Feasibility of a randomized controlled trial of symptom screening and feedback to healthcare providers compared with standard of care using the SPARK platform

2019 ◽  
Vol 28 (6) ◽  
pp. 2729-2734
Author(s):  
Sadie Cook ◽  
Emily Vettese ◽  
George A. Tomlinson ◽  
Dilip Soman ◽  
Tal Schechter ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Healthcare Providers ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Symptom Screening

scholarly journals Protocol for a multicenter randomized controlled trial comparing a non-opioid prescription to the standard of care for pain control following arthroscopic knee and shoulder surgery

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Aaron Gazendam ◽  
◽  
Seper Ekhtiari ◽  
Nolan S. Horner ◽  
Nicole Simunovic ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Pain Control ◽  
Shoulder Arthroscopy ◽  
Controlled Trial ◽  
Arthroscopic Surgery ◽  
Standard Of Care ◽  
Opioid Prescription ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Arthroscopic Knee

Abstract Background Opioids continue to be the analgesic of choice for postoperative pain control following arthroscopic knee and shoulder surgery. Despite their widespread use, there are limited evidence-based clinical practice guidelines for postoperative opioid prescribing. The Non-Opioid Prescriptions after Arthroscopic Surgery in Canada (NO PAin) Trial is a randomized controlled trial (RCT) designed to determine whether a non-opioid analgesia approach to postoperative pain, compared to usual care, reduces oral morphine equivalents (OME) consumed in patients undergoing outpatient knee and shoulder arthroscopy. Methods This is a multi-centre, RCT with a target sample size of 200 patients. Adult (18+ years of age) patients undergoing outpatient knee and shoulder arthroscopy will be randomized to a non-opioid postoperative protocol (intervention) or the current standard of care (control). The intervention will consist of a standardized non-opioid analgesic prescription, a limited rescue opioid prescription, and a patient education infographic. The control is defined as the treating surgeons’ pre-trial postoperative analgesic regimen. Exclusion criteria include chronic opioid use, concomitant open surgery, contraindications to the prescribed analgesics or ongoing workers compensation/litigation. The primary outcome is OMEs consumed at 6 weeks postoperatively. Secondary outcomes will include patient-reported pain and satisfaction, quantity of OMEs prescribed, number of opioid refills, and any adverse events up to 6 weeks postoperatively. Utilizing the intention to treat principle for all analyses, independent samples t-test and presented with a p-value as well as a mean difference (MD) with 95% confidence intervals (CIs) will be performed for primary and secondary outcomes. Discussion The ongoing opioid epidemic and overprescribing of opioids in orthopaedics serve as the rationale for this trial. There is a lack of evidence upon which to develop post-operative pain management guidelines for patients undergoing arthroscopic surgery. A prospective evaluation of this relatively inexpensive intervention will demonstrate whether an explicit effort to reduce the number of opioids prescribed results in a reduction in the amount of opioids consumed and help to inform future studies and guidelines. Trial registration The NO PAin trial has been prospectively registered with clinicaltrials.gov (NCT04566250).

scholarly journals Testing a Real-Time Tenofovir Urine Adherence Assay for Monitoring and Providing Feedback to Preexposure Prophylaxis in Kenya (PUMA): Protocol for a Pilot Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Paul Drain ◽  
Kenneth Ngure ◽  
Nelly Mugo ◽  
Matthew Spinelli ◽  
Purba Chatterjee ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Real Time ◽  
Point Of Care ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Preexposure Prophylaxis ◽  
Adherence Monitoring ◽  
First Time

BACKGROUND The worldwide expansion of preexposure prophylaxis (PrEP) with oral tenofovir-disoproxil-fumarate/emtricitabine will be critical to ending the HIV epidemic. However, maintaining daily adherence to PrEP can be difficult, and the accuracy of self-reported adherence is often limited by social desirability bias. Pharmacologic adherence monitoring (measuring drug levels in a biomatrix) has been critical to interpreting PrEP trials, but testing usually requires expensive equipment and skilled personnel. We have recently developed a point-of-care (POC) immunoassay to measure tenofovir in urine, allowing real-time adherence monitoring for the first time. OBJECTIVE The goal of this study is to examine a point-of-care adherence metric in PrEP to support and increase adherence via a randomized controlled trial. METHODS The paper describes the protocol for a pilot randomized controlled trial to test the acceptability, feasibility, and impact on long-term adherence of implementing a POC urine test to provide real-time adherence feedback among women on PrEP. Eligible women (n=100) will be HIV-negative, ≥18 years old, and recruited from a clinic in Kenya that provides PrEP. Participants will be randomized 1:1 to the intervention of providing real-time feedback via the assay versus standard of care adherence counseling. Acceptability by participants will be assessed by a quantitative survey, as well as by qualitative data collected via in-depth interviews (n=20) and focus group discussions (n=4 groups, 5-10 women each). Feasibility will be assessed by the proportion of women retained in the study, the mean number of missed visits, the proportion of planned urine assessments completed, and messages delivered, while in-depth interviews with providers (n=8) will explore the ease of administering the urine test. Tenofovir levels in hair will serve as long-term adherence metrics. A linear mixed-effects model will estimate the effect of the intervention versus standard of care on logarithmically transformed levels of tenofovir in hair. RESULTS This study has been funded by the National Institute of Health, approved by the Kenya Medical Research Institute Institutional Review Board, and will commence in June 2020. CONCLUSIONS A novel urine assay to measure and deliver information on adherence to PrEP in real-time will be tested for the first time in this trial planned among women on PrEP in Kenya. Study findings will inform a larger-scale trial assessing the impact of real-time adherence monitoring/feedback on HIV prevention. Improving adherence to PrEP will have long-term implications for efforts to end the HIV epidemic worldwide. CLINICALTRIAL ClinicalTrials.gov NCT03935464; https://clinicaltrials.gov/ct2/show/NCT03935464 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/15029

scholarly journals Digital Treatment of Back Pain versus Standard of Care: The Cluster-Randomized Controlled Trial, Rise-uP

2020 ◽  
Vol Volume 13 ◽  
pp. 1823-1838
Author(s):  
Janosch A Priebe ◽  
Katharina K Haas ◽  
Leida F Moreno Sanchez ◽  
Karin Schoefmann ◽  
Daniel A Utpadel-Fischler ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Back Pain ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Cluster Randomized Controlled Trial ◽  
Randomized Controlled ◽  
Cluster Randomized

scholarly journals GoPerio - impact of a personalized video and an automated two-way text-messaging system in oral hygiene motivation: study protocol for a randomized controlled trial

Trials ◽  
2019 ◽  
Vol 20 (1) ◽  
Author(s):  
Valentin Garyga ◽  
Florian Pochelu ◽  
Béatrice Thivichon-Prince ◽  
Walid Aouini ◽  
Julie Santamaria ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Behavior Change ◽  
Motivational Interviewing ◽  
Oral Hygiene ◽  
Controlled Trial ◽  
Standard Of Care ◽  
Randomized Controlled ◽  
Secondary Outcomes ◽  
Personalized Video

Abstract Background Oral hygiene is of paramount importance for the preservation of oral health, and for patients affected by periodontal disease establishing an effective oral hygiene routine is the first step of therapy. Several clinical frameworks have been developed to foster behavior change, such as motivational interviewing. However, two obstacles can be identified. First, patients tend to forget the advice they were given during the consultation. Second, it is hard to maintain motivation in the long term, thus leading to relapse. An innovative eHealth solution was designed with the aim to tackle both obstacles and supplement the current clinical standard of care. The primary objective is to compare the full mouth plaque scores of study groups (eHealth plus standard of care versus standard of care only) at 8 weeks of follow up. The main secondary objective is to compare the full mouth bleeding score at 8 weeks of follow up. Methods/design The “GoPerio” study is a multicenter, randomized, controlled trial assessing the impact of a novel eHealth concept for oral hygiene motivation (personalized video of oral hygiene routine available for the patient via a cloud server plus interactive text messages) in addition to the current standard of care (motivational interviewing plus tooth scaling and polishing). The minimum sample size required is 86 patients. Participants will be randomized (allocation ratio 1:1): test group (eHealth plus standard of care) versus control group (standard of care only). The primary outcome is oral hygiene as measured by the full mouth (six sites per tooth) plaque control record (PCR) index. The main secondary outcome is gingival inflammation as measured by the full mouth (six sites per tooth) bleeding on probing (BOP) index. Both the primary and the main secondary outcomes are evaluated by blinded and calibrated examiners at 8 weeks of follow up. The other secondary outcomes are patient satisfaction and patient behavior change and motivation. Discussion The study will investigate the value of an innovative eHealth approach to strengthen patient motivation for oral hygiene. If proven effective, such an approach would supplement the current clinical standard of care, resulting in improved clinical outcomes with negligible impact on productivity in a dental practice. Trial registration ClinicalTrials.gov, NCT03109808. Registered on 12 April 2017. Sponsor: Hospices Civils de Lyon. BP 2251, 3 quai des Célestins, 69,229 Lyon cedex 02. Protocol version: 1.0 as of 21 September 2016.

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