Preeclampsia

PREGNANCY INDUCED HYPERTENSION & TELEMEDICINE

ASKLEPIOS Howard University, College of medicine Program director : Dr Celia Maxwell, MD Project supervisor : Dr ERNEST L. CARTER, MD PhD

Aristotle University, Medical school Program director : Dr Nicos Maglaveras

KLEOPATRA KOURAKI MD SUPERVISOR : Dr ERNEST L. CARTER MD PhD

WASHINGTON DC, August 2002 HOWARD UNIVERSITY

Index 1. OVERVIEW 2. MARKETING 3. WORKFLOW 4. MEDICAL PERIPHERALS 5. TELECOMMUNICATIONS 6. FINANCIALS

1. OVERVIEW

Purpose of the project Develop a system that will allow the home monitoring of pregnant women with Pregnancy Induced Hypertension (P.I.H.) with the use of telemedicine

What is Pregnancy Induced Hypertension  Pregnancy Induced Hypertension or Preeclampsia

is a potentially life-threatening complication of pregnancy

 It causes mild to severe hypertension in a

previously normotensive pregnant woman

 It also causes problems with placental blood

supply to the fetus

 Sometimes it affects the mother's liver, kidney,

and brain function. Women with severe preeclampsia can develop life-threatening seizures (eclampsia).

RISK FACTORS    

   

Mother under 18 or over 35 years old First pregnancy Multifetal gestations Preeclampsia in a previous pregnancy (30% recurrence) Chronic hypertension Diabetes Kidney problems Obesity

SYMPTOMS • Weight gain • Swelling of hands and face • Headaches • Visual disturbances (scotoma, blurred vision, flashing lights) • Decreased urine output • Nausea and vomiting • Abdominal pain

TESTS     

Signs of hemolysis (elevated LDH, Bilirubin) Thrombocytopenia Elevated liver function tests Elevated uric acid Proteinuria

What is Telemedicine Telemedicine is the use of advanced technology to exchange health information (audio , visual , text )

and provide health care services (diagnosis, consultation, treatment, education) across geographic, time, social and cultural barriers

What is the aim of Telemedicine A Telemedicine project is successful, when it achieves to Save time Save money Improve the quality of healthcare

It may seem complicated…

But in reality, it is just a network of physicians requiring consults from an expert

2. MARKETING

Europe

Mediterranean

Greece

Macedonia

Population:

2 675 000

Target area

Thessaloniki : 1 100 000 1-2 hours distance : 820 000 2-3 hours distance : 755 000

Population Thessaloniki :

1 100 000

Grebena : Kozani :

40 000 155 000

Pieria :

130 000

Kastoria :

55 000

Imathia :

150 000

Florina :

55 000

Pella :

145 000

Serres :

200 000

Kilkis :

90 000

Drama :

105 000

200 000

Kavala :

+145 000

Serres : Chalkidiki :

+ 105 000

820 000

755 000

Estimated patients’ number Population living in target area : 2 700 000 Average national birth ratio : 10 children per 1000 citizens per year ⇓ Estimated pregnancies : 27 000 per year Occurrence of pregnancy induced hypertension : 6-8% ⇓ Estimated patients : 1 890 per year

Competition In the target area around the city of Thessaloniki there are  Several obstetricians, but none with expert knowledge on antepartum fetal ultrasounds  Several clinics for childbirth without organized Intensive Care Units able to handle severe cases  No organized Neonatology Intensive Care Units (NICU)

Current situation 

On suspicion of preeclampsia, patients travel to Thessaloniki to get diagnosed and determine a treatment plan



Patients with mild preeclampsia travel to Thessaloniki to see one of the 5-10 experts on fetal ultrasound for follow-up, sometimes staying overnight



Patients at risk come to Thessaloniki to get hospitalized, receiving daily or weekly visits from their relatives

Current cost for patient 30 $ for local physician 60 $ for consultant 150 $ for ultrasound session 60 $ daily hospitalization fees 30 $ for traveling expenses 60 $ for lodging Traveling and lodging expenses for visiting relatives

 Each follow-up visit : 250$ 4 weeks hospitalization : 1800$+family expenses

Our solutions  Create a web page that will enable the home monitoring all of the patients on a daily basis  Create 6 remote sites scattered around the target area, able to perform fetal monitoring and fetal ultrasounds and transmit them to the consultant  Create one consultant site in Thessaloniki, receiving ultrasound images and reviewing patient data

Advantages 1. Pregnant women stay at home and receive dayto-day monitoring without being hospitalized until it is absolutely necessary 2. Patients don’t have to travel 1 to 3 hours to undergo scheduled or emergency ultrasounds 3. Patients’ relatives don’t have to travel to visit them

Save Time Save Money Improve Quality

Proposed cost • 150$ weekly monitoring fee • 100$ for teleultrasound sessions (estimated number/patient: 3) • 50$ for weekly house calls (estimated number/patient: 6) Average follow up duration : 4 weeks

 Total cost / patient is 1200$

3. WORKFLOW

i.

Initial Diagnosis

A woman gets pregnant

She visits her obstetrician for a follow-up

Obstetrician suspects P.I.H.

Obstetrician’s assistant contacts remote site and requires consult

Local physician’s assistant schedules time & date for consult

Inform consultant site about new patient

Physician conducts examination & enters data into internet database •Demographics •History of pregnancy •Maternal health

Patient arrives at remote site

Assistant •Turns on Echo & Fetal monitor •Turns on telecommunication equipment (VTC) •Sets up linkage

When ready, assistant notifies consultant site

Consultant reviews patient record

Consultant notifies he/she is ready for consult

VTC • Introduction with patient • Clarifies details of record with physician

Ultrasound

Physician places transducer in protocol positions Consultant gives instructions (only audio)

Consultant stores images needed approves

If needed:

Consultant

General examination

VTC

stores images needed

Physician sends images

approves

Discuss patient condition with physician & patient

Consultants gives instructions (only audio)

Consultant gives orders immediately Diagnosis & Treatment plan

Consult ends

Consultant reviews patient’s electronic record and sends orders later

Assistant

No P.I.H

P.I.H. mild

Start Home Monitoring

Hospitalization

23-33 GW

>33 GW

Schedules visits for Ultrasound

Advice on termination

<23 GW

P.I.H. severe

Gives patient equipment and Instructions for home monitoring

Amniocentesis Fetus immature

Fetus mature Corticosteroids 48h

Induce Labor

Follow up a. Home monitoring b. House call c. Visit to Local practice

a. Home monitoring 3 times daily : measure blood pressure

Once a day : fill in form with measurements and complaints

If necessary: necessary Type in questions or request teleconference with consultant

Send data through the internet

Consultant’s assistant reviews new data on a daily basis

Urgent

Notify Consultant immediately

Not certain

Notify consultant the same day Consultant reviews new data

Normal

Consultant reviews data once a week

Assistant sends email once a week for reassurement

Normal

Urgent

Call patient, give order for hospitalization

Adjustments needed

Send instructions over internet

Pathological

Not sure, need for Ultrasound or house call

Notify local physician Notify patient

Answers patient’s questions, if asked for, schedules teleconference appointment

Physician’s assistant schedules appointment with patient and notifies consultant’s assistant

b. House call Once a week or on Consultant’s request Physician makes house call and Takes to Lab and scans lab results to send over internet Draws blood

Performs fetal monitoring

Stores and forwards information to consultant

Consultant reviews results along with the weekly data from the patient

c. Visit to Local practice Physician Reviews patient record Examines patient Enters new data into record

Patient arrives at remote site Every 3 weeks On Consultant’s request

Assistant Notifies consultant site Turns on Echo & Fetal monitor Turns on telecommunication equipment (VTC) Sets up linkage

When ready, assistant notifies consultant site

Consultant reviews new data on patient record

Consultant notifies he is ready for consult

VTC •Conversation with patient •Clarifies details of record with physician

General examination Physician sends images Consultants gives instructions (only audio) Consultant approves

Echo

VTC

Physician places transducer in protocol positions

Discuss patient condition with physician & patient

Consultant gives instructions (only audio) Consultant stores images needed Consultant approves

Consultant gives orders immediately Diagnosis & Treatment plan

Consult ends

Consultant reviews and sends orders later

4. MEDICAL PERIPHERALS

CONSULTANT SITE • • •

PC with high resolution screen VTC Server with storage room

Estimated price : 2 500$

Estimated price : 500$

Estimated price : 15 000$

REMOTE SITE • PC • VTC • ULTRASOUND • FETAL MONITOR • GENERAL EXAMINATION CAMERA

The AMD-5600 Curved Array Probe for the SmartProbe UltrasoundTM is used for all obstetrical and abdominal scanning applications. The 3.5 MHz probe has the familiar look and feel of big system probes. Specifications •Frequency: 3.5MHz •Elements: 128 •Pitch (mm): 0.520 •Elevation Width (mm): 15.0 •Geometric Focus (mm): 90 •Azimuth Radius (mm): 65.0 •Azimuth Length (mm): 66.6 List Price : $14,000

Specifications •Dimensions: 4.72" (120mm) L x 2.37" (60mm) W x .99" (25mm) D •Weight (including battery): Approximately 0.40 lbs. (180g) •Battery type: 1 x 9V alkaline •Modulation: FM Tone •Center Frequency: 1900Hz •Frequency Deviation: 100Hz/1mV The AMD-9600 Personal 12/8 Lead

Cardiotocogram (CTG) Recorder/Transmitter can send

comprehensive ECG data anytime, anywhere via an acoustic coupler connection. The AMD-9600 Personal 12/8 Lead ECG has a 3 wire patient cable and 4 fixed ECG electrodes for recording the 12 or 8 lead ECG. The recorded ECG is then transmitted to a workstation running AMD-9500 Receiving Software, where it can be interpreted immediately by medical professionals. The AMD9600 uses the AMD-9500 Receiving Software, Applications include diagnosis of cardiac symptoms, remote cardiac monitoring and heart monitoring during clinical trials.

•Memory Size: 32KB •Sampling Rate: 375 samples/second •LBS Resolution: 39m V •Frequency Response: 0.05Hz to 150Hz •CMRR Ratio: 60dB or better (at 50/60Hz) •Input Range: +2.5mV •Input Impedance: >1212 ohms •DC Offset Correction: +200mV List Price : $860

Specifications •Dimensions: 2.2"W x 3.7"D x 2.9"H •Weight: .5 lbs. •Magnification: Auto-zoom from 1-50x. •Polarization: Push-button •Zoom: Push-button •Pixels: 410,000 from a 1/4" CCD •Horizontal Resolution: Greater than 430 lines •Signal to Noise Ratio: Greater than 48dB •Output Signal: Composite and S-Video •Output Format: NTSC

The AMD-2500 general examination camera is the first analog camera to combine power zoom, auto focus, freeze frame capture, and electronic image polarization in one diagnostic device. This multi purpose analog camera has wide applications in primary care, emergency medicine/trauma care, dermatology, ophthalmology, wound care and is an excellent device to document sexual abuse or child abuse. The AMD-2500 general examination camera is the "do it all, go anywhere" analog camera!

•Integrated Freeze-frame: Push-button •Color Adjustments: Auto white balance •ACC: Full iris control •Lighting: Fluorescent •Operating Temperature Range: 0 degree C - 40 degree C •Operating Humidity: Less than 90% •Power Consumption: 5W •Voltage Range: 110/220 VAC 10%, 50/60 Hz, or 12VDC •Lens: General purpose lens close focus, 50x polarized lens, and optional 200x polarized contact lens

List Price : $5,490

HOME •

PC with internet OR Fax machine

•

Optional : VTC Blood Pressure Monitor Electronic Weight Scale Vital Signs Monitor

Specifications •Dimensions: 2.63" (66.7mm) H x 6.45" (163.7mm) W x 4.37" (111mm) D •Weight: Approximately 0.860 lbs. (390g) •Type: Oscillometric •Measurement Range: 20-280mmHG (BP); 40-200 beats/minute (Pulse) +3mmHG or 2%, whichever is greater (BP); +5% (Pulse) •Display: Digital, character height: 0.63" (16mm) The AMD-9200 Blood Pressure Monitor allows users to measure their pulse and blood pressure in a "one step" monitoring procedure to manage hypertension. Once the user slips on the blood pressure cuff and presses the "Start" button, the AMD-9200 Blood Pressure Monitor automatically inflates, digitally displays systolic and diastolic blood pressure, and then automatically transmits data to a receiving station over a standard phone line. Systolic and diastolic blood pressure data may subsequently be displayed in graphic and alpha numeric formats. A great low cost approach to manage hypertension in the home. Used with AMD-9100 Multi-Patient Receive Software

•Pressurization: Automatic, using a micropump •Depressurization: Constant-Air-Release Valve System •Deflation: Automatic exhaust •Power source: Four AA batteries (1.5V each) •Battery Life: Approximately 3 months with one use/day •Telephone Connection: RJ-11 List Price : $450

The AMD-9300 Weight Scale is a clinically accurate scale that electronically sends user weight and automatically transmits the user’s weight measurement over a standard phone line to a receiving station. The station collects these readings in a database and displays the results in graphic and alphanumeric displays. The AMD-9300 Weight Scale's reliability and accuracy make routine and long-term monitoring easy and efficient. Ideal for in home management of patients with hypertension or diabetes. Used with AMD-9100 Multi-Patient Receive Software Specifications •Dimensions: 2.05" (5.2cm) H x 12.25" (31.1cm) W x 12.01" (30.5cm) D •Weight: Approximately 5.96 lbs. (2.7kg) •Measurement Device: Load Cell •Measurement Range: 0.1 lbs. (50g) to 300 lbs. (136kg) •Display: Liquid crystal, character height: 1" (2.5cm) •Operating environment: 10° to 35°C at less than 85% relative humidity •Power: One DC-9V Alkaline battery, auto power off •Telephone Connection: RJ-11 List Price : $636

Specifications •Dimensions: 6.5"(16.5 cm) H x 8.6"(21.8 cm) W x 5.0"(12.7 cm) L •Weight: 6 lbs. (2.8 kg) •Data Output: RS-232 •Blood Pressure Accuracy: Meets or exceeds SP10-1992 AAMI standards •Cuff Pressure Range: 0-300 mmHg •Pressure Preset Levels: 120,140,160,200,240 or 280 mmHg •Systolic Determination: Max: 250 mmHg; Min: 60 mmHg •Diastolic Determination: Max: 160 mmHg; Min 30 mmHg

The AMD-8200 Vital Signs Monitor automates electronic collection of all body vital signs information critical for patient evaluation, including primary care, pediatrics, or home care. The AMD-8200 Vital Signs Monitor provides a digital display of temperature, diastolic and systolic blood pressure, pulse and blood oximetry SPo2. The system can store up to 99 sets of data that can be seen on the monitor or downloaded. The monitor can be integrated with a PC via an RS-232 port. In addition, a visual and audible alarm can be set when blood pressure (diastolic or systolic) or pulse exceed set limits. The lightweight design and rechargeable battery allow for easy portability for all primary care, pediatric, and home care applications

•Pulse Rate Determination: Max: 200 bpm; Min: 40 bpm •Temperature Accuracy: Meets or exceeds ASTM E112-86 standards •Temperature Determination: Normal and Monitor Mode, Max: 108.0 deg. F (42.2 deg. C); Min: 84.0 deg. F (28.9 deg. C) •Power Requirements: N. American version: 120 VAC, 60 Hz. •International version: 220-240 VAC, 50-60 Hz •Internal Battery: Lead Acid, with external recharger •Safety Standards: IEC 60601-2-30, UL 2601-1, CAN/CSA C22.2 No.601.1 •Conformity: CE

List Price : $2,995

5.TELECOMMUNICATIONS

Telephone Telephone lines are available throughout the target area, allowing for the following functions • Patients communicate with the remote site to schedule house calls and ultrasound appointments • The patients can call the consultant site any time an emergency presents itself • The consultant can call the patient if there are emergency instructions to be given (e.x. hospitalization order)

Internet The entire project is based on the existence of a web page. The web page can be accessed with plain internet connection, over POTS or ISDN The information on the web page is divided into 4 categories, 3 of which need personal password to be accessed. All internet users (no password needed) • Information on Pregnancy Induced Hypertension and related links • Information on the organization and the services provided

Patients (patient password) • Charts to input daily data • Ability to communicate with doctor • Ability to communicate with other patients • Alerts to remind scheduled appointments Local obstetrician (remote password) • Patient history • Charts to input new data Consultant (consultant password) • Patient history • New data from patients and local physicians • Ability to communicate with patients

Daily measurements Mon Blood pressure . 8am 4pm 12pm Pulse Weight Urine protein Fetal movements

Tue

Wed

Thu

Fri

Sat

Sun

Complaints Mon Tue Wed Thu Fri Swelling (face, feet, hands)

Nausea-vomiting Headache Agitation Visual disturbances (scotoma, blurred vision) Abdominal pain Reduced urine output

Sat Sun

Facsimile (fax) Patients that do not own a PC (personal computer) are given forms, similar to those that can be found on the internet page  They fill in the forms in the designated time and manner and they consequently fax it to the consultant’s office, where the assistant transfers the data into the computer database

ISDN An ultrasound session is required for the initial diagnosis and thereafter every 3 weeks or whenever the consultant requests one The transmission of real-time ultrasound image of good quality requires the combination of 3 128 K ISDN lines, to achieve the desired bandwith of 384 Kbps. ISDN lines are available everywhere in the target area

6. FINANCIALS

EXPENSES Expenses are divided into 3 categories : Remote : 6 Remote sites with Physician and Assistant Consultant : 1 consultant site with Physician and Assistant Corporate : staff, which resides at the same site as Consultant

Remote REMOTE MONTH PERSONNEL

EQUIPMENT

ADMINISTRATIVE

Physician Assistant PC+VTC ECHO Fetal Monitor Camera Miscellaneous Rent Rennovation Office expenses

TELECOMMUNICATIONS Installment Monthly fee Charges Total/month Total/month/6 sites

1 2500 1250

6 2500 1250

12 2500 1250

18 2500 1250

24 2500 1250

3000 14000 1000 5500 100

100

100

100

100

250

250

250

250

250

250

250

250

120 130

120 130

120 130

120 130

4600 27600

4600 27600

4600 27600

4600

250 3000 250 120 120 130 31220

187320

27600

Consultant CONSULTANT MONTH PERSONNEL

EQUIPMENT

ADMINISTRATIVE

Physician Assistant

1 3750 1250

6 3750 1250

12 3750 1250

18 3750 1250

24 3750 1250

PC+VTC Software Miscellaneous

3000 6000 100

100

100

100

100

Rent Rennovation Office expenses

500 6000 500

500

500

500

500

500

500

500

500

120 120 380

120 380

120 380

120 380

120 380

21720

6600

6600

6600

6600

TELECOMMUNICATIONS Installment Monthly fee Charges Total/month

Corporate CORPORATE MONTH PERSONNEL

EQUIPMENT

ADMINISTRATIVE

Coordinator Legal Hardware technichian Software technician PC+VTC Server ISP provider Miscellaneous

6 1250 1250 1250 1250

12 1250 1250 1250 1250

18 1250 1250 1250 1250

24 1250 1250 1250 1250

3000 15000 100 100

100 100

100 100

100 100

100 100

40 20 120

20 120

20 120

20 120

20 120

26880

5340

5340

5340

5340

Rent Rennovation Office expenses

TELECOMMUNICATIONS Installment Monthly fee Charges Total/month

1 1250 1250 3000 3000

REVENUES Patients Target number of patients/month : 72 (12 for each remote site) Average length of follow-up : 4 weeks Estimated number of Ultrasounds : 3 Estimated sessions of Fetal Monitoring : 6

Advertising Insert 6 alternating advertising banners into web page

REVENUES MONTH Number of patients

1 6

6 36

12 72

18 72

24 72

Weekly fee/patient Revenues from weekly fee

150 3600

150 21600

150 43200

150 43200

150 43200

Fee/ultrasound Revenues from ultrasound

100 1800

100 10800

100 21600

100 21600

100 21600

Fee/House call Revenues from house calls

50 1800

50 10800

50 21600

50 21600

50 21600

50 2 433

50 2 433

50 2 433

Advertisement fee Number of customers Revenues from ads Total/month Total

7200 7200

43200 151200

86833 564198

86833 86833 1085196 1606194

BUDGET  Total expenses during first year : 670 000$  Estimated time of breakeven : 14 months  Estimated monthly profit when target number of patients is reached : 160 000$

BUDGET MONTH REVENUES

EXPENSES

BUDGET/month BUDGET/total

Weekly fee Ultrasounds House calls Advertisement

Remote Consultant Corporate

1 3600 1800 1800 0

6 21600 10800 10800 0

12 43200 21600 21600 433

18 43200 21600 21600 433

24 43200 21600 21600 433

187320 21720 26880

27600 6600 5340

27600 6600 5340

27600 6600 5340

27600 6600 5340

-228720

3660 -282420

47293 -106662

47293 177096

47293

-228720

460854

Conclusion • Wireless communication, videoconferencing, and the Internet have made telemedicine a reality • Telemedicine is still in its infancy, but undergoing rapid development • Health-care providers take note: Your practice is about to become more efficient—and cutting edge • The future belongs to 'e-health', the health sector's equivalent of 'e-commerce'