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Be Careful What You Wish For—Managing Devices and Data In Your Patient's Home (Text Version)

Slide Presentation from the AHRQ 2008 Annual Conference

On September 9, 2008, Lee R. Goldberg, M.D., M.P.H, made this presentation at the 2008 Annual Conference. Select to access the PowerPoint® presentation (167 KB).

Slide 1

Be Careful What You Wish For—Managing Devices and Data In Your Patient's Home

Lee R. Goldberg, MD, MPH
Associate Professor of Medicine
Heart Failure/Transplant Program
University of Pennsylvania
September 9, 2008

Slide 2

In the "Perfect World"

Chronic diseases would be managed by "daily" monitoring that would allow both clinician intervention and patient self management leading to improved "quality" and "outcomes."
The "savings" could be used for other purposes within the Health Care System like prevention.

Slide 3

Prior Studies

Hypothesis: We hypothesize that patients with disease X who are treated with home monitoring technology Y will have an improvement in outcome Z.
Little focus on the mechanism of changes in outcomes—what specifically is driving the outcomes (good or bad).

Slide 4

Assumptions

Monitoring can impact outcomes and self management.
The impact is positive (does not increase cost or cause harm).
Clinicians want or need to know the data.
Clinicians can identify when and how to respond from a potentially large volume of data.
The data are "actionable."
The data are "reliable."
"Systems" are in place that can quickly and easily incorporate all the data into the patient record.

Slide 5

The Reality

Many studies have shown improvements in a variety of outcomes from utilization to quality of life to improved survival.
These improvements have been difficult to duplicate outside the confines of a single center or research project—"Implementation of Innovations."
Some studies have shown increased costs/utilization (?improved access) or no impact at all.
The individual centers involved combined with risk (and access to care) of the population studied seems to drive the outcome.
Managing the data and incorporating it into clinical practice is a significant challenge.

Slide 6

What Could be Going On? Outside of the technology...

Improved access to care in general.
Improved adherence to Guideline Based Care.
Improved self-management.
Identification of other barriers to care—financial, psycho-social, comorbid illness.
Novelty of the technology.
Device acts as a "reminder."
Regular human contact....

Need to collect data about these factors during a study to get at "mechanism."

Slide 7

What is "Improved Outcome"?

Perspective—who is interested? (Competing Interests)
- 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.

Slide 8

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.

Slide 9

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"?
How should we manage the data?
Where is the magic?
- Technology?
- People?

Slide 10

Our Study—Assessing Quality of Telehealth: Home Heart Failure Care Comparing Patient-Driven Technology Models

R01 HS015459

A study comparing 3 different care models of outpatient heart failure care:
- Usual care.
- Electronic monitoring (scale, blood pressure [BP] cuff, questions, +/- glucometer) with nurse case management.
- Electronic monitoring with self-management—interactive voice response system.

Slide 11

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.
"Testing data flow and human contact."

Slide 12

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.

Slide 13

Our Secondary Hypotheses (continued)

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.

Slide 14

Measured Outcomes

Hospitalizations for heart failure (HF), cardiovascular and all causes.
Hospital length of stay (LOS).
Emergency room (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 Health-Related Quality of Life (HRQoL) and its dimensions assessed by the Kansas City Cardiomyopathy Questionnaire.
Acute care visits to physicians.
Satisfaction with care.

Slide 15

Technology

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

Slide 16

Implementation: Designing the Intervention

Designing the "IVR" [interactive voice response] 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.

Slide 17

Implementation: Safety Pilot of the IVR

Given challenges with the IVR safety pilot using simulated patients was performed:
- Members of Institutional Review Board (IRB).
- Family members of study staff.
- AHRQ staff.
Multiple technical and clinical issues identified and corrected.
Delayed enrollment but improved safety and understanding of a new patient management system.

Slide 18

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.

Slide 19

General Vendor Considerations

Privacy—Health Insurance Portability and Accountability Act (HIPAA) issues.
Service guarantee:
- System monitoring—continuous?
Approved equipment (Food and Drug Administration [FDA]/Federal Communications Commission [FCC]).
Support hours.
Interface issues:
- Fax.
- Web.
- E-mail.
- Pager (text messaging).
Integration:
- Electronic Medical Record (EMR) interface.

Slide 20

Home Information Technology (IT) Implementation Issues

The table presents the "Safety Issues" and "Options" for specific "Variables."

Variables	Safety Issues	Options
Device Installation	Dependent on Patient	Shipment 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 data	Pass 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

Note: 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 AJMQ 23(3):208-14, May-June 2008.

Slide 21

Home IT Implementation Issues (continued)

The table is a continuation of the table on Slide 20.

Variables	Safety Issues	Options
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

Slide 22

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.

Slide 23

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.

Slide 24

Status

156 subjects randomized.
Last patient out May 31, 2008.
Database lock—July 21, 2008.
Data analysis underway.

Slide 25

Challenges

Several "technology" related challenges:
- Server down.
- Communication down.
- IVR "errors."
Provider issues:
- "Too many alerts" in IVR arm.
- Alert "fatigue."
Educate around adjusting parameters to make alerts meaningful.

Slide 26

Subjects

Seem to prefer the nurse case management arm (is this our bias or just more contact with these subjects?)
- 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?

Slide 27

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.
Indian Health Service (IHS) group—many more hospitalizations and ER visits in all arms (clearly a higher risk group).
But... the IVR group appears to have at least as good outcomes—could this be cost-effective "self-management"—it does not appear to be "inferior."

Slide 28

Conclusions

Several challenges to home monitoring:
- Provider.
- Vendor.
- Subject.
- Data management.
- Payers.
Studies need to be performed to understand what drives changes in outcomes as opposed to focusing on a specific technology or program.
Studies need to be performed on "best practice" for data management with standardized HIPAA compliant interfaces with alerts.
Desperate need for vendor regulation, standardization and/or certification so that we know what we are testing (and what the subjects are getting).
Despite skepticism from clinicians, the IVR system appears to be "non-inferior" to the nurse case management system:
- Cost implications.
- Mechanism implications.

Current as of January 2009

Internet Citation:

Be Careful What You Wish For—Managing Devices and Data In Your Patient's Home. Slide Presentation from the AHRQ 2008 Annual Conference (Text Version). January 2009. Agency for Healthcare Research and Quality, Rockville, MD. http://www.ahrq.gov/about/annualmtg08/090908slides/Goldberg.htm