World Bank Document · 2016. 9. 30. · HIV patients on treatment x x Chronic patient record x x TB Treatment record x x TB Screening tool x x x x x x x Appointment/carrier cards

SEPTEMBER 2016 In collaboration with:

INTRODUCTION

Extensive progress has been made in the evaluation of South Africa’s new National Adherence Guidelines (AGL) for chronic diseases. After an extensive period of preparations, baseline assessment, patient file review and routine data enhancement at the selected health facilities, actual patient enrolment into the evaluation started in July 2016.

This brochure summarizes the findings from the baseline assessment in the 24 evaluation sites and

the first lessons drawn from preparing these health facilities for the evaluation.

Five AGL minimum package interventions are being evaluated under this study:

1. Fast track initiation counseling

2. Enhanced adherence counseling for unstable patients

3. Adherence clubs

4. Decentralized medication delivery

5. Early tracing of all missed appointments

The overall aims of the evaluation are to assess the

impact of these interventions on HIV patients’

treatment outcomes; estimate the costs of the

interventions; and describe the cascade of care for

TB, hypertension, and diabetes at these same

clinics. The study is a matched cluster randomized

study in 24 clinics, 12 of which will receive early

implementation of the minimum package and 12

will delay implementation and serve as control

sites. Clinics were matched on clinic characteristics:

total remaining on ART, clinic size, setting, location

and viral suppression. The two parts of the

evaluation – intervention effectiveness and process

of AGL scale-up—are detailed in two separate

protocols which have been approved by all

necessary bodies.

Teams have been hired by the academic partner

(Boston University/HE2RO) and put in place in

each of the four evaluation provinces chosen by

DOH, which are Gauteng, KwaZulu Natal, Limpopo

and North West. All evaluation activities are

specified in standard operating procedures.

The time scale of the evaluation is continuous

learning from scale-up and implementation, end-

2016 results on patient and health care workers

views (process evaluation), and effectiveness

results by late 2017.

The evaluation benefits for broad support by site-

level, district and provincial DOH staff and local

implementation partners at site and district level

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EVALUATION of the NATIONAL ADHERENCE GUIDELINES for CHRONIC DISEASE SEPTEMBER 2016

DIVERSITY OF METHODS OF RECORDING AND STORING DATA One of the key findings has been the diversity of

methods of recording and storing data on patients

within the evaluation sites Ekurhuleni (Gauteng),

Mopani (Limpopo), Bojanala (North West) and

uThungulu (KwaZulu-Natal).

Facilities use a number of paper registers to track

vital information on patients within their clinics.

These include both standardised registers and

stationery (e.g. the PHC tick register, HIV patient

stationery, chronic patient record, TB treatment

record) and non-standard registers (e.g., for

counselling sessions, tracing, adherence club). Not

all clinics use all the standardized registers. There

is partial use of TB monitoring tools, such as the TB

register & sputum register (83% of facilities), the

notification of medical condition for TB (38%) and

the TB screening tool (38%).

DATABASES AND REGISTERS IN USE AT EACH OF THE 24 EVALUATION SITES AS OF END DECEMBER 2015

CLINIC

EKURHULENI, GP MOPANI, LP BOJANALA, NW UTHUNGULU, KZN

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DATABASES

TIER.Net x x x x x x x x x x x x x x x x x x x x x x x x

eHealth (Ekurhuleni District) x x x x

DHIS x x x x x x x x x

Lab-track (NHLS) x x x x

STANDARD REGISTERS

Headcount register x x x

PHC comprehensive tick register x x x x x x x x x x x x x x x x x x

HCT counselling and testing register x x x x x x x x x x x x x x x x x x

TB register x x x x x x x x x x x x x x x x x x x x

Sputum register (TB patients) x x x x x x x x x x x x x x x x x x x x

Notification of med. condition (TB) x x x x x x x x x

NHLS Specimen Shipping List Book x x x x x x

Daily clinic register (Pink register) x x x x x

Pre-ART register x x x

NON-STANDARD REGISTERS Counselling session register x x x x x x x x x x

Tracing register x x x x x x x x x x x x

Adherence club register x x x x x x

Chronic register x x x

STANDARD STATIONARY WITHIN PATIENT FILES HIV patients on treatment x x x x x x x x x x x x x x x x x x x x x x x x

Chronic patient record x x x x x x x x x

TB Treatment record x x x x x x x x x x x x x x x x x x x x x x x x

TB Screening tool x x x x x x x x x

Appointment/carrier cards x x x

All sites within the evaluation are currently using

TIER.Net (versions 1.8.3 and 1.8.4) meaning the data

are computerised and downloadable. TIER.Net will

provide the majority of the data for the evaluation

and there has been significant strengthening of these

routine data based on a diagnostic to maximise their

completeness.

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THE IDEAL DATA FLOW IN A PHC CLINIC Given the number of registers, stationary and

clinical databases, it is essential for the evaluation

to understand how the data are generated and

registers are completed. The ideal flow of data is

illustrated below, and the routine data

strengthening activities are working towards this

ideal. Where a register or stationery is not used at a

clinic, alternative methods of recording may be put

in place (e.g., clinic or provider grown tools) or data

gaps may arise.

DATA FLOW PROCESS IN A PUBLIC SECTOR FACILITY

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QUALITY OF COMPLETION OF REGISTERS Not all clinics use all the standardised registers and for

those that do, they are kept in various degrees of

completeness. Each of the listed registers contributes

data to the evaluation, if well completed.

QUALITY OF COMPLETION AND RELEVANCE FOR EVALUATION

STANDARD REGISTERS

PHC comprehensive tick register Varied level of completion. The major gap has been incomplete folder numbers for each patient. For the evaluation, this is a useful means to identify patients who were screened, diagnosed and treated for hypertension and diabetes.

HCT counselling and testing register Reasonable completion overall, but very limited on baseline CD4. For the evaluation this is a tool to understand linkages between HIV testing and ART.

TB register High level of completion in clinics using it.

Sputum register (TB patients) High in clinics using it. Headcount register High level of completion.

Daily clinic (pink) register Inconsistent recording of folder number, which is problematic.

Pre-ART register Extremely low completion. Not useful to evaluation due to limited completeness.

NON-STANDARD REGISTERS Counselling session register Varied use, AGL SOPs might lead to better use of a standard registers.

Tracing register Varied – inconsistent approaches and formats across facilities. Valuable to the evaluation to understand tracing success, if completed well.

Adherence club register Varied use, AGL SOPs might lead to standard and supported register.

Chronic register Varied and being phased out. It is a useful means to quickly identify patients who were screened, diagnoses and treated for hypertension and diabetes.

STANDARD STATIONARY WITHIN PATIENT FILES HIV patients on treatment High. There are concerning data gaps in terms of Viral Load recording, as well as completion of the

Social Assistance areas that may affect understanding of adherence.

Chronic patient record Varied completion. Unfortunately, this form is not widely available. TB Treatment record High completion. It provides information to understand the TB treatment experience.

TB Screening tool When completed the quality is high, but it is frequently not completed.

Appointment/carrier cards Inconsistent use (these are kept by the patient)

NATIONAL ID NUMBERS One key piece of data that is

incompletely captured is the national ID

number. Across the evaluation sites,

42% of active patients on TIER.Net had

their RSA ID recorded (January 2016). Of

all Tier.Net records (105,307), 23% were

active and with RSA ID.

North West and Gauteng had the lowest

completion rate of active patients with

North West facilities recording below

25%. This may be due to differing

numbers of patients with national IDs at

the sites (as non-South Africans would

not have an ID) but this limits the number

of patients for whom mortality can be

cross referenced with the national death

index.

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DIVERSITY OF ADHERENCE SUPPORT MODELS One important insight from the baseline assessment

has been in the diversity of models for adherence

support. By end 2015, nearly all evaluation sites were

implementing the fast track initiation counseling

model, the tracing of patients who miss appointments

and adherence counselling for ART patients with an

unsuppressed viral load. However, there was high

diversity in the ways these models were being

implemented:

Enhanced adherence counselling were led by

professional nurses, lay counsellors or

community-based organisations. Some were

using the MSF Adherence Plan.

Tracing interventions varied greatly with some

sites tracing using phone calls only after varying

durations of time after a missed appointment,

and others implementing tracking using

community based outreach teams that also visit

homes.

The two interventions that were not being

implemented on a wide scale were adherence

clubs and decentralised medication delivery. For

the 12 sites using some form of adherence clubs

or decentralised drug delivery schemes, nearly

all were in KZN and following SOPs developed by

MSF. Some adherence clubs were multi-disease

clubs.

Decentralized medication delivery was only used

in KZN (1–13 pick-up sites).

Overall, adherence interventions were frequently

implemented in a way that differed from the AGL,

nevertheless, they were being implemented in some

form.

CLINICS IMPLEMENTING SOME FORM OF THE GUIDELINES PROPOSED IN THE ADHERENCE GUIDELINES

Overall, facilities in uThungulu/KZN provided the

highest number of these 6 key adherence services

with an average of 4.7 of the 6 services provided per

facility. Bojanala/NW facilities provided on average

2.2 of the 6 services, and Ekurhuleni/GP and

Mopani/LP facilities on average 1.7 and 1.8 of the 6

services, respectively.

CLINIC (C=control site)

Fast track initiation

counselling

Counselling for unsuppressed

VL

Decentralised medication

delivery Adherence clubs Tracing of lost

patients Fast lane

appointments

GA

UTE

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Motsamai X

Phola Park X X X X Khumalo X X X X

Tamaho (C) X X X

Ramokonopi (C) X X Zonkezizwe 1 (C) X X X

LIM

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Grace Mugodeni X X X X

Giyani Tzaneen X X

Motupa (C) X

Dzumeri (C) X X Nkowankowa (C) X X

NO

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Lethabile X X X Hebron X X

Tlhabane X X

Wonderkop (C) X X X Majakaneng (C) X X

Bafokeng (C) X

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L King Dinizulu X X X X X Thokozani X X X X

Buchanana X X X X

Nkwalini (C) X X X X X Nseleni (C) X X X X X

Ntambanana (C) X X X X X

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STATISTICS ON RE-ENTRY INTO CARE The evaluation sites were

also described in terms of

their retention in care

statistics of ART patients,

using TIER.Net data (as of 5

January, 2016). The number

of active ART patients over

the past 2 years (2014-

2015) was 78,569. A total

of 26,904 (34%) had a gap

of more than 90 days

between visits.

The diversity in retention

rates was considerable. In

all sites except three, the

main reason listed for a

patient being out of care is

being lost to follow up, at 50% or greater. Deaths

comprised no more than 10% of all patients out of

care, though in most sites this was collected through

passive reporting and may underestimate total

mortality. In some sites transfer was a major reason

for being out of care, being listed as high as 75% in

some sites in North West. In most other provinces,

transfers accounted for only 10-25% of patients out of

care.

VIRAL LOAD SUPPRESSION The baseline assessment also analysed viral load data

from each site for 2015.

The proportion of patients with a viral load

measure in the last 12 months varied greatly,

from 71% in Limpopo to 90% in Gauteng with

even greater variation at the clinic level

(range:40–99%).

The rate of suppression among those

with a viral load result also varied by

province with a low in North West of

67% to a high of 86% in KwaZulu Natal.

The assessment also found that time to

ART initiation was challenging to calculate,

mainly because pre-ART data was not

historically completed for all patients and

calculating the time between eligibility for

ART and date of initiation can be difficult.

Prior to starting data enhancement no

facility had more than 50% of records with

pre-ART dates and many facilities had little or no

information. Completion of pre-ART data was

subsequently addressed as part of data enhancement

and by the implementing partners to ensure that time

to initiation of treatment can be accurately and

correctly calculated for all HIV patients.

0

2,000

4,000

6,000

8,000

10,000

12,000

14,000

16,000

Gauteng KwaZulu Natal Limpopo North West

Viral load tests data by province (TIER.Net 2015 data)

Total active VL Taken last 12 mos VL Result VL Suppressed

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CHRONIC DISEASE SCREENING AND CO-MORBIDITIES As part of the process of assessing the quality of data

being collected and putting in place a plan to

enhance routine data collection, a patient file review

was done at each site:

1. Verifying information captured in patient files

against what was recorded on electronic and

paper records and exploring how files were

linked - to establish data gaps and areas that

needed attention as part of the data

enhancement process.

2. Identifying TB, hypertension and diabetes

mellitus patients, and assessing whether newly

screened, diagnosed or treated patients could

be identified through existing registers for the

evaluation (and if not how to identify these

patient files).

The file review included patients from the chronic

and acute streams of the evaluation sites. A

convenience sample of 30-80 acute and chronic

patient files was reviewed. There were no estimates

done for Limpopo due to lack of file creation for non-

HIV chronic patients.

Out of 826 files reviewed, 76% (n=626) were

chronic patients, including 44% (n=360) HIV

patients, 2% (n=16) with a current diagnosis of

TB, 30% (n=249) prevalent hypertension

patients, and 8% (n= 66) prevalent diabetes

patients.

Of the files reviewed, 391 (47%) of clinic

patients were screened for TB, 338 (41%) were

screened for hypertension, and 89 (11%) were

screened for diabetes at their last visit.

Relative prevalence and comorbidities of this

convenience sample of clinic files:

Of the 360 HIV patients, 13% (n=47) had one

comorbidity (diabetes, hypertension, or TB),

and 1% (n=4) had two comorbidities.

Of the 246 HIV negative patients, three-

quarters (73%, n=172) had a hypertension

diagnosis, and nearly a quarter (22%, n=51)

were comorbid with hypertension and diabetes.

CHRONIC DISEASE PREVALENCE AND COMORBIDITIES FOR A CONVENIENCE SAMPLE OF CLINIC FILES NW, GP, KZN)

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These results are somewhat comparable to results

for HIV positive patients in a study in Western

Cape, North West, Northern Cape and Limpopo

looking at all clinical encounters at selected

primary health care clinics i , but co-morbidity

being less frequent than in another South African

study which reported 30% of patients with two or

more comorbidities although patients tended to

be older. ii Taken together, this suggests our

estimates for comorbidity may be underestimated.

CONCLUSION AND OUTLOOK The process of engaging with the evaluation sites

has led to a number of key insights:

We have learned how the data flows work at

the participating health facilities in order for

data to go from patient interactions (point of

care) to a completed database (in electronic

form and downloadable).

Through site assessments and patient file

reviews at each evaluation site, we have

understood the quality and completion of

routine data and identified data gaps

We have determined the adherence

interventions/approaches in use prior to the

introduction of the AGL at the intervention sites

We have worked closely with the sites to

ensure good routine data collection

procedures through the enactment of data

improvement plans, in order to have the

outcome data required for the evaluation.

During evaluation site visits, we identified

challenges to implementing the AGL interventions:

These are relating to human resources (e.g.

staff shortages, not enough data staff),

equipment (broken SMS printers, lack of scales

and blood pressure cuffs), data systems (not

enough TIER computers, no space for filing) and

infrastructure (drug shortages).

There is a joint effort by DOH, local

implementation partners and the evaluation

team to resolve these challenges as they arise.

Data collection for the impact evaluation started

June 2016, and this part of the evaluation requires

no patient contact and relies fully on routinely

collected data at the evaluation sites. In includes HIV

patients, as well as TB, hypertension and diabetes

patients. The quality and completeness of the

routine data will be continuously monitored at each

facility throughout the period of the study.

Data collection for the process evaluation is ongoing

and will include surveys among HIV patients

receiving AGL services and health care staff providing

them.

Following the process of AGL introduction and scale-up of standardised AGL interventions in the

12 intervention sites has already provided valuable early learning for the national AGL scale-up.

For additional information, please contact: Mokgadi Phokojoe, Director Care and Support, National Department of Health ([email protected])

Nicole Fraser-Hurt, World Bank Group ([email protected])

i Lalkhen & Mash, 2015. Multimorbidity in non-communicable diseases in South African primary healthcare SAMJ 105; 134-138 ii Negin J, et al. Prevalence of HIV and chronic comorbidities among older adults AIDS 2012; 26 Suppl 1:S55–S63

Documents

World Bank Document · 2016. 9. 30. · HIV patients on treatment x x Chronic patient record x x TB Treatment record x x TB Screening tool x x x x x x x Appointment/carrier cards