search
Back to results

Phenotyping Adherence Through Technology-Enabled Reports and Navigation

Primary Purpose

Diabetes, Hypertension, Hyperlipidemias

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
The PATTERN Intervention
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Each participant must: Be an adult aged 65 or older Speak English as their primary language Have a diagnosis of at least diabetes, hypertension, and hyperlipidemia 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    Usual Care

    The PATTERN Intervention

    Arm Description

    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 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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    Fidelity
    The investigators will examine participants' completion rates of the routine medication adherence assessment. This will be identified via the EHR.

    Full Information

    First Posted
    February 17, 2023
    Last Updated
    July 6, 2023
    Sponsor
    Northwestern University
    Collaborators
    The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT05766423
    Brief Title
    Phenotyping Adherence Through Technology-Enabled Reports and Navigation
    Official Title
    Phenotyping Adherence Through Technology-Enabled Reports and Navigation: The PATTERN Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 1, 2023 (Anticipated)
    Primary Completion Date
    March 1, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Northwestern University
    Collaborators
    The Claude D. Pepper Older Americans Independence Centers, National Institute on Aging (NIA)

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Diabetes, Hypertension, Hyperlipidemias

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Usual Care
    Arm Type
    No Intervention
    Arm Description
    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.
    Arm Title
    The PATTERN Intervention
    Arm Type
    Active Comparator
    Arm Description
    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 Type
    Behavioral
    Intervention Name(s)
    The PATTERN Intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Medication Adherence
    Description
    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.
    Time Frame
    About 2-4 Weeks
    Secondary Outcome Measure Information:
    Title
    Fidelity
    Description
    The investigators will examine participants' completion rates of the routine medication adherence assessment. This will be identified via the EHR.
    Time Frame
    By the scheduled clinic visit (baseline)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Each participant must: Be an adult aged 65 or older Speak English as their primary language Have a diagnosis of at least diabetes, hypertension, and hyperlipidemia 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Allison P Pack, PhD, MPH
    Phone
    312-503-0274
    Email
    allison.pack@northwestern.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Phenotyping Adherence Through Technology-Enabled Reports and Navigation

    We'll reach out to this number within 24 hrs