CAN RESEARCH AND EVALUATION MOVE THE NEEDLE ON TELEHEALTH AND mhealth?
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1 CAN RESEARCH AND EVALUATION MOVE THE NEEDLE ON TELEHEALTH AND mhealth? DESIGNING, CONDUCTING AND DISSEMINATING STUDIES THAT INCREASE UNDERSTANDING OF BENEFITS AND INCENTIVES ISPOR: May 2017 Declaration of Conflicts None of the Presenters have financial conflicts to declare For Annette Totten The findings and conclusions in this presentation and the reports I discuss are mine and my co-authors, who are responsible for its contents; the findings and conclusions do not necessarily represent the views of AHRQ. Therefore, no statement should be construed as an official position of AHRQ or of the U.S. Department of Health and Human Services. Telehealth Evidence Map funded under contract #AHRQ/HHSA , EPC V 1
2 INTRODUCTIONS Presenters Elise Berliner Director, Technology Assessment Annette M. Totten Faculty, Pacific Northwest Evidence based Practice Center Vivian H. Coates Vice President Information Services and Health Technology Assessment Julie Polisena Manager, Clinical Research Participants Objectives and Outline Provide an overview of different approaches to evaluating and studying Telehealth and mhealth Describe the weaknesses of the current evidence base Discuss key, current, and pending policy and practice decisions Determine how evidence can help with these decisions Link specific research and evaluation questions to these decisions Propose research that is likely to move the field forward 2
3 Definitions Telehealth and mhealth are HUGE Need to limit the scope to even talk about it Figure reprinted from A Review of Telehealth Service Implementation Frameworks by van Dyk under the terms and conditions of the Creative Commons Attribution license Telehealth (one possible definition) the use of technology to facilitate an interaction between a patient and the health care system or interaction between two or more providers when the interaction is directly related to an individual patient s care Over distance or time Not telephone only Includes Remote Patient Monitoring Video Store and Forward Transmission of data/images 3
4 mhealth Limited for this presentation: to overlap with telehealth Mobile apps: software programs that run on mobile communication devices (e.g., smartphones, tablet computers, portable computers) with or without wireless connectivity. Accessories that attach to a mobile communication device or a combination of accessories and software can also be considered mobile apps. Some mhealth apps are designed to help people manage their own health, promote healthy living, and gain access to personalized medical information when and where they need it. Others are designed to help healthcare professionals facilitate or improve patient care. For patient care, mhealth apps can be divided into two main categories: Those that focus on disease management (e.g., diabetes, blood pressure, mental health conditions) FOCUS TODAY Those that facilitate overall wellness (i.e., fitness, lifestyle and stress, diet and nutrition) Infrastructure Client devices: Software, hardware, and services that are used to assist in managing and monitoring the client s condition. Central systems: Applications to assist clinicians in managing multiple clients through the central monitoring service and mobile clinical staff providing local support to these clients. The central client management system collects and displays the client s condition-specific vital signs and stores clinical and assessment documentation. Communication network Hardware, software, network, and communication infrastructure required for service delivery and operational support to maintain the integrity of the home telehealth system. Provider devices and care team activities Software and hardware used for health service delivery to clients using telehealth and for client-to-provider and provider-to-provider information sharing. It also includes clinical staffing and the professional services that are necessary for consultative support to users and clients using home telehealth. 4
5 Current Evidence Base for Telehealth HUGE MESSY Does it address decision makers needs? 5
6 Evidence Based Practice Centers (EPC) Sponsored by AHRQ Pacific Northwest Evidencebased Practice Center OHSU University of Washington Spectrum Research Telehealth Evidence Map ov/ehc/products/624/2254/telehe alth-report pdf EPC/AHRQ Evidence synthesis products Systematic Reviews Other Evidence Products Technical Briefs Evidence maps Varied Users Sometimes known, sometimes not Individuals, organizations and policymakers Individual decisions to guidelines 6
7 Literature is HUGE and Messy Telehealth Systematic Reviews by Clinical Focus 7
8 ECRI Institute Nonprofit health services research institute with nearly 50 years experience in laboratory evaluation of healthcare technology (medical devices) 25 years experience in health technology assessment, systematic review, comparative effectiveness reviews and forecasting of drugs, devices, procedures, interventions, including telehealth and mhealth We serve over 5,000 providers, public and private payers, government agencies, ministries of health, voluntary sector organizations, associations, and accrediting agencies worldwide U.S. Agency for Healthcare Research and Quality (AHRQ): Evidence-based Practice Center, Patient Safety Organization, National Guideline Clearinghouse, National Quality Measures Clearinghouse, AHRQ Healthcare Horizon Scanning System 8
9 ECRI s Methods (Evidence Synthesis and Evidence Generation) Systematic reviews use GRADE approach to assessing strength of evidence Rapid reviews - quick look at evidence, benefits, harm Forecasting panels of experts Laboratory evaluation (Health Devices program) Performance Safety Workflow Patient Experience Interoperability Maintenance User Experience Cost of Ownership ECRI Telehealth/mHealth Research Examples U.S. Dept. of Defense (DOD): evaluated effectiveness of Telepsychiatry compared to face-to-face interventions. U.S. Veteran s Administration/DOD: for Chronic Obstructive Pulmonary Disease guideline, assessed studies that used telehealth interventions in addition to or in place of standard care. U.S. Centers for Medicare & Medicaid Services (CMS): assessed the evidence on Remote Cardiac Monitoring in ambulatory patients. Hospitals and Health Systems: wearable technologies that allow monitoring of patient vital signs in low-acuity settings; assessed criteria for prescribing mobile health Apps Health Plans: wireless implantable hemodynamic monitoring 18 9
10 ECRI: Evidence Gaps in Telehealth/mHealth Telehealth Wireless implantable hemodynamic monitoring: Strength of evidence very low for key outcomes (eg, decreased mortality, improved quality of life) Studies too small Reduction in heart failure related admissions (low strength of evidence) Lack of reimbursement Handheld ultrasound for emergency medicine, rural health Very limited evidence, small studies Limited to no reimbursement Anecdotal evidence abundant 50% of Kaiser Permanente clinician consults now via telehealth, including genetic counselling Payers and policy makers need evidence! ECRI: Evidence Gaps in Telehealth/mHealth mhealth No criteria or standards for physician prescribing of mhealth Apps Many Apps not useful and have deficiencies in quality Patient experience inadequate for vulnerable populations (eg, elderly, low literacy) Privacy and security concerns Lack of evidence on efficacy Apps used as accessories to regulated medical devices may perform better than stand alone Apps (eg, Smartphone-enabled ECG Monitor) 10
11 CADTH: Introduction Independent, not-for-profit organization Objective evidence Optimal use of health technologies CADTH: Programs Rapid Response Service Health Technology Assessment Optimal Use 11
12 CADTH: Telehealth and Indications Chronic illnesses Cardiology Emergency medicine Pathology Cognitive impairment Mental health Education and counselling CADTH: Telehealth and Reasons for Requests Background information Policy development Clinical practice Resource allocation Alternative health service delivery Expansion of programs and services 12
13 CADTH: Types of Questions on Telehealth Clinical effectiveness Cost-effectiveness Evidence-based guidelines Ethics/legal issues Health services impact CADTH: Evidence Gaps on Telehealth Limited evidence on specific indications Lack of cost-effectiveness studies Lack of evidence-based guidelines 13
14 Frameworks Discussion Part 1 What are the key current issues facing telehealth OR mhealth? What are the facilitators and barriers? From what perspectives? Who is making decisions today, tomorrow, next week? What drives decisions? Money? Infrastructure? Training? How could RESEARCH OR EVIDENCE make a difference? 14
15 Discussion Part 2: Planning an ACTIONABLE study (for the selected question) Ideal Design P=Population (Patients/Providers) I =Intervention (mode/infrastructure) C=Comparators O=Outcomes T=Timing Follow-up Period S= Setting Data Needed What would make this feasible? How to move forward? 15
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