A pragmatic cluster randomised controlled trial of a guideline-based educational outreach intervention to improve quality of adult respiratory care in South African primary care clinics: the PALSA (Practical Approach to Lung Health in South Africa) trial

ISRCTN	ISRCTN13438073
DOI	https://doi.org/10.1186/ISRCTN13438073
Secondary identifying numbers	N/A

Submission date: 03/05/2005
Registration date: 22/08/2005
Last edited: 20/12/2007

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Merrick Zwarenstein
Scientific

Institute for Clinical Evaluative Sciences
G1 06
2075 Bayview Ave
Toronto
M4N 3M5
Canada

Phone	+1 416 4804055 ext. 7439
Email	merrick.zwarenstein@ices.on.ca

Study information

Study design	Randomised controlled trial.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Scientific title
Study acronym	PALSA (Practical Approach to Lung Health in South Africa)
Study objectives	The trial was undertaken to test whether PALSA improves the quality of respiratory care for patients with cough and/or difficult breathing in real world primary care clinics. Priority respiratory diseases among adults attending primary care services, including tuberculosis (TB), lower and upper respiratory tract infections, obstructive lung disease (asthma and chronic obstructive pulmonary disease), and human immunodeficiency virus (HIV) co-infection.
Ethics approval(s)	Added as of 13/08/2007: 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.
Health condition(s) or problem(s) studied	Respiratory diseases
Intervention	Educational outreach to groups of intervention clinic nurse practitioners, based on a clinical practice guideline on integrated adult respiratory case management and delivered with accompanying support materials. Prescribing provisions for intervention clinic nurse practitioners will be expanded to include cotrimoxazole prophylaxis for symptomatic HIV infection, inhaled steroids for asthma (with review by a physician within one month) and a short course of oral corticosteroids for exacerbations of obstructive lung disease. Control clinic nurse practitioners will receive no new training. Usual training, received by both intervention and control groups, includes short off-site training on the use of essential drugs including asthma medications and antibiotics, and the national TB protocol. Due to staff and budget restrictions, fewer than 5% of staff in any year attend these courses.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Inhaled corticosteroids, antibiotics, cotrimoxazole
Primary outcome measure	1. Sputum testing for tuberculosis 2. Inhaled corticosteroid prescriptions 3. Antibiotic prescriptions 4. Cotrimoxazole prescription among patients with tuberculosis
Secondary outcome measures	1. TB case detection 2. Mortality 3. Smoking cessation advice received 4. Smoking cessation 5. Readiness to quit smoking 6. Frequency and severity of respiratory symptoms 7. Health-related quality of life (Euroqol) 8. Health care utilisation 9. Cost of care
Overall study start date	08/04/2003
Completion date	29/11/2003

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	40 primary care clinics, 1999 patients
Key inclusion criteria	Forty primary care clinics in a high tuberculosis and HIV burden province of South Africa (Free State). Data will be collected from patients 15 years and older who provide written consent and who present with any one of the following: 1. Difficult breathing on the day of interview or during the last 6 months 2. Current cough for 7 days or more 3. Recurrent cough in the last 6 months 4. Current cough and a temperature in excess of 38°C and/or a respiratory rate of 30 breaths per minute or more
Key exclusion criteria	Patients referred elsewhere urgently by their nurse practitioner will be excluded.
Date of first enrolment	08/04/2003
Date of final enrolment	29/11/2003

Locations

Countries of recruitment

Canada
South Africa

Study participating centre

Institute for Clinical Evaluative Sciences

Toronto
M4N 3M5
Canada

Sponsor information

University of Cape Town Lung Institute (South Africa)
University/education

P.O. Box 34560
Groote Schuur
Cape Town
7937
South Africa

Website	http://www.lunginstitute.co.za/
"ROR"	https://ror.org/03p74gp79

Funders

Funder type

Research organisation

International Development Research Centre (Canada) (IDRC File No. 101489)
Government organisation / Local government

Alternative name(s): Centre de recherches pour le développement international, IDRC, CRDI
Location: Canada

Free State Department of Health (South Africa)

No information available

Medical Research Council (South Africa)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

University of Cape Town Lung Institute (South Africa)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	01/10/2005		Yes	No