Trial Outcomes & Findings for Electronic Tools to Increase Recognition and Improve Primary Care Management for Hypertension in Chronic Kidney Disease (NCT NCT03679247)

NCT ID: NCT03679247

Last Updated: 2024-11-26

Results Overview

Difference in SBP from baseline to 180 days

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 2026 participants
• Primary outcome timeframe: 180 days
• Results posted on: 2024-11-26

Participant Flow

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.

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.

Unit of analysis: Group of patients sharing a PCP Panel

Participant milestones

Measure	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).	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
Overall Study STARTED	1029 87	997 87
Overall Study COMPLETED	1029 87	997 87
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Intervention n=1029 Participants 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).	Control n=997 Participants The control arm will continue to provide usual care. Control: Usual Care, PCP will receive an email with general information about CKD guidelines	Total n=2026 Participants Total of all reporting groups
Age, Continuous	74.2 years STANDARD_DEVIATION 0.3 • n=5 Participants	75.4 years STANDARD_DEVIATION 0.6 • n=7 Participants	75.3 years STANDARD_DEVIATION 0.3 • n=5 Participants
Sex: Female, Male Female	670 Participants n=5 Participants	553 Participants n=7 Participants	1223 Participants n=5 Participants
Sex: Female, Male Male	359 Participants n=5 Participants	444 Participants n=7 Participants	803 Participants n=5 Participants
Race/Ethnicity, Customized race Race · Asian	24 Participants n=5 Participants	21 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized race Race · Black	191 Participants n=5 Participants	151 Participants n=7 Participants	342 Participants n=5 Participants
Race/Ethnicity, Customized race Race · White	681 Participants n=5 Participants	671 Participants n=7 Participants	1352 Participants n=5 Participants
Race/Ethnicity, Customized race Race · Other	79 Participants n=5 Participants	97 Participants n=7 Participants	176 Participants n=5 Participants
Race/Ethnicity, Customized race Race · Unknown	54 Participants n=5 Participants	57 Participants n=7 Participants	111 Participants n=5 Participants
Region of Enrollment United States	1029 Participants n=5 Participants	997 Participants n=7 Participants	2026 Participants n=5 Participants
systolic blood pressure	154.3 mmHg STANDARD_DEVIATION 14.2 • n=5 Participants	153.7 mmHg STANDARD_DEVIATION 14.4 • n=7 Participants	154.0 mmHg STANDARD_DEVIATION 14.3 • n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Difference in SBP from baseline to 180 days

Outcome measures

Measure	Intervention n=1029 Participants 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).	Control n=997 Participants The control arm will continue to provide usual care. Control: Usual Care, PCP will receive an email with general information about CKD guidelines
Change in Systolic Blood Pressure (SBP) From Baseline to 180 Days	14.6 mmHg Interval 13.1 to 16.0	11.7 mmHg Interval 10.2 to 13.1

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 15 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 19 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lipika Samal

Brigham and Women's Hospital

Phone: 6177327063

Email: lsamal@bwh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place