Medication Adherence Clinical Decision Support (ADH Wizard)
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03748420|
Recruitment Status : Active, not recruiting
First Posted : November 20, 2018
Last Update Posted : August 6, 2021
|Condition or disease||Intervention/treatment||Phase|
|Hyperlipidemia Hypertension Diabetes Medication Nonadherence||Other: Adherence-enhanced clinical decision support Behavioral: ReachOut Adherence intervention||Not Applicable|
Patients are randomly allocated 1:1 through a computer-generated program to either control or intervention.
Control: All control patients will continue to receive the basic Electronic Medical Record (EMR)-linked Clinical Decision Support (CDS) tool for cardiovascular (CV) risk factor management. This CDS includes algorithmically derived identification of high CV risk patients and prioritized treatment suggestions for lipids, Blood Pressure (BP), glycemic control, weight, tobacco, and aspirin use based on distance from goal, current medications, labs, allergies, and safety considerations. The basic CDS does not include any information on medication adherence. Patients will receive basic CDS plus usual care.
Intervention: For intervention patients, the basic CDS system for CV risk-factor control is enhanced to support a team-based care model that identifies risk of non-adherence, computes adherence information and incorporates it in the CDS, creates a registry to direct proactive pharmacist outreach, and coordinates action plans. To do this, the CDS Web service will combine EMR-identified medications with Epic Medication Adherence score (e-PDC) data. Algorithms will identify poor adherence using e-PDC scores available within the Epic EMR at patient encounters. When medication adherence issues are identified, alert messages will appear on the CDS tools for patients and providers. Patients with index visits will be followed-up for 6 months as they continue to receive CDS at subsequent encounters. At 6 months, patient e-PDC as well as clinical outcomes will be reevaluated. Patients with persistent adherence issues identified are added to a registry that is used by the pharmacists to conduct outreach. Pharmacist outreach will be conducted primarily by phone, but in-person arrangements are also an option. Pharmacists conducting outreach will identify themselves to patients as part of the care team working with the primary care provider (PCP). Examples of specific action plans that may be recommended includes education, recommending lower cost alternative medications or combination medications, addressing side effects, using pill boxes, modifying pill-taking schedules and/or using reminder systems, or referrals to medication therapy management (MTM) services or health educators. Pharmacists will be guided by a script template for the phone outreach that walks them through the IMB intervention and data collection. The pharmacists involved will have full read/write access to the EMR in full compliance with HIPAA regulations. They can make medication changes through established care protocols and/or communicate with the prescriber through secure messaging or phone consultation. The date of the pharmacist outreach and actions that result from the IMB intervention will be documented in the EMR and incorporated into subsequent CDS tools and registries to reflect the new patient state.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||8357 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Team-Based and Technology-Driven Adherence Intervention to Improve Chronic Disease Outcomes|
|Actual Study Start Date :||August 19, 2020|
|Estimated Primary Completion Date :||July 2022|
|Estimated Study Completion Date :||July 2022|
No Intervention: Usual Care
Basic clinical decision support alone
Experimental: ReachOut Adherence intervention
Adherence-enhanced clinical decision support plus pharmacist-based adherence outreach
Other: Adherence-enhanced clinical decision support
Clinical decision support system integrating electronic medication data with claims data on prescription fills
Behavioral: ReachOut Adherence intervention
The pharmacist outreach intervention is based on the theoretically grounded and evidence-based Information-Motivation-Behavioral framework endorsed by the World Health Organization to improve adherence
- Change in blood pressure medication adherence [ Time Frame: 12 months after an index visit ]Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all blood pressure medications
- Change in blood pressure control [ Time Frame: 12 months after an index visit ]Mean change in systolic blood pressure (SBP) from the last BP within the 12 months prior to the index visit, to the last BP value within 12 months after the index visit.
- Change in non-insulin glycemic medication adherence [ Time Frame: 12 months after an index visit ]Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all non-insulin glycemic medications
- Change in glycemic control [ Time Frame: 12 months after an index visit ]Change in A1C (glycated hemoglobin) value from the last lab test within the 12 months prior to the index visit, to the last lab test within 12 months after the index visit.
- Change in statin medication adherence [ Time Frame: 12 months after an index visit ]Number of patients who achieve an Epic Medication Adherence Score (e-PDC) greater than or equal to 80% for all statin medications
- Cost of the intervention [ Time Frame: 12 months after an index visit ]Intervention costs and incremental medical care costs attributable to the intervention, defined from the health system perspective.
- Long-term Health Impact [ Time Frame: Simulated 10, 20 and 30-years post intervention ]We will estimate the long-term health impact as predicted by the HealthPartners Institute ModelHealthTM: Cardiovascular Disease microsimulation model.
- Long-term cost-effectiveness [ Time Frame: Simulated 10, 20 and 30-years post intervention ]We will estimate the cost-effectiveness of the intervention as predicted by the HealthPartners Institute ModelHealthTM: Cardiovascular Disease microsimulation model.
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): NCT03748420
|United States, Minnesota|
|HealthPartners Care System|
|Bloomington, Minnesota, United States, 55425|
|Principal Investigator:||JoAnn M Sperl-Hillen, MD||HealthPartners Institute|