Trial Outcomes & Findings for VISN Collaborative for Improving Hypertension Management With ATHENA-HTN (NCT NCT00374452)

Results Overview

The outcome measure was mean percentages of Events after index visit to primary care by patients. The Events were the first event in the patient record after the index clinic visit for the patient, as follows. Event 1 is intensification of pharmacotherapy for hypertension. Event 2 is patient achieves below-target blood pressure (BP). Event 3 is patient does not achieve below-target BP nor is there intensification of pharmacotherapy for hypertension. Event 4 is patient does not achieve BP target, does not have intensified pharmacotherapy, and does not return for further BP measurements. Each patient was assigned one and only one Event. If a patient has pharmacotherapy intensified and also achieved BP below-target, the patient was assigned to whichever happened first. An initial model fitting all 4 events did not detect a difference by study arm for mean percentage of Event 4; final findings are based on a denominator of Events 1 - 3.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

103 participants

Primary outcome timeframe

up to one year after index visit

Results posted on

2018-03-29

Participant Flow

The study initially involved 5 medical centers with 103 participants across the medical centers. One of the 5 medical centers completed installation of ATHENA-HTN system, but did not continue with the intervention period, so the intervention included 4 medical centers with 82 participants.

Unit of analysis: Clinic sites within medical centers

Participant milestones

Participant milestones
Measure	Guideline Link Only Link to The Seventh Report of the Joint National Committee on Prevention Detection Evaluation and Treatment of High Blood Pressure (JNC7) and to VA-Department of Defense (DoD) hypertension guidelines Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA-DoD and JNC7 hypertension guidelines.	ATHENA-CDS-HTN ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines. ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
Overall Study STARTED	34 10	48 10
Overall Study Intervention Started	30 10	46 10
Overall Study COMPLETED	29 10	43 10
Overall Study NOT COMPLETED	5 0	5 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Guideline Link Only Link to The Seventh Report of the Joint National Committee on Prevention Detection Evaluation and Treatment of High Blood Pressure (JNC7) and to VA-Department of Defense (DoD) hypertension guidelines Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA-DoD and JNC7 hypertension guidelines.	ATHENA-CDS-HTN ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines. ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
Overall Study Left clinic before intervention started	4	1
Overall Study Change in job role before intervention	0	1
Overall Study Left clinic after intervention started	1	1
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

VISN Collaborative for Improving Hypertension Management With ATHENA-HTN

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Guideline Link Only n=10 clinics Link to JNC7 and to VA-DoD hypertension guidelines Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC7 hypertension guidelines.	ATHENA-CDS-HTN n=10 clinics ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines. ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.	Total n=20 clinics Total of all reporting groups
Age, Customized Age >= 18 years	30 Participants n=5 Participants	46 Participants n=7 Participants	76 Participants n=5 Participants
Sex/Gender, Customized Mean percentage male participants per clinic	35.5 percentage of male participants n=5 Participants	24.6 percentage of male participants n=7 Participants	30.1 percentage of male participants n=5 Participants
Region of Enrollment United States	30 Participants n=5 Participants	46 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

Timeframe: up to one year after index visit

The outcome measure was mean percentages of Events after index visit to primary care by patients. The Events were the first event in the patient record after the index clinic visit for the patient, as follows. Event 1 is intensification of pharmacotherapy for hypertension. Event 2 is patient achieves below-target blood pressure (BP). Event 3 is patient does not achieve below-target BP nor is there intensification of pharmacotherapy for hypertension. Event 4 is patient does not achieve BP target, does not have intensified pharmacotherapy, and does not return for further BP measurements. Each patient was assigned one and only one Event. If a patient has pharmacotherapy intensified and also achieved BP below-target, the patient was assigned to whichever happened first. An initial model fitting all 4 events did not detect a difference by study arm for mean percentage of Event 4; final findings are based on a denominator of Events 1 - 3.

Outcome measures

Outcome measures
Measure	Guideline Link Only n=10 clinic sites Link to JNC7 and to VA-DoD hypertension guidelines Link to Hypertension Guidelines: Primary care providers were sent, once, a link (URL) to the VA/DoD and JNC hypertension guidelines.	ATHENA-CDS-HTN n=10 clinic sites ATHENA display providing guideline-based recommendations to clinicians at the time of patient care. Link to JNC7 guidelines. ATHENA-Hypertension clinical decision support system: ATHENA display provides guideline-based recommendations to clinicians at the time of patient care.
Mean Percentages of Events After Index Visit to Primary Care by Patient Event 3	16.2 mean percentage of events	13.7 mean percentage of events
Mean Percentages of Events After Index Visit to Primary Care by Patient Event 1	25.4 mean percentage of events	30.6 mean percentage of events
Mean Percentages of Events After Index Visit to Primary Care by Patient Event 2	59.6 mean percentage of events	55.2 mean percentage of events

Adverse Events

Guideline Link Only

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ATHENA-CDS-HTN Plus Guideline Link

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

Mary K. Goldstein, MD

VA Palo Alto Health Care System

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place