUS! While the paper focused on why the application of DTx in the Veterans Affairs (VA) would be beneficial for veterans and an FDA approved product by Sandoz/Pear was used, other opportunities exist. As such, and as part of the VA’s Strategic Plan, the following is a set of recommendations on how Sandoz and other POTENTIAL PARTNERS could engage the VA. Included is a Strategic Engagement Planning Worksheet. 

Problem

Drug overdose deaths involving prescription opioids rose from 3,442 in 1999 to 17,029 in 2017.1 As part of the opioid and prescription opioid crisis, Substance Use Disorder (SUD) has taken a significant toll on individuals and communities the past several years.2 SUD is a chronic, relapsing addictive disease caused by recurrent abuse of alcohol or drugs – or a combination of other behavioral health factors. No demographic or group is immune, including veterans. Figure 1 illustrates how substance abuse is higher among younger veterans, and the number of patients seen by the Veterans Health Administration (VHA) continues to rise.3

Among Veterans receiving VA healthcare, there has been a sharp rise in the number of patients diagnosed with opioid use disorder (OUD) from 25,031 in 2003 to 69,142 in 2017. Afghanistan and Iraq Veterans with PTSD are using VA health care more frequently than Veterans of other eras. Afghanistan and Iraq Veterans with PTSD may also be at increased risk for poorer physical and mental health.9 As the largest provider of SUD in the nation, VA has taken proactive steps to increase access to medications indicated for OUD, which is an essential component of evidence-based care.4

A myriad of factors bearing on veterans (and civilians too) exist. Mental health conditions and SUD are associated with higher use of VA Medical Care (VAMC) services. SUD commonly co-occurs with and complicates other conditions.5 The VHA statistics indicate 440,000 VA patients were prescribed opioids (PO); 55,000 VA patients were diagnosed as having OUD, placing them at higher risk.6-8 For example, more than 2 of 10 Veterans with PTSD have SUD and almost 1 out of every 3 Veterans seeking treatment for SUD also has PTSD.10

For patients (civilian and veterans) diagnosed with SUD, inconsistent quality of treatment, patient motivation, and limited access has led to poor treatment outcomes, including low rates of abstinence and high dropout rates exists in any setting across the nation.2 Treatment means resource-intensive and face-to-face interactions–Cognitive Behavior Therapy (CBT) in individual settings for about 8-12 weeks. A major challenge is keeping patients motivated between CBT sessions or the patient’s Life Space with provider teams. It becomes more complicated when a Veterans’ Life Space challenge takes place in the context of readjustment to civilian life: social isolation, unemployment, homelessness, cognitive impairment (e.g., traumatic brain injury [TBI]) and mental health issues: depression and posttraumatic stress disorder [PTSD]).6,8,11-13

Studies show that PTSD and substance use are related to people who served in the military and civilian populations. Some cope with PTSD by drinking heavily, using drugs, or smoking too much. Individuals with drugs or alcohol problems are likely to develop PTSD.10 Lack of ability to monitor or intervene promptly outside of CBT or the veteran's Life Space or help patients identify difficult situations drive them to unhealthy actions outside the clinical setting. Consequences include decreased quality of life for patients and families, less provider satisfaction, increased costs and time invested in the process, and other destructive life events.

Solution 

The Veterans Affairs (VA) and Veterans Health Administration (VHA) leadership teams should take advantage of converging strategic opportunities and the policies, capitalize on essential trends regarding digital health, especially digital therapeutics, embrace change management, and think about the possibilities.   

First, several emerging converging strategic opportunities exist to help veterans and the nation to reduce SUD. The 21st Century Cures Act (Cures Act) is designed to accelerate medical product development and bring innovations to patients who need them now. The law incorporates the patient’s perspective into the development of drugs, biologics, and devices in the FDA's decision-making process.14-16 Enter the Digital Therapeutics (DTx) Era. Digital health describes technologies to engage patients for health-related purposes. DTx is a category of evidence-based products within the digital health landscape. DTx is distinguished from digital health categories by their evidence-based therapeutic interventions, integration of advanced technology best practices into the clinical practices, and empowerment of patients, providers, and payers with innovative tools to improve quality, safe, and effective data-driven interventions.15  Figure 2 summarizes the digital health and Digital Therapeutics (DTx) Era.

Congress passed the Veteran’s Affairs (VA) MISSION (Maintaining Internal Systems and Strengthening Integrated Outside Networks) Act, aka., VAMA.17 The VAMA provides guidance –healthcare is a process, not a place--to America's most extensive integrated health care system, the Veterans Health Administration (VHA) on how to better care for 9 million (of 22 million veterans) enrolled Veterans at 1,240 medical facilities (170 medical centers; 1,061 outpatient sites).18,19 Additional statistics are provided in Figure 3 below:

The VAMA directs consolidation of community care programs into a Veterans Community Care Program (CCP) to coordinate care for Veterans--right care at the right time from the right provider regardless of place. The VA is developing regulations to implement the VAMA while developing policies, training staff, and awarding contracts. Veterans, their families, community providers, and VA staff can expect ongoing improvements and engagement as the VA creates the CCP.20 The VA awarded contracts to manage provider networks for Regions 1, 2, and 3 of the VA’s new Community Care Network (CCN).21

The VA’s direct link with community providers ensures the VA provides get the right care at the right time. The CCN is a contract vehicle allowing the VA to purchase care for veterans from community health care providers using industry-standard approaches, guidelines, coordinate care, and manage the CCN. TriWest Healthcare Alliance expanded its network to support veteran and provider care coordination across the nation until the CCN is fully implemented. The Veterans Affairs (VA) and Veterans Health Administration (VHA) leadership teams should capitalize on these emerging opportunities and partner with companies with proven concepts to demonstrate to the nation the possibilities.

Second, most VA Medical Centers (VAMC) operate a SUD specialty care program for the treatment of drug and alcohol problems. Seven percent of Veterans receiving outpatient treatment at the VAMCs centers and clinics were diagnosed with SUD. Every VAMC operates a SUD specialty care program for the treatment of drug and alcohol problems.23 In Fiscal Year 2009, SUD programs treated 152,000 Veterans, of whom 128,000 had diagnoses of SUD, including 28.2 percent who received diagnoses of alcohol problems only; 19.3 percent who had diagnoses for drug problems only and 52.4 percent who had both alcohol and drug problems.23 The VA employs evidence-based psychosocial and pharmacologic interventions, including motivational enhancement therapy (MET), cognitive-behavioral therapy (CBT) for relapse prevention, contingency management, 12-step facilitation counseling. SUD Programs offer a continuum of services, including standard outpatient treatment, intensive outpatient treatment, residential rehabilitation treatment programs, and inpatient programs. SUD-focused behavioral programs couples counseling, as well as pharmacotherapies such as buprenorphine and other drugs. Veterans are likely to use VA for outpatient (O/P) care and VA-emphasized services, including specialized mental health care for PTSD and O/P psychiatric substance abuse counseling. Services may not be covered by private insurance or may not be as extensive as VA coverage, which usually provides these services with no or minimal cost-shares.9 

Third, the VA has an opportunity to complement and enhance current CBT practices with FDA Digital Therapy (DTx) applications. For example, according to open sources and FDA documents, Sandoz partnered with Pear Therapeutics to develop the first FDA-approved prescription digital therapy (DTx) applications: reSET? and reSET-O? with approved safety and effectiveness labels to help treat and motivate SUD patients.24,25 Pear's DTx aim is to support 12-week SUD CBT programs by interacting with patients through mobile and desktop applications between face-to-face sessions regardless of location in their “Life Space.”  Figure 4 illustrates how the application works:

The program includes digital feedback loops to monitor patient data in real-time, detect day-to-day behavioral and biological changes in condition, improve adherence, and enhance outcomes by helping patients better understand and coach themselves to better health, wellness, and resilience.2,24 Sandoz and Pear will work with providers to bring reSET?* to patients with Substance Use Disorder and reSET-O? to patients with Opioid Use Disorder (OUD) who are currently receiving buprenorphine to better address the full burden of their illnesses. When providers prescribe reSET-O?, the patient is contacted by a patient care specialist and is provided with an access code. The patient then downloads and installs reSET-O? app on their smartphone or tablet and enters the access code to unlock treatment. Patients begin working and learning with reSET-O? by completing lessons, answering quiz questions, reporting medication usage, and reporting substance use, cravings, and triggers. While the patient sees the clinician in therapy sessions and patients use the app, progress on reSET-O? is tracked via the Clinician Dashboard.26 reSET-O? serves as a training, monitoring, and reminder tool for healthcare providers by leveraging the Clinician Dashboard. The dashboard helps clinicians gain deeper insights into their patients' progress toward recovery, including patient-reported buprenorphine adherence to allow for transparency and meaningful counseling during in-person therapy sessions.26

Finally, while reSET? and reSET-O? are specific examples, VA leadership should consider the possibilities of digital therapy applications for individual segments of the VA population, such as rural and female veterans. For example, digital health could reach veterans in rural settings. 3.4 million rural veterans (41%) comprise the total number of veterans enrolled in VA health care system While SUD treatment services are available to veterans connected with VA Medical Centers (VAMC) across the country, many veterans are not connected with a local VAMC, and even when they are, access can be challenging. This situation is especially real for rural veterans who may not have a qualified provider in the area.27. Access to care, especially mental health services, is problematic for rural veterans. Access to mental health care via telehealth and application of digital therapy applications such as reSET? and reSET-O? have the potential to improve the quality of life for veterans. Veterans living in rural areas who received home-based (HBTMH) reported they prefer to receive mental health treatment using TMH would recommend TMH services to other veterans, and they felt safe and less subjected to perceived stigma, including SUD.27  integration of reSET? and reSET-O? could enhance recovery and abstinence. As another example, the personalization of digital therapy applications for female veterans is a distinct possibility. Rates of problematic substance use among female veterans have been increasing. SUD diagnoses among female veterans utilizing VA services have increased by 81% from 2005 to 2010. Female veterans find it difficult to disclose substance use to providers due to perceived stigma and shame, have higher rates of childhood sexual abuse, military sexual trauma, and domestic violence, and those with PTSD are particularly at risk of developing substance-related problems. Female veterans are likely to benefit from specialized SUD treatment and gender-tailored treatment, which may increase treatment utilization, attendance, and comfort. Female veterans receiving care at VAMCs offering specialized services for women were more likely to engage in treatment and were more receptive to SUD treatment when the services were accessible.27 

Concerns

Concerns should be embraced and considered; however, they should not be used as a means to rule out the possibilities. Concerns such as efficacy, risks and risk mitigation, application to complex patients, and capabilities beyond the scope of the application should be considered.

First, providers will be concerned about efficacy and confidence. Peer-reviewed data demonstrate higher retention rates in outpatient treatment.26 reSET?* has been clinically validated to significantly improve outcomes while providing patients a discreet way to access care when and where they need it.24 Adding reSET?* to outpatient therapy significantly improved abstinence in abuse and retention compared to the standard of care alone.24 For example, reSET-O? was evaluated in a randomized trial of 170 OUD patients with buprenorphine treatment paired with a CBT program. The clinical trial showed that reSET-O? had an overall retention rate of 82.4 percent through the end of 12 weeks of treatment compared with 68.4 percent overall retention rate for patients who did not use reSET-O.28

Second, the risk may be high, given the VAMA act mandates; however, risk mitigation can be employed. The VA Office of the Inspector General (OIG) determined expansion of community partnerships poses risks to patients who are prescribed opioids outside of VA. Recommendations centered on:

1.        Transparency and sharing between VA and Non-VA providers

2.        Use of evidence-based guidelines for prescribing opioids

3.        Purchased care for non-VA care must include up-to-date medications and medical history

4.        Non-VA providers submit opioid prescriptions directly to a VA pharmacy for dispensing and recording of the prescriptions in the patient’s VA electronic health record,

5.        VAMC leaders determine non-VA provider’s opioid prescribing practices are not in conflict with OSI or take immediate action if required.3

To manage the risk, the VHA developed and deployed two initiatives in 2014 to improve the safety and management of chronic pain in veterans: the Opioid Safety Initiative (OSI),29, and enabled VA providers to participate in State prescription drug monitoring programs (PDMP).30 The VA implemented several purchased care programs to enable veterans to access medical care in the community, including the Veterans Choice Program (Choice) program under the Veterans Access, Choice, and Accountability Act. Also, the VA could decide to only employ DTx within VA facilities, especially early on under the guise of a demonstration project.

Third, the DTx app may not be able to address co-occurring conditions among veterans. Dual diagnoses of veterans with SUDs commonly meet criteria for co-occurring mental health disorders, such as PTSD, depression, anxiety, and adjustment disorder. Among Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) veterans diagnosed with an SUD, 82%–93% were diagnosed with another comorbid mental health disorder. Individuals presenting with multiple diagnoses of SUDs and comorbid disorders demonstrate greater symptom severity and poorer treatment outcomes. Dually diagnosed veterans are also more likely to have experienced homelessness and receive VA disability benefits. Thus, there is an urgent need for efficacious treatments aimed at treating not only the SUD but also co-occurring disorders. These issues are likely to impact treatment and should be addressed during treatment. Findings from studies of integrated treatments show that substance use typically decreases significantly and does not increase with the addition of trauma-focused interventions. However, there is insufficient evidence to conclude that integrated treatments are superior to SUD-only or PTSD-only singular treatments. Further research is needed to determine whether integrated treatments outperform evidence-based SUD and PTSD treatments.27 Integration of digital therapy applications may detract from this specific challenge among veterans.

Lastly, digital therapy applications will not reduce stigma and may be difficult or beyond the scope of the current applications to be integrated into primary care. While this is a significant issue, several other factors are bearing on stigma. Stigma is sometimes encountered by veterans seeking SUD treatment. Efforts to integrate SUD care within the context of other mental health care services would be helpful. Instead of having to seek care at the "addiction clinic," veterans could be seen at a general "mental health clinic" that would address a myriad of issues (e.g., anxiety, depression, bereavement, PTSD, couples, and family therapy). Furthermore, integrating SUD care into primary care would take it another step further in reducing stigma and increasing access to care.27

Summary and Recommendations

Veterans with SUD deserve access to sufficient, convenient, and innovative treatment options that produce superior outcomes. There is a clear need for the development of novel, effective, evidence-based interventions to address the health care needs of our veterans and their family members struggling with SUDs. We are entering the Digital Therapeutics (DTx) era, and our veterans I deserve access now. For patients (civilian and veterans) diagnosed with SUD, inconsistent quality of treatment, patient motivation, and limited access have led to poor treatment outcomes, including low rates of abstinence and high dropout rates exists in any setting across the nation.2 

The major problem and solution is how to motivate patients in their Life Space. Digital therapy (DTx) applications offer an opportunity. VA leadership teams should take advantage of converging strategic opportunities and the policies, capitalize on essential trends regarding digital health, especially digital therapeutics, embrace change management, and think about the possibilities.  At the same time, concerns should be embraced and considered; however, they should not be used as a means to rule out the possibilities. Concerns such as efficacy, risks and risk mitigation, application to complex patients, and capabilities beyond the scope of the application should be considered.

For companies such as Sandoz and Pear Therapeutics, engagement with key stakeholders for advice, support, and next steps should be considered at the VA central office and discussions with Chiefs of mental health services with SUD programs. Once further guidance is provided, the possibilities and concerns can be addressed through the VA’s various Centers of Innovation (COIN) and Centers of Excellence (COE). Efforts to overcome barriers to those seeking treatment are needed so that veterans in need of services can access treatment and experience long-term recovery.  A demonstration project could follow this approach in partnership with companies such as Sandoz and Pear Therapeutics to illustrate the possibilities of using digital therapeutics for veterans.

While not part of the article, the Appendix summarizes how other companies and partners can seek access to the VA to present other innovations to support veterans.  The Appendix summarizes VA entry points and how to engage VA stakeholders and others on the possibilities.

Note on Appendix 

While the paper focused on why the application of DTx in the Veterans Affairs (VA) would be beneficial for veterans and an FDA approved product by Sandoz/Pear was used, other opportunities exist. As such, and as part of the VA’s Strategic Plan, the following is a set of recommendations on how Sandoz and other POTENTIAL PARTNERS could engage the VA. Included is a Strategic Engagement Planning Worksheet.

About the Author: Douglas “DrQD” Anderson, DHA, MSS, MBA, FACHE shares his 30+ years of experience and research as a consultant, coach, speaker, facilitator, and educator on strategic management and thinking, CQI, communication, and strategic health leader (SHELDR) development. His focus is on helping local communities integrate social services with healthcare delivery systems. He is coauthor of Health Systems Thinking: A Primer and Systems Thinking for Health Organizations, Leadership, and Policy: Think Globally, Act Locally. Follow him on Twitter: @Doug_Anderson57 and his Strategic Health Leadership (SHELDR) E-Zine. Contact him at [email protected] for opportunities to help you and your team succeed.

Disclosure and Disclaimer:  Douglas E. Anderson has no relevant financial relationships with commercial interests to disclose. The author’s opinions are his own and do not represent an official position of any organization. Any publications, commercial products or services mentioned in his publications are for recommendations only and do not indicate an endorsement. All non-disclosure agreements (NDA) apply.

References: All references or citations will be provided upon request. Not responsible for broken or outdated links, however, report broken links to [email protected]

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