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Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03679247
Recruitment Status : Recruiting
First Posted : September 20, 2018
Last Update Posted : November 17, 2021
Information provided by (Responsible Party):
Lipika Samal, Brigham and Women's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Chronic Kidney Diseases Hypertension Other: Intervention Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases

Arm Intervention/treatment
Experimental: Intervention
Intervention arm will receive guidance within electronic health record from clinical decision support system.
Other: Intervention
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).

Experimental: Control
The control arm will continue to provide usual care.
Other: Control
Usual Care, PCP will receive an email with general information about CKD guidelines

Primary Outcome Measures :
  1. Mean Systolic Blood Pressure (SBP) [ Time Frame: 6 months ]
    Change in mean SBP between baseline and 6 months compared across arms

Secondary Outcome Measures :
  1. Controlled blood pressure rate [ Time Frame: 6 months ]
    Proportion of patients in each arm with BP <140/90 mmHg 6 months after enrollment

  2. Urine Albumin to Creatinine Ratio [ Time Frame: 6 months ]
    Value Urine Albumin to Creatinine Ratio 6 months after enrollment

  3. eGFR [ Time Frame: 6 months ]
    Value EGFR 6 months after enrollment

  4. Medication ordered [ Time Frame: 6 months ]
    Proportion of patients with recommended medication ordered

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

PCPs who have patients meeting inclusion criteria below will be enrolled.

Inclusion Criteria:

  • 18 years or older
  • Has visit with PCP at one of the intervention practices during the 2 years before the study period
  • Chronic Kidney Disease, defined as two prior estimated glomerular filtration rate (eGFR) 16-59 mL/min/1.73m2 separated by 90 days (as calculated by CKD-EPI) or two prior urine albumin to creatinine ratio (UACR) >30 mg/g separated by 90 days

Exclusion Criteria:

  • Residents in training
  • Physicians only seeing urgent care and walk-in patients
  • Patients with a most recent eGFR ≤ 20 or two previous eGFRs within 2 years separated by at least 90 days ≤ 15

Information from the National Library of Medicine

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 identifier (NCT number): NCT03679247

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Contact: Lipika Samal, MD 617-732-7812 LSAMAL@BWH.HARVARD.EDU

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United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02120
Contact: Lipika Samal   
Sponsors and Collaborators
Brigham and Women's Hospital
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Principal Investigator: Lipika Samal, MD Brigham and Women's Hospital
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Lipika Samal, Director of Brigham and Women's Primary Care Practice-based Research Network, Brigham and Women's Hospital Identifier: NCT03679247    
Other Study ID Numbers: 2018P000692
First Posted: September 20, 2018    Key Record Dates
Last Update Posted: November 17, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Vascular Diseases
Cardiovascular Diseases
Urologic Diseases
Renal Insufficiency