Medical Technology Innovation for Rehabilitation Medicine in the Military Health System

The U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division, on behalf of the U.S. Army Medical Command (Brooke Army Medical Center and the Army Medical Department Center and School, JBSA Fort Sam Houston, TX) is issuing this Request for Information (RFI) for Market Research purposes. This is not a solicitation or request for competitive proposals. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. It is not to be construed as a commitment by the Government nor will the Government pay for the information solicited. No solicitation document exists or is guaranteed to be issued as a result of this RFI. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. This is NOT a solicitation for proposals, proposal abstracts, or quotations. The Government will NOT pay for information and materials received in response to this RFI and is no way obligated by the information received. This notice is for market research purposes only to obtain information regarding (1) the availability and capability of all qualified performer sources, (2) including small businesses; HUB Zone small businesses; service-disabled small businesses; veteran-owned small businesses; woman-owned small businesses; small disadvantaged businesses; and universities and educational institutions, (3) their size classification relative to the North American Industry Classification System (NAICS) Code for the proposed acquisition. The applicable NAICS Code is 541712 - Research and Development in the Physical, Engineering and Life Sciences (except Biotechnology). OBJECTIVES The specific focus of the Medical Technology Innovation for Rehabilitation Medicine in the Military Health System project is to assess the value (diagnostic, interventional, and therapeutic) of various technologies that improve and enhance delivery of rehabilitation services related to musculoskeletal pain and injuries, which are the #1 cause of attrition and missed duty days in military service members. The length of anticipated service for this project is a total of 60 months from award, with a basic effort contract period of 12 months and four (4) 12 month options. The four specific areas that require documented expertise are listed in the below. RESPONDENTS MUST PROVIDE EVIDENCE IN THEIR RESPONSE SHOWING THAT THEY HAVE THE REQUISITE ABILITY/EXPERTISE AND CURRENT EXPERIENCED PERSONNEL ON STAFF TO PERFORM THE REQUIREMENTS IN ALL AREAS AS SHOWN. MOST SPECIFICALLY RESPONDENTS MUST HAVE SPECIFIC EXPERIENCE MANAGING PROJECTS WITH THE NECESSARY TECHNOLOGIES (MYOTONPRO, ACTIGRAPH ACCELEROMETER, APP DEVELOPMENT, AND THE CRANIAL ELECTRICAL STIMULATION) REQUIRED FOR THESE EFFORTS. Overview Area 1: Cranial Electrical Stimulation (CES) is a neurological medical treatment device that delivers a microcurrent (100 to 500 microamperes) via ear clip electrodes connected to a handheld device. The technology was originally developed by the Soviet Union in the mid 1950's to enhance sleep under the moniker "electrosleep" and spread throughout Europe and Asia until researchers in the U.S. began testing the technology in the 1960s[19]. The type of CES proposed for use in this study is known by the commercial name Alpha-Stim (Electromedical Products International Inc., Mineral Wells, TX). This study will be aimed at assessing the feasibility of a dual-device non-invasive electrical stimulation treatment prior to a rehabilitation session for an orthopaedic injury that was just recently immobilized, and its impact on improving outcomes and decreasing the risk for development of neuropathic pain. We will evaluate the clinical feasibility and effectiveness of incorporating the Alpha-Stim and InterX treatment into a standard rehabilitation protocol to address clinical features often associated with neuropathic pain development (i.e., allodynia, range of motion deficits, and skin temperature) as well as its impact on reduced pain medication. Anticipated labor is of a 0.75 FTE project coordinator. The project coordinator will be hired to help coordinate all shall provide all aspects of the project, to include monthly study reports, reports to AAMTI and the IRB, oversight and study compliance, and ensuring that all enrollment goals are being met. The project coordinator must have a masters or doctorate level degree, preferably a clinical degree. Also, it is anticipated that a Statistician for 0.01 FTE will be required. Overview Area 2: Fractures that require immobilization are a common injury in the Military Health System. They often come with a myriad of post-immobilization related adverse outcomes. Indeed, orthopaedic patients that require immobilization are at high risk for developing symptoms of Complex Regional Pain Syndrome. The Alpha-Stim and Inter-X devices are evolving non-invasive electrical stimulation devices that show promise for treating chronic pain and improving joint range of motion. The Inter-X is a handheld neurostimulation device applied on the skin of the involved area that delivers a high-amplitude, high-density sinusoidal wave stimulation. Alpha-Stim is a neurological medical device that delivers a microcurrent via a transcranial earlobe clip. The pilot testing proposed in this project will assess the feasibility of delivering this combined treatment, and the impact on pain relief and proprioception improvement in patients that require immobilization after an orthopaedic musculoskeletal injury. Anticipated labor is two 0.5FTE study coordinators in year 1, and one 0.5FTE study coordinator in year 2. Study coordinators will be responsible for obtaining all equipment and working with our clinical partners, fine-tuning methodology and calibration of equipment. The study coordinators will perform subject recruitment and clinical coordination of women's health clinics at both San Antonio Military Medical Center and Blanchfield Army Community Hospital. Study coordinators will, obtain informed consent, administer all self-report outcome measures, myoton measurements, and maintain participants and IRB records. The Study Coordinators will be located at SAMMC and BACH Overview Area 3: The ActiGraph accelerometer (model wGT3X-BT, ActiGraph Corp., Pensacola, FL) will be used to assess habitual physical activity. The ActiGraph devices and supporting software will be purchased commercially from ActiGraph Corp. (Pensacola, FL). Over the last 10 years wearable sensors have become more common as outcome measures and for activity tracking. Improvement in technology has resulted in sensors that are unobtrusive to wear and the instrumentation has improved in precision and reliability. The ActiGraph accelerometer measures triaxial acceleration and provides information about the intensity and duration of the physical activity associated with movement and has been shown to be reliable and valid instrument to measure habitual physical activity. Anticipated labor is a 0.5 FTE project manager. The project manager will be hired to help coordinate enrollment of patients, coordination of follow-ups, management of project-related procedures, data collection, and patient interaction Overview Area 4: A home exercise program is essential to the treatment for chronic pain from musculoskeletal injuries. Most home exercise prescriptions are limited to verbal discussion and handouts in the clinic. There is less attention on enabling patient utilization and ensuring compliance outside the clinic. This is an important gap to address because this may be one of the critical components to ensure success of therapeutic exercise prescriptions. A novel, smartphone based application could improve patient engagement with exercise programs and provide increased insight into factors related to compliance and noncompliance. Patients are easily enrolled in the system, and the application engages with them on a daily basis to remind them about their exercise program. This technology has tremendous potential to improve adherence to exercise programs, improve outcomes for musculoskeletal injuries, and significantly decrease overall healthcare expenditures within the Military Health System. Smartphone-based Compliance Tool This tool will be built using the Twilio Application Programming Interface (API) for the management of SMS (short message service, aka text message). This service provides a HIPAA-compliant and two-factor authentication secure messaging platform with enough flexibility to incorporate a variety of useful smart-logic question approaches. A custom web application will be built around the Twilio API that allows the user to add and track patients by using only a subject identifier, so that all data is de-identified. SMS platforms are already a proven concept and used within the Military Health System, as Tricare beneficiaries enjoy the benefits of secure SMS messages to their providers via RelayHealth. The smartphone application will be built to interface with the custom web application to push individual compliance reminders, customized to a schedule based on day and time. For example, the patient can respond YES or NO regarding whether they have completed their exercises that day. The smartphone-based exercise compliance app will send up to 3 reminders a day, or stop after 1 reminder if the patient has answered YES. It will also ask them their average pain rating for that day and if pain has influenced their ability to comply with their home exercises. This project includes development of the mobile app (graphic design and full code), for multiple platforms (iOS and Android), as well as the web-based infrastructure for managing SMS reminders and communication between patients and providers. Beta testing will occur via Testflight, a fully functioning product is needed within 3 months of the start of any resulting contract date. Anticipate labor is a project manager (0.8 FTE) and a clinical assistant (1.0 FTE) during Year 1, both to have either a Masters or Doctorate degree, or preferably a clinical degree. The project manager and the clinical assistant will be hired to help facilitate this program and collect the required data on the 120 subjects including coordinating enrollment of patients, coordinating follow-ups, and management of project-related procedures, data collection, and patient interaction. DISCLAIMER AND IMPORTANT NOTES The Government will not pay for any information submitted in response hereto. Responders are solely responsible for all expenses associated with responding to this RFI. This notice does not obligate the Government to issue a solicitation or to award a contract. Responses to this notice are not offers and cannot be accepted by the Government to form a binding contract. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to the respondents with respect to any information submitted. Submission Instructions: Responses shall be submitted and received via Email to [email protected] no later than 2:00PM EST April 28, 2017. Documents shall be no more than 15 pages total, electronic in Microsoft Word, Excel, Power Point, and/or Adobe Portable Document Format (PDF) and provided as attachments to the Email. No telephonic responses to this RFI will be considered. All information received in response to this RFI that is marked proprietary will be handled accordingly. Responses to the RFI will not be returned. Responses to this RFI are not offers and cannot be accepted by the Government to form a binding contract. Responders are solely responsible for all expenses associated with responding to this RFI. Responders must include information on their organization (not counted towards page limitations shown above): 1. Company Name, Address and Single Point of Contact with Name, Title, Telephone Number and E-mail Address. 2. DUNS Number and Cage Code 3. Confirmation of Current Active Registration in System for Award Management (SAM), SAM registration information may be found at the following website: https://www.sam.gov/portal/public/SAM 4. Primary NAICS Code(s) and Business Size (i.e., small/large)