Optimizing Research Data Acquisition With Smart Pill Bottles
NCT Number: NCT06522698
Acronym: SPB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Post Operative Pain|Opioid Use
Interventions: DEVICE: Smart Pill Bottle
Sponsor: Ciusss de L'Est de l'Île de Montréal
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 155
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-01
Completion Date: 2025-07-01
Locations: Maisonneuve-Rosemont Hospital - CIUSSS de l'Est de l'Île de Montréal, Montréal-Est, Quebec, H1T2M4, Canada

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.

Primary Outcome Measures: Patient adherence to data collection method, 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), 3 months
Secondary Outcome Measures: The quality of data acquired through the SPBs, 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., 3 months|The costs incurred from carrying out the project, 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., 3 months|The time for recruitment of patients, 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), Up to12 months|Prevalence of persistent opioid consumption 90 days after surgery, 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), 7 days|Prevalence of Chronic post-surgical pain 90 days after surgery, 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)., 7 days|Change in Quality of Life, 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., 3 months