Phenotyping Adherence Through Technology-Enabled Reports and Navigation

Sponsor

Northwestern University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05766423

Collaborator

The Claude D. Pepper Older Americans Independence Centers (Other), National Institute on Aging (NIA) (NIH)

Enrollment

Arms

15.5

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Hypertension Hyperlipidemias	Behavioral: The PATTERN Intervention	N/A

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

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Official Title:

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

Anticipated Study Start Date :

Mar 15, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Usual care includes: The normal standard clinical practices at the participating practice. No specific materials to promote PATTERN, and no materials that include routine adherence assessments or care alert notifications.
Active Comparator: The PATTERN Intervention The intervention components include: Routine adherence assessments completed by participants. Care alert notifications directed to a nurse pool and/or member of the clinical care team.	Behavioral: The PATTERN Intervention The intervention components include: Routine (e.g., monthly) adherence assessments that request patients to self-report via MyChart upon their medication use. Assessments provide a continuous link between the health center and the patient beyond the point of care. 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 routine 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.

Arm

Intervention/Treatment

No Intervention: Usual Care

Usual care includes: The normal standard clinical practices at the participating practice. No specific materials to promote PATTERN, and no materials that include routine adherence assessments or care alert notifications.

Active Comparator: The PATTERN Intervention

The intervention components include: Routine adherence assessments completed by participants. Care alert notifications directed to a nurse pool and/or member of the clinical care team.

Behavioral: The PATTERN Intervention

The intervention components include: Routine (e.g., monthly) adherence assessments that request patients to self-report via MyChart upon their medication use. Assessments provide a continuous link between the health center and the patient beyond the point of care. 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 routine 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.

Outcome Measures

Primary Outcome Measures

Medication Adherence [4 Months]
Participants' medication adherence will be measured at 4 months 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 [4 Months]
The investigators will examine participants' completion rates of the routine medication adherence assessment. This will be identified via the EHR.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Allison Prickett Pack, Research Assistant Professor, Northwestern University

ClinicalTrials.gov Identifier:

NCT05766423

Other Study ID Numbers:

STU00217555
P30AG059988

First Posted:

Mar 13, 2023

Last Update Posted:

Mar 13, 2023

Last Verified:

Mar 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hyperlipidemias

Study Results

No Results Posted as of Mar 13, 2023