Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03652272|
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : March 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Medication Adherence||Behavioral: EMC2||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||330 participants|
|Intervention Model:||Parallel Assignment|
|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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Development and Evaluation of an Electronic Health Record-based Medication Complete Communication (EMC2) Strategy (Phase 2)|
|Actual Study Start Date :||February 8, 2019|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||July 2019|
Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:
No Intervention: 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.
- Medication Specific Knowledge [ Time Frame: Baseline-3 Months ]Patients will be asked about their medication's 1) indication, 2) risks or warnings, and 3) side effects. Correct answers will be tailored per medication and total scores will range from 0-100, reflecting the percent correct of possible points.
- Medication Adherence- Ask 12 [ Time Frame: Baseline-3 Months ]The ASK-12 survey covers three adherence domains: inconvenience/forgetfulness, treatment beliefs and behavior. Scores range from 12-60, with higher scores translating to greater barriers to adherence.
- Medication Adherence - Proper Use [ Time Frame: Baseline- 3 Months ]Patients will be asked the last day they took their medication and how. A patient's proper timing (last day and # of times per day), dosing (number of pills per dose), and spacing between doses (for BID, TID medications only) will be coded as correct or incorrect. Patients will be classified as having properly used their medication if they correctly reported all components.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03652272
|Contact: Pauline Zhengfirstname.lastname@example.org|
|United States, Illinois|
|Chicago, Illinois, United States, 60611|
|Contact: Pauline Zheng 312-503-5644 email@example.com|
|Principal Investigator:||Michael S Wolf, PhD MPH||Northwestern University|
|Principal Investigator:||Stacy C Bailey, PhD MPH||Northwestern University|