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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
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Michael S. Wolf, Northwestern University

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.

Condition or disease Intervention/treatment Phase
Medication Adherence Behavioral: EMC2 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 330 participants
Allocation: Randomized
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

Arm Intervention/treatment
Experimental: EMC2

Following patient movement through a provider visit, the following activities will occur for a select list of pre-specified medications:

  1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
  2. Patients will receive a Medication Guide + Summary with their After Visit Summary
  3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
  4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.
Behavioral: EMC2
  1. Prescribers will receive a 'Best Practices Alert' which recommends patient counseling on medication use and provides an overview of key medication risks
  2. Patients will receive a Medication Guide + Summary with their After Visit Summary
  3. Patients will be asked to complete a brief questionnaire on medication use via the patient portal post visit (at both 1 week and 1 month post visit for this phase of the study)
  4. Portal assessment results and feedback will be provided to the clinic via an inbox message. Clinic staff will respond to any identified problems according to their own clinical care protocols.

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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

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


Contacts
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Contact: Pauline Zheng 3125035644 pauline.zheng@northwestern.edu

Locations
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United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Contact: Pauline Zheng    312-503-5644    pauline.zheng@northwestern.edu   
Sponsors and Collaborators
Northwestern University
Eli Lilly and Company
Investigators
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Principal Investigator: Michael S Wolf, PhD MPH Northwestern University
Principal Investigator: Stacy C Bailey, PhD MPH Northwestern University

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Responsible Party: Michael S. Wolf, Associate Vice Chair for Research, Department of Medicine, Northwestern University
ClinicalTrials.gov Identifier: NCT03652272    
Other Study ID Numbers: STU00207507
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: March 19, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is currently no plan to share IPD.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Michael S. Wolf, Northwestern University:
medication safety
adherence
electronic health record