Telehealth and Research Brandon M. Welch, MS, PhD Suparna Qanungo, PhD Brian E. Bunnell, PhD

Telehealth Research Need for Telehealth Research Research using telehealth Support clinical research with telemedicine technology Telehealth is a tool, NOT the intervention Research about telehealth

Clinical Research 101 Is better than ?

Clinical Research 101 Outcomes vs Outcomes Evaluate a new methodology or treatment on real patients Hypothesis, control-intervention, compare outcomes

Clinical research process Recruit Screen Informed consent Baseline data Intervention Outcomes data Steps of clinical research Recruit Inform Consent Collect baseline data Provide intervention Retain Collect outcomes data Analyze Publish

Cost of pharma clinical trials http://journals.sagepub.com/doi/full/10.1177/1740774515625964

2% (35) of US population participates in clinical trials

Of those invited to participate, 21% show up for initial screening, 7% enroll and only 5% complete the trials

Of those invited to participate, 21% show up for initial screening, 7% enroll and only 5% complete the trials

Impact on clinical trials 80-90% Studies fail to recruit target number patients within allotted time 85% Studies fail to retain enough patients to continue Underpowered results → inconclusive results Convenience sample lacks diversity → not representative of population Waste of time, effort, and money 80-90% of trials fail to recruit the target number of patients within the allotted time 85% of clinical trials fail to retain enough patients to continue Getz K. The Gift ofParticipation: A guide to making informed decisions about volunteering for a clinical trial. Bar Harbor, ME: Jerian Publishing; 2007. http://cuttingedgeinfo.com/2011/clinical-trial-cost-drivers/ Forum on Drug Discovery, Development, and Translation, et al. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary National Academies Press (2010) N.S. Sung, et al. Central challenges facing the national clinical research enterprise JAMA, 289 (2003), pp. 1278–1287 The average per-patient cost is about $5,500 for a Phase I trial; $6,500 for a Phase II trial; and more than $7,600 for a Phase III trial.²

Patient motivators to participate

Informed consent challenges Catch patient while at clinic Travel to get consent Scheduling to meet Remote site clinic staff must go through regulatory training Remote site increases errors and lost consent forms Disrupts clinic staff workflow

Telehealth as a solution Increase access to clinical trials Increase geographic diversity Make participation more convenient Streamline consent workflow Reduce consent burden on remote sites

Live demo

Telesurvey

Telesurvey

To do: Watch video Complete consent Next step: Start survey Start

Telesurvey To do: Watch video Complete consent Complete survey Start

Complete in waiting room prior to call Need help? We’re available by video call. Start call now

Complete in waiting room prior to call

Teleconsent Understand

To do: Watch video Next step: Complete consent Start Start survey

To do: Watch video Complete consent Start

To do: To do: Watch video Watch video Complete consent Start Start Complete consent

3 way teleconsent

Recruitment websites

Video call offline Video call online Video call online

Video call offline Video call online Video call online

Proposed features

Record Session Start recording?

Gina’s Face Gina’s ID

Digital Medical Devices

Research ABOUT Telehealth Build evidence base for funding and adoption You’re already doing telemedicine, so collect, analyze, and publish Qualitative methods (Suparna) Quantitative methods (Brian) How and where to publish

Assessing and Addressing Needs Needs Assessment What are the unmet needs? Mixed-methods approach Decide which needs you can meet with your program Clinical Trials P - Patient, Population, Problem I - Intervention C - Comparison O - Outcome

Progression of Clinical Research Development and Preliminary/Pilot Testing Feasibility and Acceptability Comparative Effectiveness/Efficacy Quality Metrics Cost Analysis Dissemination and Implementation

Efficacy and Effectiveness Open trial (50 pts get treatment) When? Testing feasibility/acceptability, established program at site, ethical considerations Pre and Post Data t Test (Paired-Samples) Compare against existing population metrics Randomized Clinical Trial (e.g., 50 pts get treatment, 50 get control) When? Testing feasibility/acceptability, establishing efficacy/effectiveness Analysis of Covariance - Compare post scores while co-varying for pre scores Repeated Measures ANOVA - Between- and within-group comparisons for each timepoint Inferiority, Equivalence, Noninferiority designs What if we already know that telehealth works?

Quality Metrics Contact success rate Patient satisfaction Telehealth Satisfaction Scale Technology Acceptability Questionnaire User experience (patient and provider) Outcome Measures Patient Engagement Readmission Rates Length of Stay ED and Observation Days Overall utilization rates

Cost Analysis Cost Benefit Analysis Cost-Effectiveness Analysis Do benefits outweigh costs? By how much? Effect is treated monetarily Cost-Effectiveness Analysis Comparison of relative costs and outcomes Cost per improvement in health (hours spent/1 point increase in mood) Economic Impact Analysis Estimate of change in economic activity after implementation of a program or policy Effect on revenue, profit, or jobs in a particular area (e.g., city, country, globe)

RE-AIM Framework RE-AIM element Definition Reach The number and percent of people from the target population who participate, and their representativeness. Effectiveness The change in outcomes observed over the duration of the intervention. Adoption The number and percent of settings and staff who are expected to use the intervention and who participate. Implementation The extent to which the intervention is delivered consistently and the time and costs associated with implementation. Maintenance The long-term effects on key outcomes, and the extent to which a program is sustained, modified, or discontinued after the initial trial phase. Agboola et al. JMIR Res Protoc 2014