Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
180

Summary

Conditions
  • Chronic Kidney Diseases
  • Hypertension
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: PCPs will be stratified based on two factors (size of CKD panel and mean SBP). Within these strata, PCPs will be randomized to intervention and control arms in a 1:1 ratio. At study start, each CKD patient seen by a participating PCP will be assigned to the same arm as their PCP. The intervention will be in place for 12 months and data collection will continue for an additional 6 months.Masking: None (Open Label)Primary Purpose: Health Services Research

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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) d...

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 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 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: 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. 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 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.

Tracking Information

NCT #
NCT03679247
Collaborators
Not Provided
Investigators
Principal Investigator: Lipika Samal, MD Brigham and Women's Hospital