Clinical trial NCT06522698: Optimizing Research Data Acquisition With Smart Pill Bottles
Official title: Optimizing Research Data Acquisition With Smart Pill Bottles: A Feasibility and Implementation Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain
Opioid Use
Keywords: Major abdominal surgery
Connected Technology
Chronic Pain
Postoperative pain
Opioid consumption
Smart Pill Bottles
Lead sponsor: Ciusss de L'Est de l'Île de Montréal
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 155
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn if smart pill bottles can be used as a tool to optimize data collection in clinical trials by increasing the quality of data collected and limiting the associated cost. The main questions it aims to answer are:

Is the use of smart pill bottles a feasible method of data collection in clinical trials in terms of patient adherence.

Is the data collected by the smart pill bottles of higher quality than that collected through human resources? What is the impact of the use of smart pill bottles on the costs involved in clinical trials ?

Researchers will collect data on postoperative opioid medication consumption with the smart pill bottle and assess the adherence of patients to the device along with the quality of data collected and the costs involved in the process.

Participants will:

Use the smart pill bottle to consume opioid medication following surgery for 3 months At the end of the 3 month period, the group will have filled out surveys detailing their opioid consumption, surgical pain and other relevant information.

Detailed description: Several studies involving harnessing new technology to approach data collection have suggested that a streamlined and automated method of collecting data through connected technology can help set up cohort studies more cost-effectively. Evaluating the use of a connected device as a research tool in clinical trials and comparing it with traditional data collection using human resources would provide valuable insights into its efficiency and effectiveness. Smart medication adherence monitoring devices are a novel technology that provides objective and granular medication utilization data along with engaging patients with their treatment. Particularly, the smart pill bottle (SPB) is a rapidly developing technology that allows for medication monitoring of solid doses with the use of electronic sensors that can collect data on medication usage in real time and offer direct communication between patients and healthcare professionals or trialists. SPBs have shown efficacy in monitoring compliance and possibly increasing medication adherence in the clinical setting and the technology has been suggested as a potential research tool that would allow automatic collection of granular and precise data on the time of medication intake, dose, and frequency. However, there hasn't been a trial comparing the efficacy of using SPBs for data collection in clinical trials versus the traditional method reliant on human resources in comparable contexts. Based on the properties of SPBs and available literature supporting the automatization and streamlining of data in clinical trials, the investigators believe that the use of these devices may allow data collection of higher quality regarding granularity, number of losses of follow-up, completeness, missing data points along with a reduction of costs incurred by avoiding the use of human resources.

The aim of this study is to evaluate the feasibility of using smart pill bottles (SPBs) to optimize data collection in the context of randomized control trials.

The project will be a prospective observational study conducted at the CIUSSS-de-l'Est-de-l'Île-de-Montréal (Hôpital Maisonneuve-Rosemont) over a period of 6 to 12 months.

To do so, 155 patients undergoing major abdominal surgery with postoperative opioid medication prescription will be recruited. These patient's medication consumption will be monitored with the use of a smart pill bottle for a duration of 90 days. The results of this cohort will be compared with a historical cohort from a previous study conducted within the same hospital network. The protocol for the current trial was purposefully designed to be comparable to that of this historical cohort.

A loan of 50 SPBs will be obtained from Thess Corporate (Company producing smart pill bottles).

Eligibility criteria: Inclusion Criteria:

* All consenting adult patients (age \>17 years) undergoing major abdominal surgery via laparotomy (any open surgery involving the abdominal compartment or its wall, excluding appendectomies, inguinal hernia repairs, abdominal wall hernia repairs, and incisional hernia repairs)

Exclusion Criteria:

* Patients enrolled in the historical cohort (POCAS study)
* Patients currently participating in another study
* Patients planned to undergo additional surgery within 90 days after the surgery
* Patients who do not understand French or English.
* Patients planned to be redirected to a secondary care or rehabilitation establishment following discharge
* Patients with diagnosed cognitive impairment

Primary outcomes:
measure: Patient adherence to data collection method
timeFrame: 3 months
Secondary outcomes:
measure: The quality of data acquired through the SPBs
timeFrame: 3 months
measure: The costs incurred from carrying out the project
timeFrame: 3 months
measure: The time for recruitment of patients
timeFrame: Up to12 months
measure: Prevalence of persistent opioid consumption 90 days after surgery
timeFrame: 7 days
measure: Prevalence of Chronic post-surgical pain 90 days after surgery
timeFrame: 7 days
measure: Change in Quality of Life
timeFrame: 3 months
Other outcomes:
Locations:
city: Montréal-Est
country: Canada
facility: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal
state: Quebec
Study officials:
affiliation: Ciusss de L'Est de l'Île de Montréal
name: Pascal Laferriere-Langlois, MD, MSc
role: PRINCIPAL_INVESTIGATOR
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