Physical Therapist Training Challenges for an Embedded Pragmatic Trial: Fibromyalgia TENS in Physical Therapy Study

Transcutaneous electrical nerve stimulation (TENS), a non-pharmacological treatment, is safe and effective for movement-evoked pain in individuals with Fibromyalgia (FM). The purpose of our NIH-funded pragmatic clinical trial, Fibromyalgia TENS in PT Study (FM-TIPS), assesses feasibility and effectiveness of adding TENS to usual physical therapy (PT) treatment in individuals with FM. We partnered with 33 sites in 6 healthcare systems, training 150+ Midwest clinicians. Outpatient PT clinic sites are cluster randomized to a TENS or a No-TENS intervention, stratified by system and clinic size. We will recruit ∼600 patients with a primary or secondary diagnosis of FM. We developed comprehensive communication and training procedures to ensure study fidelity and adapted over the course of the study to enhance learning. We will provide an overview and the impact of the pandemic on these procedures. Representatives for each healthcare system, each clinic and the study team were identified for communication and training. Training included initial study introduction, human subjects protection, and study procedures. We used a hybrid approach with written, video, onsite, and virtual instruction. All materials and procedures, for clinician and patient-facing materials, website, videos, equipment use (iPad for screening, TENS units), and clinician procedures for PT visits 1-3, were piloted and reviewed by clinicians from each healthcare system. Additional communication and feedback include weekly enrollment reports, monthly newsletters, relationship building with clinicians, enrollment incentives, and continuing education webinars. The pandemic required creative and evolving solutions to maintain study involvement and recruitment. Barriers for enrollment are screening PT Visit 1, comfort level of clinicians for PT Visits 2 and 3, delays/alterations in training and planning, clinician demands, clinicians/patient illness, and staff shortages in the clinics. Current enrollment, study training and implementation has been affected by COVID-19 and we developed creative methods for training and implementation for FM-TIPS. Grant support from Research supported in this USASP was supported by National Institutes of Health Heal Initiative Grant UG3/UH3 AR076387-01 and UL1TR002537.

Facilitators and Barriers to Implementation of a Transcutaneous Electrical Nerve Stimulation Intervention in a Pragmatic Clinical Trial

Fibromyalgia TENS in Physical Therapy (PT) Study (FM-TIPS) is testing feasibility and efficacy of Transcutaneous Electrical Nerve Stimulation (TENS). We present our experience for implementing TENS into PT clinics and virtual training to participants on TENS in a pragmatic clinical. FM-TIPS is a pragmatic, cluster-randomized clinical trial examining if the addition of TENS to routine PT improves movement-evoked pain in fibromyalgia (FM). FM patients (n=600) will be enrolled from 35 PT clinics across six Midwest healthcare systems into either a TENS or no-TENS group. All subjects randomized by TENS clinics receive TENS starting on Day 1. The no-TENS clinics start after completion of the primary outcome on Day 60. In the TENS group, Physical therapists (PTs) provide TENS education in person, while in the no-TENS group, study staff provide TENS education virtually. To facilitate implementation, we selected a study-specific TENS unit that provides mixed frequency TENS with intensity as the only adjustable parameter. All PTs were trained in proper use of the TENS unit in-person. While most PTs embraced the addition of TENS, some had not used TENS and had difficulty adapting practice to include TENS. For virtual visits in the no-TENS group, a standardized procedure was developed and completed by study staff PTs. TENS units were shipped to subject's and zoom visits were scheduled at the subject's convenience within a 10-day window. Most subjects completed virtual TENS training and implementation without difficulties. Technology limitations provided a significant barrier for some subjects. Most clinics have adopted and incorporated TENS intervention. Implementing virtual TENS training in a pragmatic trial can be successful for participant intervention. Due to the current COVID-19 pandemic, participants are more aware of the need to complete interventions via virtual mechanisms. Barriers to virtual TENS instruction are often due to internet and device limitations. FM-TIPS work is supported by the National Institutes of Health (NIH) through the NIH HEAL Initiative under award number UG3AR076387 from the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This work also received logistical and technical support from the PRISM Resource Coordinating Center under award number U24AT010961 from the NIH through the NIH HEAL Initiative. The content is solely the responsibility of the authors and does not necessarily represent the official views of the NIH or its HEAL Initiative.

The impactof COVID-19 on the conductof trials in the neuronext network

The Network for Excellence in Neuroscience Clinical Trials (NeuroNEXT) is a large, federally funded neurology clinical trial network that was established in 2011. At the start of the COVID-19 pandemic, five clinical studies were active in the network. Rapid response to the evolving COVID-19 situation was critical as clinical study staff transitioned to remote work and on-site research activities were limited. During this session, we will discuss the impacts of the global pandemic on the active clinical trials in the NeuroNEXT network. The ongoing clinical trials were in various stages of study start-up, participant follow-up, and study closeout. Each study required investigators to develop solutions that were simple, yet flexible, all while maintaining study integrity and patient safety. We will highlight the specific adjustments made to the trials and summarize strategies to be carried forward to future studies. The structure of our session will be five presentations covering the following topics: 1. Introduction of NeuroNEXT and the Active Clinical Trials (Brenda Thornell, BS;∼8 min): • Overview of NeuroNEXT Network Structure. • Overview of status of the NeuroNEXT Network (NN) trials impacted by COVID. • Identification of COVID impact. 2. Site Communication and Monitoring (David Klements, MS, CCRP & Michele Costigan, RN, BSN, CCRC;;14 min): • Drafting guidance to study sites for implementation of protocol modifications. • Tracking local restrictions and guidelines by each site and geographic region. • Regular meetings/teleconferences with sites to discuss challenges and potential solutions with conducting study activities during the pandemic. • Remote monitoring. • Drug accountability-dispensing, compliance, and returns. 3. Protocol Changes and Data Collection (Trevis Huff, BSE;∼13 min): • Capturing National Institutes of Health/Food and Drug Administration requested COVID-19 impact data. • Allowing for and tracking telehealth/remote visits. • Accommodating Drug Dispensing/Shipping/ Receiving challenges 4. Reporting on COVID Study Impacts (Elizabeth Klingner, MS and Anna Gudjonsdottir, MS;;11 min): • COVID related protocol deviations and adverse events. • Recruitment and retention before and after the pandemic. • Data quality. • Analysis implications 5. Lessons Learned and Recommendations (Janel Fedler, PhD;;4 min): • Adjustments that maintain trial integrity and patient safety. • Documentation and communication. • Design and conduct of future trials. • Following the presentations, there will be a 10-min Q&A.

Impact of COVID-19 on a Pragmatic, Cluster Randomized Clinical Trial for Fibromyalgia

Our objective was to present our experience on adapting to the challenges of COVID-19 pandemic on a pragmatic clinical trial. Transcutaneous Electrical Nerve Stimulation (TENS) in Physical Therapy (PT) Study (FM-TIPS) is a pragmatic, cluster-randomized clinical trial examining if the addition of TENS to routine PT improves movement-evoked pain in fibromyalgia (FM). FM patients (n=600) were enrolled from 24 PT clinics (12 PT only, 12 PT with TENS) across five healthcare systems. COVID-19 has significantly impacted PT practice and in-person interactions. In response, all PT clinics saw reduced volumes of patients, some clinics furloughed PTs, and some clinics were permanently closed. This led us to put contracts, reliance agreements, and training of clinics on hold and to seek additional clinics that could fill the gap for those who could no longer participate. It also led to a delay in onboarding healthcare systems and inpatient enrollment. In order to protect the integrity of the study and minimize missing data due to potential restrictions of in-person visits we developed alternative strategies. This includes procedures for home instruction of TENS via telehealth, a plan for bringing on backup clinics, and a plan for training virtually and in-person using personal protective equipment and social distancing. Assessment of primary outcome and questionnaire data were transitioned for the patient to perform at home through a patient-portal with embedded patient-specific videos. We have also set up a phone line for patients to call with additional questions or concerns. The impact of COVID-19 on statistical design and analysis was discussed including a plan for uneven enrollment across clinics and a sub-analysis of data for patients enrolled during or after the pandemic. In conclusion, COVID-19 altered the original study design of this large-pragmatic trial to account for greater flexibility for providers and patients to facilitate continued enrollment. NIH.