Understanding and enhancing approaches to quality improvement in small and medium-sized private facilities in Tanzania

• Register: ISRCTN
• Last refreshed on: 24 August 2021
• Main ID: ISRCTN93644888
• Date of registration: 09/03/2016
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: Understanding and enhancing approaches to quality improvement in small and medium-sized private facilities in Tanzania
• Scientific title: Effect of approaches to quality improvement in small and medium-sized private facilities: A randomised controlled trial in Tanzania
• Date of first enrolment: 14/03/2016
• Target sample size: 240
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN93644888
• Study type: Interventional
• Study design: Cluster randomised controlled trial (Other)
• Phase: Not Applicable

Countries of recruitment

Tanzania

Contacts

• Name: Catherine Goodman

Key inclusion & exclusion criteria

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)

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


Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

1. Clinical quality of care 2. Business performance
Not Applicable
1. Clinical quality of care 2. Business performance

Intervention(s)

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.

Primary Outcome(s)

Current Primary Outcome Measures (as of 17/01/2018):
1. Correct treatment measured 18-24 months after the start of the intervention using standardised patients presenting four cases (suspected malaria, tuberculosis, asthma, and upper respiratory tract infection).
2. Compliance with infection prevention and control practices measured 18-24 months after the start of the intervention using observations of health worker-patient interactions

Previous 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(s)

Current Secondary Outcome Measures (as of 17/01/2018):
1. Perceived quality of care is measured using patient exit interviews at 18-24 months
2. Facility caseload is measured using the health facility questionnaire at 18-24 months
3. Facility revenue is measured using the health facility questionnaire at 18-24 months
4. User fees paid is measured using the standardised patients and patient exit interviews at 18-24 months
5. SafeCare assessment score is measured using the SafeCare assessment tool implemented by PharmAccess at baseline and at 18-24 months
6. Management practices score is measured in two different ways using: i) the health facility questionnaire at 18-24 months; ii) a sub-set of management-related criteria in the SafeCare assessment tool implemented by PharmAccess at baseline and at 18-24 months
7. History taking & examination, diagnosis, unnecessary and harmful care, dosing and advice measured using standardised patients at 18-24 months
8. Compliance with infection prevention and control practices by domain (hand hygiene, injection and blood draw safety, personal protective equipment safety, disinfection of reusable medical devices, and waste segregation) measured at 18-24 months using observations of health worker-patient interactions

Previous 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

Secondary ID(s)

MR/N015061/1

Source(s) of Monetary Support

Medical Research Council, Economic and Social Research Council, Department for International Development, UK Government, Wellcome Trust

Ethics review

Status:
Approval date:
Contact:

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 3. Tanzania's National Institute of Medical Research, 17/02/2017, Ref: NIMR/HQ/R.8a/Vol.IX/2415

Results

• Results available: Yes
• Date Completed: 31/12/2019