Trial Outcomes & Findings for Measuring Adherence to Control Hypertension (NCT NCT01257347)

Last Updated: 2017-04-05

Results Overview

This is assessed using an algorithm in which patients are categorized as adherent or non-adherent based on electronic monitoring. If patients are adherent (summary measure of adherence to blood pressure medications in the week prior to visit is ≥ 80%), then hypertension management is appropriate if clinicians intensify the hypertension regimen or order testing for secondary hypertension. If patients are non-adherent (summary measure of adherence \< 80%), then hypertension management is appropriate if clinicians take action to increase adherence through counseling or regimen simplification.

Recruitment status

COMPLETED

Study phase

Target enrollment

124 participants

Primary outcome timeframe

1 month clinic visit

Results posted on

2017-04-05

Participant Flow

Primary care providers (the cluster units) and patients were recruited from 2010 to 2014 from 2 hospital-based primary care clinics in New York City.

200 patients were consented for the run-in and 100 were eligible for the trial and data analysis. 24 out of 49 primary care providers recruited had patients in the trial.

Participant milestones

Participant milestones
Measure	Usual Care Control: Physicians Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.35 patients belonged to providers in the control group.	Electronically-Measuring Adherence Intervention: Physicians Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (\<10 minutes) in the interpretation and use of the report at the time of enrollment. 65 patients belonged to providers in the intervention group.	Usual Care Control: Patients Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.	Electronically-Measuring Adherence Intervention: Patients Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.
Overall Study STARTED	12	12	35	65
Overall Study COMPLETED	12	12	35	65
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Measuring Adherence to Control Hypertension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Usual Care Control: Physicians n=12 Participants Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.	Electronically-measuring Adherence n=12 Participants Electronically-measuring adherence to antihypertensive medications: During clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings, and will list suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (\<10 minutes) in the interpretation and use of the report at the time of enrollment.	Usual Care Control: Patients n=35 Participants Patients with uncontrolled hypertension - during clinical visits, clinicians will not be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.	Electronically-Measuring Adherence Intervention: Patients n=65 Participants Patients with uncontrolled hypertension - during clinical visits, clinicians will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications.	Total n=124 Participants Total of all reporting groups
Age, Continuous	46 years STANDARD_DEVIATION 11 • n=5 Participants	48 years STANDARD_DEVIATION 10 • n=7 Participants	64 years STANDARD_DEVIATION 9 • n=5 Participants	64 years STANDARD_DEVIATION 8 • n=4 Participants	47 years STANDARD_DEVIATION 11 • n=21 Participants
Sex/Gender, Customized Female	6 participants n=5 Participants	7 participants n=7 Participants	22 participants n=5 Participants	50 participants n=4 Participants	13 participants n=21 Participants
Sex/Gender, Customized Male	6 participants n=5 Participants	5 participants n=7 Participants	13 participants n=5 Participants	15 participants n=4 Participants	11 participants n=21 Participants
Race/Ethnicity, Customized Hispanic or Latino	3 participants n=5 Participants	1 participants n=7 Participants	28 participants n=5 Participants	47 participants n=4 Participants	4 participants n=21 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	9 participants n=5 Participants	11 participants n=7 Participants	7 participants n=5 Participants	18 participants n=4 Participants	20 participants n=21 Participants
Race/Ethnicity, Customized Unknown or Not Reported	2 participants n=5 Participants	2 participants n=7 Participants	7 participants n=5 Participants	18 participants n=4 Participants	4 participants n=21 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	0 participants n=21 Participants
Race/Ethnicity, Customized Asian	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	0 participants n=4 Participants	0 participants n=21 Participants
Race/Ethnicity, Customized Black or African American	0 participants n=5 Participants	1 participants n=7 Participants	18 participants n=5 Participants	25 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized White	10 participants n=5 Participants	9 participants n=7 Participants	8 participants n=5 Participants	17 participants n=4 Participants	19 participants n=21 Participants
Race/Ethnicity, Customized More than one race	0 participants n=5 Participants	0 participants n=7 Participants	2 participants n=5 Participants	4 participants n=4 Participants	0 participants n=21 Participants
Region of Enrollment United States	12 Participants n=5 Participants	12 Participants n=7 Participants	35 Participants n=5 Participants	65 Participants n=4 Participants	124 Participants n=21 Participants

PRIMARY outcome

Timeframe: 1 month clinic visit

Outcome measures

Outcome measures
Measure	Usual Care Control Group n=35 Participants Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.	Electronically-measuring Adherence n=65 Participants At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (\<10 minutes) in the interpretation and use of the report at the time of enrollment.
Percentage of Visits With Appropriate Hypertension Management	34 percentage of patient-clinician visits	69 percentage of patient-clinician visits

SECONDARY outcome

Timeframe: 1 month clinic visit

This will be determined based on abstracting information from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider intensified the blood pressure regimen (added or increased dose of medications). All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.

Outcome measures

Outcome measures
Measure	Usual Care Control Group n=19 Participants Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.	Electronically-measuring Adherence n=34 Participants At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (\<10 minutes) in the interpretation and use of the report at the time of enrollment.
Percentage of Visits With Regimen Intensification During 1-month Visit, Adherent in Week Prior to Outcome Visit, Only	26 percentage of patient-clinician visits	56 percentage of patient-clinician visits

SECONDARY outcome

Timeframe: 1 month clinic visit

This will be determined based on interviewing patients immediately after the 1-month visit using a standardized questionnaire. A research assistant who is blinded to group assignment will ask patients questions that assess whether clinicians counseled them about taking their blood pressure medications during that most recent visit. These questions are adapted from a validated questionnaire that assesses provider communication about blood pressure medications.

Outcome measures

Outcome measures
Measure	Usual Care Control Group n=18 Participants Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.	Electronically-measuring Adherence n=32 Participants At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (\<10 minutes) in the interpretation and use of the report at the time of enrollment.
Percentage of Visits With Counseling Performed During 1-month Visit, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period	39 percentage of patient-clinician visits	84 percentage of patient-clinician visits

SECONDARY outcome

Timeframe: 1 month clinic visit

Population: patient-provider visits

This will be determined by abstracting data from the electronic medical record after the 1-month visit using a standardized instrument. An outcome assessor who is blinded to clinician and patient group assignment will assess whether, during the 1-month visit, the provider simplified the regimen by switching from a short-acting, multi-day dosing medication to a long-acting, once per day medication or switched two medication to a single combination pill. All prescribing and test ordering at the recruitment clinic is recorded in the electronic medical record.

Outcome measures

Outcome measures
Measure	Usual Care Control Group n=18 Participants Clinicians in the control arm will not receive any electronically-monitored medication adherence information at the 1-month visit and will be expected to manage hypertension according to their usual care.	Electronically-measuring Adherence n=32 Participants At clinical visits with patients with uncontrolled hypertension, clinicians in the intervention arm will be provided with a quantitative summary of their patients' electronically-monitored adherence to antihypertensive medications. The summary will be in the form of a report that fits onto one page and lists the percent of days patients correctly adhered to each of the monitored BP medications and the mean adherence to the whole regimen. Adherence data will be provided for the 7-days and 1-month prior to the clinic visit. The report will also show the number of days patients exceeded the recommended number of pill container openings. The report will also provide suggested clinical actions according to adherence status. Clinicians in the intervention arm will get a brief training (\<10 minutes) in the interpretation and use of the report at the time of enrollment.
Percentage of Visits With Hypertension Regimen Simplification, Non-adherent in Week Prior to Outcome Visit or Over Entire Monitoring Period	6 percentage of patient-clinician visits	9 percentage of patient-clinician visits

Adverse Events

Usual Care Control: Physicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electronically-Measuring Adherence Intervention: Physicians

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care Control: Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Electronically-Measuring Adherence Intervention: Patients

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

Ian Kronish, MD, MPH

Columbia University Medical Center

Phone: 2123421335

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place