Trial Outcomes & Findings for Phenotyping Adherence Through Technology-Enabled Reports and Navigation (NCT NCT05766423)
NCT ID: NCT05766423
Last Updated: 2025-06-11
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
73 participants
Primary outcome timeframe
About 2-4 Weeks
Results posted on
2025-06-11
Participant Flow
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 Of 36 allocated in Usual Care, 1 participant withdrawn and 3 consented but didn't schedule an interview, therefore were excluded from the study.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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
37
|
|
Overall Study
COMPLETED
|
32
|
32
|
|
Overall Study
NOT COMPLETED
|
4
|
5
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Consented, not scheduled
|
3
|
5
|
Baseline Characteristics
1 participant in intervention group with missing race data.
Baseline characteristics by cohort
| Measure |
Usual Care
n=32 Participants
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.
|
The PATTERN Intervention
n=32 Participants
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.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
75.1 years
STANDARD_DEVIATION 7.5 • n=5 Participants
|
74.9 years
STANDARD_DEVIATION 6.1 • n=7 Participants
|
75.0 years
STANDARD_DEVIATION 6.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
19 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
18 Participants
n=7 Participants • 1 participant in intervention group with missing race data.
|
37 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
11 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
12 Participants
n=7 Participants • 1 participant in intervention group with missing race data.
|
23 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
|
Race/Ethnicity, Customized
Race · Asian Indian
|
0 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
1 Participants
n=7 Participants • 1 participant in intervention group with missing race data.
|
1 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
|
Race/Ethnicity, Customized
Race · Japanese
|
1 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
0 Participants
n=7 Participants • 1 participant in intervention group with missing race data.
|
1 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
|
Race/Ethnicity, Customized
Race · Other
|
1 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
0 Participants
n=7 Participants • 1 participant in intervention group with missing race data.
|
1 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
|
Race/Ethnicity, Customized
Race · Refused
|
0 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
1 Participants
n=7 Participants • 1 participant in intervention group with missing race data.
|
1 Participants
n=5 Participants • 1 participant in intervention group with missing race data.
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
29 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Refused
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Health Status
Excellent
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Health Status
Very good
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Health Status
Good
|
17 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Health Status
Fair
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Health Status
Poor
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: About 2-4 WeeksParticipants' 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.
Outcome measures
| Measure |
Usual Care
n=32 Participants
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.
|
The PATTERN Intervention
n=32 Participants
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.
|
|---|---|---|
|
Medication Adherence
|
21.6 score on a scale
Standard Deviation 6.2
|
23.8 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: By the scheduled clinic visit (baseline)Population: Only the participants in PATTERN Intervention group were sent the medication adherence assessment.
The investigators will examine participants' completion rates of the routine medication adherence assessment. This will be identified via the EHR.
Outcome measures
| Measure |
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.
|
The PATTERN Intervention
n=32 Participants
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.
|
|---|---|---|
|
Fidelity
|
0 Participants
|
15 Participants
|
Adverse Events
Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
The PATTERN Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place