Condition category
Respiratory
Date applied
03/05/2005
Date assigned
22/08/2005
Last edited
20/12/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Merrick Zwarenstein

ORCID ID

Contact details

Institute for Clinical Evaluative Sciences
G1 06
2075 Bayview Ave
Toronto
M4N 3M5
Canada
+1 416 4804055 ext. 7439
merrick.zwarenstein@ices.on.ca

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

PALSA (Practical Approach to Lung Health in South Africa)

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.

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Inhaled corticosteroids, antibiotics, cotrimoxazole

Primary outcome measures

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 trial start date

08/04/2003

Overall trial end date

29/11/2003

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

40 primary care clinics, 1999 patients

Participant exclusion criteria

Patients referred elsewhere urgently by their nurse practitioner will be excluded.

Recruitment start date

08/04/2003

Recruitment end date

29/11/2003

Locations

Countries of recruitment

South Africa

Trial participating centre

Institute for Clinical Evaluative Sciences
Toronto
M4N 3M5
Canada

Sponsor information

Organisation

University of Cape Town Lung Institute (South Africa)

Sponsor details

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

Sponsor type

University/education

Website

http://www.lunginstitute.co.za/

Funders

Funder type

Research organisation

Funder name

International Development Research Centre (Canada) (IDRC File No. 101489)

Alternative name(s)

Centre de recherches pour le développement international, IDRC

Funding Body Type

government organisation

Funding Body Subtype

government non-federal

Location

Canada

Funder name

Free State Department of Health (South Africa)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Medical Research Council (South Africa)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

University of Cape Town Lung Institute (South Africa)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Results in http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16195293

Publication citations

  1. Results

    Fairall LR, Zwarenstein M, Bateman ED, Bachmann M, Lombard C, Majara BP, Joubert G, English RG, Bheekie A, van Rensburg D, Mayers P, Myers P, Peters AC, Chapman RD, Effect of educational outreach to nurses on tuberculosis case detection and primary care of respiratory illness: pragmatic cluster randomised controlled trial., BMJ, 2005, 331, 7519, 750-754, doi: 10.1136/bmj.331.7519.750.

Additional files

Editorial Notes