Phenotyping Adherence Through Technology-Enabled Reports and Navigation

Not Applicable

Completed

• Conditions: Medication Adherence
• Interventions: Behavioral: The PATTERN Intervention

• Registration Number: NCT05766423
• Lead Sponsor: Northwestern University

Brief Summary

This study is being conducted to adapt and pilot test a technology-enabled, primary care strategy for routinely monitoring medication use and adherence among older adults with multiple chronic conditions and polypharmacy.

Detailed Description

Our study aims are to:

Aim 1: Adapt the PATTERN intervention for use in primary care using input from key stakeholders. During Aim 1, the Northwestern research team will solicit opinions from key informants (patients, clinicians, practice administrators) to ensure PATTERN meets the needs of primary care.

Aim 2: Assess the PATTERN intervention's feasibility and acceptability for use in primary care. During Aim 2, the investigators will conduct a 2-arm, patient-randomized controlled trial at a Northwestern Medicine primary care practice. Participants will be recruited and randomly assigned, using a random number generator application, to either the PATTERN intervention or usual care. Usual care refers to the normal standard clinical practices at the participating practice. Participants will be followed for 6 months.

Study Timeline

• Study First Submitted: 2023-02-17
• Study First Submitted QC: 2023-03-02
• Study First Posted: 2023-03-13
• Study Start: 2024-01-18
• Primary Completion: 2024-08-15
• Study Completion: 2024-08-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

Inclusion Criteria

Each participant must:

• Be an adult aged 65 or older
• Speak English as their primary language
• Have multiple chronic conditions
• Be prescribed 8 or more medications
• Be primarily responsible for administering own medication
• Receive medical care at the participating primary care practice
• Have access to the internet and an active email address
• Be signed up for the patient portal (MyChart)

Exclusion Criteria

No participant can:

• Have severe, uncorrectable visual, hearing or cognitive impairments that would preclude study consent or participation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The PATTERN Intervention	The PATTERN Intervention	The intervention components include: 1. An adherence assessment completed by participants ahead of a regularly scheduled clinic visit. 2. Care alert notifications directed to a nurse pool and/or member of the clinical care team.

Primary Outcome Measures

Name	Time	Method
Medication Adherence	About 2-4 Weeks	Participants' medication adherence will be measured at about 2-4 weeks after their clinic visit using a validated self-report measure: ASK-12. The 12-item measure assesses general medication attitudes and beliefs across three domains: 1) inconvenience/forgetfulness, 2) treatment beliefs, and 3) behaviors. Response options range from "Strongly Disagree" to "Strongly Agree". Scores can range from 12-60 with higher scores representing greater barriers to adherence.

Secondary Outcome Measures

Name	Time	Method
Fidelity	By the scheduled clinic visit (baseline)	The investigators will examine participants' completion rates of the routine medication adherence assessment. This will be identified via the EHR.

Trial Locations

Locations (1)

Northwestern University; 🇺🇸 Chicago, Illinois, United States