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

Primary Purpose

Chronic Kidney Diseases, Hypertension

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Control
Sponsored by
Brigham and Women's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Kidney Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Intervention

Control

Arm Description

Intervention arm will receive guidance within electronic health record from clinical decision support system.

The control arm will continue to provide usual care.

Outcomes

Primary Outcome Measures

Mean Systolic Blood Pressure (SBP)
Change in mean SBP between baseline and 6 months compared across arms

Secondary Outcome Measures

Controlled blood pressure rate
Proportion of patients in each arm with BP <140/90 mmHg 6 months after enrollment
Urine Albumin to Creatinine Ratio
Value Urine Albumin to Creatinine Ratio 6 months after enrollment
eGFR
Value EGFR 6 months after enrollment
Medication ordered
Proportion of patients with recommended medication ordered

Full Information

First Posted
September 11, 2018
Last Updated
February 14, 2023
Sponsor
Brigham and Women's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03679247
Brief Title
Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease
Official Title
Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
October 26, 2022 (Actual)
Study Completion Date
October 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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: 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Diseases, Hypertension

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Intervention arm will receive guidance within electronic health record from clinical decision support system.
Arm Title
Control
Arm Type
Experimental
Arm Description
The control arm will continue to provide usual care.
Intervention Type
Other
Intervention Name(s)
Intervention
Intervention Description
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 Type
Other
Intervention Name(s)
Control
Intervention Description
Usual Care, PCP will receive an email with general information about CKD guidelines
Primary Outcome Measure Information:
Title
Mean Systolic Blood Pressure (SBP)
Description
Change in mean SBP between baseline and 6 months compared across arms
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Controlled blood pressure rate
Description
Proportion of patients in each arm with BP <140/90 mmHg 6 months after enrollment
Time Frame
6 months
Title
Urine Albumin to Creatinine Ratio
Description
Value Urine Albumin to Creatinine Ratio 6 months after enrollment
Time Frame
6 months
Title
eGFR
Description
Value EGFR 6 months after enrollment
Time Frame
6 months
Title
Medication ordered
Description
Proportion of patients with recommended medication ordered
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lipika Samal, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34937722
Citation
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.
Results Reference
derived

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

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