Promoting the Universal Medication Schedule Via Mobile and EHR Technologies

• Sponsor: Northwestern University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02248857
• Collaborator: Merck Sharp & Dohme LLC (Industry)
• Enrollment: 452
• Location: 1
• Arms: 3
• Duration (Months): 24
• Patients Per Site Per Month: 18.8

Study Details

Study Description

Brief Summary

The purpose of this study test the effectiveness of the Universal Medication Schedule (UMS), which was designed as a strategy to standardize and simplify medication instructions to support safe and effective prescription drug use among diabetic.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes	Other: UMS Strategy; Other: SMS Texting Reminders	N/A

Detailed Description

Research has shown the UMS (1) improves patients' understanding of how much to take of a medicine and when, and (2) reduces the number of times per day patients would take a multi-drug regimen. In this study, UMS tools will be exported into a second electronic health record platform to demonstrate ease of dissemination. Also, as patients may require assistance outside of clinic visits to adapt their prescription regimen to the UMS, this study will test the potential benefit of daily short message service (SMS) text reminders via cell phone.

We will conduct a three-arm, provider-randomized controlled trial among English and Spanish-speaking adults taking three or more prescription drugs to evaluate the effectiveness of the UMS strategy, with and without SMS text reminders, to improve patient understanding, consolidation, and adherence compared to usual care.We will conduct a three-arm, provider-randomized trial at two community health centers in Chicago, IL to evaluate the UMS and UMS+SMS text reminder strategies compared to usual care. English and Spanish-speaking patients who are prescribed three or more medications will be recruited and assessed by phone at baseline, three months, and six months.

Study Design

• Study Type: Interventional
• Actual Enrollment: 452 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Health Services Research
• Official Title: Promoting the Universal Medication Schedule Via Mobile and EHR Technologies: A Physician-randomized Control Trial
• Study Start Date: Dec 1, 2014
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Usual Care Employ the current standard of care. No intervention.
Experimental: 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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	Other: 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.
Experimental: UMS strategy + SMS texting reminders In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.	Other: 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.; Other: SMS Texting Reminders; In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.

Outcome Measures

Primary Outcome Measures

1. Prescription Understanding [6 months after baseline]

   Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.

Secondary Outcome Measures

1. Medication Knowledge [6 months after baseline]

   Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.

2. Medication Adherence: Pill Count [6 months after baseline]

   Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.

3. Medication Adherence: PMAQ [6 months after baseline]

   Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.

4. Medication Adherence: Pharmacy Records [6 months after baseline]

   Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.

Other Outcome Measures

1. Changes in Blood Pressure [6 months before baseline to 1 year after baseline]

   An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).

2. Changes in Hemoglobin A1c (hbA1c) [6 months before baseline to 1 year after baseline]

   An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).

3. Changes in Low-density Lipoprotein Cholesterol (LDL) [6 months before baseline to 1 year after baseline]

   An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diagnosis of type II diabetes

• age 30 or older

• taking 3 or more prescription medications for chronic conditions

• English or Spanish speaking

Exclusion Criteria:

• self-reported severe, uncorrectable vision

• hearing impairment

• cognitive impairment

• not responsible for administering his/her own medications

• not able to receive text messages on their cell phone

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Northwestern University	Chicago	Illinois	United States	60611

Sponsors and Collaborators

• Northwestern University
• Merck Sharp & Dohme LLC

Investigators

• Principal Investigator: Michael Wolf, PhD, MPH, Northwestern University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael S. Wolf, Professor, Northwestern University
• ClinicalTrials.gov Identifier: NCT02248857
• Other Study ID Numbers: STU00097744
• First Posted: Sep 25, 2014
• Last Update Posted: Mar 25, 2019
• Last Verified: Dec 1, 2018

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Michael S. Wolf, Professor, Northwestern University: UMS; medication schedule; diabetes; drug labeling

Study Results

Participant Flow

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Period Title: Baseline
STARTED	157	168	127
COMPLETED	157	168	127
NOT COMPLETED	0	0	0
Period Title: Baseline
STARTED	157	168	127
COMPLETED	111	134	96
NOT COMPLETED	46	34	31
Period Title: Baseline
STARTED	148	165	123
COMPLETED	120	136	106
NOT COMPLETED	28	29	17

Baseline Characteristics

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders	Total
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.	Total of all reporting groups
Overall Participants	157	168	127	452
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	131 83.4%	142 84.5%	95 74.8%	368 81.4%
>=65 years	26 16.6%	26 15.5%	32 25.2%	84 18.6%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	56.5 (9.4)	56.4 (9.3)	57.5 (9.9)	56.7 (9.5)
Sex: Female, Male (Count of Participants)
Female	100 63.7%	108 64.3%	87 68.5%	295 65.3%
Male	57 36.3%	60 35.7%	40 31.5%	157 34.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	113 72%	127 75.6%	91 71.7%	331 73.2%
Not Hispanic or Latino	43 27.4%	41 24.4%	36 28.3%	120 26.5%
Unknown or Not Reported	1 0.6%	0 0%	0 0%	1 0.2%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	1 0.6%	1 0.6%	3 2.4%	5 1.1%
Asian	3 1.9%	6 3.6%	1 0.8%	10 2.2%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%	0 0%
Black or African American	32 20.4%	27 16.1%	23 18.1%	82 18.1%
White	112 71.3%	130 77.4%	96 75.6%	338 74.8%
More than one race	1 0.6%	0 0%	2 1.6%	3 0.7%
Unknown or Not Reported	8 5.1%	4 2.4%	2 1.6%	14 3.1%
Region of Enrollment (participants) [Number]
United States	157 100%	168 100%	127 100%	452 100%

Outcome Measures

1. Primary Outcome

Title	Prescription Understanding
Description	Predictive probabilities of prescription understanding will be calculated based on patients' ability to correctly dose their prescription medications using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Correct dosing per medication will be scored as yes or no, reflecting having demonstrated all of the following: proper dose (# of pills), spacing (hours between doses), frequency (# of times per day), and total pills per day. Results are presented as predicted probabilities with 95% Confidence Intervals.
Time Frame	6 months after baseline

Outcome Measure Data

Analysis Population Description

All participants who completed the 6 month assessment and had complete data for the outcome for at least 1 medication.

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Measure Participants	120	134	104
Measure Medications	559	611	455
Least Squares Mean (95% Confidence Interval) [Probability]	0.81	0.82	0.78

2. Secondary Outcome

Title	Medication Knowledge
Description	Predictive probabilities of medication knowledge will be calculated based on patients' ability to identify each medication's purpose and side effects, risks, warnings, and benefits using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Patients will be asked through a structured questionnaire about each of the above via structured, open-ended items. Each medication will be scored as correct/incorrect if the participant knew the purpose and could name at least 1 side effect, risk, or warning of the medication. Results are presented as predicted probabilities with 95% Confidence Intervals.
Time Frame	6 months after baseline

Outcome Measure Data

Analysis Population Description

All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Measure Participants	120	137	104
Measure Medications	611	654	488
Least Squares Mean (95% Confidence Interval) [Probability of medication knowledge]	0.21	0.28	0.26

3. Secondary Outcome

Title	Medication Adherence: Pill Count
Description	Predictive probabilities of medication adherence will be calculated based on telephone pill counts using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. Pills taken/pills prescribed will be calculated for each medication and scored as adherent for that medication if that score is between 80% and 120%. Results are presented as predicted probabilities with 95% Confidence Intervals.
Time Frame	6 months after baseline

Outcome Measure Data

Analysis Population Description

All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Measure Participants	109	128	98
Measure Medications	296	366	277
Least Squares Mean (95% Confidence Interval) [Probability of adherence]	0.41	0.31	0.34

4. Secondary Outcome

Title	Medication Adherence: PMAQ
Description	Predictive probabilities of medication adherence will be calculated based on a 4-item validated Patient Medication Adherence Questionnaire (PMAQ) using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. The PMAQ assesses adherence behaviors by asking patients to self-report missed/wrong doses in past 4 days, scoring each medication as adherent for that medication if no missed doses were reported. Results are presented as predicted probabilities with 95% Confidence Intervals.
Time Frame	6 months after baseline

Outcome Measure Data

Analysis Population Description

All participants who completed the 6 month assessment and had complete outcome data for at least 1 medication

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Measure Participants	120	137	104
Measure Medications	609	654	487
Least Squares Mean (95% Confidence Interval) [Probability of adherence]	0.71	0.72	0.77

5. Secondary Outcome

Title	Medication Adherence: Pharmacy Records
Description	Predictive probabilities of primary medication adherence will be calculated based on the proportion of days covered (PDC) with medication obtained from pharmacy records using unadjusted Generalized Estimating Equation models, specifying the binomial family and logit link, with medication as the unit of analysis. PDC is calculated by summing the number of days' supply obtained by a patient during a given time period and dividing by the number of days for which the patient was prescribed the medication. Each medication is scored as adherent if the patient was covered for that medication more than 80% of the time. Results are presented as predicted probabilities with 95% Confidence Intervals.
Time Frame	6 months after baseline

Outcome Measure Data

Analysis Population Description

Participants who filled medications at Walgreens during the study period.

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Measure Participants	33	45	33
Measure Medications	168	217	177
Least Squares Mean (95% Confidence Interval) [Probability of adherence]	0.49	0.59	0.55

6. Other Pre-specified Outcome

Title	Changes in Blood Pressure
Description	An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Systolic blood pressure will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).
Time Frame	6 months before baseline to 1 year after baseline

Outcome Measure Data

Analysis Population Description

All participants with both a baseline and 6 month systolic blood pressure measurement

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Measure Participants	94	115	91
Mean (Standard Deviation) [mmHG]	-1.4 (14.1)	0.5 (14.0)	0.1 (15.5)

7. Other Pre-specified Outcome

Title	Changes in Hemoglobin A1c (hbA1c)
Description	An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Hemoglobin A1c (hbA1c) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).
Time Frame	6 months before baseline to 1 year after baseline

Outcome Measure Data

Analysis Population Description

All participants with both a baseline and 6 month hbA1c measurement

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Measure Participants	114	136	105
Mean (Standard Deviation) [percent of glycated hemoglobin]	-0.2 (1.3)	-0.1 (1.5)	-0.2 (1.4)

8. Other Pre-specified Outcome

Title	Changes in Low-density Lipoprotein Cholesterol (LDL)
Description	An exploratory analysis will be conducted to investigate the impact of receiving the UMS in either intervention arm on biologic outcomes for these prevalent conditions. Low-density lipoprotein cholesterol (LDL) will be obtained from patients' electronic health records. Differences will be measured between the last clinical measurement prior to baseline assessment and the last measured value during the study period (closest to 6 month assessment).
Time Frame	6 months before baseline to 1 year after baseline

Outcome Measure Data

Analysis Population Description

All participants with both a baseline and 6 month LDL measurement

Arm/Group Title	Usual Care	UMS Strategy	UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.	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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.	In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
Measure Participants	19	29	9
Mean (Standard Deviation) [mg/dL]	-10.1 (26.7)	-17.1 (66.5)	-23.4 (38.7)

Adverse Events

Arm/Group Title	Usual Care		UMS Strategy		UMS Strategy + SMS Texting Reminders
Arm/Group Description	Employ the current standard of care. No intervention.		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. Prescription instructions will be adapted to UMS to establish four standard time intervals for prescribing and dispensing of medicine. UMS instructions also use simplified text and numeric characters instead of words to detail dose. Single-page, plain language medication information sheets with content from a patient's perspective and following health literacy best practices. A list of their current medications each corresponding to a set of instructions and a checkbox for morning, noon, evening, and bedtime medicine to help patients visually depict when to take their medicines.		In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription. 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 Texting Reminders: In addition to the components from the UMS strategy arm, patients will receive daily text reminders for 7 days, with the option of extending reminders, following a study medication prescription.
All Cause Mortality
	Usual Care		UMS Strategy		UMS Strategy + SMS Texting Reminders
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Usual Care		UMS Strategy		UMS Strategy + SMS Texting Reminders
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/168 (0%)		0/127 (0%)
Other (Not Including Serious) Adverse Events
	Usual Care		UMS Strategy		UMS Strategy + SMS Texting Reminders
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/157 (0%)		0/168 (0%)		0/127 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.