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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 10
- 主要终点
- Impact of MedReviewRx on the prevalence of potentially inappropriate medications (PIMs) in New Brunswick nursing homes (NBNHs).
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •If both the patient and proxy are unable to complete the survey, the patient will be excluded from the survey component of the study.
结局指标
主要结局
Impact of MedReviewRx on the prevalence of potentially inappropriate medications (PIMs) in New Brunswick nursing homes (NBNHs).
时间窗: Baseline to 3 months
The impact on PIMs will be determined by the proportion of nursing home residents who have one or more PIMs reduced or stopped after the treating physician receives a MedSafer report
次要结局
- Number of falls(90-days following the third intervention cycle (3-months))
- Proportion of patients with one or more PIM reduced or stopped following each cycle.(90-days following the third intervention cycle (3-months))
- Number of deaths(90-days following the third intervention cycle (3-months))
- Number of fractures(90-days following the third intervention cycle (3-months))
- Number of restraints(90-days following the third intervention cycle (3-months))
- Number of participants with transfers out of the institution (return to independent living)(90-days following the third intervention cycle (3-months))
- Number of transfers to the hospital(90-days following the third intervention cycle (3-months))
- Change in functional status based on interRAI activities of daily living (ADL) scores.(90-days following the third intervention cycle (3-months))
- Number of participants with episodes of delirium based on responses to questions in Section C of the interRAI LTCF assessment form(90-days following the third intervention cycle (3-months))
- User experience with MedSafer reports and MedReviewRx. Measured by survey responses.(90-days following the third intervention cycle (3-months))
- User experience with MedSafer reports and MedReviewRx. Measured through informal feedback received by the study team.(90-days following the third intervention cycle (3-months))
- User experience with MedSafer reports and MedReviewRx. Measured through interview data.(90-days following the third intervention cycle (3-months))
- Number of changes from baseline in composite safety data(90-days following the third intervention cycle (3-months))