Diabetes Mellitus, Type 2, Medication Adherence
Conditions
Brief summary
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals. 1. Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. 2. Determine if the effects of these UMS strategies vary by patients' literacy skills and language. 3. Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions. 4. Assess the costs required to deliver either intervention from a health system perspective.
Detailed description
The investigators will leverage increasingly available technologies to impart a Universal Medication Schedule (UMS) in primary care to help patients living with diabetes safely use and adhere to complex drug regimens. The UMS standardizes the prescribing and dispensing of medicine by using health literacy principles and more explicit times to describe when to take medicine (morning, noon, evening, bedtime). This eliminates variability found in the way prescriptions are written by physicians and transcribed by pharmacists onto drug bottle labels. The proposed intervention will standardize prescribing within an electronic health record (EHR) so all medication orders include UMS prescription instructions ('sigs') and patients receive a medication information sheet with their after-visit summaries. Additionally, to help patients remember when to take prescribed medicines we will link unidirectional short message service (SMS) text reminders to the EHR, delivering medication reminders to patients around UMS intervals. The investigators will conduct a 3-arm, multi-site trial to test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. The investigators will enroll a total of 900 English and Spanish-speaking patients with poorly controlled type 2 diabetes mellitus. Enrolled patients will complete follow-up interviews 3 and 6 months following their baseline interview. The aims of the investigation are to: 1. Test the effectiveness of the UMS, and UMS + SMS text reminder strategies compared to usual care. 2. Determine if the effects of these UMS strategies vary by patients' literacy skills and language. 3. Using mixed methods, evaluate the fidelity of the two strategies and explore patient, staff, physician, and health system factors influencing the interventions. 4. Assess the costs required to deliver either intervention from a health system perspective.
Interventions
BEHAVIORALUMS Strategy
Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
BEHAVIORALSMS Text Messaging
Patients will receive daily text message reminders about when to take medicines based on UMS intervals.
Sponsors
Icahn School of Medicine at Mount Sinai
Emory University
Northwestern Memorial Hospital
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Type 2 diabetes mellitus diagnosis 2. Most recent hba1c value ≥7.5%. 3. Seek care at participating general internal medicine practices in Chicago or New York City. 4. English or Spanish speaking 5. Take 5 or more prescription drugs for chronic conditions (including 1 study medication)
Exclusion criteria
1. Severe uncorrectable vision or hearing impairment 2. Cognitive impairment (≥2 errors on a 6-item dementia screening tool or a chart-documented diagnosis of dementia) 3. Not primarily responsible for administering his/her medications 4. Does not own a cell phone that can receive text messages 5. Not comfortable receiving text messages
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence: Pill Count | 6 months after baseline | Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Medication Adherence: 24-hour Recall | 6 months after baseline | Adherence will be measured for each prescription medication using self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients are asked to specify the amount taken (i.e. dose) and when taken (to determine frequency and interval between doses). A patient is considered adherent on a specific medication if they answered all correctly: 1.dose, 2.frequency, 3.interval between doses |
| Medication Adherence: ASK-12 | 6 months after baseline | Adherence will be measured by the ASK-12 Adherence Barrier Survey, a subjective assessment of general adherence behaviors and barriers to treatment adherence. The ASK-12 is scored by summing the selected responses (with scores ranging from 12 to 60) with higher scores indicating greater barriers to adherence. |
| Treatment Knowledge | 6 months after baseline | Identification of drug purpose |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| UMS Strategy Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. These materials will be generated within the electronic health record.
1. Prescription instructions will be adapted to the UMS format to establish four standard time intervals (morning, noon, evening, bedtime) for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose.
2. Single-page, plain language medication information sheets with important medication-related information following health literacy best practices.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions. | 244 |
| UMS Strategy + SMS Text Messaging In addition to the components from the UMS strategy arm, patients will receive daily text message reminders for 6 months.
UMS Strategy: Patients of providers randomized to the UMS arm will receive study-related educational tools at their primary care visit to support the understanding, regimen consolidation, and use of prescriptions.
SMS Text Messaging: Patients will receive daily text message reminders about when to take medicines based on UMS intervals. | 265 |
| Usual Care Patients of providers randomized to the usual care arm will receive their standard care | 241 |
| Total | 750 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| 3Month | Death | 1 | 1 | 2 |
| 3Month | Lost to Follow-up | 7 | 9 | 8 |
| 3Month | Protocol Violation | 0 | 0 | 3 |
| 3Month | Unavailable for 3Month | 11 | 10 | 11 |
| 3Month | Withdrawal by Subject | 1 | 5 | 1 |
| 6Month | Death | 1 | 1 | 2 |
| 6Month | Lost to Follow-up | 16 | 15 | 16 |
| 6Month | Withdrawal by Subject | 2 | 3 | 1 |
| Baseline | Lost to Follow-up | 1 | 2 | 3 |
| Baseline | Withdrawal by Subject | 1 | 3 | 2 |
Baseline characteristics
| Characteristic | Total | Usual Care | UMS Strategy + SMS Text Messaging | UMS Strategy |
|---|---|---|---|---|
| Age, Continuous | 61.20 years STANDARD_DEVIATION 10.54 | 60.60 years STANDARD_DEVIATION 9.96 | 61.82 years STANDARD_DEVIATION 10.91 | 61.12 years STANDARD_DEVIATION 10.69 |
| Race/Ethnicity, Customized American Indian/Alaskan Native | 12 Participants | 1 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Asian | 21 Participants | 5 Participants | 9 Participants | 7 Participants |
| Race/Ethnicity, Customized Black | 318 Participants | 91 Participants | 122 Participants | 105 Participants |
| Race/Ethnicity, Customized More than one race | 29 Participants | 6 Participants | 9 Participants | 14 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Other Pacific Islander | 3 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 3 Participants | 1 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized White | 364 Participants | 136 Participants | 120 Participants | 108 Participants |
| Recruitment Site Mount Sinai | 358 Participants | 124 Participants | 108 Participants | 126 Participants |
| Recruitment Site Northwestern | 392 Participants | 117 Participants | 157 Participants | 118 Participants |
| Sex: Female, Male Female | 445 Participants | 141 Participants | 154 Participants | 150 Participants |
| Sex: Female, Male Male | 305 Participants | 100 Participants | 111 Participants | 94 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 244 | 2 / 267 | 4 / 244 |
| other Total, other adverse events | 0 / 244 | 0 / 267 | 0 / 244 |
| serious Total, serious adverse events | 0 / 244 | 0 / 267 | 0 / 244 |
Outcome results
Primary
Medication Adherence: Pill Count
Adherence will be measured for each prescription medication using an objective pill count of the number of pills within each prescription bottle. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at baseline and 6Month. Pills taken will be calculated by subtracting the number of pills from the total quantity prescribed. Pills prescribed will be calculated by multiplying the number of pills prescribed each day by the number of days since the medication was filled. A proportion of pills taken over pills prescribed (PT/PP) of 80% or more is considered adherent.
Time frame: 6 months after baseline
Population: Observations were excluded if: 1.Medications were not in pill form; 2.Participants couldn't provide quantities on their bottles; 3.Missing Fill or Start Dates, 4.Participants started their medications on the same date as their pill count date; 5. Missing medications labels; 6. Participants combined medication bottles and discarded their old bottles; 7. Pills taken \> Quantity on bottle; 8. PRN Medications 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| UMS Strategy | Medication Adherence: Pill Count | 0.28 Probability of adherence (PT/PP =>0.80) |
| UMS Strategy + SMS Text Messaging | Medication Adherence: Pill Count | 0.29 Probability of adherence (PT/PP =>0.80) |
| Usual Care | Medication Adherence: Pill Count | 0.30 Probability of adherence (PT/PP =>0.80) |
Secondary
Medication Adherence: 24-hour Recall
Adherence will be measured for each prescription medication using self-report of how many pills and how often each medicine was taken over the last 24 hours. Patients are asked to specify the amount taken (i.e. dose) and when taken (to determine frequency and interval between doses). A patient is considered adherent on a specific medication if they answered all correctly: 1.dose, 2.frequency, 3.interval between doses
Time frame: 6 months after baseline
Population: Observations were excluded if participants did not complete the 24-hour recall questions.~2 Participants from the UMS Strategy were also excluded due to a Protocol Violation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| UMS Strategy | Medication Adherence: 24-hour Recall | 0.72 Probability of Adherence (Yes) |
| UMS Strategy + SMS Text Messaging | Medication Adherence: 24-hour Recall | 0.67 Probability of Adherence (Yes) |
| Usual Care | Medication Adherence: 24-hour Recall | 0.69 Probability of Adherence (Yes) |
Secondary
Medication Adherence: ASK-12
Adherence will be measured by the ASK-12 Adherence Barrier Survey, a subjective assessment of general adherence behaviors and barriers to treatment adherence. The ASK-12 is scored by summing the selected responses (with scores ranging from 12 to 60) with higher scores indicating greater barriers to adherence.
Time frame: 6 months after baseline
Population: Observations were excluded if participants did not complete the ASK12 survey 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| UMS Strategy | Medication Adherence: ASK-12 | 23.0 score on a scale (12-60) |
| UMS Strategy + SMS Text Messaging | Medication Adherence: ASK-12 | 23.89 score on a scale (12-60) |
| Usual Care | Medication Adherence: ASK-12 | 23.22 score on a scale (12-60) |
Secondary
Treatment Knowledge
Identification of drug purpose
Time frame: 6 months after baseline
Population: Observations were excluded if participants did not answer the question. 2 Participants from the UMS Strategy were also excluded due to a Protocol Violation.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| UMS Strategy | Treatment Knowledge | 0.73 Probability of Knowledge |
| UMS Strategy + SMS Text Messaging | Treatment Knowledge | 0.73 Probability of Knowledge |
| Usual Care | Treatment Knowledge | 0.75 Probability of Knowledge |