Phenotyping Adherence Through Technology-Enabled Reports and Navigation

NCT ID: NCT05766423

Last Updated: 2025-06-11

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-18

Study Completion Date

2024-08-15

Brief Summary

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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

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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.

Conditions

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Medication Adherence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Usual Care

Usual care includes:

1. The normal standard clinical practices at the participating practice.
2. No specific materials to promote PATTERN, and no additional materials that include adherence assessments or care alert notifications.

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type ACTIVE_COMPARATOR

The PATTERN Intervention

Intervention Type BEHAVIORAL

The intervention components include:

1. 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.
2. 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.

Interventions

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The PATTERN Intervention

The intervention components include:

1. 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.
2. 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Claude D. Pepper Older Americans Independence Centers

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Allison Pack, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern University

Chicago, Illinois, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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P30AG059988

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU00217555

Identifier Type: -

Identifier Source: org_study_id

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