AdherenceNCT02820753

A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens

A study testing EHR + (Text or Portal) in people with Adherence, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 50 years and older
Conditions the study is for: Adherence
What is being tested?: EHR + (Text or Portal)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 677 participants
Where: 1 siteUnited States
Study dates: 3 Apr 2017to 21 Sep 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University
Chicago, Illinois, 60611

Other trials in United States

About this study

Read the detailed 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:

Compare the effectiveness of the UMS EHR tools, with or without SMS and/or Portal interventions.
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
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.

Conditions: Adherence
Being tested: EHR + (Text or Portal)
Keywords: Universal Medication Schedule, Health Literacy, Medication adherence
Medical subject headings: Medication Adherence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

EHR + (Text or Portal)Behavioural
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.

Study groups in NCT02820753
Study group	Role	What they receive
Enhanced Usual Care	No intervention	Patients who have not received the initial 6 weeks of text message reminders telling them to take their medicines; or did not complete at least 1 portal survey that asks them if they filled their medications, if they had any side effects or concerns; or did not receive either intervention will be considered as enhanced usual care. Patients will only receive EHR tools (patient-friendly med-sheets about their medicines, MedList putting their medicines into the Universal Medication Schedule, and UMS sigs on their Rx bottles).
Text or Portal	Active comparator	Participants who received EHR strategies as well as, the initial 6 weeks of SMS messaging continuously that remind them to take their medicines; or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention. Receives: Behavioral: EHR + (Text or Portal)

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 6 months after Baseline
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.
Measured: 6 Months after Baseline
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.
Measured: 6 Months after Baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Apr 201721 Sep 2020

First posted1 Jul 2016 (estimated)
Study start3 Apr 2017
Primary completion21 Sep 2020
Study completion21 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for AdherenceStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 677 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02820753
Sponsor's protocol ID: 1R01AG046352-01A1
Status last verified: Jan 2022
First submitted: 16 May 2016
Last updated: 1 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Bailey SC, Wismer GA, Parker RM, Walton SM, Wood AJJ, Wallia A, Brokenshire SA, Infanzon AC, Curtis LM, Kwasny MJ, Wolf MS. Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults. Contemp Clin Trials. 2017 Nov;62:21-26. doi: 10.1016/j.cct.2017.08.013. Epub 2017 Aug 18.
PubMed 28823927

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Universal Medication Schedule to Promote Adherence to Complex Drug Regimens
ClinicalTrials.gov ID: NCT02820753
Acronym / sponsor ID: 1R01AG046352-01A1
Conditions: Adherence
Keywords: Universal Medication Schedule, Health Literacy, Medication adherence
Study type: Interventional
Recruitment status: Completed
Enrolment: 677 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Collaborators: University of North Carolina, Emory University, Vanderbilt University
Study start: 3 Apr 2017 (actual)
Primary completion: 21 Sep 2020 (actual)
Study completion: 21 Sep 2020 (actual)
First posted: 1 Jul 2016 (estimated)
Results: Posted 1 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The study aims to:

Compare the effectiveness of the UMS EHR tools, with or without SMS and/or Portal interventions.
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
Assess the costs required to deliver each of the interventions from a health system perspective

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Enhanced Usual Care	No intervention	–Patients who have not received the initial 6 weeks of text message reminders telling them to take their medicines; or did not complete at least 1 portal survey that asks them if they filled their medications, if they had any side effects or concerns; or did not receive either intervention will be considered as enhanced usual care. Patients will only receive EHR tools (patient-friendly med-sheets about their medicines, MedList putting their medicines into the Universal Medication Schedule, and UMS sigs on their Rx bottles).
Text or Portal	Active comparator	Behavioral: EHR + (Text or Portal)Participants who received EHR strategies as well as, the initial 6 weeks of SMS messaging continuously that remind them to take their medicines; or logged on to the patient portal and completed at least one survey will be considered as receiving the intervention.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

age 50+
English or Spanish speaking
Prescribed 3+ medications
Primarily responsible for administering own medication
Owns a cell phone and feels comfortable receiving texts

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
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.	Behavioural	Text or Portal

Primary outcome

Medication Adherence - Pill Count
Time frame: 6 months after Baseline
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.
Medication Adherence - Proper Use
Time frame: 6 Months after Baseline
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.
Medication Adherence - ASK12
Time frame: 6 Months after Baseline
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.

Results and safety

Results posted to the registry on 1 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Enhanced Usual Care	256	256
Text or Portal	421	421

Primary outcome: Medication Adherence - Pill Count

Time frame: 6 months after Baseline. Least squares mean (95% Confidence Interval). Unit: Probability of adherence (PT/PP => 0.8)

Measure	Enhanced Usual Care n = 143	Text or Portal n = 293
Value	0.46 (0.41 to 0.52)	0.53 (0.48 to 0.57)

Enhanced Usual Care vs Text or Portal: Mean Difference (Net): 0.26 (95% CI 0.01 to 0.51), p = 0.04, Mixed Models Analysis

Population analysed: 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

Primary outcome: Medication Adherence - Proper Use

Time frame: 6 Months after Baseline. Least squares mean (95% Confidence Interval). Unit: Probability of Proper Use (Yes)

Measure	Enhanced Usual Care n = 255	Text or Portal n = 421
Value	0.71 (0.68 to 0.73)	0.71 (0.69 to 0.73)

Enhanced Usual Care vs Text or Portal: Mean Difference (Net): 0.04 (95% CI -0.08 to 0.15), p = 0.53, Mixed Models Analysis

Population analysed: Observations were excluded if 1. the medication bottle had a missing label, or 2. participants did not complete the 24 hour med recall use questions

Primary outcome: Medication Adherence - ASK12

Time frame: 6 Months after Baseline. Least squares mean (95% Confidence Interval). Unit: score on a scale

Measure	Enhanced Usual Care n = 255	Text or Portal n = 421
Value	22.40 (21.75 to 23.05)	22.06 (21.48 to 22.65)

Enhanced Usual Care vs Text or Portal: Mean Difference (Net): -0.34 (95% CI -1.16 to 0.48), p = 0.41, Mixed Models Analysis

Adverse events

Time frame: 6 Months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Enhanced Usual Care	0 of 256 (0%)	0 of 256 (0%)	0 of 256
Text or Portal	0 of 421 (0%)	0 of 421 (0%)	1 of 421

Limitations and caveats (from the sponsor): Due to an NIA administrative hold from July 2018-April 2019, recruitment has halted for that time period and 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. Additionally, due to restrictions to in-person interviews due to COVID-19, we were unable to recruit new patients starting March 12, 2020

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28823927Bailey SC, Wismer GA, Parker RM, Walton SM, Wood AJJ, Wallia A, Brokenshire SA, Infanzon AC, Curtis LM, Kwasny MJ, Wolf MS. Development and rationale for a multifactorial, randomized controlled trial to test strategies to promote adherence to complex drug regimens among older adults. Contemp Clin Trials. 2017 Nov;62:21-26. doi: 10.1016/j.cct.2017.08.013. Epub 2017 Aug 18.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael S Wolf, PHD principal investigator

Northwestern University

Stacy C Bailey, PHD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing EHR + (Text or Portal) in people with Adherence, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Medication Adherence - Pill Count (time frame: 6 months after Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02820753, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.