PCORI Biweekly COVID-19 Scan: Psychotherapeutic Intervention for Veterans, Clinical Trial Modules for Vaccine Development (September 15-28, 2022)
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
Concerns about a possible “twindemic” of the flu and COVID-19 have surfaced this year following a particularly rough flu season in the Southern hemisphere. Pfizer recently administered doses to the first participants in their phase 3 mRNA flu vaccine study, joining Moderna, whose trial began in June. Pfizer is also seeking an emergency use authorization (EUA) for their SARS-CoV-2 Omicron BA.4/BA.5 bivalent booster for children 5 through 11 years of age.
The potential emergence of further Omicron sublineages or of a Pi variant is adding to these winter concerns. In the hopes of identifying future threats as early as possible, scientists are using wastewater testing to track so-called cryptic SARS-CoV-2 lineages that might be evolving in people with chronic infections.
More data are emerging on neurologic post-COVID conditions (PCC). One year after having acute COVID-19, individuals in the US Department of Veterans Affairs national healthcare databases show an increased risk of many long-term neurologic disorders, both physical (joint pain, myalgia, neuropathy, hearing and vision impairments) and mental (e.g., memory problems, depression, anxiety) (see Topics to Watch for a new care model for veterans).
Recent reviews highlight the similarity between PCC and myalgic encephalomyelitis/chronic fatigue syndrome (ME/CFS) and outline how few specialists are available to treat such patients. The limited availability of care and the costs of treating a long-term chronic condition are expected to exacerbate the racial disparities of PCC. For example, one new care model requiring a $99 per month membership fee plus $170 for a 30-minute visit (only laboratory tests are covered by insurance) is available only in California, Oregon, Washington, Florida, and Arizona.
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing. Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Post-Acute COVID-19 Syndrome Coping and Recovery (PACS-CR) Psychotherapeutic Intervention to Treat Veterans with Post-COVID Conditions
At a Glance
- As many as 1 of 3 people who have acute COVID-19 develop post-COVID conditions (PCC), and veterans who have had acute COVID-19 have a 60% increased risk of mental health conditions or related prescriptions.
- The US Department of Veterans Affairs is investigating a psychotherapeutic intervention, PACS-CR, for use in veterans with PCC.
- The intervention consists of 12 weekly group teletherapy sessions aimed at improving psychological adjustment, resiliency, and coping in patients with PCC, all of which can improve functional status and quality of life.
- PACS-CR is being investigated in an unphased pilot clinical trial with primary completion expected in January 2024. The pilot study is intended to inform a future large-scale randomized controlled trial.
The PACS-CR psychotherapeutic intervention (US Department of Veterans Affairs Office of Research & Development, Washington, DC) is being investigated for use in veterans with PCC, the long-term, often debilitating condition experienced by about one-third of patients diagnosed with COVID-19.
Data from a retrospective study of 153,848 veterans who had COVID-19 showed a 60% increased risk of any mental health diagnosis or mental health–related drug prescription compared with a group of veterans who did not have COVID-19. This increase in new or worsened mental health conditions, including anxiety, depression, stress-related disorders, substance use disorders, and sleep disorders, contributes to the long-term disease burden of COVID-19.
The PACS-CR psychotherapeutic intervention, based on the CHIME conceptual framework of personal recovery processes (ie, connectedness, hope and optimism about the future, identity, meaning in life, and empowerment), consists of 12 weekly, 90-minute group telehealth sessions and optional topical group meetings, with additional 3 month follow-up after completion of the program. It aims to increase psychological adjustment, resiliency, and coping in veterans with PCC, which might improve their functional status and quality of life. The intervention is being piloted in a small, unphased, single-arm (i.e., no comparator), clinical trial of 36 veterans that is expected to reach primary completion in January 2024. This study is intended to inform a future, large-scale randomized controlled trial.
We were unable to find information regarding the potential cost of implementing this intervention.
An increase in the number of veterans experiencing PCC and mental health conditions after acute COVID-19 infection highlights a need for tailored therapeutic interventions to mitigate the long-term effects of COVID-19.
Early feedback from ECRI internal stakeholders suggested that, if the intervention is effective, PACS-CR could improve veterans’ quality of life by promoting recovery from PCC symptoms and return to normal activities. An effective therapeutic intervention might improve support for mental health conditions and reduce the stigma associated with receiving therapy. Additionally, the use of telehealth might improve disparities by removing geographic and financial barriers to accessing in-person therapy. However, use of PACS-CR might be limited for veterans who do not have or cannot use the technology required for the intervention, disproportionately increasing disparities for older and lower-income veterans. Data from the ongoing pilot study and larger, longer-term studies are needed to determine this intervention’s effectiveness before it is broadly disseminated.
- Category: Treatment
- Areas of potential impact: Patient outcomes, population health outcomes, health care costs, health care disparities
Preconfigured Decentralized Clinical Trial Modules for Vaccine Development
At a Glance
- The COVID-19 pandemic accelerated adoption of decentralized clinical trials (DCTs), which use technology and local health care providers to provide investigative treatments to patients in their home communities. DCTs have multiple potential advantages compared with traditional, centralized clinical trials, such as increased patient enrollment, quicker development, and cost savings.
- However, barriers to the uptake of DCTs remain, such as the upfront cost of new software, determining how to use it effectively, ensuring data security and patient privacy, managing the risk of trial protocol deviations, and collecting large amounts of data.
- Software company Medable recently announced it is now offering preconfigured, vaccine-specific DCT modules, designed to enable faster vaccine trials, better site and patient experiences, and expedited data delivery.
- The preconfigured DCT modules might decrease vaccine trial deployment times from more than 12 weeks on average to as little as 5 weeks.
The COVID-19 pandemic accelerated adoption of decentralized clinical trials (DCTs), which use technology and local health care providers to provide investigational treatments to patients in their home communities while conducting controlled clinical studies. DCTs have multiple potential advantages compared with traditional, centralized clinical trials, such as increased patient recruitment, retention, population representation, and real-world data collection. DCTs have been shown to decrease drug development time and result in cost savings. However, barriers to and challenges of implementing DCTs remain, such as the upfront cost of new software, determining how to use the software effectively, ensuring data security and patient privacy, managing the risk of trial protocol deviations, and managing large amounts of data.
Medable (Palo Alto, California), a software company whose stated aim is to transform clinical drug development using disruptive technologies, has supported over 300 decentralized and hybrid clinical trials globally since their founding in 2012. The company recently announced it is now offering preconfigured, vaccine-specific DCT modules, designed to enable faster vaccine trials, better site and patient experiences, and expedited data delivery. These preconfigured modules might decrease vaccine trial deployment times from more than 12 weeks on average to as little as 5 weeks, and the modules can be customized based on individual protocol needs.
A financial modeling analysis performed by the Tufts Center for the Study of Drug Development concluded that earlier forms of Medable-enabled DCTs generated a roughly $10 million return on a $2 million investment for phase 2 trials and a $39 million return on a $3 million investment for phase 3 studies.
Preconfigured, vaccine-specific DCT modules might encourage vaccine developers to adopt this methodology, which may quicken responses to novel SARS-CoV-2 variants or other emerging infectious threats such as monkeypox.
Early feedback from ECRI internal stakeholders suggested these modules might reduce costs and risks to clinical trial sponsors and might reduce the time it takes for new vaccines to reach the public. The study performed by Tufts demonstrated tangible financial and efficiency benefits from using DCTs. These advantages, combined with the off-the-shelf nature of preconfigured trials, might encourage trial sponsors to pursue this option for vaccine development. Enabling quicker responses to novel SARS-CoV-2 variants and other emerging threats might improve patient and population outcomes.
Prior research has illustrated that most patients were willing to participate in clinical trials for which they are eligible. However, stakeholders noted, because the topic of vaccine development has recently been subject to increased scrutiny surrounding misinformation, decentralized vaccine trials might be met with skepticism, and additional public outreach might be needed to improve awareness, understanding, and enrollment.
- Category: Systems and management
- Areas of potential impact: Patient outcomes, population health, clinical and/or caregiver safety, health care delivery and process, health care disparities, health care costs, patient health information security
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
In May 2021, the COVID-19 supplement was modified and merged with the HCHSS. The Biweekly COVID-19 Scans continue, while the Status Reports and High Impact Reports were folded into the PCORI Horizon Scanning Database and High Potential Disruption Reports.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: October 7, 2022
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