Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT03679247 |
Other study ID # |
2018P000692 |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
February 26, 2021 |
Est. completion date |
October 26, 2022 |
Study information
Verified date |
February 2023 |
Source |
Brigham and Women's Hospital |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
In this project the investigators will create computer reminders through user-centered design
and will validate the logic using retrospective electronic health record (EHR) data. Then the
investigators will test the reminders in primary care clinics to see if they improve
treatment of high blood pressure in early chronic kidney disease.
Hypothesis: The mean systolic blood pressure of the chronic kidney disease (CKD) population
can be decreased by an intervention with three innovative features: 1) methods to synthesize
EHR data in order to identify under-diagnosed chronic conditions, 2) iterative improvement in
clinical decision support (CDS) content through human factors methods to maximize the
"informativeness" of the CDS, and 3) the use of behavioral economic principles to create
behavioral "nudges" internal and external to the CDS.
Description:
Specific Aim 1: To develop and validate the intervention. Specific Aim 1a: To develop and
validate the CDS that will: 1) synthesize existing laboratory tests, medication orders, and
vital sign data; 2) increase recognition of CKD, 3) increase recognition of uncontrolled HTN
in CKD patients; and 4) deliver evidence-based CKD and hypertension (HTN) management
recommendations.
Specific Aim 1b: To improve the design and content of the CDS, we will use human factors
methods, specifically usability testing.
Specific Aim 1c: To develop a "wrap-around" intervention including two behavioral "nudges":
1) pre-checked default orders, and 2) an email to obtain commitment from primary care
providers (PCPs) to obtain their commitment to follow the CDS recommendations.
Aim 1a Study Procedures:
Develop Rules for Evidence-based Recommendations for HTN in CKD: The investigators will
leverage past work that they have done in a study that delivered recommendations based on
national guidelines. An example of one of the rules is to determine whether anti-hypertensive
agents have been prescribed but are not at highest potency. If so, the CDS will deliver a
recommendation to increase the dosage. The investigators will also include one-click access
to recommended orders.
Implementation: Before the start of the trial, the CDS will be moved to the Production
environment in "silent mode" where it will record when it would fire, but it will not be
displayed to the user. This step will allow us to validate that the rules are accurately
identifying patients and producing the correct recommendations through a chart review. The
CDS will be activated in the Production environment on the start date of the clinical trial
in Aim 2.
Aim 1b Study Procedures:
Usability Test Procedure: Usability testing clinical scenarios will be developed by subject
matter experts. Contextual inquiry sessions will be conducted with PCPs and the investigators
will ask for feedback on the usability test procedure, as well as content of test scenarios.
The goal of Aim 1b is to iteratively improve other important aspects of the CDS that
contribute to the overall informativeness of the CDS. The investigators will conduct two
rounds of usability testing with PCPs. After each test, the research team and Epic build
specialist will make iterative changes to the content of the CDS and layout of information.
Qualitative analysis: Qualitative methods will be employed to analyze the data. The
transcripts will be organized by task and participant and then quotes will be identified that
illustrate a user expectation, frustration, or misinterpretation of content or functionality.
Aim 1c Study Procedures:
1. Pre-checked, no-action default: The first nudge will be part of the CDS. The
investigators will display the CDS with certain options pre-selected.
2. Pledge email to obtain commitment from PCPs to follow the CDS recommendations: As a
starting point, we need to ensure that PCPs are aware of the clinical practice
guidelines. At the beginning of the study, we will send an advertisement email to all
PCPs in the network. In addition, as part of the intervention, we will ask intervention
arm PCPs to commit to following the recommendations presented to them in the best
practices advisory (BPA), or writing their rationale in the CDS if they choose not to.
By clicking a link in an email, the intervention PCP will come to a REDCap survey asking
them to type their name to pledge to consider the CDS recommendations provided in our
BPAs. The control PCPs will receive a control email without the specific details about
the study and without the REDCap link.
Specific Aim 2: To test the effectiveness of the intervention. Specific Aim 2a: To evaluate
whether the intervention developed in Aim 1 significantly decreases mean systolic blood
pressure in a population of CKD patients with blood pressure > 140/90. They will evaluate the
effectiveness of the intervention in a pragmatic, cluster-randomized controlled trial,
randomized at the level of the physician. Secondary outcomes will include
hypertension-specific process measures, such as treatment intensification.
Specific Aim 2b: To evaluate whether the intervention improves process measures for quality
of CKD care including: annual serum creatinine test, and annual urine albumin test.
Specific Aim 2 Study Procedures Please see below for detailed description of the clinical
trial.