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

• ClinicalTrials.gov Identifier: NCT03679247
• Recruitment Status: Completed
• First Posted: September 20, 2018
• Last Update Posted: February 16, 2023
• Sponsor: Brigham and Women's Hospital
• Information provided by (Responsible Party): Lipika Samal, Brigham and Women's Hospital

Tracking Information

• First Submitted Date: September 11, 2018
• First Posted Date: September 20, 2018
• Last Update Posted Date: February 16, 2023
• Actual Study Start Date: February 26, 2021
• Actual Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 12, 2021)

Mean Systolic Blood Pressure (SBP) [ Time Frame: 6 months ]

Change in mean SBP between baseline and 6 months compared across arms

Original Primary Outcome Measures (submitted: September 18, 2018)

Systolic Blood Pressure (SBP) [ Time Frame: 12 months ]

Final systolic blood pressure within 12 months after enrollment

Current Secondary Outcome Measures (submitted: February 12, 2021)

• 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

Original Secondary Outcome Measures (submitted: September 18, 2018)

• Difference in SBP over 12 month period (difference-in-differences) [ Time Frame: 12 months ]
  Final SBP within 12 months after enrollment minus baseline SBP to account for any baseline SBP differences
• Controlled blood pressure rate [ Time Frame: 12 months ]
  Proportion of patients in each arm with BP <140/90 mmHg 12 months after enrollment
• Systolic Blood Pressure (secondary) [ Time Frame: 48 months ]
  Intent to intervene analysis with imputation of missing BP measurements
• Physician Use of Clinical Decision Support [ Time Frame: 48 months ]
  Interaction with the clinical decision support (CDS), signing of orders, or accountable justification documentation within the CDS.
• Continuing Professional Development Reaction questionnaire [ Time Frame: 48 months ]
  Validated 12 item questionnaire that measures intention to change behavior.

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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

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:

1. 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.
2. 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.

• Study Type: Interventional
• Study Phase: Not Applicable

Study Design

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

Condition

• Chronic Kidney Diseases
• Hypertension

Intervention

• 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).
• Other: Control
  Usual Care, PCP will receive an email with general information about CKD guidelines

Study Arms

• Experimental: Intervention
  Intervention arm will receive guidance within electronic health record from clinical decision support system.
  Intervention: Other: Intervention
• Experimental: Control
  The control arm will continue to provide usual care.
  Intervention: Other: Control

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 19, 2021): 184
• Original Estimated Enrollment (submitted: September 18, 2018): 180
• Actual Study Completion Date: October 26, 2022
• Actual Primary Completion Date: October 26, 2022 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03679247
• Other Study ID Numbers: 2018P000692
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Lipika Samal, Brigham and Women's Hospital
• Original Responsible Party: Same as current
• Current Study Sponsor: Brigham and Women's Hospital
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Lipika Samal, MD; Brigham and Women's Hospital

• PRS Account: Brigham and Women's Hospital
• Verification Date: February 2023