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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK116898 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | Providers overseeing patients in the intervention arm will receive guidance within electronic health record from clinical decision support system. |
|
| Control | Experimental | Providers overseeing patients in the control arm will continue to provide usual care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days | Difference in SBP from baseline to 180 days | 180 days |
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Patients meeting inclusion criteria below will be enrolled.
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lipika Samal, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02120 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41151782 | Derived | 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. | |
| 40097147 | 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. |
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Groups of patients sharing the same PCP panel (PCP or PCP plus a nurse practitioner or physician assistant) were grouped as units. The units were stratified based on two factors (size of unit and mean SBP). Within these strata, units were randomized to intervention and control arms in a 1:1 ratio. While randomization was done at the PCP panel level, data analyses were done at the patient level.
This multiclinic clinical trial, including 15 hospital-based, ambulatory, and community health center-based clinics, occurred from February 2021 to February 2022. All adult patients with a visit to a PCP in the last two years were eligible and those with evidence of CKD and hypertension were included.
| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | Patients will receive care from providers who will receive guidance within electronic health record from clinical decision support system. 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). |
| FG001 | Control | Patients will receive care from providers who will continue to provide usual care. Control: Usual Care, PCP will receive an email with general information about CKD guidelines |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Intervention arm will receive guidance within electronic health record from clinical decision support system. 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days | Difference in SBP from baseline to 180 days | Posted | Mean | 95% Confidence Interval | mmHg | 180 days |
|
180 days +/- 60 days
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Intervention arm will receive guidance within electronic health record from clinical decision support system. 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lipika Samal | Brigham and Women's Hospital | 6177327063 | lsamal@bwh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 22, 2020 | Sep 9, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D008722 | Methods |
| ID | Term |
|---|---|
| D008919 | Investigative Techniques |
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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.
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| Control | Other | Usual Care, PCP will receive an email with general information about CKD guidelines |
|
| 38466302 | 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. |
| 37437601 | 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. |
| 34937722 | 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. |
| BG001 | Control | The control arm will continue to provide usual care. Control: Usual Care, PCP will receive an email with general information about CKD guidelines |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
| systolic blood pressure | Mean | Standard Deviation | mmHg |
|
| OG001 | Control | The control arm will continue to provide usual care. Control: Usual Care, PCP will receive an email with general information about CKD guidelines |
|
|
| 15 |
| 1,029 |
| 0 |
| 1,029 |
| 0 |
| 1,029 |
| EG001 | Control | The control arm will continue to provide usual care. Control: Usual Care, PCP will receive an email with general information about CKD guidelines | 19 | 997 | 0 | 997 | 0 | 997 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |