Opioid Use, Post Operative Pain
Conditions
Keywords
Major abdominal surgery, Connected Technology, Chronic Pain, Postoperative pain, Opioid consumption, Smart Pill Bottles
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).
Interventions
DEVICESmart Pill Bottle
Patients in the intervention group will have their opioid medication consumption monitored through a smart pill bottle that records medication usage and streamlines the data into an online platform accessible by the medical staff. This group will also fill out surveys delivered through the smart pill bottle's online platform.
Sponsors
Ciusss de L'Est de l'Île de Montréal
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient adherence to data collection method | 3 months | The percentage of patients that will have used the smart pill bottle (SPB) until the end of the 90-day period or until the absence of pain, as opposed to any change in medication intake strategy that results in ceasing the use of the SPB. (High percentage is a better outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The quality of data acquired through the SPBs | 3 months | The granularity of data acquired, the preciseness of data points, the number of loss of follow-up compared with the historical cohort from the POCAS study which collected data from a comparable patient group through human resources. |
| The costs incurred from carrying out the project | 3 months | The costs incurred from carrying out the project compared with the historical cohort from the POCAS study which collected data from a comparable patient group through human resources. |
| The time for recruitment of patients | Up to12 months | The time for recruitment of patients compared with the historical cohort from the POCAS study which collected data from a comparable patient group through human resources. (Lower time is a better outcome) |
| Prevalence of Chronic post-surgical pain 90 days after surgery | 7 days | The presence of chronic post-surgical pain (CPSP) in the 7 days prior to the interrogation (interrogation occurs at 90 days post-op). CPSP will be defined as any pain at the surgical site for patients who had pain at that site before surgery (by 1 point on the general numerical pain scoring question of the BPI questionnaire) (12). |
| Change in Quality of Life | 3 months | The change in the reported quality of life at 90 days post-op. QOL will be measured as a continuous variable on the SF-12 questionnaire. |
| Prevalence of persistent opioid consumption 90 days after surgery | 7 days | Persistent opioid consumption (POC) 90 days after surgery as reported by the SPBs. POC will be defined as consumption of any quantity of opioids in the 7 days prior to the 90-day interrogation. This definition will be accurate for both preoperative chronic and non-chronic opioid users. (Higher rate of persistent consumption is a worse outcome) |
Countries
Canada
Contacts
Primary ContactPascal Laferriere-Langlois, MD, MSc
Backup ContactNadia Godin, NR
Outcome results
None listed