Title: Completion of data collection, cleaning and analysis for randomized controlled trial of the impact of OpenMRS and decision support tools to improve HIV care in Rwanda.
Hamish Fraser (Brown University, RI, USA), Michael Mugisha and Aline Umubeybeye (School of Public Health, Rwanda)
Benefits to OpenMRS community
With the growth of OpenMRS including several large scale rollouts comes a strong need to better understand how it functions in different environments and with different use cases, the user experience of different user classes, and the impact on clinical care. Such evaluation data would help to define the most valuable use cases, what improvements are required for OpenMRS (which can help drive the road map), and strengthen the case for funding OpenMRS development and implementation.
The proposed project is the final stage of a large scale and long term evaluation of the use of OpenMRS to support HIV care in a low income setting – Rwanda. There are several important studies that have looked at the use of OpenMRS for HIV care in 1 – 3 sites such as a randomized controlled study showing a strong impact of alerts and reminders for pediatric HIV care at Moi University in Eldoret[Martin Were Pediatrics 2013]. In addition there is one multi-site study of the impact of alerts and reminders on HIV care in Kenya with a different EHR which showed a significant positive effect on detection and management of treatment failure[Tom Oluoch, Lancet HIV. However there is a lack of comprehensive real world evaluation of OpenMRS in larger projects with many sites.
The Rwanda eHealth Implementation Science project funded by the CDC, has been studying the usability, use, user experience, data quality, and stability of 112 OpenMRS implementations in HIV clinics in Rwanda (the process evaluation). It has also collected data for a costing studyof the development, implementation and use of an improved version of OpenMRS including improved patient summaries and decision support systems.
The third component of the study is a randomized, controlled trial (RCT) of the impact of an enhanced version of OpenMRS implemented in 56 intervention sites. This trial has 4 end points:
- The time for a patient who tests HIV positive to start ARV treatment
- The percentage of patients that have a viral load result at 8 months after starting treatment (6 months to test + 2 months for result to return and be entered into EHR)
- The time for clinicians to respond to treatment failure based on a high viral load result
- The percentage of patients with elevated viral load at the end of study
Short description of the project.
The current study status is that the process evaluation and costing study are complete regarding data collection and at the write up stage. The RCT is under way with the enhanced EHR software installed on the OpenMRS servers at the 56 intervention sites in July 2018. The study is due to end in July 2019.
Currently the CDC funds are no longer available for the final data collection process, data cleaning and analysis for the RCT. Many delays have plagued the project and this has ultimately led to final project funds being “timed out”. Requirements to complete the RCT are funds to cover collecting an image of the OpenMRS EHR databases for 112 sites, collecting some additional outcome data and missing data at those sites, analyzing the data, and renewing the Rwanda MOH IRB approval in September 2019.
This project has already yielded extensive data from the process evaluation and costing studies. These studies will provide valuable insights in to the performance, usability, data quality and costs of implementing OpenMRS at Scale. They also provide unique insights into the way a large scale OpenMRS roll out functions 4 years or more after the initial implementation and while managed locally by the MOH and other Rwandan agencies. Six publications are in process from the process evaluation and costing study. Inability to collect the final data from the RCT will result in loss of highly valuable data that could help improve OpenMRS.
High level project plan
Collect database images from OpenMRS servers at all 112 sites. Collect additional data on key variables at the 112 sites. This will involve technical and data management staff visiting each site. Cost will include salaries, transport and local lodging.
Enter data into study database and clean data.
Carry out analysis of the data.
Renew the IRB approval in Rwanda in September 2019
These are low, the hard work has mostly been done and the critical deliverable is collecting the data for analysis.
$35,000 to $50,000. Some flexibility