Ignite Creation Date:
2024-05-06 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 12:53 PM
Study NCT ID:
NCT03652272
Status:
COMPLETED
Last Update Posted:
2022-04-15
First Post:
2018-08-28
Brief Title:
Development and Evaluation of an Electronic Health Record-based Medication Complete Communication EMC2 Strategy
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Development and Evaluation of an Electronic Health Record-based Medication Complete Communication EMC2 Strategy Phase 2
Status:
COMPLETED
Status Verified Date:
2022-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 EHRpatient 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 ie 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 nurseclinic staff andor physician if a patient has a medication risk alert detailing the nature of the issue ie 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 nursesclinic staff involved with care management
6 Clinic Counseling If a problemconcern 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 n165 per site the investigators anticipate 90 retention among the recruited sample by 3 months n297 The investigators therefore will over sample to accommodate some attrition
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 EHRpatient 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 ie 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 nurseclinic staff andor physician if a patient has a medication risk alert detailing the nature of the issue ie 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 nursesclinic staff involved with care management
6 Clinic Counseling If a problemconcern 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 n165 per site the investigators anticipate 90 retention among the recruited sample by 3 months n297 The investigators therefore will over sample to accommodate some attrition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None