Evaluation of PatientToc in Community Pharmacies

NCT05235620 | Enrolling By Invitation DMC

• 1 other identifier: 2008163459
• Study Type: observational
• Target: 1,175
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Medication Adherence

Outcome Measures

Primary Outcomes (1)

• Self-reported medication adherence, measured by Brief Medication Questionnaire

  Validated survey consisting of 4 items asking respondents to consider their medication adherence for each regularly scheduled prescription medication of interest over the past 7 days

  Monthly, up to 7 months

Secondary Outcomes (14)

• Self-reported medication adherence measured by the Merck Medication Adherence Estimator (Adherence Estimator),

  Monthly, up to 7 months

• Medication regimen complexity measured by the Medication Regimen Complexity Index (MRCI),

  Monthly, up to 7 months in select patients only

• Pharmacy-level population medication adherence measured by from pharmacy-level EQuIPP data

  Prior to and at the end of the intervention

• Acceptability of intervention

  Monthly, up to 7 months

• Adoption of intervention

  Monthly, up to 7 months

Study Arms (2)

Pharmacy staff

Pharmacy staff working at pharmacies which have chosen to implement PatientToc software for this implementation science project and evaluation. Pharmacy staff will be observed and participate in interviews pertaining to their experiences using PatientToc.

Other: PatientToc use in pharmacies

Pharmacy patients

Patients engaged in completing medication adherence-related questionnaires in the PatientToc software at their pharmacies. Patient-level medication, health history, and self-reported adherence information will be collected from patients meeting eligibility criteria. Patients will also be observed and interviewed about their experiences using PatientToc.

Other: PatientToc use in pharmacies

Interventions

PatientToc use in pharmacies OTHER

PatientToc has been adapted for use in pharmacies. Patients using specific medications will be prompted to complete questionnaires about their self-reported adherence.

Pharmacy patients; Pharmacy staff

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pharmacy staff and patients at pharmacies agreeing to implement PatientToc as part of this implementation science project.

Pharmacist/pharmacy staff eligibility criteria: * Aged 18 years or older * Employee (paid) or PharmD rotation student trainee/volunteer at the pharmacy during the time of PatientToc™ implementation Pharmacy patient eligibility criteria: The specific pharmacy workflow for introducing patients to PatientToc™ may vary by participating pharmacy. For example, all pharmacy patients might have the opportunity to complete PROs in the tablet/mobile application (if desired by the pharmacy) with only a subset included in our evaluation. This variation does not change our study/evaluation procedures and is allowed to facilitate successful PatientToc™ implementation in patient care. For the purposes of this evaluation, individual-level data will be sought from patients who are: * ≥ 50 years of age * Have one or more specific chronic conditions (i.e., hypertension, Type 2 diabetes, and dyslipidemia; per self-report, ICD code if available, and/or inferred by medications filled) requiring routine (regularly scheduled, not "as needed" dosing) * Medications are oral (solid dosage form) * Prescription medication filled at least once previously by the study pharmacy as 30-day supplies. In situations where patients with 30-day supplies also fill some medications as 90-day (or other quantity) supplies, they will be enrolled if their first medication chosen for PROs completion was a 30-day supply. * Baseline non-adherence as determined by responses to the BMQ PRO for one or more targeted medications, specifically, the first medication chosen for PROs completion by the patient for their primary condition of interest (hypertension, Type 2 diabetes, and dyslipidemia) when they have more than one of these conditions and take more than one targeted medication. * Able to provide consent and read and/or comprehend English or another language for which the intervention and study materials (e.g., consent documents) is available OR has a legal representative (self-reported) with authority to act on their behalf to complete PROs/interview/other data collection and consent documents.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Purdue University: lead
• University of Wisconsin, Madison: collaborator
• University of Minnesota: collaborator
• University of Arkansas: collaborator
• L.A. Net Community Health Resource Network: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator
• Indiana Clinical and Translational Sciences Institute: collaborator

Study Sites (1)

Purdue University

West Lafayette, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Pharmacies

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Facilities; Health Care Facilities Workforce and Services

Study Officials

• Margie E Snyder, PharmD, MPH

  Purdue University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pharmacy Practice

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 11, 2022
• Study Start: July 1, 2023
• Primary Completion: March 28, 2024
• Study Completion: March 28, 2024
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)