1. Assessing Quality of Telehealth: Home Heart Failure Care Comparing Patient-Driven Technology Models R01 HS015459 Lee R. Goldberg, MD, MPH Associate Professor of Medicine Heart Failure/Transplant Program University of Pennsylvania September 27, 2007

2. What is “Quality”? Perspective – who is interested? –Patient –Provider –Payer –Health Care Institutions –Society Cost (only reduction in costs or effectiveness? Total vs. Hospital?) “Quality of Life” Improved adherence to “Evidence Based Medicine” Safety - improved or not worsened? System performance – Does the technology perform as designed or intended? Improved survival Competing Interests

3. Heart Failure – A Good Target for Disease Management Common chronic disease High costs – direct and indirect Decreased quality of life High mortality Extensive research to guide therapy –Appropriate therapies extend life and improve symptoms Therapies are “challenging” to use and implement in this high risk population Technology available to monitor

4. Factors for Successful Implementation of a Telemedicine System for Heart Failure Prompt consistent response to received patient data to provide rapid feedback Clinical algorithms that include “action plans” that avert negative consequences in response to an “alert” situation Patient trust of the system and its clinicians Reliable, easy to use technology Notification to clinicians of missed data collection

5. Barriers to Successful Implementation of Telemedicine Interventions Reimbursement for supervision of telemedicine and disease management systems Trained clinicians to manage the data and the disease Mechanisms to consistently and reliably review patient data and alerts Development of appropriate algorithms to respond to patient data in a manner that improves patient outcomes Medical-legal liability for data collected Professional licensure across state lines Lack of evidence for types and frequency of patient data collected and impact Clinicians’ fear of being replaced by technology Physician acceptance

6. Lingering Questions Type of technology - Intensity –Is simple better? – scale versus implantable monitor –Is there too much data? – can we “hurt” people by responding too quickly? Dose of technology –Daily monitoring necessary? Duration of intervention –How long to continue? –Withdrawal effect or do patients “learn”?

7. Our Study A study comparing 3 different care models of outpatient heart failure care –Usual care –Electronic monitoring (scale, BP cuff, questions, +/- glucometer) with nurse case management –Electronic monitoring with self-management – interactive voice response system

8. Our Primary Hypotheses Both electronic disease management strategies will be superior to usual care in reducing hospitalizations The patient self-management electronic disease management arm will not be inferior to nurse case management disease management arm

9. Our Secondary Hypotheses “Quality of life” will be improved for the patients in the electronic disease management arms as compared to usual care “Quality of life” will not be different between the two electronic disease management arms Adherence to heart failure guideline care will be improved in the electronic disease management arms Self Management will reduce the cost of HF care more than Case Management by eliminating the cost of nursing case management.

10. Our Secondary Hypotheses Assessment of Self Management patients’ vital signs and symptoms by the expert clinical decision support system, coupled with tailored self-care algorithms, will improve patients’ self efficacy in the management of their disease more so than in patients in the Case Management group. Self Management and Case Management patients will have greater satisfaction with care than Standard care patients. Physician’s satisfaction will be higher with Self Management and Case management approaches to patient management than Standard care.

11. Measured Outcomes Hospitalizations for HF, cardiovascular and all causes. Hospital length of stay (LOS) ER visits for HF, cardiovascular and all causes. Survival, mortality and fatal and nonfatal myocardial infarctions Self-efficacy in management of heart failure as well as HRQoL and its dimensions assessed by the Kansas City Cardiomyopathy Questionnaire Acute care visits to physicians. Satisfaction with care

12. Our Sites Geographically and Population Diversity University of Pennsylvania, Philadelphia, PA – Coordinating Center –Urban and suburban practices in and around Philadelphia metropolitan region Charleston Area Medical Center, West Virginia St. Vincent’s Health Care, Billings, Montana Indian Health Service – Montana University of Louisville – Data Coordinating Center

13. Inclusion Criteria Documented HF (systolic, with <45% LVEF, or diastolic dysfunction with normal LVEF) via echocardiogram, MUGA or coronary angiography within the last 18 months. Male or Female >/= to 18 yrs of age Working telephone Cognitive ability to use equipment Ability to stand unsupported for 20 seconds NYHA classification of II – IV (verified by CRC at enrollment.) HF managed by a primary care physician, internist and/or cardiologist.

14. Exclusion Criteria Life expectancy less than 6 months or Hospice Care Outpatient inotropic therapy (Milrinone, Dobutamine) End stage renal; creatinine >/= 3.0 Patient non-competent or unwilling to provide voluntary consent Weight > 350 lbs Detailed current disease management program

15. Technology Shipped to patient’s home Connected to phone line Equipment identical for the two technology arms

22. Implementation: Designing the Intervention Designing the “IVR” for the electronic only disease management arm –Sensitivity versus specificity –Consensus on the “clinical” content Review by experienced heart failure clinicians –Patient focused Easy to use Easy to understand Short and to the point –Safe –Many concerns and delays during the design phase

23. Implementation: Safety Pilot of the IVR Given challenges with the IVR safety pilot using simulated patients was performed –Members of IRB –Family members of study staff –AHRQ staff Multiple technical and clinical issues idenitified and corrected Delayed enrollment but improved safety and understanding of a new patient management system

24. Implementation: Vendor Issues Technology “up-time” –Many technical issues with IVR –Many technical issues with servers, phone lines, etc. Troubleshooting with subjects and providers –Support for installation –Support for problems Equipment issues –Defective –Batteries Availability of vendor on off hours

25. General Vendor Considerations Privacy – HIPAA issues Service guarantee –System monitoring – continuous? Approved equipment (FDA/FCC) Support hours Interface issues –Fax –Web –E-mail –Pager (text messaging) Integration –?EMR interface

26. VariablesSafety IssuesOptions Device InstallationDependent on PatientShipment of device directly to patient with patient installing Shipment of device to patient then visiting nurse installing Delivery and installation by health provider Shipment of device to patient then technology (home security) service set up support Transmission of patient data Assurance of encryption Limitation of access Ability to validate company’s software and encryption standards Ability to transmit data using cellular technology Method of delivery to the healthcare provider (electronically, facsimile, etc) Storage and Archiving of patient data Access to patient dataPass code protected access Fingerprint access Assurance of HIPAA compliance Confidential data exposure Patient data on the internet Patient data to insurers Patient data to vendor employees or business partners Telehealth Implementation Issues Farberow B, Hatton V, Leenknecht C, Goldberg LR, Hornung CA, Reyes B. Caveat Emptor: The Need for Evidence, Regulation and Certification of Home Telehealth Systems for the Management of Chronic Conditions, AJMQ in press.

27. Telehealth Implementation Issues Distribution of equipment as per Good Manufacturing Guidelines (GMP) Contaminated equipment Faulty devices Faulty electrical wiring Equipment cleaned Equipment tested Documentation of all procedures Leasing vs. Purchasing of Devices Changes in hardware or software Cleaning policies Response for equipment malfunction Company support hours Level of expertise Company support and hours 24 hour on-call Notification of changes; time frame, manner of notification Technical support Clinical support Response time to call Concerns reported by a patient to company technical staff What does the technical staff tell the patient, who do they inform Proper training of staff Policies and procedures for troubleshooting and referring clinical issues to clinicians VariablesSafety IssuesOptions Farberow B, Hatton V, Leenknecht C, Goldberg LR, Hornung CA, Reyes B. Caveat Emptor: The Need for Evidence, Regulation and Certification of Home Telehealth Systems for the Management of Chronic Conditions, AJMQ in press.

28. Implementation: Overcoming Provider Resistance Providers (practices) concerns –Too much time to review data/alerts –Coverage during day and on nights/weekends/holidays – “critical labs” –Medical-legal concerns about responsibility for data – where and how to document –Educate to respond (not just file) –Educate to respond appropriately Comfort with adjusting medications over the phone Use of extra visits/ER when appropriate only “Learning curve” observed with most clinicians

29. Implementation: Subjects Phone line (land line) –Not cellular only –Not Voice over internet (VOIP) –In the home? (or access daily nearby?) Ability to install equipment Ability to hear and see well enough to use the equipment Ability to stand on the scale

30. Status 134 subjects randomized About 33% have completed 12 month follow- up About 50% have completed 9 month intervention follow-up

31. Snapshot NStandard CareCase Management Self ManagementP Overall1092541 43 Site109 0.92 Billings5513(52.0)22(53.7) 20(46.5) Philadelphia367(28.0)13(31.7) 16(37.2) West Virginia185(20.0)6(14.6) 7(16.3) Sex109 0.49 Male448(32.0)16(39.0) 20(46.5) Female6517(68.0)25(61.0) 23(53.5) Race109 0.67 Caucasian8721(84.0)32(78.1) 34(81.0) African American143(12.0)7(17.1) 4(9.5) Hispanic20(0.0) 2(4.7) American Indian/Alaskan Native31(4.0)1(2.4) Native Hawaiian/pacific Islander10(0.0)1(2.4) 0(0.0) Other10(0.0) 1(2.4) Unknown10(0.0) 1(2.4) Age10967.7±13.966.7±12.8 69.3±11.00.01

32. Challenges Several “technology” related challenges –Server down –Communication down –IVR “errors” Provider issues –“too many alerts” in IVR arm –Educate around adjusting parameters to make alerts meaningful

33. Subjects Seem to prefer the nurse case management arm –Interacting with a “person” –Nurses identify other issues that may increase cost but improve either quality of care or patient satisfaction Battery replacement Accuracy of scale questioned –Technical due to carpeting and scale placement?

34. Early Results Many anecdotes from call center, providers and subjects –Identified serious medication errors –Intervened to avoid ER or hospitalization –Identified several “educational opportunities” –“Missed” data transmission is an important parameter to be followed –Nurse Case Managers seem to promote patient self-care and encourage patient-clinician communication IHS group – many more hospitalizations and ER visits in all arms

35. Conclusions Several barriers to implementation of telehealth –Provider –Vendor –Subject Despite this our early results look promising with both technology arms performing well Desperate need for vendor regulation, standardization and/or certification