The Patient-Centered Outcomes Research Institute (PCORI) has approved funding awards totaling more than $165 million for new patient-centered comparative clinical effectiveness research (CER), including three studies that will evaluate the effectiveness of telehealth interventions to treat Type 2 diabetes, chronic low back pain, and opioid use disorder.
"These latest PCORI-funded comparative clinical effectiveness research studies will generate evidence for various care approaches, including virtual delivery methods, when managing conditions such as diabetes, heart conditions, and other health concerns affecting patients across the nation," said Nakela L. Cook, M.D., M.P.H., PCORI's executive director, in a statement. "Through research approaches that will engender trust and trustworthiness, the findings of these studies will offer valuable insights for patients and those who care for them to make better-informed healthcare decisions."
A study by researchers at the University of Alabama at Birmingham will compare two telehealth methods for managing Type 2 diabetes in underserved primary care settings. The research team’s goal is to determine whether each intervention alone is more effective in helping manage Type 2 diabetes or if the combination of both interventions would be more effective.
One intervention is remote patient monitoring (RPM), in which the healthcare team will check and manage participants’ blood sugar remotely. To make this easier for participants, the study team will provide the necessary devices and a mobile Wi-Fi data plan to transmit the data, so participants will not need internet connectivity. If a patient’s blood sugar remains high for a long time, a registered nurse and healthcare provider will offer guidance and support.
The second intervention is digital health coaching, which involves one-on-one weekly phone calls with a health coach. This approach offers personalized support and guidance on managing Type 2 diabetes, including advice on nutrition, exercise and taking medications.
The last intervention is the combination of both the RPM and digital health coaching programs. Participants in the study will be randomly assigned to the digital health coaching, remote patient monitoring or combination group for a six-month period. The study team will measure participants’ blood sugar at the beginning of the study and then at six, 12 and 18 months. The team’s main focus will be on how participants’ blood sugar level changes after 12 months.
Telehealth vs. in-person opioid use disorder (OUD) treatment
A study at the University of California, Davis, will study in-person vs. telehealth opioid use disorder (OUD) treatment after patients leave the emergency department.
Then researchers note that approximately 9,000 people in the United States die every month from drug overdoses; three-quarters of these overdoses involve opioids. OUD is a major risk factor for overdose, so treating OUD is important for reducing drug overdose deaths in the United States.
Buprenorphine is a prescription medication used to treat OUD that has been proven to prevent overdose and save lives when patients with OUD take it regularly. Starting patients with OUD on buprenorphine when they come to hospital emergency departments is an evidence-based practice that is especially helpful for patients with OUD who have trouble getting treatment in outpatient clinics due to barriers such as low income, lack of transportation or homelessness.
Unfortunately, in many studies the median buprenorphine adherence is less than six months; thus, there is a need for strategies to increase long-term buprenorphine use among patients after they leave the emergency department.
Outpatient OUD treatment via telehealth (through video or phone visits) is a promising but untested strategy for helping patients stay on buprenorphine after they leave the emergency department. Telehealth OUD treatment was traditionally used for patients in rural areas, but it has become much more common and accepted since the COVID pandemic. Getting care through video or phone visits may reduce logistical barriers to treatment (e.g., no need for transportation) and reduce the stigma that patients with OUD often report when they interact with clinic staff at outpatient addiction clinics.
The objective of this study is to compare long-term buprenorphine treatment outcomes for patients who start buprenorphine in the emergency department and are then referred to outpatient buprenorphine treatment either via telehealth or at an in-person clinic. The study team will also examine whether treatment outcomes are better when patients can choose whether they are referred to telehealth versus in-person treatment. The study hypothesis is that rates of establishing outpatient treatment, long-term buprenorphine retention and patients’ experience with care will be better for patients referred to telehealth than for patients referred to in-person treatment.
The research team will test this hypothesis by conducting a clinical study at three emergency departments that participate in CA Bridge, a statewide California program to encourage substance-use treatment in emergency departments.
Compared to the general population with OUD, patients who seek OUD care in the emergency department are disproportionately low-income, non-white and unstably housed. Thus, improving buprenorphine treatment among patients who start treatment in the emergency department also has potential to reduce disparities in OUD treatment and, ultimately, overdose rates. Findings from the study will be immediately applicable to clinicians and patients in the nearly 300 hospital emergency departments across California that participate in the CA Bridge program as well as to hospitals in 20 other states that have implemented or are developing emergency department-based OUD treatment programs based on the CA Bridge model.
Telerehabilitation for low-back pain
PCORI also will fund a study by Johns Hopkins University researchers that will compare the effectiveness of telerehabilitation and in-clinic physical therapy (PT) for patients with chronic low-back pain (LBP) to demonstrate whether telerehabilitation will provide non-inferior clinical effects to in-clinic PT.
The study team will enroll 1,000 patients with chronic LBP who present to primary or specialty care at one of three health systems in Baltimore and Utah. Patients will be randomly assigned to receive an eight-session evidence-based PT treatment delivered via in-person or telehealth visits and will be followed for 12 months.
In early 2020, the Center for Medicare and Medicaid Services announced temporary authorization for reimbursement of PT services delivered using real-time video visits. Shortly afterward, the majority of commercial payers followed suit. A nonrandomized clinical trial found patients with chronic spine pain experienced similar changes in pain, disability and quality of life with multidisciplinary rehabilitation delivered using real-time video visits compared to those that received in-clinic care.
This study team conducted a prospective longitudinal study that found a standardized PT protocol delivered using real-time video visits resulted in significant improvement in disability, pain intensity, pain interference, physical function and sleep disturbance among patients with chronic LBP.
Primary outcomes will be disability. Secondary outcomes will be pain intensity and interference, physical function and patient engagement with treatment. Exploratory outcomes will be mental health, fatigue, social participation, and opioid and other LBP-related healthcare utilization. Moderating factors will be psychosocial risk for poor outcome and pain self-efficacy.
The researchers say results from this study will provide important information for patients, clinicians, physical therapists and payers to make informed decisions about optimizing delivery of evidence-based physical therapy to improve quality of life for patients with chronic LBP.
