Data Analysis
SECTION 5
Feasibility scenarios from the Collaboratory’s NIH Collaboratory Trials
Contributors
Charles Cannon, MD, PHD,
Carol S. Channing MVP, MD, DDS
The following table, excerpted from the Collaboratory’s Lessons Learned document, gives concrete examples of different feasibility assessments and pilot-testing tasks done by the NIH Collaboratory Trial study teams.
| Scenario | Solution |
| Patient-reported outcomes, such as the Brief Pain Inventory, were not embedded into the EHR system to allow extraction from the record. | The team built infrastructure, added resources and processes to the system, and used the healthcare system’s infrastructure to ensure feasibility and sustainability within regular clinical workflow. |
| Navigating local systems was challenging. | Involved the QI infrastructure in trial planning. QI project managers are embedded in healthcare systems and can guide projects. |
| The study team did not anticipate some of the delays associated with data validation. | Reallocated funds for additional IT and data analyst efforts. |
| The study team faced challenges linking data from acute care settings and nursing homes. Because the primary outcome is hospitalization rate/person day-alive, the data needed to be matched between nursing homes and hospitals. | Added additional IT resources to help link the systems. |
| This study is randomizing 24 level 1 trauma centers across the United States. Capabilities of the EHR systems are varied, and there is no single administrative database. | The study team asked all level 1 and 2 trauma centers to complete a survey regarding EHR capabilities and found that while some sites will be able to automate PTSD screening, other sites will need to screen manually. Develop methods to work with all sites regardless of capability and create a 10-domain EHR screen for risk factors for PTSD and other comorbid conditions. |
| A small change to work flow or the IT system is often viewed as a large change by health system personnel. | More activity than expected was required at the local level and with individual practitioners and administrators to engage the personnel at the facilities. |
| The study team initially planned for structured, step-wise electronic tools that were time-consuming to use but would provide a detailed therapy plan. | After discussing the tool with medical directors and physicians, they developed more user-friendly, less burdensome tools. |
| Management of multiple chronic conditions varies across different healthcare systems. | Study facilitators developed different workflows to accommodate the variations in resources at every site. These were roles in the healthcare systems and required more multidisciplinary review of the proposed workflows. |
| Updates in real-time with the use of the EHR meant that the lists of eligible and active patients at the clinics were continuously changing, which caused discordance between the lists that had been gathered for research purposes. | The team worked with the statisticians and added a secondary analysis. |
| The study team did not want to recruit facility leadership to participate in the study and then be told that they were assigned to control since the partners felt that all facilities would want to have the videos. | They chose to "prerandomize" by first applying eligibility criteria to existing data on all of the partner facilities and then give them the opportunity to exclude other facilities based on recent leadership changes, etc. They then divided facilities into a priori strata and randomly selected the 120 treatment facilities from the pool, leaving the rest as controls. In this way, no facilities that wanted to participate were disappointed, and the partners were confident that they would have a high participation rate. |
| The initial sample size was based on broad estimates of the prevalence of multiple chronic conditions across the healthcare systems and was limited by lack of cluster-level detailed information. | In the planning phase, the cluster units were redefined from individual practitioners to practice sites. The team queried EHR systems with the new cluster definition and collaborated with statisticians at the NIH to establish appropriate sample size. |
Conduct Resources
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REFERENCES
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