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| ID | Type | Description | Link |
|---|---|---|---|
| P30AG059988 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| The Claude D. Pepper Older Americans Independence Centers | OTHER |
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Care | No Intervention | Usual care includes:
| |
| The PATTERN Intervention | Active Comparator | The intervention components include:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The PATTERN Intervention | Behavioral | The intervention components include:
|
| 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 |
| 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) |
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Inclusion Criteria:
Each participant must:
Exclusion Criteria:
No participant can:
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| Name | Affiliation | Role |
|---|---|---|
| Allison Pack, PhD, MPH | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | 60611 | United States |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Usual Care | Usual care includes:
|
| FG001 | The PATTERN Intervention | The intervention components include:
The PATTERN Intervention: The intervention components include:
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Usual Care | Usual care includes:
|
| BG001 | The PATTERN Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | About 2-4 Weeks |
|
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Deaths, serious adverse events, and nonserious adverse events were not assessed for the participants in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Usual Care | Usual care includes:
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Assistant Professor | Northwestern University | 312-503-0274 | allison.pack@northwestern.edu |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 9, 2024 | Mar 17, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 9, 2024 | Mar 17, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
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|
The intervention components include:
The PATTERN Intervention: The intervention components include:
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | 1 participant in intervention group with missing race data. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Health Status | The participants were asked about their self-reported overall health. The measure is a 5-point Likert scale range from excellent health to poor health. | Count of Participants | Participants |
|
| The PATTERN Intervention |
The intervention components include:
The PATTERN Intervention: The intervention components include:
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|
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| Secondary | Fidelity | The investigators will examine participants' completion rates of the routine medication adherence assessment. This will be identified via the EHR. | Only the participants in PATTERN Intervention group were sent the medication adherence assessment. | Posted | Count of Participants | Participants | By the scheduled clinic visit (baseline) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | The PATTERN Intervention | The intervention components include:
The PATTERN Intervention: The intervention components include:
| 0 | 0 | 0 | 0 | 0 | 0 |
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| D001519 | Behavior |