Effect of educational outreach to nurses on tuberculosis
case detection and primary care of respiratory illness:
pragmatic cluster randomised controlled trial
Lara R Fairall, Merrick Zwarenstein, Eric D Bateman, Max Bachmann, Carl Lombard,
Bosielo P Majara, Gina Joubert, Rene G English, Angeni Bheekie, Dingie van Rensburg, Pat Mayers,
Annatjie C Peters, Ronald D Chapman
Objectives To develop and implement an educational
outreach programme for the integrated case
management of priority respiratory diseases (practical
approach to lung health in South Africa; PALSA) and
to evaluate its effects on respiratory care and
detection of tuberculosis among adults attending
primary care clinics.
Design Pragmatic cluster randomised controlled trial,
with clinics as the unit of randomisation.
Setting 40 primary care clinics, staffed by nurse
practitioners, in the Free State province, South Africa.
Participants 1999 patients aged 15 or over with
cough or difficult breathing (1000 in intervention
clinics, 999 in control clinics).
Intervention Between two and six educational
outreach sessions delivered to nurse practitioners by
usual trainers from the health department. The
emphasis was on key messages drawn from the
customised clinical practice guideline for the outreach
programme, with illustrative support materials.
Main outcome measures Sputum screening for
tuberculosis, tuberculosis case detection, inhaled
corticosteroid prescriptions for obstructive lung
disease, and antibiotic prescriptions for respiratory
Results All clinics and almost all patients (92.8%,
1856/1999) completed the trial. Although sputum
testing for tuberculosis was similar between the
groups (22.6% in outreach group v 19.3% in control
group; odds ratio 1.22, 95% confidence interval 0.83
to 1.80), the case detection of tuberculosis was higher
in the outreach group (6.4% v 3.8%; 1.72, 1.04 to
2.85). Prescriptions for inhaled corticosteroids were
also higher (13.7% v 7.7%; 1.90, 1.14 to 3.18) but the
number of antibiotic prescriptions was similar (39.7%
v 39.4%; 1.01, 0.74 to 1.38).
Conclusions Combining educational outreach with
integrated case management provides a promising
model for improving quality of care and control of
priority respiratory diseases, without extra staff, in
resource poor settings.
Trial registration Current controlled trials
Tuberculosis, driven largely by the HIV/AIDS epi-
demic, is a growing problem in lower and middle
income countries,including South Africa.1–3The World
Health Organization estimates that about two thirds of
people with tuberculosis are never diagnosed as having
the disease and so cannot benefit from treatment,4
leaving the epidemic unchecked despite increasing
global coverage by treatment programmes.5
Improved passive case detection is fundamental to
alert clinicians identifying tuberculosis in patients
In South Africa such patients account for one third
of ambulatory visits and usually receive initial care from
a nurse practitioner at a public sector clinic. Among
these patients, asthma is undertreated,7 8antibiotics are
overprescribed,9 10and tuberculosis is underdiagnosed.4
The DOTS Expansion Working Group considers
the lack of trained staff to be the most important con-
straint on the control of tuberculosis.11We recognised
that knowledge translation strategies, increasingly used
to close gaps between evidence and practice in the
developed world,12might improve quality of care in
South Africa within existing constraints on human
resources. We developed a syndromic case manage-
ment intervention for respiratory illness in adults6and
implemented it in the Free State province, South
Africa, using educational outreach visits to nurse prac-
titioners in primary care clinics by specially trained
We used a pragmatic cluster randomised design for our
trial. Pragmatic trials evaluate the effects of health
service interventions under the human, financial, and
The guideline and desk blotter are on bmj.com
University of Cape
of Cape Town,
Lara R Fairall
Eric D Bateman
Rene G English
Division of Nursing
School of Health
of Cape Town
School of Medicine,
Health Policy and
of East Anglia,
University of the
Bosielo P Majara
University of the
BMJ VOLUME 3311 OCTOBER 2005bmj.com
logistic constraints of typical, real world situations.13 14
The unit of randomisation was the clinic, although we
collected outcome data from individual patients.
Educational outreach (non-commercial, short, face to
face, in-service interactive education by a trusted
outsider) is an effective strategy for promoting evidence
based choices among physicians (median improvement
6%, range −4% to 17%).15We selected this model (box)
over off-site education because it was sustainable,
drawing on and expanding the educational role of exist-
ing supervisorystaff, and
disruption in understaffed front line facilities.
We developed an algorithmic guideline using symp-
toms and simple signs for the diagnosis and manage-
ment of respiratory diseases in adults, including
tuberculosis,asthma and chronic obstructive pulmonary
disease, acute upper and lower respiratory tract
infections, and opportunistic infections in patients with
HIV.We collaborated with front line clinicians and man-
agers to ensure local applicability and consistency with
national tuberculosis policies16and essential drugs lists.17
We incorporated key messages from the guideline (fig 1
and see bmj.com) into a colourful, illustrated flip chart
for use by the nurse trainers during educational
outreach visits, and into a desk blotter (see bmj.com) for
the nurse practitioners whom they trained. These were
tested in pilot sites and adapted before implementation.
Eight senior nurses running the tuberculosis
programme attended a five day workshop on the tech-
niques of interactive educational outreach and the
clinical content of the guidelines, especially the key
educational outreach sessions, each lasting one to
three hours to all clinical staff, in groups, in each of
their intervention clinics over a three month period.
The Free State department of health permitted
nurse practitioners in intervention clinics to newly pre-
scribe inhaled corticosteroids for asthma (with review
by a physician within one month), short course oral
corticosteroids for exacerbations of obstructive lung
disease, and cotrimoxazole prophylaxis for sympto-
matic HIV infection. The nurses had long been
permitted to renew physician initiated prescriptions.
deliver threeor four
Control clinics received no new training. Usual off-
site training, received by fewer than 5% of staff each
year, continued in both groups.
Participants and randomisation
The estimated prevalence of HIV among people
attending antenatal clinics in impoverished communi-
ties of the Free State,predominantly in rural areas with
high rates of tuberculosis and HIV (tuberculosis notifi-
cation rate (all cases) 494/100 000 in 2002),18was
30.1% in 2003.19On a typical day around 200 people
attend one of these clinics; about one third of these are
children. A clinic is staffed by a median of nine nurses,
some of whom see only children or pregnant women.
Problem cases are referred to doctors who visit weekly.
On the basis of total annual attendances, we
included in our study the 40 largest eligible primary care
clinics. Randomisation was stratified by district. Clinics
were ranked by size and allocated to intervention or
control arms using a random number table in blocks of
four. Allocation was carried out by a trial statistician
before intervention or patient recruitment.
In each clinic waiting room a trained fieldworker
screened all adult patients, independent of the nurse
practitioners, for cough or difficult breathing on pres-
entation or within the past six months. Patients aged
15 years or over who answered yes to either query and
who were willing to take part in the study, were invited
to meet the research team after their consultation with
the nurse. Fieldworkers then obtained written consent
and interviewed patients with any one of the following:
difficult breathing on the day of interview or during the
past six months; current cough for seven days or more;
recurrent cough in the past six months; and current
cough with a temperature above 38°C or a respiratory
rate of 30 breaths per minute or more. We excluded
patients who had been urgently referred elsewhere by
Components of the practical approach to lung
health in South Africa (PALSA) intervention
• A median of two educational outreach sessions to
groups of primary care nurse practitioners delivered
by trained nurse supervisors
• Expanded prescribing provisions for nurse
practitioners to include inhaled corticosteroids for
asthma, short course oral corticosteroids for
exacerbations of obstructive lung disease, and
cotrimoxazole prophylaxis for symptomatic HIV
• Illustrated support materials for outreach sessions:
flip chart for nurse trainers and desk blotters
(incorporating key messages) for the nurse
practitioners they trained
• Locally tailored, evidence based, brief (22 pages),
symptom and sign based guideline on common
respiratory conditions in adults (tuberculosis, TB/HIV
coinfection, respiratory tract infections, and obstructive
Coughing > _ 2 weeks - > Send sputa for TB.
Test for HIV because TB is common
in HIV patients. Cotrimoxazole prophylaxis
delays symptoms and prolongs healthy
life in HIV patients.
Diagnose LRTI in patients with cough plus
difficult breathing and/or pain on
coughing/breathing and/or fever. If severe
refer; if new or purulent sputum prescribe
amoxicillin for 7 days and follow-up in
Diagnose URTI in patients with blocked or
runny noses and/or sore throats and/or
mild fever but no difficult breathing
and no chest pain.
Prescribe symptomatic treatments only.
Diagnose asthma in patients with recurrent
wheeze, difficult breathing and cough.
Prescribe inhaled corticosteroids.
Diagnose COPD in patients with persistent
wheeze, difficult breathing and cough
(and a history of smoking).
People are more likely to stop smoking if
advised to do so by a health professional…
and smoking makes all lung conditions
worse so tell your patients to quit today!
Lower Respiratory Tract
Upper Respiratory Tract
Obstructive Lung Disease
(Asthma and COPD –
Fig 1 Key messages as presented to front line nurses
Centre for Health
University of the
University of the
Cape Town, South
TB Alliance DOTS
Annatjie C Peters
general health support
Toronto at St
BMJ VOLUME 3311 OCTOBER 2005 bmj.com
their nurse practitioner. Recruitment began one
month after the start of educational outreach and
lasted one week in each clinic, with clinics staggered
over five months (May to September 2003).
Fieldworkers interviewed patients after their consulta-
tion, andthree months
Interviews were carried out in one of the five local lan-
guages, chosen by the patient. The questionnaire was
translated in accordance with internationally accepted
practices.20Patient held records and dispensed drugs
were examined and, for patients with tuberculosis
cards, details were noted.
Patients and fieldworkers were blind to the
intervention status of each clinic. Nurse trainers and
nurse practitioners allocated to the intervention arm
could not be blinded for obvious reasons.
Outcome measures and sample size calculations
For tuberculosis, the primary goal was to increase case
detection, documented on the tuberculosis card or by
patient report;in South Africa this diagnosis is based on
the results of sputum microscopy, or culture.16Sputum
testing for tuberculosis was indicated by patient report.
For obstructive lung disease, the primary goal was to
improve therapy, indicated by prescriptions for inhaled
corticosteroids. Receiving counselling for smoking
cessation and stopping smoking were indicated by
patient report. For respiratory tract infections, the
primary goal was to rationalise prescribing, indicated by
antibiotic prescription.Improved care of HIV/AIDS was
indicated by the number of patients receiving voluntary
counselling and testing, and by cotrimoxazole prescrip-
tion among patients with tuberculosis. Appropriate
referral of patients with severe disease (indicated by any
of the following: temperature ≥38°C, respiratory rate
over 30 breaths per minute,breathlessness at rest,use of
accessory muscles) was measured by patient reported
referral to a doctor. Outcomes were assessed one and
four months after the intervention began and were
deemed present if reported at either interview.
In advance of the trial, policymakers specified the
minimal important improvement for the case detection
of tuberculosis by the health service to be 25%. Our ini-
tial sample size calculations showed that too few
patients with tuberculosis would attend within a feasible
study duration to detect this difference. We therefore
selected as a surrogate the more common measure of
sputum sampling for tuberculosis. One thousand
patients per arm provided 90% power (?=0.05) to
detect 10% improvements in sputum screening for
tuberculosis and inhaled corticosteroid prescriptions,
and a 10% reduction in antibiotic prescriptions. We
assumed an intra-clinic correlation coefficient of 0.02.21
We analysed outcomes on an intention to treat basis.To
evaluate the effect of the intervention with stratification
as a cofactor, we used a logistic regression model. The
model parameters were estimated by the generalised
estimating equations approach, which takes into
account the clustering of patients within clinics. Odds
ratios are presented with 95% confidence intervals.
All 40 clinics completed the trial (fig 2). The character-
istics of the patients at enrolment were similar between
the groups (table 1).
Clinics randomised (n=40)
Primary care clinics (n=200)
Primary care clinics in Free State (n=236)
Randomised intervention (n=20)Randomised to usual care (n=20)
Refused consent (n=0)
Refused consent (n=1)
Lost to follow-up (n=73)
Admitted to hospital or too ill
for interview (n=3)
Unable to trace (n=44)
Lost to follow-up (n=7000)
Admitted to hospital or too ill
for interview (n=2)
Unable to trace (n=46)
Clinics excluded (n=36):
Circulation of staff (n=25)
Piloting of materials (n=11)
Fig 2 Trial profile
Table 1 Characteristics of patients and clinics allocated to an
educational outreach programme (practical approach to lung
health in South Africa) or no new training (control group).
Values are numbers (percentages) unless stated otherwise
No of clinics
Median total No of adult attendances a quarter
Median No of nurses per clinic
Tuberculosis treatment service available
24 hour emergency service available
Median distance (km) from local referral hospital
No of patients
Mean age (years)
Never attended school
Attended primary school only
Attended secondary school
Unemployed without welfare
Mean pack year history (smokers only)
BMJ VOLUME 3311 OCTOBER 2005 bmj.com
Of the 2000 patients enrolled, 1999 completed the
initial interview and one refused consent;1856 (92.8%)
were re-interviewed at four months. Forty eight
patients (2.4%) were reported by their families to have
died. The groups had similar mortality (intervention,
22/1000; control, 26/999: odds ratio 0.84, 95%
confidence interval 0.46 to 1.53).
Training intensity fell short of the targets. Nurses in
educational outreach visits (range 0-4 visits).
a median oftwo
Sputum screening for tuberculosis was higher among
patients in the intervention arm but not significantly so
(odds ratio 1.22, 0.83 to 1.80; table 2). During the three
months of the study period 57 new cases of tuberculo-
sis were diagnosed in intervention clinics compared
with 34 in control clinics (odds ratio 1.72, 1.04 to 2.85).
The groups had similar numbers of patients diagnosed
as having tuberculosis before outreach started (inter-
vention clinics, 108; control clinics, 109).
Obstructive lung disease
Almost twice as many prescriptions were filled out for
inhaled corticosteroids in the intervention group than
in the control group (13.7%,137/1000 v 7.7%,77/999;
odds ratio 1.90, 1.14 to 3.18; table 2).
At enrolment 164 patients in the intervention
group and 193 patients in the control group reported
that they were current smokers.The groups had similar
rates for counselling on smoking cessation (68.3%,
112/164 v 65.8%, 127/193 in controls) and smoking
cessation for the period between interviews (12.2%,
20/164 v 10.4%, 20/193).
The prescription rates of antibiotics commonly used
for respiratory indications did not differ between the
groups (odds ratio 1.01, 0.74 to 1.38; table 2).
The groups were similar for voluntary counselling and
testing (9.7%, 97/1000 v 7.3%, 73/999 in controls) and
for prescriptions for co-trimoxazole among patients
with a diagnosis of tuberculosis during the study (7.8%,
13/167 v 7.5%, 11/147 in controls).
A higher proportion of severely ill patients in the inter-
vention group were referred to a doctor than in the
control group (10.5%, 27/257 v 4.8%, 8/166; odds
ratio 2.59, 1.06 to 6.19).
An educational outreach intervention on syndromic
management of respiratory diseases in adults improved
the case detection of tuberculosis and the treatment of
asthma by nurse practitioners working in typical South
African primary care clinics. In this pragmatic trial, the
intervention was a “black box”and the relative contribu-
tions of the various elements of this multifaceted
intervention cannot be distinguished. Although trainers
reported using almost all of their visit time for
education, they were also middle managers and may, in
passing,have provided some managerial support.
Clinic and patient follow-up were exceptionally
high, enhancing the internal validity of our trial. The
cluster randomised design was accounted for in the
analysis. Follow-up was short (only four months);
longer term effects could be diluted by the turnover of
staff and could decline with time. Emerging studies,
however, suggest that evidence based education strate-
gies may trigger long term change in practice.22 23
Appropriateness of care improved across several of
the most important conditions: the effect of the
intervention on tuberculosis case detection was higher
than expected. By contrast, the effect on sputum
collection was small.This suggests that the intervention
improved clinical selection of cases for sputum
Inhaled corticosteroid prescribing for asthma also
increased, which may be appropriate given that these
drugs are known to be underprescribed in South
Africa.8A post hoc analysis also suggested that these
prescriptions were clinically appropriate, in that
response to ? agonists was more often reported by
patients who were prescribed inhaled corticosteroids
in the intervention group than in their equivalent con-
trols (85%, 117/137 v 73%, 56/77), suggesting that the
treated disease was asthma.
The lack of change in antibiotic prescribing may
well be appropriate for this severe case mix; only 4.8%
of the sample reported symptoms consistent with
uncomplicated upper respiratory tract infection, lower
than in comparable surveys. In patients with prede-
fined markers of severe disease, referral to physicians
was higher in the intervention group.
counselling and testing remained unchanged. Nurses
may have seen little point in this practice at a time
before antiretroviral treatment was made available in
Repeated central drug shortages
prevented the intervention from achieving increases in
prescribing of co-trimoxazole prophylaxis. The failure
to increase advice on smoking cessation may reflect
light smoking at low prevalence (table 1) and thus the
low salience of this issue for nurse practitioners dealing
with patients with acute severe infectious disease.
Table 2 Trial outcomes
Sputum screening for tuberculosis
Tuberculosis case detection
Prescriptions for inhaled corticosteroids
Prescriptions for antibiotics
No (%) in
No (%) in
1.22 (0.83 to 1.80)
1.72 (1.04 to 2.85)
1.90 (1.14 to 3.18)
1.01 (0.74 to 1.38)
*Denominator limited to all patients who had not been diagnosed as having tuberculosis before educational outreach started.
BMJ VOLUME 3311 OCTOBER 2005bmj.com
The intervention was carried out in small towns Download full-text
and rural primary care clinics in a poor province with
a high rate of tuberculosis and HIV infection. It was
delivered by existing staff, and was effective despite the
low number of educational contacts, reportedly due to
difficulties accommodating visits in clinic schedules.
The Free State and other provinces are adapting
educational outreach for HIV/AIDS and implement-
ing it widely.We suggest that in other lower and middle
primary care, equipping middle managers as outreach
trainers is feasible within existing constraints on staff
and could improve quality of care.
Our trial was a collaboration between evaluation
science and policy development, producing a widely
applicable and rigorously evaluated intervention for
real world conditions. The challenges facing Africa
need more of these partnerships.
We thank our PALSA nurse trainers from the Free State
Department of Health: Leona Smith, Annette Exley, Sandra
Korkie,Tebogo Mothibeli,Francis MacKay,Mariana Thirtle,and
Elizabeth Bolofo; fieldwork supervisors Mariëtte van Rensburg
and Gloria Gogo from the Centre for Health Systems Research
and Development, University of the Free State, for coordination
of patient recruitment and interviews; Ineke Buskens for
training our nurse trainers;Michael Wyeth and Val Myburgh for
layout and illustration of training materials;Chris Seebregts and
Clive Seebregts from the Biomedical Informatics Research Divi-
sion, Medical Research Council, for data collection support,
database design, and collation; Chrismara Güttler and Amanda
Fourie from the Medical Research Council for data capture;
Sonja Botha for data checking and cleaning; and Sonja van der
Merwe and Annette Furter from the Free State Department of
Health for logistical assistance in setting up pilot sessions and
retrieving routine data. For crucial early support and guidance
we thank Victor Litlhakanyane and Mosiuoa Shuping from the
Free State Department of Health, European Union funded col-
laborations AfroImplement and PRACTIHC (pragmatic ran-
domised controlled trials in health care) for technical support;
Refiloe Matji formerly of the South African National tuberculo-
sis control programme; Robert Scherpbier formerly of Practical
Approach to Lung Health at WHO; Salah-Eddine Ottmani of
Practical Approach to Lung Health; Louis Niessen from
Erasmus University; and Andy Oxman from the Department of
Health Services Research, Norwegian directorate for health and
Contributors: MZ conceived the project and designed the first
protocol. EDB and RGE led development of the guideline. LRF,
RGE, AB, ACP, PM, MZ, and RDC contributed to the
development and implementation of the intervention. MZ, LRF,
MB, and EDB established links with policymakers. LRF, CL, MB,
EDB, BPM, MZ, and GJ contributed to the final protocol and
design of the questionnaire. DvR, LRF, and BPM oversaw data
collection. CL led the analysis with LRF. LRF, CL, MZ, MB, and
EDB interpreted the data. LRF, MZ, and BPM prepared the first
draft of this paper, and all authors contributed to the final
version. MZ and LRF are guarantors.
Funding:This research was completed with the aid of a research
grant from the International Development Research Centre,
Canada and the Medical Research Council, South Africa. The
research was completed independent of the funders. Additional
funding was provided by the Free State Department of Health
and the University of Cape Town Lung Institute.
Competing interests: None declared.
Ethical approval: The study was approved by the research ethics
committee of the Faculty of Health Sciences, University of the
Free State. The Free State Department of Health gave
permission for the trial.
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What is already known on this topic
In Africa, passive case detection of tuberculosis has
not increased detection rates to levels at which the
epidemic could be controlled
To date, training is of doubtful effectiveness and has
largely been conducted off site, interrupting clinical
services, and limiting sustainability and coverage
What this study adds
Educational outreach training in syndromic
approaches achieved large improvements in the
quality of tuberculosis and asthma care without
interrupting services, and within existing staff
Well designed pragmatic randomised controlled
trials usefully inform policy decisions
BMJ VOLUME 331 1 OCTOBER 2005bmj.com