Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease
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|ClinicalTrials.gov Identifier: NCT03679247|
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : November 17, 2021
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Diseases Hypertension||Other: Intervention Other: Control||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||184 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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|
|Official Title:||Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease|
|Actual Study Start Date :||February 26, 2021|
|Estimated Primary Completion Date :||September 1, 2024|
|Estimated Study Completion Date :||September 1, 2024|
Intervention arm will receive guidance within electronic health record from clinical decision support system.
The intervention will be a clinical decision support (CDS) system that contains three main features: 1) methods to synthesize electronic health record (EHR) data in order to identify under-diagnosed chronic conditions (synthesize existing medical data to increase recognition of CKD and uncontrolled HTN in CKD patients and deliver management recommendations based on this evidence), 2) improve the design and content of the CDS using human factors methods, specifically usability testing, and 3) the use of two behavioral "nudges" (pre-checked default orders and an email to obtain commitment from PCPs to obtain their commitment to follow the CDS recommendations).
The control arm will continue to provide usual care.
Usual Care, PCP will receive an email with general information about CKD guidelines
- Mean Systolic Blood Pressure (SBP) [ Time Frame: 6 months ]Change in mean SBP between baseline and 6 months compared across arms
- Controlled blood pressure rate [ Time Frame: 6 months ]Proportion of patients in each arm with BP <140/90 mmHg 6 months after enrollment
- Urine Albumin to Creatinine Ratio [ Time Frame: 6 months ]Value Urine Albumin to Creatinine Ratio 6 months after enrollment
- eGFR [ Time Frame: 6 months ]Value EGFR 6 months after enrollment
- Medication ordered [ Time Frame: 6 months ]Proportion of patients with recommended medication ordered
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03679247
|Contact: Lipika Samal, MD||617-732-7812||LSAMAL@BWH.HARVARD.EDU|
|United States, Massachusetts|
|Brigham and Women's Hospital||Recruiting|
|Boston, Massachusetts, United States, 02120|
|Contact: Lipika Samal firstname.lastname@example.org|
|Principal Investigator:||Lipika Samal, MD||Brigham and Women's Hospital|