Welcome
Support Centre
25 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
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 10.1186/ISRCTN13438073
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym PALSA (Practical Approach to Lung Health in South Africa)
Serial number at source N/A
Study hypothesis 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.
Lay summary
Ethics approval 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.
Study design Randomised controlled trial.
Countries of recruitment South Africa
Disease/condition/study domain Respiratory diseases
Participants - 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
Participants - exclusion criteria Patients referred elsewhere urgently by their nurse practitioner will be excluded.
Anticipated start date 08/04/2003
Anticipated end date 29/11/2003
Status of trial Completed
Patient information material
Target number of participants 40 primary care clinics, 1999 patients
Interventions 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.
Primary outcome measure(s) 1. Sputum testing for tuberculosis
2. Inhaled corticosteroid prescriptions
3. Antibiotic prescriptions
4. Cotrimoxazole prescription among patients with tuberculosis
Secondary outcome measure(s) 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
Sources of funding 1. International Development Research Centre (Canada) (IDRC File No. 101489)
2. Free State Department of Health (South Africa)
3. Medical Research Council (South Africa)
4. University of Cape Town Lung Institute (South Africa)
Trial website
Publications Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16195293
Contact name Dr  Merrick  Zwarenstein
  Address Institute for Clinical Evaluative Sciences
G1 06
2075 Bayview Ave
  City/town Toronto
  Zip/Postcode M4N 3M5
  Country Canada
  Tel +1 416 4804055 ext. 7439
  Fax +1 416 4806048
  Email merrick.zwarenstein@ices.on.ca
Sponsor University of Cape Town Lung Institute (South Africa)
  Address P.O. Box 34560
Groote Schuur
  City/town Cape Town
  Zip/Postcode 7937
  Country South Africa
  Sponsor website: http://www.lunginstitute.co.za/
Date applied 03/05/2005
Last edited 20/12/2007
Date ISRCTN assigned 22/08/2005
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.