Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03652272 |
| Other study ID # |
STU00207507 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
February 8, 2019 |
| Est. completion date |
September 27, 2021 |
Study information
| Verified date |
April 2022 |
| Source |
Northwestern University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
