Clinical trial NCT04762303: Spread and Scale of a Polypharmacy App
Official title: Spread and Scale of a Polypharmacy App to Improve Health Outcomes of Older Adults Living in New Brunswick Nursing Homes: an Effectiveness-Implementation Hybrid Type 2 Study Design for a Stepped Wedge Cluster Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Polypharmacy
Deprescribing
Adverse Drug Event
Keywords: Polypharmacy
Deprescribing
Adverse Drug Event
Older Adults
Long-Term Care
Medication Use
Medication Review
Nursing Home
Prescription Check-Up
Lead sponsor: Centre for Innovation and Research in Aging, Canada
Sponsor class: OTHER
Collaborators: name: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Horizon Health Network
name: Missing Link Technologies
name: New Brunswick Community College
First posted: 2021-02-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Medication overload is an epidemic causing widespread harm, particularly to older Canadians. While most prescriptions are intended to help people live longer and healthier lives, taking multiple medications can increase frailty, and lead to dangerous side effects.This is a mixed-methods study to determine the impact of MedReviewRx on prescribing in New Brunswick Nursing Homes (NBNHs). MedReviewRx is an application which allows MedSafer to analyze a person's medications and medical conditions and produce a report with suggestions for how to simplify medications and make them safer. MedSafer reports will be used to assist physicians and pharmacists identify potentially inappropriate medications (PIMs) and conduct medication reviews in NBNHs. The prevalence of PIMs in NBNHs before MedReviewRx will be measured and the change in PIM use after implementation will be calculated. User experience with MedSafer reports and MedReviewRx will be explored. Patient and Family attitudes towards deprescribing will also be studied. Investigators hypothesize that implementing MedReviewRx in New Brunswick Nursing Homes (NBNHs) will promote deprescribing which will lead to a decrease in the number of PIMs and a decrease in medication costs for older adults living in NBNHs.

Detailed description: Medication overload is an epidemic causing widespread harm, particularly to older Canadians. While most prescriptions are intended to help people live longer and healthier lives, taking multiple medications can increase frailty, and lead to dangerous side effects. As people age, the way medicines work may change and certain medicines are more likely cause problems with memory, thinking and balance. To minimize these risks, it is important to regularly review all medicines an older adult is taking. A medication review can be complicated, and it takes time. MedSafer is a computer program that helps physicians and pharmacists identify medicines that may no longer be needed or are dangerous. The software runs an analysis of a person's medications and medical conditions and produces a report with suggestions for how to simplify combinations of medications and make them safer. The process of safely reducing medications is called deprescribing. A computer application powered by MedSafer was built for nursing homes. This Polypharmacy App was piloted at a large urban nursing home. Initial impression of the system was positive. Improvements were made and it was rebranded as MedReviewRx. The current study will test MedReviewRx in other nursing homes in New Brunswick. MedReviewRx allows health care providers (prescribers, pharmacists and nurses) in nursing homes to access MedSafer analysis on a tablet or laptop. The investigators expect that access to this information will promote deprescribing in nursing homes, reduce potentially inappropriate medications (PIMs) and result in cost savings.

This study is a hybrid type 2 effectiveness-implementation design for quality improvement research that will make use of mixed methods of evaluation. Implementation consists of using MedReviewRx. Effectiveness analysis consists of measuring the impact of the MedReviewRx on PIMs. Exploratory surveys (the mixed methods component of the study) which look at qualitative and quantitative user feedback and patient and caregiver attitudes about deprescribing will be used to explain study findings. Informal feedback, surveys and semi-structured interviews will be used to examine user experience with MedReviewRx. The Revised Patient Attitude Towards Deprescribing (rPATD) questionnaire "older adult" version for the patients and a "caregiver" version for family members/substitute decision makers will be used to describe patient and family member attitudes about deprescribing medications.

Estimated study duration is 18 months. Deployment will approximate a Stepped Wedge Cluster Randomized Trial Design (SW-CRT). This type of study design allows us to approximate a randomized clinical trial. It has many advantages and is considered the most robust type of study design for a pragmatic quality improvement intervention. All clusters act as an internal control (before and after) as well as a control for the other clusters (external control). This novel study design addresses issues with seasonality and allows all clusters to participate in the intervention, which is an advantage when the intervention is related to quality improvement. It also allows us to measure for within and between cluster comparisons. Moreover, stepped-wedge trials are claimed by many researchers to have a statistical advantage over parallel cluster randomized trials. In the same direction, more researchers state that on one hand, for cluster randomized trials (CRTs), the stepped wedge design is far more efficient than the parallel group and ANCOVA design in terms of sample size. On the other hand, these researchers also state that the stepped wedge design requires a substantially smaller sample size than a parallel group and ANCOVA design.

The study will have three clusters with a combined total of approximately 750 nursing home beds. Nursing home resident turnover rates may be as high as 30% per year therefore the researchers anticipate that up to 1000 residents will be screened by MedSafer at least once and 300 of them, or more, will have a potentially inappropriate medication (PIM) identified. A random generator was used to place participating nursing homes into the following three clusters:

Cluster 1: 3 months control + 9 months intervention

Cluster 2: 6 months control + 6 months intervention

Cluster 3: 9 months control + 3 months intervention

As illustrated, the study will begin with a minimum three-month control phase. During the control phase, MedReviewRx will not be accessible to health care professionals at the nursing homes. This serves to obtain baseline deprescribing levels for each nursing home. Every three to four months thereafter, a cluster of nursing homes will enter intervention mode.

During the control phase, nursing home residents and their families or substitute decision makers will be recruited to complete a survey to explore patient attitudes about deprescribing in this NB study population. The rPATD questionnaire "older adult" version will be provided to nursing home residents and the "caregiver" version will be provided to family members and substitute decision makers. Survey questions will be entered in Lime survey to promote electronic completion whenever possible. A recruitment poster will be displayed at study sites and a recruitment communication will be sent to family members and substitute decision makers identified in the resident's admission package. Paper copies will also be available from the study site contact. Residents and family members who ask nursing home staff about the survey will have their contact information forwarded to the Centre for Innovation and Research in Aging (CIRA) research manager to answer questions and obtain verbal consent to have a survey e-mailed to them. If e-mail is not available, a research assistant will contact the participant to administer the survey over the phone. Study site contacts may also distribute paper copies of the surveys if requested and permitted by the study site. Stamped envelopes addressed to the CIRA research manager will be provided with each paper survey distributed.

Also during the control phase, health care providers and study site staff will be recruited to register for MedReviewRx. A recruitment communication will be sent by e-mail and placed in study site mailboxes. Study recruitment will also be encouraged at interdisciplinary nursing home meetings such as Pharmacy and Therapeutics and Medical Advisory Committee meetings. User training will be provided by the study site contact or designate(s) as determined by the site-specific implementation plan. Nursing home site contacts will participate in an interview to evaluate MedReviewRx implementation. Implementation interviews will be conducted within the first 3 months of the site intervention phase videoconference by the CIRA research manager or designate via telephone or Zoom.

During the intervention phase, MedReviewRx will be made available to nursing homes with the understanding that it will be used to facilitate medication reviews and prescription check-ups. MedReviewRx provides clinicians with access to individualized and prioritized deprescribing information from MedSafer which: a) identifies PIMs, b) explains why the medication is potentially inappropriate and c) provides instructions on how to safely stop/taper the medication. Nursing homes will also have the option to print MedSafer deprescribing reports from MedReviewRx for clinicians who do not have computer access or who choose not to register to use MedReviewRx. If reports are printed, they will be placed in a binder for the prescriber to sign and date indicating that they have read the report. Prescribers and nursing home staff will be encouraged to write feedback directly on the report if they wish too. To assess the proportion of reports that were read, and feedback provided on the reports, signed reports will be kept in a locked cabinet for research assistants to collect.

Clinicians will review deprescribing opportunities (electronically or via a paper report) and determine if medications can be tapered or stopped. Medication changes are discussed with the resident or substitute decision maker as part of usual care. This process will not change with the implementation of MedReviewRx. If the prescriber decides to alter a medication based on the deprescribing opportunities provided by MedSafer and their expert knowledge, the prescriber will do so in the same manner as they did prior to implementation of MedReviewRx, and discussion with the resident and/or substitute decision maker will occur according to the process in place at each nursing home. During the intervention phase, an analysis of deprescribing opportunities will be conducted by MedSafer once every 3 months for each resident in the nursing home. Results will be stored in the MedReviewRx system to be accessed at any time.

User feedback on MedReviewRx and MedSafer deprescribing information will be solicited from prescribers, pharmacists and nursing home staff throughout the study using surveys. Surveys may be completed via Lime Survey, on paper or by telephone (depending on the preference of the person). Three surveys will be distributed by e-mail to registered MedReviewRx users as well as other study site prescribers, pharmacists and nurses who may have access to printed reports from MedReviewRx. A MedReviewRx user feedback survey will be distributed at the end of the first and third quarter of the intervention and an acceptability and feasibility survey will be distributed at the end of the study. Informal feedback received by e-mail from users will be reviewed and actioned by the CIRA research manager or designate. E-mail feedback will be documented anonymously in an excel spreadsheet and reported to the study principle investigators within 1 week of receipt to determine if tasks need to be submitted to the technical team for software updates. Rapid cycle improvements in usability of the system and MedSafer output will be made based on survey results and informal feedback.

Informal feedback written on printed MedSafer reports will be documented in an excel spreadsheet and included in the analysis of qualitative feedback provided by survey and interview. Frequency of MedReviewRx use will be measured electronically by counting the number of times a user accesses their account. Overall experience with the research project will be evaluated using semi-structured interview conducted at the end of the intervention period.

Eligibility criteria: Inclusion Criteria:

* All residents of the participating New Brunswick nursing homes (NBNHs)
* All residents who are 65 years of age or older
* All residents who are taking a potentially inappropriate medication (as identified by MedSafer)

Exclusion Criteria:

* If both the patient and proxy are unable to complete the survey, the patient will be excluded from the survey component of the study.

Primary outcomes:
measure: Impact of MedReviewRx on the prevalence of potentially inappropriate medications (PIMs) in New Brunswick nursing homes (NBNHs).
timeFrame: Baseline to 3 months
Secondary outcomes:
measure: Proportion of patients with one or more PIM reduced or stopped following each cycle.
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Proportion of patients with one or more PIM reduced or stopped following each cycle.
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Proportion of patients with one or more PIM reduced or stopped following each cycle.
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Number of deaths
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Number of deaths
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Number of deaths
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Number of fractures
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Number of fractures
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Number of fractures
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Number of falls
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Number of falls
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Number of falls
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Number of restraints
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Number of restraints
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Number of restraints
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Number of transfers to the hospital
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Number of transfers to the hospital
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Number of transfers to the hospital
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Change in functional status based on interRAI activities of daily living (ADL) scores.
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Change in functional status based on interRAI activities of daily living (ADL) scores.
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Change in functional status based on interRAI activities of daily living (ADL) scores.
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Number of participants with transfers out of the institution (return to independent living)
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Number of participants with transfers out of the institution (return to independent living)
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Number of participants with transfers out of the institution (return to independent living)
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Number of participants with episodes of delirium based on responses to questions in Section C of the interRAI LTCF assessment form
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Number of participants with episodes of delirium based on responses to questions in Section C of the interRAI LTCF assessment form
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Number of participants with episodes of delirium based on responses to questions in Section C of the interRAI LTCF assessment form
timeFrame: 90-days following the third intervention cycle (3-months)
measure: Number of changes from baseline in composite safety data
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Number of changes from baseline in composite safety data
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Number of changes from baseline in composite safety data
timeFrame: 90-days following the third intervention cycle (3-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured by survey responses.
timeFrame: 90-days following the first intervention cycle (9-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured by survey responses.
timeFrame: 90-days following the second intervention cycle (6-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured by survey responses.
timeFrame: 90-days following the third intervention cycle (3-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured through interview data.
timeFrame: 90-days following the first intervention cycle (9-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured through interview data.
timeFrame: 90-days following the second intervention cycle (6-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured through interview data.
timeFrame: 90-days following the third intervention cycle (3-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured through informal feedback received by the study team.
timeFrame: 90-days following the first intervention cycle (9-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured through informal feedback received by the study team.
timeFrame: 90-days following the second intervention cycle (6-months)
measure: User experience with MedSafer reports and MedReviewRx. Measured through informal feedback received by the study team.
timeFrame: 90-days following the third intervention cycle (3-months)
Other outcomes:
measure: Cost savings
timeFrame: 1 year
measure: Patient and family attitudes about deprescribing
timeFrame: 90-days following the first intervention cycle (9-months)
measure: Patient and family attitudes about deprescribing
timeFrame: 90-days following the second intervention cycle (6-months)
measure: Patient and family attitudes about deprescribing
timeFrame: 90-days following the third intervention cycle (3-months)
Locations:
city: Fredericton
country: Canada
facility: York Care Centre
state: New Brunswick
city: Moncton
country: Canada
facility: Faubourg du Mascaret
state: New Brunswick
city: Moncton
country: Canada
facility: Spencer Nursing Home
state: New Brunswick
city: Quispamsis
country: Canada
facility: Shannex Embassy Hall
state: New Brunswick
city: Saint John
country: Canada
facility: Loch Lomond Villa
state: New Brunswick
Study officials:
affiliation: Horizon Health Network
name: Carole Goodine, Pharm D
role: PRINCIPAL_INVESTIGATOR
affiliation: McGill University Health Centre/Research Institute of the McGill University Health Centre
name: Emily McDonald, MD
role: PRINCIPAL_INVESTIGATOR
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