Overview April 8-9, 2011. How does TAMA work? TAMA has two interfaces: a cell-phone, voice-driven interface for patients, and a web-based interface

Overview

April 8-9, 2011

How does TAMA work?TAMA has two interfaces: a cell-phone, voice-driven interface for patients, and a web-based interface for clinics

TAMA Functional Overview 2

TAMA Platform

TAMA

Patient Health Records

Clinical Expertise

CommunicationsPatient Clinic

TAMA Services

Clinic ServicesPatient Services

What services does TAMA provide?


Pill Reminder

Appointment Reminder

Health Tips

Self-reported Adherence

Symptoms

Socialization

Alerts

Reports

Patient Admin

TAMA

TAMA Admin

Clinic Registration

Clinic User Registration

Drug Name Management

Master Data Management

Patient-TAMA interactions


Patient Registration at clinic Upon treatment initiation, the patient record is created in TAMA. Relevant medical record data is entered into TAMA. The patient’s individual preferences for system usage are configured in TAMA.

Appointment / Clinic Visits Patient meets doctor and is prescribed medicines at specific times of day Patient comes to clinic for treatment follow up as per TAMA Appointments Schedule Protocol

Patient receives calls from TAMA for Daily Pill Reminder. Self Reported Adherence calls . Health messages Appointment reminder calls

Patient makes calls to TAMA for Symptom Reporting Socialization Request Patient calls to confirm daily pill reminder

During the clinical trial, patient can be in any of the following statuses: ACTIVE INACTIVE STUDY_COMPLETE PREMATURE_TERMINATE_BY_CLINIC PATIENT_WITHDRAWS_CONSENT MOVED_LOCATION LOSS_TO_FOLLOW_UP

At the end of 1 year, Study trial is complete.

Monitoring and Calculating adherence


Pill reminder Calls ART Pill(s) prescribed ART Pill times at which pill is to be taken is specified ART Pill reminder calls are made daily to patient as per pill times Patient’s positive / negative confirmation over IVR captured

Self Reported Adherence (SRA) Calls Patient is called by TAMA for SRA and asked to respond to a 4 day recall. Frequency of SRA calls: to be selected as per patient’s choice of

once a month or twice a month

Adherence Calculation Based on patient responses to taking medicines, patient’s adherence is calculated

Tracking Treatment Effectiveness Lab Test Reports tracked: CD4 count, PVL count

In every patient record, two times will be identified:

pillTime: this is the time when patient is expected to take his/her medication and also the time at which TAMA will call patient to remind him to take his medicine and to capture his response whether he has taken etc.

Pill Window: A permitted dosage time window will be defined (system wide). If patient takes his/her pills within this window (i.e. pillTime +/- PILL_WINDOW) only then will it considered as TAKEN_DOSAGE. Outside this window, TAMA will note it as MISSED_DOSAGE.

bestCallTime: this is some other time in the day when the patient feels (s)he will be free to listen to other messages from TAMA

Self Reported Adherence Call (Priority 1) Appointment Reminders (Priority 2) Health Tips (Priority 3)

To collect these messages in a single place (as and when they are generated) and play them at patient’s “bestCallTime”, every patient will have his/her own Outbox in TAMA.

Schedule of TAMA calls to patient mobile


Pill Reminders


Patient has opted for Pill Reminder calls. TAMA makes scheduled Pill Reminder calls to patients at “pillTime” to take ART medications. Patient can give responses by pressing the appropriate phone keypad number as directed by TAMA.

The responses that a patient can give are:1. MEDICINE_TAKEN

2. WILL_NOT_TAKE_MEDICINE

3. MEDICINE_NOT_TAKEN_YET_PLEASE_CALL_LATER

4. WILL_TAKE_MEDICINE_IMMEDIATELY AFTER_CALL

In case the patient’s phone is not reachable for the entire duration of Pill Window, TAMA will assume dosage to be a missed dosage.

NO_RESPONSE or NO_CONTACT:

The patient can call TAMA before TAMA calls patient or in between pill reminder calls (within pill Window timeframe) from TAMA and confirm to TAMA that (s)he has taken his pill(s). After pill window, patient cannot call TAMA and confirm taking medicine

MEDICINE_TAKEN

Self Reported Adherence Calls –


Patients will be requested to report a 4 day recall of adherence to taking of medicine. Patient can give responses by pressing the appropriate phone keypad number as directed by TAMA.:

In the last four days, for how many days did you miss taking all your doses? If you missed even one of your many doses in a day, please report as a missed dose.

If you did not miss any dose on any day If you missed any dose on ONE day If you missed any dose on TWO days If you missed any dose on THREE days If you missed any dose on all FOUR days

Self reported Adherence is one of the calls made at bestCallTime

At what frequency should Self Reported Adherence calls be made to patient: One a month? Twice a month?

Adherence Status Calculation


Calculation of Adherence of patients will differ based on the method used for collecting Adherence Information: 1. Daily Pill reminder2. Self Reported Adherence

Adherence of Patients will be categorized in bands based on:

Adherence percentage on any particular day will be calculated as in the following slides

Adherence Levels Value (doctors inputs required)

GOOD ADHERENCE_MARK ?

BAD_ADHERENCE_MARK ?

Adherence Status Calculation (…contd)


Patients activated on Pill Reminder Calls:

Adherence Percentage = total number of dosages actually taken till date % total number of scheduled dosages till date

Adherence Status for that day is set as per:

RED: Adherence percentage < BAD_ADHERENCE_MARK% (low value)

GREEN: Adherence percentage > GOOD_ADHERENCE_MARK % (high value)

YELLOW: BAD_ADHERENCE_MARK % < Adherence percentage < GOOD_ADHERENCE_MARK%

Adherence Status Calculation (…contd)


Patients activated on Self Reported Adherence 4 Day Recall

Adherence Percentage = If TAMA did not call the patient today about collecting Self Reported Adherence information, there is no Adherence Percentage for this

patient today, then set the adherenceStatus for that day = YELLOW

If TAMA called and patient’s response is available, then

Adherence % = 4 - Patient response %

4

Set adherenceStatus for that day accordingly:

GREEN: Adherence percentage > GOOD_ADHERENCE_MARK %

RED: Adherence percentage < BAD_ADHERENCE_MARK %

YELLOW: Otherwise

If the patient did not respond to today’s call from the Adherence module, then set adherenceStatus for that day = YELLOWA “missed call” is not counted as a “missed dosage” in Self Reported Adherence case. i.e. TAMA did try to measure the Adherence today but TAMA has no data

Appointments Schedule Protocol


Appointment Schedule Protocol as shown is entered in TAMA. Patients are expected to come to the clinic over the one year study period as per this schedule.

Patient’s First Visit date defines patient’s regular follow-up dates for the coming year

Next Appointment Due date is suggested by system as per Appointment Schedule Protocol. This can be changed by doctor/Study Nurse

Appointment Reminders are sent to patient as per Next Appointment Due Date

Week 0

Week 4

Week 12

Week 24

Week 36

Week 48

Appointment Reminder Calls


Patient will start receiving reminder calls <n> days prior to the Next Appointment Due Date.

If the patient does not call till m (n>m) days before the Next Appointment Due Date, TAMA will generate alerts for the

clinic Alert web interface for the Study Nurse to see.

Between the Study Nurse and the patient, they will try to reach each other and choose a firm Appointment Date and

enter the date in TAMA.

If appointment is fixed, reminders to fix Appointment to patient will stop.

Once Appointment Date is fixed, Alert also is closed

x (x < m) days before the Appointment Date, TAMA will start sending daily reminders to patient to remind him of the

fixed date.

If patient does not turn up for fixed Appointment or patient does not fix appointment, Appointment Lost Alert is

generated for Study Nurse

Fixing an Appointment

TAMA application flow 14

Next Appointment Due Date

Starting from this date TAMA posts Appointment Reminder in patient Outbox daily .

TAMA starts leaving voice messages for patient daily from this date to remind patient of Fixed Appointment Date

Study Nurse and patient talk on this date to each other and fix an Appointment Date in the

future. Patient. Message posts and alerts are switched off.

timeline

Firm Appointment Date

Web Clinic alert for Appointment Reminder

TAMA does not enforce fixing of Appointment; it will only remind both patient and clinic of scheduled expected check-up. Patient could come to clinic with no prior appointment.

Firm Appointment DatePatient does not come to clinic.

TAMA leaves an Appointment Loss Alert on Clinic Alerts Web Interface.

No further messages are posted to patient

Patient comes to clinic and a new Next Appointment Due Date is assigned.

Appointment Scheduling – Missed Appointment


What happens to future appointments if an appointment is missed? Do the appointments just continue on the same schedule or is there some adjustment made to accommodate for the missed appointment? Are they out of the program? Do they just pick up where they left off? Do they re-enroll at week 0?Or patient calls up to say he can only come 2 weeks after the Next Appointment Due Date? How does this affect the Next Appointment Due Date?Or patient does not come and is not contactable for 15 days after Next Appointment Date and he then lands up at the clinic for a check up?How does patient fit back into the previous Appointments Schedule Protocol?

Symptoms Reporting & Health Tips


Specific information to be captured by TAMA to effectively provide Symptoms Reporting feature and Health tips have to be finalized (TBD)

Patient’s physical examination – anatomy list and their possible ailments

Lab test reports – list of lab tests along with their normal ranges of measurement (numerical)

Opportunistic Infections list

Side Effects / Adverse Effects

…

…

Symptoms Reporting Calls


Patient calls TAMA to report symptoms he is suffering from. TAMA will

try to gather enough significant information from patient and use it to

give him some advice on what to do

Symptoms Call IVR interaction Option 1


Symptom11

Symptom12

Symptom13

Symptom14

Symptom15

Symptom16

Symptom17

Advice 1

Symptoms Call IVR interaction Option 2


Symptom11

Symptom12

Symptom13

Symptom14

Symptom15

Symptom16

Symptom17

Advice 1

Symptoms, Algorithm, Advice to be defined by doctors


Symptom # Symptom List

Symptom #1 Symptom1 Name

Symptom #2 Symptom2 Name …

Logic

Patient Health condition

Symptoms Advice+ Algorithm+

Advice # Advice Messages ??

Advice 1 Come to HIV clinic

Advice 2 Go to local physician.

Advice 3 Go to local pharmacy and pick up OTC medicine <name of medicine>

Advice 4 Don’t worry, keep taking your HIV medication, you should fell better soon

Opportunistic Infections

Duration since ART initiation

++

Health Tip Messages


Patient will receive two types of Health Tips messages:

1. Temporal or General Health Tips – such as first month of ART regimen or festival time eating habits etc

2. Patient health status based Health tip – i.e. health tip tailored to patient condition

Health Tip Messages (to be defined)


Health tips Health tips type: Temporal (non-patient

specific) & Patient health condition specific

Categorization: Yes / NO Health tips category + health tips

for each category Health tips individual – no

categorization

Health tip type (Temporal / health condition based)

Health tip category Health tip

Logic Identify Conditions that trigger health tips to be generated for

a patient e.g. change in health record – identify the specific fields

OR based on number of days that patient has been on

ART medication OR Value of specific health fields (Pregnancy – YES/ NO)

Basis to decide whether a patient is to receive a health tip or not - Should it be possible to manually select Health tip category for a patient (via Clinic web interface) or should they be posted automatically based on Conditions

Health tip type (Temporal / health condition)

Condition to trigger posting of health tip

Basis to decide whether patient is to receive this health tip or not (Manual / Automatic based on Condition)

Socialization Calls


Patient calls TAMA indicate that (s)he wants to talk to someone. Patient’s

request call to TAMA leaves an alert on Clinic’s web interface for the Study

Nurse to view and take appropriate action (maybe talk to patient herself or

have someone else talk to patient).

Data Entry done here

Patient data entry into TAMA- Workflow 1


Doctor(s)

Registration

Goes for Physical Examination

Lab

Study Nurse

Doctor gives diagnosis

Doctor prescribes ART medicines

Doctor sets pillTime for taking ART medicines

Doctor sets Next Appointment Due Date based on Appointment Schedule Protocol & patient preference

Study Nurse

Doctor recommends Lab tests

Lab hands patient reports

Patient goes to lab to get tests done

Patient takes lab test reports to Study Nurse

Patient


Patient data entry into TAMA- Workflow 2


Doctor(s)

Registration


Lab

Study Nurse





Study Nurse



Lab sends reports

Patient


Patient data entry into TAMA - Workflow 3


Patient

Doctor(s)

Registration


Recommends Lab Tests

LabLab hands patient reports


DoctorDoctor gives diagnosis

Patient takes lab reports to doctor




Study Nurse

No Data Entry doneData Entry done here



Registration


Lab

Study Nurse




Study Nurse




Patient takes doctors diagnosis, treatment advice, Next Appointment Due Date, lab test reports to

Study Nurse

Patient

Doctor(s)

Data Entry done hereData Entry done here










Patient takes lab test reports to Study Nurse

Patient

Doctor(s)

Lab

Study NursePatient takes doctors diagnosis, treatment advice, lab

test reports to Study Nurse

Study Nurse sets Next Appointment Due Date based on Appointment Schedule Protocol & patient preference

Patient Registration into TAMA by Study Nurse


Patient will be registered by Study Nurse into TAMA (exact layout of User Interface is under design):

Basic patient information1. Clinic ID of patient (given by clinic to

patient outside of TAMA)2. Mobile phone no.3. Date of Birth4. Gender5. Name of Principal Doctor in charge of

patient

Information on Past Medical History of patient1. Name of Non HIV Ailment

suffered in past, approximate date, whether still on treatment (yes/No)

2. Opportunistic Infections suffered3. Reason for being tested for HIV4. Possible Mode of transmission5. Diagnosis prior to TAMA

TAMA Usage related – as per choice of patient1. TAMA passcode for IVR usage 2. Language for interaction with TAMA

IVR3. Selection of TAMA features that

patient wants to use:i. Daily Pill Reminder calls or

Self Reported Adherence Calls

ii. Appointment Reminder calls

iii. Health tips4. Best time to receive and respond on

above topics -Self reported Adherence Call + Appointment Reminders + Health Tips

Note: Time for receiving pill reminders is assumed to be dependant on ART regimen and can be specified at the time of prescribing ART medicines by doctors

The Study Nurse can later modify any of this information except Clinic ID, Date of Birth.

Workflow based on Workflow 1

Confirm: Status of patient upon Registration is ACTIVE? Registration date = First Appointment Date = baseline date?

First Check-up (Appointment) of patient by Doctors


Once Patient is registered in TAMA, patient goes to doctor(s) for physical examination, diagnosis and treatment advice:Physical ExaminationThe following information may

require to be entered in TAMA to describe the current condition of patient:

1. Weight2. Height3. BP4. Pulse5. Temperature6. Conscious / unconscious7. Various:

1. Body Part (ear, Eye, Skin etc.)

2. Specific condition of body part (Eye – lusterless, pallor etc)

Treatment AdviceART Medicine Regimen1. Generic Name of Drug2. Brand Name of Drug3. Frequency - Number of times a day4. Specific times e.g. 9am, 9pm etc5. Before meal / After meal6. Forewarnings7. Reason for stopping medicine

Non-ART medications8. Generic Name of medicine9. Brand name10. Frequency11. Before meal/after meal12. No of days13. Forewarning14. Start Date15. Stop Date16. Reason for stopping medicine

Lab Tests advisedDoctor will be able to select specific lab tests for the patient from a list of possible lab tests.

Diagnosis1. Diagnosis2. Opportunistic Infections

Note:1. Pill reminder is for ART medication only2. Pill reminder call times will be as specified here

Clarification:1. Which name will Pill reminder use - Generic Name or Brand name?2. What variations are to be considered for single ART pill dosage and

multiple ART pill dosage – if any?3. Can Study Nurse modify all of these information, some of them, none of

them?

Clarification:1. Other than simply

identifying the name of lab test, is there other information that needs to be entered in TAMA?

Workflow based on Workflow 1

Next Appointment Due date


Towards the end of an interaction of the patient at the clinic, patient has to be given a date to return for a follow-up.

TAMA will suggest a next appointment due date as per Appointment Schedule Protocol. This can be changed to some other tentative date at this time itself e.g. patient knows for sure

that he cannot come around this time as he will be traveling.

Note: 1. This is a tentative date only and will be used by TAMA to schedule Appointment Reminder calls to

the patient reminding him to call the clinic and fix a firm appointment date. 2. These calls will be initiated by TAMA a few days (n days) in ahead of the Next Appointment Due

Date.3. <n> will be configurable in the system and will be the same for all patients and all clinics

Clarifications1. Who would typically perform this activity – Doctor or Study Nurse?2. To what extent can Due Date be delayed. If patient cannot come for 10 days after Due date as per protocol, should

he be then marked as missed current due appointment and date be given after skipping a scheduled visit as per protocol (i.e. missing one in between)

Lab Test Reports


1. Name of Lab Test2. Date on which tested3. Test result / value4. Normal Range5. Unit of measurement

Clarifications:1. How does Study Nurse get access to Reports:

i. Patient submits report to Study Nurseii. Report comes in directly from Lab

2. Would the tests advised that day be done that day itself? 3. Would the doctor want to see the report before prescribing medicines?

Data from reports of lab tests done on patient will be entered in TAMA by Study Nurse as required. Only numerical lab test reports will be captured in TAMA. The information to be entered:

Clarifications:

1. Any action by TAMA for Lab test report abnormality?

Follow up appointment at the clinic by patients


1. Fresh new Appointment record is created and fresh information relevant for that date will be entered

2. Study Nurse can also change registration details as mentioned earlier

End of Treatment End of 48 weeks Patient wants to withdraw Doctor finds it necessary to take patient off intervention program

To indicate End of Treatment, Patient Status must be changed from ACTIVE to one below by Study Nurse

INACTIVE STUDY_COMPLETE PREMATURE_TERMINATE_BY_CLINIC PATIENT_WITHDRAWS_CONSENT MOVED_LOCATION LOSS_TO_FOLLOW_UP


Clinic Alerts for Study Nurse


Clinic will receive alerts on the TAMA web User Interface for

1. Symptom Reported Call

2. Adherence Level-Red

3. Socialization Call

4. Appointment Reminder Alert, Appointment Loss Alert

Alerts Status can be changed from NEW -> CLOSED

Generate Reports


The Study Nurse will be able to generate reports such as:

1. Dosages missed – along with date, adherence percentage, alerts raised / closed dates

2. Appointment Reminder Calls– dates of Next appointment due date, reminder call start date, reminder

call stop date, new appointment date, date on which new appointment date is fixed

3. Adherence Status – i.e. status = RED / GREEN / YELLOW, adherence percentage, date when

measured, delta change from pervious measure

4. Symptom Reported– Details of interaction between TAMA and patient (date of call, TAMA messages

played and patient responses as well as final advice)

5. Socialization Requests – List of socialization request calls made by patient, alert raised for them and

date alert is closed

TAMA components and interface


Database

Application Management Framework

Messaging and Communications

IVR Web

MOTECH platform

Clinical Knowledge DB

TAMA

Patient

Clinician – Study Nurse

Patient Health Records

TAMA featuresClinical

Decision System (TBD)

TAMA Deployment


Patient

Clinic 1

TAMA deployed in a central location

with mobile telephony and Internet connectivity

“Dumb Phone”, only supporting voice and text

PC + Internet

Clinic n

PC + Internethttp

Internet connectivity

voice

mobile phone connectivity

Patient

“Dumb Phone”, only supporting voice and text

Internet connectivity at clinics?


Thank You

Documents

Overview April 8-9, 2011. How does TAMA work? TAMA has two interfaces: a cell-phone, voice-driven interface for patients, and a web-based interface