Phenotyping Adherence Through Technology-Enabled Reports and Navigation

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.

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

Conditions
-----------------
Diabetes, Hypertension, Hyperlipidemias

Intervention / Treatment
-----------------
* Behavioral: The PATTERN Intervention


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Care<br>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. | |
| Active Comparator: The PATTERN Intervention<br>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. | Behavioral: The PATTERN Intervention<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |