Condition category
Not Applicable
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Michael Schull


Contact details

2075 Bayview Ave
M4N 3M5
+1 416 480 6100 ext. 3793

Additional identifiers

EudraCT number number

Protocol/serial number

MGC - 105989-001

Study information

Scientific title

Strengthening human resources for health through simplified clinical tools and educational outreach: a cluster-randomised trial



Study hypothesis

Our hypothesis is that the PALM-PLUS guideline/training intervention will be associated with improved staff retention and satisfaction, and better patient outcomes.

Ethics approval

Malawi National Health Sciences Research Committee approved on the 10th December 2009 (ref: NHSRC 687)

Study design

Unblinded cluster randomised trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type


Patient information sheet


Training methods in primary care centres


The project centres on the STAT-PALM guidelines and novel training method. The STAT-PALM guidelines and training program will be developed through a review and modification of the proven PALSA-PLUS guidelines in light of Malawian national guidelines, and through consultations with the Ministry of Health, Malawian nurses and clinical officers, the Medical Council of Malawi and the Nursing and Midwifery Council of Malawi regarding content and accreditation of the training, drafting of the content, review of the content by stakeholders, and graphic design of the clinical tools (desktop maps and flipcharts) and training materials. Relevant Malawian national guidelines have been collected, and our guideline developers have been adapting and drafting specific guideline pages. These are then subjected to review in Malawi, and circulated to the appropriate Department Heads within the MoH for review and comments (e.g., National tuberculosis unit, human immunodeficiency virus [HIV] Unit, Malaria Unit, etc) as well as frontline clinicians/specialists in the district or region. The reviewers are expected to check that the content is correct and appropriate, and to check that the algorithms flow properly and reflect available drugs/resources in Malawian Health Center settings. These comments are then transcribed and clarified if needed and discussed, then incorporated into the next draft of the guidelines, which are then returned to the same partners for review until they are accurately completed. Once the flow, content and materials have been completed, the various senior Malawi MOH Unit and Department personnel will sign off and approve them, then they will be sent to be printed and bound.

Training follows the proven innovative and evidence-based model of PALSA-PLUS, called educational outreach, a form of point-of-care training that provides case-based, onsite, training in clinical settings where primary care providers work. Trainers will be front-line healthcare workers from the MoH and other partners including the Christian Hospital Association of Malawi (CHAM) and other NGOs who will be trained to provide outreach training and support to their fellow front-line healthcare workers during focused (1 - 2 hours), intermittent, interactive sessions. A Master Trainer, already trained by the Knowledge Translation Unit (KTU) Team in Cape Town, South Africa, will be responsible for training all facility trainers. Curriculum development will also be informed by a training needs assessment during the curriculum design process. The initial facility trainer training is conducted offsite during the one week intensive course, during which the facility trainers are equipped with the necessary content, and their training skills developed and evaluated using an iterative process of training and feedback. In order to minimise travel between remote health centres, 12 facility trainers will be trained, and will conduct an average of 16 training sessions (one per health centre) each week. At health centres, integration of antiretroviral treatment (ART) into primary healthcare services will be facilitated through the training of all, rather than selected, healthcare workers at each health centre. A minimum of 6 and a maximum of 10 training sessions will occur at each health centre, over a maximum period of 16 weeks. Point-of-care guideline tools will be developed and distributed (e.g., a thin [approximately 30 pages] sturdy laminated ring binder containing the entire guideline, colourful and easy to follow algorithms designed to be on the primary care provider's desktop during each patient encounter, desk blotters with key STAT-PALM messages, laminated cards with key guideline messages on lanyards to be worn around the provider's neck). Ongoing routine training conducted by the DHO will continue in both intervention and control health centres.

The STAT-PALM training differs significantly from the current healthcare worker training in Malawi and elsewhere, which are usually didactic, taught by experts (rather than peers), and where HCWs are removed from their clinical setting for days to weeks at a time and compensated with per diems. The Master Trainer will conduct a follow-up visit with facility trainers and their trainees to assess progress and uptake. On a quarterly basis, facility trainers will meet with the Master Trainer and a high-level core trainer from Dignitas and/or the KTU to review progress, discuss challenges to implementation, and share experiences with a view to improving the quality of the trainings and subsequent versions of the guidelines. The guidelines distribution and training will occur at intervention sites only. No active distribution of the STAT-PALM materials or training sessions will occur in control facilities, however routine ongoing health centre supervision by DHO personnel and off-site DHO training courses will continue in all sites.

Intervention type



Not Applicable

Drug names

Primary outcome measure

1. Health centre staffing retention: months remaining in same job post-intervention, measured at staff-person level. Can do overall and by health cadre. Denominator is staff at work at study start.
2. Staff turnover (sum of retention/recruitment/loss): Denominator to be calculated based on ideal ratio of HCWs to patient visits (e.g., no. of attendances in last year
3. Staff satisfaction: Individually scored questions from validated questionnaire

Secondary outcome measures

1. Cotrimoxazole prophylaxis among HIV+ pregnant women attending ante-natal care at health centre
2. HIV testing among pregnant women
3. Anti-retroviral treatment (ART) among HIV+ pregnant women attending ante-natal care at health centre
4. Non-ART prevention-of-mother-to-child-transmission of HIV treatment provided to HIV+ pregnant women attending ante-natal care at health centre
5. New adult ARV follow-ups at health centre
6. New adult TB follow-ups at health centre
7. New TB treatment among ART patients at health centre
8. New HIV diagnosis among TB patients at health centre
9. New ART initiations among TB patients at health centre
10. Initiation of malaria treatments at health centre
11. Immunizations (overall and measles specific) given 0 - 5 years at health centre
12. New child ART initiations at health centre
13. HIV tests in children at health centre

Overall trial start date


Overall trial end date


Reason abandoned (if study stopped)


Participant inclusion criteria

1. Centres: All public primary care health centres within Zomba District (30 centres)
2. Individuals: All health professional staff (no age limit, either sex) eligible to provide clinical services within the randomised health centres

Participant type


Age group




Target number of participants

30 health centres and approximately 200 clinical staff (in total) working in them

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date


Recruitment end date



Countries of recruitment


Trial participating centre

G-147, 2075 Bayview Ave
Toronto, Ontario
M4N 3M5

Sponsor information


International Development Research Center (IDRC) (Canada)

Sponsor details

Global Health Research Initiative
150 Kent Street
PO Box/CP 8500
K1G 3H9
+1 613 696 2618

Sponsor type

Research organisation



Funder type

Research organisation

Funder name

Global Health Research Initiative (Canada) - a research funding partnership of five agencies and departments of the Government of Canada, including the Canadian International Development Agency (CIDA), the Canadian Institutes of Health Research (CIHR), Health Canada (HC), the International Development Research Centre (IDRC), and the Public Health Agency of Canada (PHAC) (ref: MGC-105989-001)

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Basic results (scientific)

Publication list

1. 2010 results in

Publication citations

  1. Results

    Schull MJ, Banda H, Kathyola D, Fairall L, Martiniuk A, Burciul B, Zwarenstein M, Sodhi S, Thompson S, Joshua M, Mondiwa M, Bateman E, Strengthening health human resources and improving clinical outcomes through an integrated guideline and educational outreach in resource-poor settings: a cluster-randomized trial., Trials, 2010, 11, 118, doi: 10.1186/1745-6215-11-118.

Additional files

Editorial Notes