Medication Adherence
Conditions
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.
Interventions
BEHAVIORALThe 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.
Sponsors
The Claude D. Pepper Older Americans Independence Centers
National Institute on Aging (NIA)
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence | About 2-4 Weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Fidelity | By the scheduled clinic visit (baseline) | The investigators will examine participants' completion rates of the routine medication adherence assessment. This will be identified via the EHR. |
Countries
United States
Participant flow
Pre-assignment details
Of 539 assessed participants, 73 met inclusion criteria and were randomized and allocated to Usual Care(n=36) and Intervention group(n=37). Of 36 allocated in Usual Care, 1 participant withdrawn and 3 consented but didn't schedule an interview, therefore were excluded from the study. Of 37 allocated in Intervention group, 5 participants consented but did not schedule an interview, therefore were excluded from the study.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 32 |
| 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.
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. | 32 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Consented, not scheduled | 3 | 5 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Total | The PATTERN Intervention | Usual Care |
|---|---|---|---|
| Age, Continuous | 75.0 years STANDARD_DEVIATION 6.8 | 74.9 years STANDARD_DEVIATION 6.1 | 75.1 years STANDARD_DEVIATION 7.5 |
| Health Status Excellent | 1 Participants | 0 Participants | 1 Participants |
| Health Status Fair | 20 Participants | 10 Participants | 10 Participants |
| Health Status Good | 29 Participants | 12 Participants | 17 Participants |
| Health Status Poor | 3 Participants | 2 Participants | 1 Participants |
| Health Status Very good | 11 Participants | 8 Participants | 3 Participants |
| Race/Ethnicity, Customized Ethnicity Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Ethnicity Not Hispanic or Latino | 60 Participants | 31 Participants | 29 Participants |
| Race/Ethnicity, Customized Ethnicity Refused | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Asian Indian | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race Black or African American | 23 Participants | 12 Participants | 11 Participants |
| Race/Ethnicity, Customized Race Japanese | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Other | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Race Refused | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race White | 37 Participants | 18 Participants | 19 Participants |
| Sex: Female, Male Female | 42 Participants | 22 Participants | 20 Participants |
| Sex: Female, Male Male | 22 Participants | 10 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
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.
Time frame: About 2-4 Weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Usual Care | Medication Adherence | 21.6 score on a scale | Standard Deviation 6.2 |
| The PATTERN Intervention | Medication Adherence | 23.8 score on a scale | Standard Deviation 7 |
Secondary
Fidelity
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)
Population: Only the participants in PATTERN Intervention group were sent the medication adherence assessment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Usual Care | Fidelity | 0 Participants |
| The PATTERN Intervention | Fidelity | 15 Participants |