Phenotyping Adherence Through Technology-Enabled Reports and Navigation

Medication Adherence Clinical Trial

Official title:

Phenotyping Adherence Through Technology-Enabled Reports and Navigation: The PATTERN Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766423
• Other study ID #: STU00217555
• Secondary ID: P30AG059988
• Status: Recruiting
• Phase: N/A
• Start date: January 18, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: Allison P Pack, PhD, MPH
• Phone: 312-503-0274
• Email: allison.pack[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 1, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• The PATTERN Intervention
The intervention components include: An adherence assessment that requests patients to self-report via MyChart about their medication use. The assessment provides a link between the health center and the patient ahead of a regularly scheduled clinic visit. Care alert notifications directed to a nurse pool and/or member of the clinical care team when a medication adherence related problem is identified by the adherence assessment. The alert will also include the type of problem the patient is experiencing (cognitive, psychological, medical, regiment, social and/or economic). Once they receive these alerts, the care team can then activate appropriate staff and/or resources to respond.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (3)

Lead Sponsor	Collaborator
Northwestern University	National Institute on Aging (NIA), The Claude D. Pepper Older Americans Independence Centers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication Adherence	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.	About 2-4 Weeks
Secondary	Fidelity	The investigators will examine participants' completion rates of the routine medication adherence assessment. This will be identified via the EHR.	By the scheduled clinic visit (baseline)