Assessing Quality of Telehealth: Home Heart Failure Care Comparing PatientDriven Technology Models R

1
Assessing Quality of TelehealthHome Heart
Failure Care Comparing Patient-Driven Technology
ModelsR01 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.
• Physicians 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 SitesGeographically 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. Vincents Health Care, Billings, Montana
• Indian Health Service Montana
• University of Louisville Data Coordinating
  Center

13
Inclusion Criteria

• Documented HF (systolic, with lt45 LVEF, or
  diastolic dysfunction with normal LVEF) via
  echocardiogram, MUGA or coronary angiography
  within the last 18 months.
• Male or Female gt/ 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 gt/ 3.0
• Patient non-competent or unwilling to provide
  voluntary consent
• Weight gt 350 lbs
• Detailed current disease management program

15
Technology

• Shipped to patients home
• Connected to phone line
• Equipment identical for the two technology arms

16
(No Transcript)
17
(No Transcript)
18
(No Transcript)
19
(No Transcript)
20
(No Transcript)
21
(No Transcript)
22
ImplementationDesigning 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
ImplementationSafety 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
ImplementationVendor 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
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
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
ImplementationOvercoming Provider Resistance

• Providers (practices) concerns
• Too much time to review data/alerts
• Coverage during day and on nights/weekends/holiday
  s 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
ImplementationSubjects

• 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
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