Chronic Kidney DiseasesNCT03679247
Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease
A study testing Intervention in people with Chronic Kidney Diseases and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Chronic Kidney Diseases, Hypertension
- What is being tested?
- Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,026 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2021to 26 Oct 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02120
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Diseases, Hypertension
- Being tested
- Intervention, Control
- Medical subject headings
- Renal Insufficiency, Chronic, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterventionOther
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).
ControlOther
Usual Care, PCP will receive an email with general information about CKD guidelines
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Providers overseeing patients in the intervention arm will receive guidance within electronic health record from clinical decision support system. Receives: Other: Intervention |
| Control | Experimental | Providers overseeing patients in the control arm will continue to provide usual care. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days
Difference in SBP from baseline to 180 days
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start26 Feb 2021
- Primary completion26 Oct 2022
- Study completion26 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseasesStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 2,026 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lipika Samal, Brigham and Women's Hospital
- Investigators
- Lipika Samal, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679247
- Sponsor's protocol ID
- 2018P000692
- Other IDs
- R01DK116898
- Status last verified
- Nov 2024
- First submitted
- 11 Sep 2018
- Last updated
- 26 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 41151782Samal 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.
PubMed 40097147Samal 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.
PubMed 38466302Samal 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.
PubMed 37437601Kilgallon 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.
PubMed 34937722
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT03679247
- Acronym / sponsor ID
- 2018P000692
- Conditions
- Chronic Kidney Diseases, Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,026 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 26 Feb 2021 (actual)
- Primary completion
- 26 Oct 2022 (actual)
- Study completion
- 26 Oct 2022 (actual)
- First posted
- 20 Sep 2018 (actual)
- Results
- Posted 26 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: InterventionProviders overseeing patients in the intervention arm will receive guidance within electronic health record from clinical decision support system. |
| Control | Experimental | Other: ControlProviders overseeing patients in the control arm will continue to provide usual care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterventionThe 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 | Intervention |
| ControlUsual Care, PCP will receive an email with general information about CKD guidelines | Other | Control |
Primary outcome
Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days
Time frame: 180 days
Difference in SBP from baseline to 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41151782Chen 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.
- Derived from this study: PubMed 40097147Samal 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.
- Derived from this study: PubMed 38466302Samal 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.
- Derived from this study: PubMed 37437601Samal 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.
- Derived from this study: PubMed 34937722Kilgallon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lipika Samal, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention in people with Chronic Kidney Diseases and Hypertension, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days (time frame: 180 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03679247, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.