Trial Outcomes & Findings for Northwestern University and Access Community Health Network Medication Education Study (NCT NCT01578577)

Last Updated: 2019-06-28

Results Overview

The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.

Recruitment status

COMPLETED

Study phase

Target enrollment

920 participants

Primary outcome timeframe

one year

Results posted on

2019-06-28

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Care This arm will serve as a control group and will not receive any intervention.	EHMI Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence. EHMI: The EHMI intervention consists of multiple components, all leveraged by the Epic EHR platform (Verona, WI). The EHMI intervention 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides	Nurse Educator + EHMI Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.
Overall Study STARTED	305	302	313
Overall Study COMPLETED	254	262	278
Overall Study NOT COMPLETED	51	40	35

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Northwestern University and Access Community Health Network Medication Education Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Care n=254 Participants This arm will serve as a control group and will not receive any intervention.	EHMI n=262 Participants Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.	Nurse Educator + EHMI n=278 Participants Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.	Total n=794 Participants Total of all reporting groups
Age, Continuous	53 years STANDARD_DEVIATION 9.5 • n=5 Participants	53.6 years STANDARD_DEVIATION 9.7 • n=7 Participants	51.6 years STANDARD_DEVIATION 9.5 • n=5 Participants	52.7 years STANDARD_DEVIATION 9.6 • n=4 Participants
Sex: Female, Male Female	183 Participants n=5 Participants	175 Participants n=7 Participants	187 Participants n=5 Participants	545 Participants n=4 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	87 Participants n=7 Participants	91 Participants n=5 Participants	249 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants	4 Participants n=7 Participants	23 Participants n=5 Participants	37 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	237 Participants n=5 Participants	250 Participants n=7 Participants	233 Participants n=5 Participants	720 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants	37 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) 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
Race (NIH/OMB) Black or African American	234 Participants n=5 Participants	243 Participants n=7 Participants	215 Participants n=5 Participants	692 Participants n=4 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants	11 Participants n=7 Participants	41 Participants n=5 Participants	65 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=5 Participants	8 Participants n=7 Participants	22 Participants n=5 Participants	37 Participants n=4 Participants

PRIMARY outcome

Timeframe: one year

The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.

Outcome measures

Outcome measures
Measure	Standard Care n=254 Participants This arm will serve as a control group and will not receive any intervention.	EHMI n=262 Participants Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.	Nurse Educator + EHMI n=278 Participants Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.	Standard Care Possibly Limited Health Literacy Standard Care Possibly Limited Health Literacy	EHMI Possibly Limited Health Literacy EHMI Possibly Limited Health Literacy	Nurse Educator + EHMI Possibly Limited Health Literacy	Standard Care Likely Adequate Health Literacy Standard Care Likely Adequate Health Literacy	EHMI Likely Adequate Health Literacy EHMI Likely Adequate Health Literacy	Nurse Educator + EHMI Likely Adequate Health Literacy Nurse Educator + EHMI Likely Adequate Health Literacy
Systolic Blood Pressure	134.5 mm Hg Standard Deviation 20.4	141.7 mm Hg Standard Deviation 22.1	134.6 mm Hg Standard Deviation 19.9	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months, 12 months

This will be assessed by measuring patient medication understanding, medication reconciliation, adherence, and health outcomes (diastolic blood pressure, and among the diabetic subgroup Hemoglobin A1c \<8.0 and LDL Cholesterol \<100). Reported here: HbA1c \<8 at 12 months. Full secondary outcomes have been published. Persell SD, Karmali KN, MD, Lazar D, Friesema EM, Lee JY, Rademaker A, Kaiser D, Eder M, French DD, Brown T, Wolf MS. Effect of electronic health record-based medication support and nurse-led medication therapy management on hypertension and medication self-management: a randomized clinical trial. JAMA Intern Med. 2018;178:1069-1077.

Outcome measures

Outcome measures
Measure	Standard Care n=130 Participants This arm will serve as a control group and will not receive any intervention.	EHMI n=111 Participants Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.	Nurse Educator + EHMI n=107 Participants Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.	Standard Care Possibly Limited Health Literacy Standard Care Possibly Limited Health Literacy	EHMI Possibly Limited Health Literacy EHMI Possibly Limited Health Literacy	Nurse Educator + EHMI Possibly Limited Health Literacy	Standard Care Likely Adequate Health Literacy Standard Care Likely Adequate Health Literacy	EHMI Likely Adequate Health Literacy EHMI Likely Adequate Health Literacy	Nurse Educator + EHMI Likely Adequate Health Literacy Nurse Educator + EHMI Likely Adequate Health Literacy
Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care.	61 Participants	48 Participants	64 Participants	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Baseline, 3 months, 6 months,12 months

We will measure how the effects of the interventions vary based on the participants' literacy levels. SBP at 12 months reported below.

Outcome measures

Outcome measures
Measure	Standard Care n=145 Participants This arm will serve as a control group and will not receive any intervention.	EHMI n=126 Participants Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm consists of multiple components. The EHMI 1) activates patients to review their medication list and identify any adherence-related concerns, 2) automates a process for providing plain language, patient-centered print medication information for new and refilled prescriptions, and 3) provides additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.	Nurse Educator + EHMI n=104 Participants Nurse Educator + EHMI: This intervention is a combination of the use of a nurse educator and the EHMI tools described in the EHMI intervention arm. A nurse educator perform the following: 1) perform medication and medical record review 2)assess adherence and medication problems 3) provide counseling to promote safe and effective medication use 4) follow-up with patients after their visit to confirm they have filled all prescriptions, and can accurately teach back their medicine regimen, 5) communicate with prescribing physician when problems are identified.	Standard Care Possibly Limited Health Literacy n=75 Participants Standard Care Possibly Limited Health Literacy	EHMI Possibly Limited Health Literacy n=90 Participants EHMI Possibly Limited Health Literacy	Nurse Educator + EHMI Possibly Limited Health Literacy n=98 Participants	Standard Care Likely Adequate Health Literacy n=34 Participants Standard Care Likely Adequate Health Literacy	EHMI Likely Adequate Health Literacy n=46 Participants EHMI Likely Adequate Health Literacy	Nurse Educator + EHMI Likely Adequate Health Literacy n=76 Participants Nurse Educator + EHMI Likely Adequate Health Literacy
Effects of These Strategies by Patients' Literacy Skills	135.5 mm Hg Standard Deviation 20.7	141.7 mm Hg Standard Deviation 20	133.8 mm Hg Standard Deviation 18.8	138.4 mm Hg Standard Deviation 22.4	138.4 mm Hg Standard Deviation 22.4	132.2 mm Hg Standard Deviation 19.4	135.5 mm Hg Standard Deviation 20.1	148.1 mm Hg Standard Deviation 25.7	138.9 mm Hg Standard Deviation 21.5

Adverse Events

Standard Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EHMI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Nurse Educator + EHMI

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

Dr. Stephen Persell

Northwestern University

Phone: 312-503-6464

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place