NAMES: Northwestern University and Access Community Health Network Medication Education Study
Study Details
Study Description
Brief Summary
Many patients have difficulty performing routine medication management tasks. Individuals with limited literacy are at high risk for these problems. The overall study objective is to rigorously evaluate two primary care-based medication therapy management strategies that leverage an electronic health record (EHR) to promote patient understanding, medication reconciliation, medication adherence and disease control among hypertensive patients at safety net clinics.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
Medication therapy management (MTM) has been described as a set of procedures that include:
medication review, assembly of a personal medication record, development of action plans, intervention when necessary, and follow-up. However, evidence showing the effectiveness of general MTM interventions is scant. MTM has often been performed separately from patients' usual sources of care (i.e., at pharmacies). This could limit its effectiveness since medication-related concerns would be discussed by clinicians who are not aware of the regimen intended by patients' prescribers. Cost is another barrier to widespread use of MTM.
Health information technology in primary care could be leveraged to assist with MTM tasks. The investigators have field tested low literacy MTM tools embedded within an EHR to 1) activate patients to review medications, 2) automate the provision of plain language, medication information, and 3) provide print tools to help patients engage providers, and consolidate their regime. These tools were developed with patient, physician, and pharmacist feedback.
For this study, the investigators combine tools to address the range of MTM tasks. In aggregate, the study refers to this as an Electronic health record-based Health literacy Medication therapy management Intervention, or 'EHMI'. The investigators will evaluate the effects of this approach among patients with uncontrolled hypertension treated in federally qualified health centers (FQHCs). This may be a relatively low-cost strategy ideal for safety net practices that use EHRs and whose patients may be at greater risk for limited literacy. It is also possible that the EHMI strategy may not result in a significant change. Therefore, the investigators will also evaluate using a nurse educator to help patients utilize EHMI tools, provide brief counseling, and track progress.
This three-arm, clinic-randomized, controlled trial conducted within a network of FQHCs will evaluate the EHMI and EHMI + Nurse Educator interventions compared to usual care. Recruited patients will be followed for 12 months. The investigators will test the impact of these two strategies on blood pressure levels, with an anticipated power to detect a 4 mm Hg difference in systolic blood pressure as the primary outcome. The investigators will also assess the impact on diastolic blood pressure, as well as HbA1c and LDL cholesterol control in the subgroup with diabetes. The investigators will determine the interventions' effects on: 1) medication understanding, 2) discrepancies, and 3) adherence. The investigators will specifically examine intervention effects among groups with different literacy levels. The investigators will also assess the fidelity and cost of the interventions to guide future dissemination efforts.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard Care This arm will serve as a control group and will not receive any intervention. |
|
| Experimental: EHMI Electronic Health Record-based Health Literacy Medication Therapy Management Intervention (EHMI)arm 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 additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence. |
Behavioral: 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 additional print tools to help patients more effectively engage their providers, consolidate their regimen, and generally promote safe use and adherence.
|
| Experimental: Nurse Educator + EHMI
|
Behavioral: 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.
|
Outcome Measures
Primary Outcome Measures
- Systolic Blood Pressure [one year]
The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted.
Secondary Outcome Measures
- Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care. [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.
- Effects of These Strategies by Patients' Literacy Skills [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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
age is 18 years or older
-
at least 3 medications are prescribed by their physician
-
standardized mean blood pressure measurement ≥130 mm Hg systolic or ≥ 80 mm Hg diastolic if they are diabetic or mean blood pressure measurement ≥ 135 mm Hg systolic or ≥ 85 mm Hg diastolic if they are not
-
a Mini-Cog Exam score of ≥ 3
-
the patient is the person primarily responsible for administering their medication
-
the patient does not intend to move or change their usual source of medical care during the next year.
Exclusion Criteria:
-
the patient's usual source of medical care is not a participating ACCESS Community Health Center
-
is non-English language speaking
-
does not meet mean blood pressure criteria
-
has a Mini-Cog Exam score of < 3
-
is not the person primarily responsible for administering medication
-
intends to move or change their usual source of medical care during the next year.
-
Is not prescribed at least 3 medications
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | ACCESS Community Health Network | Chicago | Illinois | United States | 60661 |
Sponsors and Collaborators
- Northwestern University
- National Institute of Nursing Research (NINR)
Investigators
- Principal Investigator: Stephen Persell, MD, MPH, Northwestern University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Medication Therapy Management
- 1R01NR012745
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Standard Care | EHMI | Nurse Educator + EHMI |
|---|---|---|---|
| Arm/Group Description | This arm will serve as a control group and will not receive any intervention. | 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: 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. |
| Period Title: Overall Study | |||
| STARTED | 305 | 302 | 313 |
| COMPLETED | 254 | 262 | 278 |
| NOT COMPLETED | 51 | 40 | 35 |
Baseline Characteristics
| Arm/Group Title | Standard Care | EHMI | Nurse Educator + EHMI | Total |
|---|---|---|---|---|
| Arm/Group Description | This arm will serve as a control group and will not receive any intervention. | 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: 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 of all reporting groups |
| Overall Participants | 254 | 262 | 278 | 794 |
| Age (years) [Mean (Standard Deviation) ] | ||||
| Mean (Standard Deviation) [years] |
53
(9.5)
|
53.6
(9.7)
|
51.6
(9.5)
|
52.7
(9.6)
|
| Sex: Female, Male (Count of Participants) | ||||
| Female |
183
72%
|
175
66.8%
|
187
67.3%
|
545
68.6%
|
| Male |
71
28%
|
87
33.2%
|
91
32.7%
|
249
31.4%
|
| Ethnicity (NIH/OMB) (Count of Participants) | ||||
| Hispanic or Latino |
10
3.9%
|
4
1.5%
|
23
8.3%
|
37
4.7%
|
| Not Hispanic or Latino |
237
93.3%
|
250
95.4%
|
233
83.8%
|
720
90.7%
|
| Unknown or Not Reported |
7
2.8%
|
8
3.1%
|
22
7.9%
|
37
4.7%
|
| Race (NIH/OMB) (Count of Participants) | ||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
234
92.1%
|
243
92.7%
|
215
77.3%
|
692
87.2%
|
| White |
13
5.1%
|
11
4.2%
|
41
14.7%
|
65
8.2%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
7
2.8%
|
8
3.1%
|
22
7.9%
|
37
4.7%
|
Outcome Measures
| Title | Systolic Blood Pressure |
|---|---|
| Description | The primary outcome is the systolic blood pressure measured approximately one year after the baseline interview is conducted. |
| Time Frame | one year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Care | EHMI | Nurse Educator + EHMI |
|---|---|---|---|
| Arm/Group Description | This arm will serve as a control group and will not receive any intervention. | 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: 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. |
| Measure Participants | 254 | 262 | 278 |
| Mean (Standard Deviation) [mm Hg] |
134.5
(20.4)
|
141.7
(22.1)
|
134.6
(19.9)
|
| Title | Effectiveness of the Electronic Health Record-based Health Literacy Medication Therapy Management Strategy (EHMI), With and Without a Nurse Educator, Compared to Standard Care. |
|---|---|
| Description | 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. |
| Time Frame | Baseline, 3 months, 6 months, 12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Care | EHMI | Nurse Educator + EHMI |
|---|---|---|---|
| Arm/Group Description | This arm will serve as a control group and will not receive any intervention. | EHMI: The EHMI intervention 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 | 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. |
| Measure Participants | 130 | 111 | 107 |
| Count of Participants [Participants] |
61
24%
|
48
18.3%
|
64
23%
|
| Title | Effects of These Strategies by Patients' Literacy Skills |
|---|---|
| Description | We will measure how the effects of the interventions vary based on the participants' literacy levels. SBP at 12 months reported below. |
| Time Frame | Baseline, 3 months, 6 months,12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Standard Care Likely Limited Health Literacy | EHMI Likely Limited Health Literacy | Nurse Educator + EHMI Likely Limted Health Literacy | Standard Care Possibly Limited Health Literacy | EHMI Possibly Limited Health Literacy | Nurse Educator + EHMI Possibly Limited Health Literacy | Standard Care Likely Adequate Health Literacy | EHMI Likely Adequate Health Literacy | Nurse Educator + EHMI Likely Adequate Health Literacy |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | This arm will serve as a control group and will not receive any intervention. | EHMI: The EHMI intervention 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 | 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 | EHMI Possibly Limited Health Literacy | Standard Care Likely Adequate Health Literacy | EHMI Likely Adequate Health Literacy | Nurse Educator + EHMI Likely Adequate Health Literacy | |
| Measure Participants | 145 | 126 | 104 | 75 | 90 | 98 | 34 | 46 | 76 |
| Mean (Standard Deviation) [mm Hg] |
135.5
(20.7)
|
141.7
(20)
|
133.8
(18.8)
|
138.4
(22.4)
|
138.4
(22.4)
|
132.2
(19.4)
|
135.5
(20.1)
|
148.1
(25.7)
|
138.9
(21.5)
|
Adverse Events
| Time Frame | 12 months | |||||
|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Note, this study did not include a systematic collection of adverse events. No adverse events related to the study procedures were reported. | |||||
| Arm/Group Title | Standard Care | EHMI | Nurse Educator + EHMI | |||
| Arm/Group Description | This arm will serve as a control group and will not receive any intervention. | 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: 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. | |||
All Cause Mortality |
||||||
| Standard Care | EHMI | Nurse Educator + EHMI | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | |||
Serious Adverse Events |
||||||
| Standard Care | EHMI | Nurse Educator + EHMI | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/305 (0%) | 0/302 (0%) | 0/313 (0%) | |||
Other (Not Including Serious) Adverse Events |
||||||
| Standard Care | EHMI | Nurse Educator + EHMI | ||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/305 (0%) | 0/302 (0%) | 0/313 (0%) | |||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Dr. Stephen Persell |
|---|---|
| Organization | Northwestern University |
| Phone | 312-503-6464 |
| spersell@nm.org |
- Medication Therapy Management
- 1R01NR012745