Evaluating Smart Pill Bottles in Clinical Trials

Clinical trials are important for testing new medical treatments to see if they work and are safe for patients. Recently, the number of clinical trials has increased significantly, with many drug developers starting more than 20,000 trials every year. This increase shows that there is a growing need for detailed scientific methods to guide medical practices and health policies.

While large clinical trials can provide good information, they often take a lot of time and money to complete. Additionally, the size of these trials can be limited by the resources available. When patients drop out of the study, it can lead to biased results. Even with the high Costs, these trials are a key part of expanding medical knowledge and improving patient care. Therefore, finding ways to make clinical trials more cost-effective is very important. This could help recruit more patients and improve the quality of the research outcomes.

#Improving Data Collection in Clinical Trials

One way to make clinical trials better and more cost-efficient is by using new technologies to collect data. Recent studies suggest that connected devices can help streamline the data collection process. For instance, smart medication tracking devices can offer detailed information on how patients take their medications while also keeping them engaged with their treatment.

One of these devices is called a smart pill bottle (SPB). It's a new technology that helps doctors monitor how and when patients take their medications. The SPB uses sensors to track medication use in real-time, allowing for direct communication between the patient and the healthcare team. Initial results show that using SPBs can improve how well patients follow their medication schedules and generate better data for researchers.

However, there hasn't been a study comparing smart pill bottles to traditional methods of data collection in a clinical trial setting. Based on existing literature, using SPBs could lead to the collection of higher quality data, with fewer gaps and missing information, while also cutting costs by reducing the need for extra human resources.

#Case Study: POCAS Trial

Earlier this year, a study called POCAS (Persistent Opioid Consumption after Major Abdominal Surgery and its Determinants) began at the University of Montreal. This study looks at how many patients continue to use opioids three months after surgery and how it relates to chronic pain and quality of life. It involved following 668 patients and collecting data through phone surveys and pharmacy reports, which took a lot of time and human effort.

The POCAS study shows how using a smart pill bottle could automate data collection and reduce costs while providing more precise information about how often and when medications are taken.

#Study Proposal: Using Smart Pill Bottles

The goal of our study is to see how well smart pill bottles can be used in clinical trials, specifically in the context of postoperative research. We want to explore how many patients adopt the use of SPBs, the quality of the data collected, and the costs involved.

#Objectives of the Study

1. Primary Objective: To evaluate how well smart pill bottles are used by patients after surgery.

2. Secondary Objectives:

   • Check the quality of data collected about Opioid Use for up to 90 days after surgery.
   • Assess the costs of using SPBs compared to traditional data collection methods.
   • Estimate how many patients continue using opioids and how this impacts their quality of life.
   • Measure Patient Satisfaction with the smart pill bottles.

3. Exploratory Objective: To use the real-time data collected by SPBs to improve statistical analysis, focusing on identifying patients at risk of developing chronic opioid use.

#Hypotheses

We think:

• Most patients will learn to use the SPBs correctly.
• The data from the SPBs will be accurate and detailed.
• Using SPBs will cost less compared to traditional data collection methods.
• The rate of ongoing opioid use will be around 10%.
• Patients will be satisfied with the use of SPBs.

#Study Design and Methods

This will be a single-center trial at the CIUSSS-de-l’Est-de-l’Île-de-Montréal (Hôpital Maisonneuve-Rosemont).

#Study Population

We will include adult patients (18 years and older) who are undergoing major abdominal surgery. We will exclude certain patients, such as those who are involved in other studies or who do not speak French or English.

Our primary focus is to see how many patients use the smart pill bottles correctly by the end of the 90-day period after their surgery.

#Data Collection

Once the patients give their consent, we will gather information about their background, medical history, and pain experiences through questionnaires. After surgery, they will use an SPB to monitor their opioid intake for 90 days.

If a patient doesn't record their medication use over a period of 48 hours, they will receive a notification asking why. If there's no response, the research staff will reach out to them directly.

At the end of the 90 days, we will collect final surveys about their health and satisfaction with the SPB.

#Timeline

We will recruit patients over a 12-month period, starting in December 2024. We aim to include around 69 patients based on expected recruitment rates. The monitoring period will last for 90 days per patient.

#Ethical Considerations

Before starting, we will get approval from the research ethics board. Patients will receive clear information about the study, and their consent will be obtained before they participate. Their information will be kept private and only used for this study.

#Financial Aspects

The smart pill bottles will be provided at no cost, but there will be expenses related to encapsulating the medication. The main costs will come from staff time and human resources needed to run the trial.

#Strengths and Limitations

This study aims to assess the effectiveness of smart pill bottles versus traditional methods. By doing this, it hopes to change how future clinical trials collect data, making processes easier and more advanced.

However, since the SPB tracks when a bottle is opened rather than how much medication is taken, there may be some inaccuracies. Additionally, the need for encapsulated medication may lead to higher costs.

#Conclusion

Using smart pill bottles could significantly improve how clinical trials are conducted, leading to better data collection and potentially lower costs. This study aims to demonstrate the benefits of advanced technology in clinical settings and its role in improving patient care.

By understanding how well these devices can work in real-world clinical trials, we can contribute to the future of medical research and improve patient outcomes.