Impact of the Pulse Oximeter on providers’ behaviour and patient management practices across resource limited settings (Outcome Study)

Executive summary

World over, pulse oximetry has revolutionized safety of anesthesia and surgery. The Lifebox foundation has been at the helm of distributing pulse oximeters across resource limited settings in a bid to ensure that a basic minimum is achieved where patient monitoring in the perioperative period is concerned. Despite these strides, there is little known about the overall impact of the use of the pulse oximeter on the health care provider’s behaviour in the workspace and on the decision-making process. This study will run over a period of twelve months. We will collect baseline data related to pulse oximetry in the selected units as well as have key informant interviews to further evaluate the impact of pulse oximetry on the quality of care. The data collected will be used to inform Lifebox’s strategic plan and the lessons learnt will be published in a peer reviewed journal.

BackgroundPulse oximetry is at the heart of the Lifebox (1) foundation’s work to improve the safety of anaesthesia. Lifebox aims to ensure that essential monitoring of oxygen levels happens with every surgery that takes place. A pulse oximeter is a simple, highly effective non-invasive monitoring device that has revolutionised the safety of anesthesia and surgery. It is considered a critical device and its use is a minimum standard for safe anaesthesia according to the World Health organization- World Federation of Societies of Anaethesiologists (WHO-WSFA) (2). It is the only piece of equipment included on the WHO Surgical Safety Checklistand yet thousands of operating rooms around the world still lack this essential monitoring device.The Lifebox pulse oximetry program launched with the founding aim to close the “oximetry gap” by equipping operating rooms with this essential safety device following a landmark paper that estimated 77,000 operating rooms in the world had no pulse oximetry (3). The Lifebox pulse oximeter was specifically designed with the low-resource settings in mind – with robust construction and rechargeable batteries that stay on even when the power fails. To date, more than 34,000 Lifebox pulse oximeters have been distributed throughout 116 countries for vital patient monitoring, with more than 33 million lives safeguarded. The distribution is accompanied by oximetry and anaesthesia safety training, recognizing that for many of the recipients this is their first patient monitoring technology.

Despite these successes, there is little evidence on how a pulse oximeter introduced into a hospital system impacts provider behaviour and critical patient care (4). In addition, need to understand how providers use and respond to hypoxaemic episodes, how information gained from pulse oximetry is communicated between providers, how these devices influence decisions and practices, or what additional needs and challenges arise following distribution to facilities.

The main purpose of this study is to understand and evaluate the impact of the pulse oximeter on providers’ behaviour and knowledge about pulseoximeter as well address the gap which yet exists in LMIC lacking the mandatory monitor.

Significance of the study

This study will inform the next steps in Lifebox foundation’s strategic plan: training and potentially guide distribution patterns and provide insight into the modifiable behaviours that may have a significant impact on patient healthcare and safety.

Objectives****Aim:

To evaluate the accessibility and impact of the use of pulse oximeter and pulse oximetry training on health care providers’ knowledge and attitudes within health facilities in selected resource-limited settings where previously oximeters were not readily available and compare them to those in a high-volume tertiary care hospital.

Specific objectives:

1. To compare the knowledge and attitudes of health workers from the selected facilities to those working in a tertiary care hospital adhering to the WHO-WFSA guidelines (2)
2. To determine the effect of the pulse oximeter and the associated pulse oximetry training offered on the knowledge and attitudes of the health workers from the selected facilities compared to baseline.
3. To determine the number of pulse oximeters per selected facility and their distribution within the facility to determine if a gap exists.

Methodology****Study Design and procedure:

1.       A prospective cohort mixed methods research design will be used to carry out this study.

2.      We will train research assistants to collect data.

3.      We shall use a pretested questionnaire to collect baseline quantitative data from the facilities (“Test centres”) and have focus group discussions and/or key informant interviews (where the selected health worker number is too small for a focus group discussion).

4. The control, or standard arm will comprise of health workers in a tertiary care “reference institute” who will be administered the same questionnaire as the study arm at baseline.

5.      Study arm will comprise of health workers who will be provided with pulse-oximeters and training regarding their use after collecting the baseline data.

6.     We will then return to the facilities 3 months post the distribution of pulse-oximeter (if needed) and training (if needed by the test centres) and collect follow up data from these facilities.

7.   The baseline and follow-up data from the study arm will be compared to the baseline data from the control arm to assess the magnitude of gaps in training at baseline as well as at 3 months follow up.

Study sites

The following centres from the north-east region of India have been selected as the “Test centres”.

1.     Naga Hospital Authority, Kohima, Nagaland, India.

2.     J.N. Institute of Medical Sciences, Porompat, Manipur, India.

3.     Tomo Riba Institute Of Health And Medical Sciences (TRIHMS), Naharlagun

4.     Kokrajhar Medical College and Hospital, Kokrajhar, Assam, India.

5.     Sohra Community health centre, Sohra, Cherrapunjee, Meghalaya, India.

6.     Tripura Cancer Hospital, Agartala, Tripura, India.

The Tata Memorial Centre, ACTREC, Navi Mumbai will be designated as the “reference centre” for recruiting participants in the control arm. Health workers as described below working in theatres, post anesthesia care units (PACU), Intensive care units (ICU), the emergency departments and the ward will be selected to participate in the study.

The study will later be expanded to include centres from additional countries as well.

Study populationAll healthcare providers who work in departments where pulse oximeters are used will be targeted for inclusion into the study. These departments include the operating room, emergency department, post anesthesia care unit, Intensive care units and the hospital wards. Anaesthesia providers, both physicians and non-physicians, nurses, other physicians and health workers involved in the emergency medical services including emergency medicine physicians will participate from the study sites as above.

Study procedures

Pulse-oximeters will be distributed to the test centres based on their individual needs. Training on using the pulse-oximeters as well as interpretation of results will be provided via a structured workshop conducted by the study investigator at each centre following the distribution of the pulse-oximeters.