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

NCT03679247 | Completed Results DMC

• 2 other identifiers: 2018P000692R01DK116898
• Study Type: interventional
• Target: 2,026
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Diseases; Hypertension

Outcome Measures

Primary Outcomes (1)

• Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days

  Difference in SBP from baseline to 180 days

  180 days

Study Arms (2)

Intervention

EXPERIMENTAL

Providers overseeing patients in the intervention arm will receive guidance within electronic health record from clinical decision support system.

Other: Intervention

Control

EXPERIMENTAL

Providers overseeing patients in the control arm will continue to provide usual care.

Other: Control

Interventions

Intervention OTHER

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).

Intervention

Control OTHER

Usual Care, PCP will receive an email with general information about CKD guidelines

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients receiving care from residents in training
• Patients receiving care from 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Related Publications (5)

• Chen SW, Gannon M, Kilgallon JL, Chay WI, Rubins D, Salmasian H, Dutta S, McEvoy DS, Wu E, Wright A, McCoy A, Samal L. Applying an Empirical Taxonomy to Alert Malfunctions in a Pragmatic Trial for Hypertension Management in Chronic Kidney Disease. Appl Clin Inform. 2025 Oct;16(5):1457-1464. doi: 10.1055/a-2702-6872. Epub 2025 Oct 28.

  PMID: 41151782 DERIVED

• Samal L, Chen SW, Lipsitz S, Baer HJ, Kilgallon JL, Gannon M, Dunk R, Chay WI, Fay R, Sainlaire M, Gao C, Wien M, Garabedian PM, Wu E, Salmasian H, Bates DW, Dykes PC, Wright A, McCoy AB. User Actions within a Clinical Decision Support Alert for the Management of Hypertension in Chronic Kidney Disease. Appl Clin Inform. 2025 May;16(3):595-603. doi: 10.1055/a-2554-3969. Epub 2025 Mar 17.

  PMID: 40097147 DERIVED

• Samal L, Kilgallon JL, Lipsitz S, Baer HJ, McCoy A, Gannon M, Noonan S, Dunk R, Chen SW, Chay WI, Fay R, Garabedian PM, Wu E, Wien M, Blecker S, Salmasian H, Bonventre JV, McMahon GM, Bates DW, Waikar SS, Linder JA, Wright A, Dykes P. Clinical Decision Support for Hypertension Management in Chronic Kidney Disease: A Randomized Clinical Trial. JAMA Intern Med. 2024 May 1;184(5):484-492. doi: 10.1001/jamainternmed.2023.8315.

  PMID: 38466302 DERIVED

• Samal L, Wu E, Aaron S, Kilgallon JL, Gannon M, McCoy A, Blecker S, Dykes PC, Bates DW, Lipsitz S, Wright A. Refining Clinical Phenotypes to Improve Clinical Decision Support and Reduce Alert Fatigue: A Feasibility Study. Appl Clin Inform. 2023 May;14(3):528-537. doi: 10.1055/s-0043-1768994. Epub 2023 Jul 12.

  PMID: 37437601 DERIVED

• Kilgallon JL, Gannon M, Burns Z, McMahon G, Dykes P, Linder J, Bates DW, Waikar S, Lipsitz S, Baer HJ, Samal L. Multicomponent intervention to improve blood pressure management in chronic kidney disease: a protocol for a pragmatic clinical trial. BMJ Open. 2021 Dec 22;11(12):e054065. doi: 10.1136/bmjopen-2021-054065.

  PMID: 34937722 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hypertension

Interventions

Methods

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Lipika Samal
• Organization: Brigham and Women's Hospital

lsamal@bwh.harvard.edu

6177327063

Study Officials

• Lipika Samal, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Brigham and Women's Primary Care Practice-based Research Network

Model Details: Groups of patients sharing the same PCP will be randomized. The groups will be stratified based on two factors (size of group and mean SBP). Within these strata, groups will be randomized to intervention and control arms in a 1:1 ratio. The intervention will be in place for 12 months and data collection will continue for an additional 6 months.

Study Record Dates

• First Submitted: September 11, 2018
• First Posted: September 20, 2018
• Study Start: February 26, 2021
• Primary Completion: October 26, 2022
• Study Completion: October 26, 2022
• Last Updated: November 26, 2024
• Results First Posted: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)