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

2. 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

3. Clinical Research 101 Is
better than ?

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

5. 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

6. Cost of pharma clinical trials

7. 2% (35) of US population participates in clinical trials

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

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

10. 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.
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

11. Patient motivators to participate

12. 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

13. 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

14. Live demo

15. Telesurvey

16. Telesurvey

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

18. Telesurvey
To do:
Watch video
Complete consent
Complete survey
Start

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

20. Complete in waiting room prior to call

21. Teleconsent Understand

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

23. To do:
Watch video
Complete consent
Start

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

25. 3 way teleconsent

27. Recruitment websites

28. Video call offline
Video call online
Video call online

30. Video call offline
Video call online
Video call online

31. Proposed features

32. Record Session
Start recording?

33. Gina’s Face
Gina’s ID

34. Digital Medical Devices

35. 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

36. 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

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

38. 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?

39. 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

40. 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)

41. 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