Trial Outcomes & Findings for CV Wizard: Does a Clinical Decision Support Tool Improve CVD Risk Factor Control in Safety Net Clinics? (NCT NCT03001713)

Last Updated: 2025-02-11

Results Overview

10-year CVD risk was estimated using the American College of Cardiology/American Heart Association pooled risk equations, which include age, race and ethnicity, sex, systolic BP, total cholesterol level, high-density lipoprotein cholesterol level, and diabetes, smoking, and antihypertensive medication status.

Recruitment status

COMPLETED

Study phase

Target enrollment

70 participants

Primary outcome timeframe

12 months

Results posted on

2025-02-11

Participant Flow

41 organizations (761 clinics) were assessed for eligibility. Of those, 26 organizations (691 clinics) either did not meet inclusion criteria (n=556 clinics) or declined participation/did not volunteer (n=135 clinics). A total of 15 organizations (70 clinics) were randomized. While individual patients were not enrolled for this clinic-randomized study, patient data from enrolled clinics was used in analyses. Clinic staff interviews not included in primary outcome analyses, so not reflected here.

Unit of analysis: clinics

Participant milestones

Participant milestones
Measure	Arm 1: Intervention (Immediate Implementation) 42 safety net community health centers (CHCs) from 8 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS). Arm 1 CHCs received implementation support that was pragmatically iterated to address any barriers to adoption/sustained use of the CDS that were identified through study activities. The investigators will apply the learnings from Arm 1 implementation with the goal of improving adoption rates in Arm 2.	Arm 2: Control (Delayed Implementation) 28 safety net community health centers (CHCs) from 7 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS) system 18 months later than Arm 1 clinics.
Overall Study STARTED	11159 42	7419 28
Overall Study COMPLETED	11159 42	7419 28
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patients newly diagnosed with diabetes during the follow-up period (n=347) were excluded from CVD risk analyses because diabetes may be diagnosed more often with CDSS use.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm 1: Intervention (Immediate Implementation) n=11159 Participants 42 safety net community health centers (CHCs) from 8 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS). Arm 1 CHCs received implementation support that was pragmatically iterated to address any barriers to adoption/sustained use of the CDS that were identified through study activities. The investigators will apply the learnings from Arm 1 implementation with the goal of improving adoption rates in Arm 2.	Arm 2: Control (Delayed Implementation) n=7419 Participants 28 safety net community health centers (CHCs) from 7 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS) system 18 months later than Arm 1 clinics.	Total n=18578 Participants Total of all reporting groups
Age, Continuous	58.3 years STANDARD_DEVIATION 8.9 • n=11159 Participants	59.3 years STANDARD_DEVIATION 8.7 • n=7419 Participants	58.7 years STANDARD_DEVIATION 8.8 • n=18578 Participants
Sex: Female, Male Female	5872 Participants n=11159 Participants	3618 Participants n=7419 Participants	9490 Participants n=18578 Participants
Sex: Female, Male Male	5287 Participants n=11159 Participants	3801 Participants n=7419 Participants	9088 Participants n=18578 Participants
Race/Ethnicity, Customized Hispanic	2785 Participants n=11159 Participants	1196 Participants n=7419 Participants	3981 Participants n=18578 Participants
Race/Ethnicity, Customized Non-Hispanic Black	2385 Participants n=11159 Participants	966 Participants n=7419 Participants	3351 Participants n=18578 Participants
Race/Ethnicity, Customized Non-Hispanic White	3891 Participants n=11159 Participants	4543 Participants n=7419 Participants	8434 Participants n=18578 Participants
Race/Ethnicity, Customized Non-Hispanic Other	658 Participants n=11159 Participants	380 Participants n=7419 Participants	1038 Participants n=18578 Participants
Race/Ethnicity, Customized Unknown	1440 Participants n=11159 Participants	334 Participants n=7419 Participants	1774 Participants n=18578 Participants
Region of Enrollment United States	11159 participants n=11159 Participants	7419 participants n=7419 Participants	18578 participants n=18578 Participants
10-year CVD risk	15.6 percent risk of CVD STANDARD_DEVIATION 12.3 • n=10984 Participants • Patients newly diagnosed with diabetes during the follow-up period (n=347) were excluded from CVD risk analyses because diabetes may be diagnosed more often with CDSS use.	16.6 percent risk of CVD STANDARD_DEVIATION 12.8 • n=7247 Participants • Patients newly diagnosed with diabetes during the follow-up period (n=347) were excluded from CVD risk analyses because diabetes may be diagnosed more often with CDSS use.	16.0 percent risk of CVD STANDARD_DEVIATION 12.5 • n=18231 Participants • Patients newly diagnosed with diabetes during the follow-up period (n=347) were excluded from CVD risk analyses because diabetes may be diagnosed more often with CDSS use.
Reversible CVD Risk	7.9 percent reversible risk of CVD STANDARD_DEVIATION 9.0 • n=10984 Participants • Patients newly diagnosed with diabetes during the follow-up period (n=347) were excluded from CVD risk analyses because diabetes may be diagnosed more often with CDSS use.	9.7 percent reversible risk of CVD STANDARD_DEVIATION 10.0 • n=7247 Participants • Patients newly diagnosed with diabetes during the follow-up period (n=347) were excluded from CVD risk analyses because diabetes may be diagnosed more often with CDSS use.	8.6 percent reversible risk of CVD STANDARD_DEVIATION 9.4 • n=18231 Participants • Patients newly diagnosed with diabetes during the follow-up period (n=347) were excluded from CVD risk analyses because diabetes may be diagnosed more often with CDSS use.

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	Arm 1: Intervention (Immediate Implementation) n=10984 Participants 42 safety net community health centers (CHCs) from 8 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS). Arm 1 CHCs received implementation support that was pragmatically iterated to address any barriers to adoption/sustained use of the CDS that were identified through study activities. The investigators will apply the learnings from Arm 1 implementation with the goal of improving adoption rates in Arm 2.	Arm 2: Control (Delayed Implementation) n=7247 Participants 28 safety net community health centers (CHCs) from 7 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS) system 18 months later than Arm 1 clinics.
1-year Change in 10-year CVD Risk	0.4 percent risk of CVD Interval 0.3 to 0.5	0.2 percent risk of CVD Interval 0.1 to 0.3

PRIMARY outcome

Timeframe: 12 months

Reversible CVD risk was calculated as follows: Standardized equations estimated the potential reduction in CVD risk if a patient's uncontrolled risk factors reached evidence-based thresholds. Change was calculated by subtracting reversible risk at follow-up from that at index visit; negative values represent favorable changes.

Outcome measures

Outcome measures
Measure	Arm 1: Intervention (Immediate Implementation) n=10984 Participants 42 safety net community health centers (CHCs) from 8 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS). Arm 1 CHCs received implementation support that was pragmatically iterated to address any barriers to adoption/sustained use of the CDS that were identified through study activities. The investigators will apply the learnings from Arm 1 implementation with the goal of improving adoption rates in Arm 2.	Arm 2: Control (Delayed Implementation) n=7247 Participants 28 safety net community health centers (CHCs) from 7 organizations were randomized to implement the sophisticated CV Wizard clinical decision support (CDS) system 18 months later than Arm 1 clinics.
1-year Change in Reversible CVD Risk	0.4 percent reversible risk of CVD Interval 0.3 to 0.5	-0.1 percent reversible risk of CVD Interval -0.3 to -0.02

Adverse Events

Arm 1: Intervention (Immediate Implementation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm 2: Control (Delayed Implementation)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Rachel Gold, PhD MPH

Kaiser Permanente Center for Health Research

Phone: 503-335-2400

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place