Phenotyping Adherence Through Technology-Enabled Reports and Navigation: The PATTERN Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 73
- Locations
- 1
- Primary Endpoint
- Medication Adherence
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Health Services Research
- Masking
- None
Eligibility Criteria
- Ages
- 65 Years to — (Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Usual Care
Usual care includes:
- The normal standard clinical practices at the participating practice.
- No specific materials to promote PATTERN, and no additional materials that include adherence assessments or care alert notifications.
The PATTERN Intervention
The intervention components include:
- An adherence assessment completed by participants ahead of a regularly scheduled clinic visit.
- Care alert notifications directed to a nurse pool and/or member of the clinical care team.
Intervention: The PATTERN Intervention (Behavioral)
Outcomes
Primary Outcomes
Medication Adherence
Time Frame: 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 Outcomes
- Fidelity(By the scheduled clinic visit (baseline))