INVESTIGATING THE DETERMINANTS OF THE QUALITY OF HEALTHCARE IN NAIROBI COUNTY, KENYA

Last registered on April 26, 2024

Pre-Trial

Trial Information

General Information

Title
INVESTIGATING THE DETERMINANTS OF THE QUALITY OF HEALTHCARE IN NAIROBI COUNTY, KENYA
RCT ID
AEARCTR-0013475
Initial registration date
April 25, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
April 26, 2024, 12:45 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Primary Investigator

Affiliation
Department of Economics, University of Gothenburg

Other Primary Investigator(s)

PI Affiliation
Population Council Kenya

Additional Trial Information

Status
In development
Start date
2023-09-01
End date
2024-12-01
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Across low and middle-income countries (LMICs) there are “missing women”, meaning that there are fewer women alive today than there demographically should be (Sen, 1992). Substantial research attention has been paid to “missing” female babies and girls – that is female children that are never born (Nie, 2011) and girls that never reach adulthood due to systematic neglect (Garg & Morduch, 1998; Gupta, 2002; Oster, 2009, 2016). However, more recent research indicates that the largest number of “missing women” are of adult age and would live in sub-Saharan Africa (Anderson & Ray, 2010; Bongaarts & Guilmoto, 2015). Comparatively less research attention has been paid to excess female mortality in adulthood and to the question of why women die prematurely. Anderson & Ray (2010) show that the largest number of “missing women” can be attributed to HIV/AIDS, injuries, and cardiovascular diseases – which disproportionally affect women. There is currently no consensus on whether these deaths are due to biological factors or whether they are due to gender-based discrimination. Determining why women die prematurely is key for developing adequate policy solutions and reaching key international development targets related to women’s health, such as the Sustainable Development Goals.

This study examines whether women face gender-based discrimination when they seek care and collects data in 250 primary care facilities in Naiorbi county Kenya. The proposed study has two main objectives. First, it uses male and female standardised patients (SPs) – healthy people pretending to be ill and visiting healthcare providers under-cover – to examine whether women with symptoms of coronary heart disease (i.e. chest pain) receive worse healthcare than men. Second, it provides evidence on how any potential gender-based discrimination might be remedied and tests the short-term effect of a provider training intervention.
External Link(s)

Registration Citation

Citation
Abuya, Timothy and Roxanne Kovacs. 2024. "INVESTIGATING THE DETERMINANTS OF THE QUALITY OF HEALTHCARE IN NAIROBI COUNTY, KENYA." AEA RCT Registry. April 26. https://doi.org/10.1257/rct.13475-1.0
Experimental Details

Interventions

Intervention(s)
This study examines whether women in face gender-based discrimination when they seek care and collects data in 250 primary care facilities in Naiorbi county Kenya. The proposed study has two main objectives. First, it uses male and female standardised patients (SPs) – healthy people pretending to be ill and visiting healthcare providers under-cover – to examine whether women with symptoms of coronary heart disease (i.e. chest pain) receive worse healthcare than men. Second, it provides evidence on how any potential gender-based discrimination might be remedied and tests the short-term effect of a provider training intervention. The training workshop will be based on a course developed by the WHO and will be evaluated with a randomised experiment. Providers working in half of the study facilities will be invited to the training. We will evaluate the effect of the training by comparing quality of care received by male and female SPs before and after the intervention.
Intervention (Hidden)
Providers working in a random sample of 125 (of 250) primary care facilities will be invited to take part in the training workshop. During the provider survey, we aim to collect contact information for all facility managers as well as healthcare providers who saw SPs. The training workshop will be conducted virtually.

We will organise up to five virtual training sessions, for which providers can sign up depending on convenience. After the workshop, providers will complete a brief quiz summarising the key points of the training and will be issued a training certificate upon completion. Providers who complete their training certificate will receive 1,000 KES as a token of appreciation, as well as to offset mobile data usage costs.

The content of the training workshop will closely follow the WHO HEARTS technical package, materials for which are freely available online (WHO 2024). The two-hour session will focus on two of the six components of WHO HEARTS, which are most relevant for the study: healthy lifestyle counselling and cardiovascular disease management in primary care. Training workshops will be held by local healthcare professionals.
Intervention Start Date
2024-06-24
Intervention End Date
2024-06-28

Primary Outcomes

Primary Outcomes (end points)
The primary outcome of interest is the clinical quality of care received by SPs, which can be measured in a variety of ways.

The clinical quality of care received by SPs is usually captured via a binary variable that indicates the quality of case management. Based on previous studies using the same SP case of stable angina in primary care, patients who either received an ECG (electrocardiogram) or were referred will be coded as having received clinically indicated treatments. The main point of interest will be variations in quality between male and female SPs.

Although important, a binary outcome of the quality of case management hides a lot of important variation, particularly in relation to how intensely patients were treated. Studies from high-income countries for instance suggest that women are often treated less intensively than men with the same symptoms. For this reason, we will also consider:
• The urgency of the received referral (when were patients told they should attend the referral facility)
• To which level patients were referred and if referrals were to specialists (for instance, a secondary care facility compared to a specialist cardiology centre)
• The proportion of relevant questions asked and examinations done, as well as the duration of the consultation – to capture general provider effort

To investigate whether providers seemed less likely to consider heart disease with female patients, we will consider:
• Whether the diagnosis given to patients was non-cardiac
• Whether the diagnosis focused on stress of mental health issues
• Whether a diagnosis was given at all

Since healthy lifestyle counselling is a key component of cardiovascular care management in primary care based both on Kenyan clinical guidelines as well as WHO HEARTS, we will consider:
• Whether patients received lifestyle counselling (nutrition, exercise, smoking and alcohol)
• The proportion of relevant recommendations covered
Primary Outcomes (explanation)

Secondary Outcomes

Secondary Outcomes (end points)
Secondary Outcomes (explanation)

Experimental Design

Experimental Design
Providers working in a random sample of 125 (of 250) primary care facilities will be invited to take part in the training workshop. All providers who usually deliver general primary care to adult patients in selected facilities will be invited to take part.
Experimental Design Details
Providers working in a random sample of 125 (of 250) primary care facilities will be invited to take part in the training workshop. During the provider survey (third phase of data collection), we aim to collect contact information for all facility managers as well as healthcare providers who saw SPs. We will contact providers telephonically or via email to invite them to the workshop. If feasible, we will also send written invitations. All providers who usually deliver general primary care to adult patients will be invited to take part.

The training workshop will be conducted virtually. Our sense it that a virtual workshop is preferable to in-person training because virtual activities are easier to implement at scale and are less disruptive to day-to-day healthcare provision. In addition, virtual training is also increasingly common for providers in Kenya.

We will organise up to five virtual training sessions, for which providers can sign up depending on convenience. After the workshop, providers will complete a brief quiz summarising the key points of the training and will be issued a training certificate upon completion. Providers who complete their training certificate will receive 1,000 KES as a token of appreciation, as well as to offset mobile data usage costs.

The content of the training workshop will closely follow the WHO HEARTS technical package, materials for which are freely available online (WHO 2024). The two-hour session will focus on two of the six components of WHO HEARTS, which are most relevant for the study: healthy lifestyle counselling and cardiovascular disease management in primary care. Training workshops will be held by local healthcare professionals. Trainers will receive some prior training on WHO HEARTS – although the individuals delivering the training will work within cardiovascular care. The aim is to have the same individuals conduct all sessions and to use the same slide deck. After the virtual training, providers will complete a brief quiz on the content of training and, if successful, receive 1,000 KES as a token of appreciation (which will be paid via mobile money).

There are two main threats to the internal validity of the evaluation. The first is that not all providers who will have consulted SPs will take part in the workshop and that not all providers who will take part in the workshop will see SPs for a follow-up consultation. We will do our best to ensure that all interested providers have the opportunity to take part in the workshop – by providing multiple sessions at convenient times and following up with providers if needed. Whenever possible we will aim to make appointments with healthcare providers seen at baseline when the follow-up is conducted. In the provider survey, providers working in selected facilities will also be asked about their usual working hours or days, as well as about potential holidays. We will use this information to try and time SP visits at endline and ensure that our sample size is sufficiently large. Nonetheless, despite these efforts and the relatively short time between baseline and endline assessment, we will not be able to match baseline and endline data for all providers. We will however be able to assess the facility-level effect of the training, given that facilities will have been randomly selected to take part.

Another issue for the internal validity of the study is potential contamination. It is possible that healthcare providers work in multiple facilities and that some work in treatment and control facilities. As we know the identity of healthcare providers seen by SPs, as well as the identity of providers who attended the training, and will have the list of all providers working in study facilities, as well as the reported workplace of each provider – hence, we will be able to verify cases of cross-contamination. However, it is still possible that some providers will not disclose secondary employers and that some contamination will occur.
Randomization Method
Randomisation done by the PI (in office by a computer).
Randomization Unit
All of the 250 facilities will be visited by male and female SPs with symptoms of angina. Enumerators will be randomly attributed to specific health facilities. Every SP will have to visit a specific facility on a specific day and timing will be based on logistical considerations only – and will be set by the PI before fieldwork commences.

The randomisation of the training intervention will happen at facility-level, as half of the 250 study facilities will be selected into the treatment group. Randomisation will be done by the PI.
Was the treatment clustered?
Yes

Experiment Characteristics

Sample size: planned number of clusters
The study will be conducted in 250 primary care facilities in Nairobi. Half of which will be randomly assigned to the treatment group (where providers are invited to take part in the training workshop).
Sample size: planned number of observations
There will be roughly 1,000 observations, assuming 500 SP visits at baseline and 500 at endline. At each stage, half of the observations are from consultations between providers and male SPs and the other half from consultations between providers and female SPs.
Sample size (or number of clusters) by treatment arms
There will be 500 observations in the treatment group (in 125 facilities) and 500 in the control group (in 125 facilities).
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
IRB

Institutional Review Boards (IRBs)

IRB Name
Amref Kenya and NACOSTI
IRB Approval Date
2024-03-14
IRB Approval Number
NACOSTI/P/24/33778
Analysis Plan

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

Post-Trial

Post Trial Information

Study Withdrawal

There is information in this trial unavailable to the public. Use the button below to request access.

Request Information

Intervention

Is the intervention completed?
No
Data Collection Complete
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials