A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

Adherence Clinical Trial

Official title:

A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02820753
• Other study ID #: 1R01AG046352-01A1
• Status: Completed
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: September 21, 2020

Study information

• Verified date: January 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will leverage available technologies and test strategies to impart the Universal Medication Schedule (UMS) in primary care to help patients understand, consolidate, safely use, and adhere to their complex medication regimens.

Description:

The study investigators will conduct a patient-randomized controlled trial using a 2x2 factorial design to compare the effectiveness of interventions, alone or in combination, to one another. 1505 English and Spanish-speaking patients who are ≥ 50 years old, from a federally qualified health center (FQHC) in Chicago, and prescribed ≥ 3 Rx medications will be randomized to receive: 1) Enhanced Usual Care (EHR tools), 2) EHR tools + SMS, 3) EHR + Portal, or 4) EHR + SMS + Portal. The study aims to: 1. Compare the effectiveness of the UMS EHR tools, with or without SMS and/or Portal interventions. 2. Evaluate the 'fidelity' (reliability) of each strategy and explore patient, staff, physician, and health system factors influencing the delivery of the interventions, alone and in combination 3. Assess the costs required to deliver each of the interventions from a health system perspective Due to an NIA administrative hold, the interventions were not implemented as planned. Hence it was determined that the primary analysis would be "per-protocol" rather than intent-to-treat to assess the effect of the interventions under optimal conditions. Participants who either received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention. Those who have not received the initial 6 weeks of texting or completed at least 1 portal survey will be considered as enhanced usual care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: September 21, 2020
• Est. primary completion date: September 21, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• age 50+
• English or Spanish speaking
• Prescribed 3+ medications
• Primarily responsible for administering own medication
• Owns a cell phone and feels comfortable receiving texts
• Access and proficient in using internet at home and has a personal email address

Exclusion Criteria:

• Major cognitive, visual, or hearing impairment
• Doesn't meet inclusion criteria.

Related Conditions & MeSH terms

• Adherence

Intervention

Behavioral:
• EHR + (Text or Portal)
Per protocol analysis: Patients who received the initial 6 weeks of SMS messaging continuously, or logged on to the patient portal and completed at least one survey.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Northwestern University	Emory University, University of North Carolina, Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Systolic Blood Pressure	Systolic blood pressure will be collected on all participants at baseline and 6 months.; Change of Systolic blood pressure from baseline will be measured, only in those who are diagnosed with hypertension. Negative Least Square Means indicate a decrease of systolic blood pressure, whereas a positive Least Square Means indicate an increase of systolic blood pressure by 6 Months.; Analyses were performed using Generalized linear models (PROC GENMOD), with an identity link.; Confounding variables, such as mean systolic blood pressure at baseline, gender, age, race, and number of prescribed medications were included as fixed effects in the models. Results are presented as adjusted least square means with 95% Confidence Intervals.	6 months after Baseline
Other	Hemoglobin A1c	Hemoglobin A1c (hbA1c) will be collected on diabetic patients only, at baseline and 6 months.; Change of hbA1c from baseline is modelled. A positive Least Square Mean indicates an increase of hbA1c at 6 months, whereas a negative Least Square Mean indicates a decrease of hbA1c.; Analyses were performed using Generalized linear models (PROC GENMOD), with an identity link.; Confounding variables, such as hbA1c at baseline, gender, age, health status, language, medication regimen complexity index (MRCI), and health literacy (Newest Vital Sign) were included as fixed effects in the models. Results are presented as adjusted least square means with 95% Confidence Intervals.	6 months after Baseline
Primary	Medication Adherence - Pill Count	Pill Count is conducted for all pill form medications using an electronic pill counter at baseline and 6 months. The proportion of pills taken over pills prescribed (PT/PP) will be calculated for each medication at each time point. 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.; Analyses were performed using 2-level Generalized linear models (PROC GENMOD), with medications nested in participants and with a logit link.; Confounding variables, such as adherence at baseline, gender, age, language, health status and medication regimen complexity index (MRCI) were included as fixed effects in the models. Results are presented as predicted probabilities with 95% Confidence Intervals.	6 months after Baseline
Primary	Medication Adherence - Proper Use	Participants are asked questions about their 24 hour recall of medication use for each of their medications; they are asked to specify the amount taken (dose), the number of times the med was taken (frequency), the total number of pills taken, and when the doses were taken (to calculate spacing: hours between doses). Proper Use will be scored as yes or no, reflecting having demonstrated all of the following: correct dose, frequency, total and spacing based on the medication bottle instructions. Results are presented as predicted probabilities with 95% Confidence Intervals.; Analyses were performed using 2-level Generalized linear models (PROC GENMOD), with medications nested in participants and with a logit link.; Confounding variables, such as recruitment time, clinic, health status, gender, age, time effect, and medication regimen complexity index (MRCI) were included as fixed effects in the models.	6 Months after Baseline
Primary	Medication Adherence - ASK12	Participants completed the ASK-12 questionnaire, a brief measure of adherence that cover three key domains: inconvenience/forgetfulness, treatment beliefs and behavior.; 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.; Analyses were performed using Generalized linear models (PROC GENMOD), with a repeated subject effect, and an identity link.; Confounding variables such as health status, gender, age, health activation (CHAI), language, time effect and number of chronic conditions were included as fixed effects in the models. Results are presented as predicted probabilities with 95% Confidence Intervals.	6 Months after Baseline