Smart Pill Bottles for Postoperative Pain

(SPB Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Pascal Laferriere-Langlois, MD, MSc

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ciusss de L'Est de l'Île de Montréal

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Pascal Laferriere-Langlois, MD, MSc

Principal Investigator

Ciusss de L'Est de l'Île de Montréal

Eligibility Criteria

This trial is for individuals who have undergone surgery and are using opioid medication to manage postoperative pain. Participants will use a smart pill bottle for 3 months to track their medication usage. The study aims to include people who can adhere to the protocol and provide accurate data.

Inclusion Criteria

I am an adult who will have major surgery on my abdomen, not including simple procedures like appendectomy or hernia repairs.

Exclusion Criteria

Patients enrolled in the historical cohort (POCAS study)

Patients with diagnosed cognitive impairment

Patients currently participating in another study

Treatment Details

Interventions

• Smart Pill Bottle (Behavioural Intervention)

Trial Overview The trial is testing whether smart pill bottles are an effective way of collecting high-quality data on opioid consumption after surgery, while also looking at how they might reduce costs in clinical trials. Patients' adherence and the impact on cost-efficiency are key focuses.

Participant Groups

Group I: Smart Pill Bottle Data Collection Group Experimental Treatment 1 Intervention

Group of patients in which data on postoperative opioid medication consumption will be collected through the use of smart pill bottles.

Who Is Running the Clinical Trial?

Ciusss de L'Est de l'Île de Montréal

Lead Sponsor

Trials

81

Recruited

6,400+

Sylvain Lemieux

Ciusss de L'Est de l'Île de Montréal

Chief Executive Officer since 2018

Maîtrise en administration publique from ENAP, Certificat en leadership et habiletés de direction from Concordia University, Baccalauréat en service social from Université de Sherbrooke

Dr. Marie-Claude Roy

Ciusss de L'Est de l'Île de Montréal

Chief Medical Officer since 2020

MD from Université de Montréal