Evaluation of PatientToc in Community Pharmacies

Medication Adherence Clinical Trial

Official title: An Evaluation of the Spread and Scale of PatientToc™ From Primary Care to Community Pharmacy Practice for the Collection of Patient-Reported Outcomes: Phase 2

Status Enrolling by invitation

Clinical Trial Summary

The purpose of this study is to evaluate the initial "spread and scale" of PatientToc™, a patient-reported outcomes (PROs) collection software, to community pharmacies for the collection and use of PROs data pertaining to medication adherence. The investigators are doing this by engaging PatientToc™ and pharmacy partners in two plan-do-study-act (PDSA) cycles to implement and refine PatientToc™ and an implementation toolkit (i.e., supports/resource tools) within a small number of community pharmacies. Investigators will then scale implementation to more community pharmacies in a rigorous theory-driven evaluation of PatientToc™ implementation using interviews, self-reported data from the pharmacy, observations, and administrative data. Collectively, the findings will inform long-term collection and use of PROs data pertaining to medication use.

Clinical Trial Description

Medication non-adherence is a problem of critical importance, affecting approximately 50% of all persons taking at least one regularly scheduled prescription medication and costing the United States more than $100 billion annually. Medication non-adherence is associated with clinical outcomes including hospitalizations and mortality. It is a complex, multi-faceted problem with many causes such as forgetfulness, access/affordability concerns, and avoiding medication due to bothersome side effects. Johnson's Medication Adherence Model (MAM) summarizes these causes by theorizing that patients must both "Remember" and "Intend" to take medication. The importance of reducing medication non-adherence is reflected in the Healthy People 2020 goals and objectives and recognized in the Centers for Medicare and Medicaid Services (CMS) star ratings program for Medicare Part D prescription drug plans (PDPs). Plans are rated annually as achieving 1 (lowest quality) to 5 (highest quality) stars. Plans receiving 5 stars are rewarded through quality bonus payments and the ability for patients to switch to the plan outside of the annual open enrollment period. Several measures used in determining star ratings are based on beneficiary medication adherence.

Community pharmacists are uniquely positioned to intervene on medication non-adherence. Community pharmacies are widely accessible and visited frequently by patients with chronic conditions, including the elderly and patients without a regular source of primary care. Community pharmacists can provide support for challenges commonly faced by patients such as limited health literacy, being un/underinsured, and limited English proficiency. Further, community pharmacies nationwide have increased efforts to improve measures influencing PDP star measures to ensure the pharmacy is positioned for financial reward through inclusion in the PDPs preferred pharmacy network and possible bonus payments. Traditional data sources for identifying and resolving medication non-adherence in community pharmacies include prescription fill histories. However, medication possession does not necessarily mean patients are taking medications as prescribed. Patient-reported outcomes (PROs), measuring adherence challenges pertaining to both remembering and intention to take medication, offer a rich data source for pharmacists and prescribers to use to resolve medication non-adherence.

Although the value of collecting and utilizing PROs for clinical and research purposes has been more widely recognized in recent years, to the investigators' knowledge, there are no examples of widespread electronic collection and use of PROs data 1) in community pharmacy settings, or 2) pertaining specifically to medication adherence in ambulatory settings. Moreover, numerous implementation challenges have been reported and the systematic collection of timely and actionable PROs data can be challenging, particularly for patient populations with limited literacy and/or health literacy. For example, paper-based data collection can be burdensome for data management/analysis and data quality concerns may be evident. Electronic data collection offers advantages but technology must ensure privacy and security standards are in place to support the reliability and validity of the data. In addition, data must be accessible to providers in a timely fashion for clinical decision making. Finally, while technology exists to facilitate the transfer of PROs data into electronic health records (EHRs) and providers want these data to populate with laboratory results, few electronic systems do so.

In December 2016, the Agency for Healthcare Research and Quality (AHRQ) released Funding Opportunity Announcement PA-17-077 which provides funding for research projects to "scale and spread" successful health information technology models that use PROs in ambulatory settings. Consequently, the investigators received funding in April 2019 to conduct research to inform long-term collection and use of PROs data pertaining to medication adherence in community pharmacies by spreading and scaling a successful model (PatientToc™, described below) for health information technology-enabled PROs collection.

Description of PatientToc: Current Use in Physician Offices PatientToc™ is a PROs collection software developed by investigators from the L.A. Net Community Health Resources Network (LA Net), a primary care practice-based research network (PBRN) in California. PatientToc™ was developed to facilitate collection of PROs data from low-literacy and non-English speaking patients in Los Angeles. L.A. Net provided a design for the product based on experience collecting PROs from more than 10,000 patients in L.A. Net practices speaking 42 different languages. The system was developed over a period of 4 years with continuous input from clinicians, community health workers, patients and researchers. PatientToc™ is used in waiting rooms, pre-visit areas, exam rooms, and educator rooms. Patients interact with a 10-inch android tablet that is either hand held or installed in a case or holder attached to a table. Consistent with research on low-literacy, the system presents one question at a time. Patients use disposable ear buds to maintain confidentiality when patients use the read aloud function. The system can deliver any PROs and responses are transmitted real time to the PatientToc™ server where staff and clinicians can access the results both as a pdf replica of a paper version of the completed survey, and as an aggregated SQL or Excel database. PatientToc™ integrates with EHRs via Health Level Seven (HL7) standards or Fast Healthcare Interoperability Resources (FHIR) interfaces, and through third party integration with service provider systems. Currently, PatientToc™ is being used in over 36 practices including 2 Federally Qualified Health Centers. Two California health plans have also used the system to transmit mandatory initial health assessments. Approximately 10,000 patients have completed PROs on PatientToc™ tablets, including the: PHQ-9, Medicare Health Risk Assessments, SBIRT screening, and others.

Aim 1: Conduct a pre-implementation developmental formative evaluation to determine community pharmacy workflow and current practices for identifying and resolving medication non-adherence, potential barriers and facilitators to PatientToc™ implementation, and create a draft implementation toolkit. This Aim was previously completed under a separate exempt protocol

Aim 2: Conduct two plan-do-study-act (PDSA) cycles to refine an implementation toolkit for spreading and scaling implementation of PatientToc™ in community pharmacies.

Aim 3: Conduct a comprehensive, theory-driven evaluation of the quality of care, implementation, and patient health outcomes of spreading and scaling PatientToc™ to community pharmacies.

Aim 4: To explore the feasibility of linking PROs data from PatientToc™ with healthcare utilization data. This will inform future research.

Aim 5: To conduct exploratory and secondary analyses to examine variations in medication therapy problems (MTPs), pharmacist interventions, and PatientToc™ outcomes by implementation scope and patient characteristics. Secondary analyses using Aim 1 data might also be completed, such as examining expected barriers from a staff perspective vs. actual concerns identified in Aims 2 and 3 pertaining to feasibility and acceptability.

Aim 6: To evaluate a novel continuing education (CE) program provided to pharmacies as part of the PatientToc™ implementation toolkit.

Aim 7: To assess participating pharmacists' perceptions of participating in this study. ;

Related Conditions & MeSH terms

• Medication Adherence

• NCT number: NCT05235620
• Study type: Observational
• Source: Purdue University
• Status: Enrolling by invitation
• Start date: July 1, 2023
• Completion date: March 28, 2024