ABSTRACT
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.
ABSTRACT
The purpose of our prospective cohort study is to address important knowledge gaps on resiliency in the rehabilitation of adults with lower-extremity injuries. Specific aims are to develop and test a resiliency instrument that is relevant to active duty military Service Members. The proposed project will leverage the infrastructure of the Maximizing Outpatient Rehabilitation Effectiveness (MORE) study that is currently being conducted at Brooke Army Medical Center. The first year of the project focused on selecting items from three well-established resiliency instruments that have been validated in civilian populations. Interviews and focus groups were conducted in up to 28 active duty military Service Members. A pre-test of the MORE resiliency instrument in 60 Service Members was conducted which finalized the instrument. Currently, we are testing the MORE resiliency instrument in 310 Service Members to determine reliability and construct and predictive validity of the instrument in active duty Service Members with lower-extremity injury. This project has HRPO approval and has enrolled 77 out of the 310 participants for the testing cohort phase of the project.
ABSTRACT
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.