Condition category
Not Applicable
Date applied
25/02/2016
Date assigned
09/03/2016
Last edited
04/04/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
The private healthcare sector is steadily growing in low- and middle-income countries (LMIC), but there is considerable concern about the safety and quality of care. Recent years have seen an increase in the number of small and medium sized private clinics, but their regulation is often poor and relatively little is known about the effectiveness of studies trying to improve the quality of care they provide. This study has been designed to look at an innovative programme developed by the international NGO PharmAccess, which aims to improve the clinical standards of health facilities in low- and middle-income countries. The PharmAccess model seeks to improve the quality of care that facilities provide, as well as to shape the broader healthcare and finance markets and policy environment. Health facilities are assessed on a set of “SafeCare” structural quality standards, trained on quality improvement and business skills, and assisted in the development of a quality and business improvement plan. They receive regular mentoring visits and are also connected with the PharmAccess Medical Credit Fund, a social investment fund which facilitates access to bank loans to finance the prigramme. The aim of this study is to evaluate the impact of the PharmAccess model on quality of care given in private health facilities in Tanzania.

Who can participate?
Health facilities operating in the private for-profit and not-for-profit sectors in Tanzania.

What does the study involve?
Participating health facilities are randomly allocated to one of two groups. Those in the first group are assessed using SafeCare assessments at the start of the study and then again after two years. This involves comparing the practices of the health facility to a set of “SafeCare” standards, covering the way the facility is run and how it is structuired (e.g. staffing, equipment, systems and documentation). These facilities are then given a tailored quality improvement plan and receive training on quality and business systems. They are also connected with the PharmAccess Medical Credit Fund (MCF), a social investment fund which helps to access to loans to finance the quality improvement plan. Facilities are also given access to a call centre and online training portal. Those in the second group are assessed at the start of the study and then again after two years with the SafeCare assessments. The results of the initial assessment are reported back to the facility but they are not advised to take any further action.
What are the possible benefits and risks of participating?
Participating health facilities could benefit from being able to improve the quality of care that they provide. There are no notable risks involved with taking part in the study.

Where is the study run from?
The study takes place in 240 private health facilities in Tanzania

When is the study starting and how long is it expected to run for?
January 2016 to December 2019

Who is funding the study?
1. Medical Research Council (UK)
2. Economic and Social Research Council (UK)
3. Department for International Development (UK)
4. Wellcome Trust (UK)

Who is the main contact?
Dr Catherine Goodman
Catherine.Goodman@lshtm.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Dr Catherine Goodman

ORCID ID

http://orcid.org/0000-0002-2241-3485

Contact details

London School of Hygiene & Tropical Medicine
Faculty of Public Health and Policy
15-17 Tavistock Place
London
WC1H 9SH
United Kingdom
+44 20 7636 8636
Catherine.Goodman@lshtm.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MR/N015061/1

Study information

Scientific title

Effect of approaches to quality improvement in small and medium-sized private facilities: A randomised controlled trial in Tanzania

Acronym

Study hypothesis

The PharmAccess model will enhance the performance of participating private health facilities in terms of improved clinical quality, business performance and perceived quality of care by patients.

Ethics approval

1. Ifkakara Health Institute, Institutional Review Board, Dar Es Salaam, Tanzania, 09/03/2016, Ref: IHI/IRB/No: 04-2016
2. London School of Hygiene and Tropical Medicine, Interventions Research Ethics Committee, 05/01/2016, Ref: 10493

Study design

Cluster randomised controlled trial

Primary study design

Interventional

Secondary study design

Cluster randomised trial

Trial setting

Other

Trial type

Other

Patient information sheet

No participant information sheet available

Condition

1. Clinical quality of care
2. Business performance

Intervention

Participating health facilities are randomly allocated to one of two groups.

Intervention group: Health facilities are assessed at two points in time (baseline and then one to two years later) using a set of “SafeCare” standards covering structural quality (e.g. staffing, equipment, systems and documentation). For example, the standard on infection control includes indicators on written policies, audit, handwashing facilities, protective clothing and waste management (www.safe-care.org). In between these assessment, facilities receive regular mentoring visits. In addition, the health facilities are provided with training on quality and business systems, and assisted in the development of a quality and business improvement plan. They are connected with the PharmAccess Medical Credit Fund (MCF), a social investment fund which facilitates access to loans to finance implementation of the plan. Loans are provided by local banks, with MCF guaranteeing all or part of the risk. Facilities are also given access to a call centre and online training portal.

Control group: Health facilities are assessed using the two SafeCare assessments, the baseline results of which will be reported back to the facility with no further action.

Intervention type

Mixed

Phase

Drug names

Primary outcome measures

Technical quality of patient care is measured two years after the start of the intervention in each health facility by:
1. Trained professionals present themselves unnanounced to a health provider as a genuine patient (the health providers are unaware that the standardised patient is acting)
2. Role-playing clinical vignettes (involving a fieldworker role-playing as a patient)
3. Observing doctor-patient interactions to assess patient safety and infection control practices using a structured questionnaire

Secondary outcome measures

1. Perceived quality of care is measured using exit interviews at two years
2. Facility caseload is measured using the health facility questionnaire at baseline and two years
3. Facility revenue is measured using the health facility questionnaire at two years
4. User fees paid is measured using the standardised patients at two years
5. Quality of management is measured using the hospital management tool at two years
6. SafeCare assessment score is measured using the SafeCare assessment tool implemented by PharmAccess at baseline and two years

Overall trial start date

01/01/2016

Overall trial end date

31/12/2019

Reason abandoned

Eligibility

Participant inclusion criteria

Inclusion criteria for health facilities:
1. Those operating within the study zones
2. Those operating under the umbrella organisations of APHFTA (Association of Private Health Facilities in Tanzania) and CSSC (Christian Social Services Commission)

Participant type

Mixed

Age group

Other

Gender

Both

Target number of participants

240 private health facilities

Participant exclusion criteria

Exclusion criteria for health facilities:
1. Does not operate within the study zones
2. Does not operate under the umbrella organisations of APHFTA (Association of Private Health Facilities in Tanzania) and CSSC (Christian Social Services Commission)
3. Provides mental health services only
4. A referral hospital

Recruitment start date

14/03/2016

Recruitment end date

31/12/2016

Locations

Countries of recruitment

Tanzania

Trial participating centre

Ifakara Health Institute
Kiko Ave
Dar es Salaam
PO Box 78373
Tanzania

Sponsor information

Organisation

London School of Hygiene and Tropical Medicine

Sponsor details

Keppel Street
London
WC1E 7HT
United Kingdom

Sponsor type

University/education

Website

http://www.lshtm.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Funder name

Department for International Development, UK Government

Alternative name(s)

Department for International Development, DFID

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Wellcome Trust

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

international

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Results will be written up for publication in an academic journal. Dissemination activities will include meetings organised through established tanzanian and international networks, local and international conferences, policy briefs, sharing results with other pharmaccess country programmes, webinars and teaching materials

Intention to publish date

01/07/2020

Participant level data

To be made available at a later date

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

24/03/2016: Ethics approval information added.