Clinical trial NCT03652272: Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy
Official title: Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy (Phase 2)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Medication Adherence
Keywords: medication safety
adherence
electronic health record
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
First posted: 2018-08-29
Enrollment: 301
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2-arm, multi-site, physician-randomized pragmatic trial to evaluate the impact and scalability of the Phase I EMC2 strategy to promote safe medication use and adherence.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: There is a well-documented need for effective interventions that can help patients understand and safely adhere to prescribed medications, particularly those with greater potential for harm if not taken correctly. The investigators will leverage health and consumer technologies with their EHR-based Medication Complete Communication (EMC2) Strategy to: 1) inform patients about medication risks and safe use, 2) promote provider education and counseling about prescribed drugs and 3) monitor patient adherence outside of visits. The EMC2 Strategy could be feasible, sustainable, and readily available to ambulatory care practices.

Detailed description: This is a 2-arm, multi-site, physician-randomized pragmatic trial to evaluate the impact and scalability of the EMC2 strategy to promote safe medication use and adherence.

Treatment Arms and Duration:

Usual Care. Usual care includes 1) variable provider counseling with limited or variable EHR notifications or counseling support; 2) no distribution of print medication information materials, including FDA Medication Guides in clinics and variable distribution in pharmacies; and 3) limited or no active surveillance of medication use post-visits.

Intervention: EMC2 Strategy.

In brief, there are several components to this strategy that will be embedded into the workflow via EHR/patient portal platforms, mostly automating their implementation. Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:

1. Physician Medication Alert: If a prescribing physician attempts to place a new order or change to an existing study medication prescription, an EHR-generated alert will notify the provider that the medication requires patient counseling. Physicians can opt to ignore this alert.
2. Provider Counseling Support: Content from the 1-page, Med Guide Summary will appear on the screen, if selected by the provider, to orient and inform provider-patient discussion.
3. Automated Delivery of Med Guide + Summary: When patients leave an encounter, the medication order in Epic will automatically cue printing of both the 1-page, health literate Med Guide Summary for study medications and a full Med Guide, if applicable (latter is required by FDA for certain medications only, the former designed to enhance comprehension).
4. Follow-Up Portal Questionnaire: Within 1 week post-visit, patients will receive an automated email prompting them to log on to the patient portal. Patients' will be asked to fill out a short set of questions related to medication adherence, and other medication-related concerns (i.e. cost, side effects). If patients have not completed the questionnaire within 2 days, another email reminder will be sent. The information submitted back by the patient will be stored in the EHR. A second questionnaire will be sent 1 month later.

   The addition of the patient portal will provide opportunities to have ongoing communications with their clinic, access to regimen-specific medication information, and to provide a feedback loop informing healthcare providers of safety and adherence-related behaviors and concerns.
5. EHR Inbox Message to Clinic: The results of the patient portal questionnaire will be sent back to the EHR, populating an inbox message notifying the nurse/clinic staff and/or physician if a patient has a medication risk alert, detailing the nature of the issue (i.e. education needed, adherence problem, side effect concerns, etc.). The system will be flexible and allow the clinic to specify actions to be taken according to their workflow preferences; the default plan is that patient contact will be undertaken by nurses/clinic staff involved with care management.
6. Clinic Counseling: If a problem/concern is flagged during the review of the portal questionnaire, there will be an expectation for a clinic staff member to respond to the concern by calling the patient. A general orientation to staff at the clinic will provide guidance on how to perform brief counseling based on each specific clinic protocol.

Number of Patients:

While the expected sample size for this pragmatic study is 300, the investigators will recruit 330 patients (n=165 per site, the investigators anticipate 90% retention among the recruited sample by 3 months (n=297). The investigators therefore will over sample to accommodate some attrition.

Eligibility criteria: Inclusion Criteria:

* Patient is age 18 and older
* Patient is English speaking
* Patient is primarily responsible for administering their own medication
* Patient must have received a new or changed prescription for a product(s), identified by Eli Lilly and the study team, within 7 days of recruitment
* Patient must have access to the internet
* Patient must have a patient portal account

Exclusion Criteria:

* Severe, uncorrectable vision
* Severe hearing impairments
* Severe cognitive impairment
* No access to the internet or patient portal account

Providers must meet the following eligibility criteria:

• Resident, Attending Physician or Mid-level provider (NP, PA) working in the NMHC Endocrinology clinic or other study sites during study dates.

\*Adults unable to consent, individuals under the age of 18, and prisoners will be excluded from this research.

Primary outcomes:
measure: Medication Specific Knowledge
timeFrame: Baseline
Secondary outcomes:
measure: Medication Adherence- Ask 12
timeFrame: Baseline-3 Months
measure: Medication Adherence - Proper Use
timeFrame: Baseline- 3 Months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Michael S Wolf, PhD MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Northwestern University
name: Stacy C Bailey, PhD MPH
role: PRINCIPAL_INVESTIGATOR
References: