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Completed

NCT Number: NCT02248857

Promoting the Universal Medication Schedule Via Mobile and EHR Technologies

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.

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Key information

Age range

30 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

UMS Strategy

Other

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

Other

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.

Primary outcomes

  1. Prescription Understanding

    Time frame: 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 outcomes

  1. Medication Knowledge

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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 outcomes

  1. Changes in Blood Pressure

    Time frame: 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)

    Time frame: 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)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Promoting the Universal Medication Schedule Via Mobile and EHR Technologies: A Physician-randomized Control Trial

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 25, 2014
Registry last updated
Mar 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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