Remote vs. In-Person Study Evaluation (RISE) Trial 1 of 3 to examine the impact of decentralized trial methods on accrual efficiency, retention, biospecimen capture, and treatment utilization: study protocol for a multi-center randomized controlled trial in the context of smoking cessation (RISE Above Smoking)
6 affiliations
- 1The University at Buffalo, Buffalo, NY USA
- 2University of Pennsylvania, Philadelphia, PA USA
- 3Medical University of South Carolina, Charleston, SC USA
- 4University of Alabama at Birmingham, Birmingham, AL USA
- 5Wake Forest University, Durham, NC USA
- 6Columbia University, New York City, NY USA
Abstract
Background: Remote trials (i.e., virtual or decentralized trials), in which patients receive some or all treatment and provide study data without the need to travel to a clinic or medical center, have emerged as a promising approach to conducting clinical trials. However, evidence for the hypothesized benefits of remote trials is weak, consisting primarily of anecdotal reports, uncontrolled studies, and expert opinion. The same is true for hypothesized limitations of remote trials such as technological barriers and aspects of trial rigor. A stronger evidence base is needed to evaluate the impact of remote trials.
Methods: Remote vs. In-Person Study Evaluation (RISE) was developed to examine the benefits and limitations of remote clinical trials and consists of separate randomized controlled trials (RCTs) for 3 different use cases. In RISE RCT 1 (RISE Above Smoking), the focus of this protocol paper, adults who smoke (AWS) cigarettes will be randomized to Remote vs. In-Person Intake Visit (written consent and eligibility screening). Intake-eligible participants will be re-randomized to Remote vs. In-Person Treatment and Assessment Visits. Recruitment will continue until 200 AWS initiate treatment. All participants will receive 8 weeks of combination nicotine replacement therapy (NRT; 14 or 21 mg transdermal nicotine patch, based on smoking rate, and 2 mg nicotine lozenges) and a printed self-help guide, and will be assessed through 3-month follow-up. Primary outcomes include accrual efficiency, retention, treatment utilization/adherence, and biospecimen completion rates. A key secondary clinical outcome (smoking cessation) will also be assessed. Subsequently, RISE RCTs 2 and 3 will employ harmonized timelines and outcomes in smaller (N = 100 participants who initiate treatment in each) single-site evaluations of remote vs. in-person trial components in different contexts: an mHealth intervention for people with depression symptoms and an opioid overdose education and naloxone intervention for people with opioid/stimulant use disorder.
Discussion: The RISE RCTs will provide novel, rigorous evidence regarding the impact of remote trial methods on trial efficiency and rigor, including the degree to which these effects generalize across clinical contexts and participant characteristics.
Trial registration: RCT 1 was preregistered on February 12 2025, on ClinicalTrials.gov, NCT06822049. https://clinicaltrials.gov/study/NCT06822049. (RCTs 2 and 3 will be registered prior to initiating recruitment to those trials.)
Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-026-09910-1.
Related
- Efficiency of Blood Utilization in Elective Neurosurgery Patients and Development of a Maximum Surgical Blood Order Schedule.
- Practical efficiency of coupling targeted temperature management to brain temperature versus systemic temperature in febrile brain-injured patients. The Brain-TTM study: A randomized controlled pathophysiology trial
- Impact of Remote Symptom Monitoring on Acute Care Utilization in Patients with Advanced Cancer Undergoing Phase I Therapies: Secondary Analysis of a Randomized Clinical Trial
- High stakes, low information, no roads: a qualitative evaluation of determinants of air ambulance utilization and decision making in rural Alaska
- Early Evaluation of Left Atrial Appendage With Cardiac Computed Tomography to Reduce Health Care Utilization
BibTeX
@article{hawk2026remote,
title = {{Remote vs. In-Person Study Evaluation (RISE) Trial 1 of 3 to examine the impact of decentralized trial methods on accrual efficiency, retention, biospecimen capture, and treatment utilization: study protocol for a multi-center randomized controlled trial in the context of smoking cessation (RISE Above Smoking)}},
author = {Larry W. Hawk and Robert A. Schnoll and Jennifer Dahne and Matthew J. Carpenter and Karen L. Cropsey and Gregory E. Wilding and CeCe Duerr and Caitlin G. Allen and Van T. Nghiem and Rachel C. Shelton and Joseph Boccardo and Casey D. Foster and Martin C. Mahoney},
journal = {Trials},
year = {2026},
month = jul,
doi = {10.1186/s13063-026-09910-1},
url = {https://doi.org/10.1186/s13063-026-09910-1},
note = {CC BY-NC-ND 4.0},
}
RIS
TY - JOUR
TI - Remote vs. In-Person Study Evaluation (RISE) Trial 1 of 3 to examine the impact of decentralized trial methods on accrual efficiency, retention, biospecimen capture, and treatment utilization: study protocol for a multi-center randomized controlled trial in the context of smoking cessation (RISE Above Smoking)
AU - Larry W. Hawk
AU - Robert A. Schnoll
AU - Jennifer Dahne
AU - Matthew J. Carpenter
AU - Karen L. Cropsey
AU - Gregory E. Wilding
AU - CeCe Duerr
AU - Caitlin G. Allen
AU - Van T. Nghiem
AU - Rachel C. Shelton
AU - Joseph Boccardo
AU - Casey D. Foster
AU - Martin C. Mahoney
PY - 2026
DA - 2026/07/31
JO - Trials
DO - 10.1186/s13063-026-09910-1
UR - https://doi.org/10.1186/s13063-026-09910-1
AB - Background: Remote trials (i.e., virtual or decentralized trials), in which patients receive some or all treatment and provide study data without the need to travel to a clinic or medical center, have emerged as a promising approach to conducting clinical trials. However, evidence for the hypothesized benefits of remote trials is weak, consisting primarily of anecdotal reports, uncontrolled studies, and expert opinion. The same is true for hypothesized limitations of remote trials such as technological barriers and aspects of trial rigor. A stronger evidence base is needed to evaluate the impact of remote trials. Methods: Remote vs. In-Person Study Evaluation (RISE) was developed to examine the benefits and limitations of remote clinical trials and consists of separate randomized controlled trials (RCTs) for 3 different use cases. In RISE RCT 1 (RISE Above Smoking), the focus of this protocol paper, adults who smoke (AWS) cigarettes will be randomized to Remote vs. In-Person Intake Visit (written consent and eligibility screening). Intake-eligible participants will be re-randomized to Remote vs. In-Person Treatment and Assessment Visits. Recruitment will continue until 200 AWS initiate treatment. All participants will receive 8 weeks of combination nicotine replacement therapy (NRT; 14 or 21 mg transdermal nicotine patch, based on smoking rate, and 2 mg nicotine lozenges) and a printed self-help guide, and will be assessed through 3-month follow-up. Primary outcomes include accrual efficiency, retention, treatment utilization/adherence, and biospecimen completion rates. A key secondary clinical outcome (smoking cessation) will also be assessed. Subsequently, RISE RCTs 2 and 3 will employ harmonized timelines and outcomes in smaller (N = 100 participants who initiate treatment in each) single-site evaluations of remote vs. in-person trial components in different contexts: an mHealth intervention for people with depression symptoms and an opioid overdose education and naloxone intervention for people with opioid/stimulant use disorder. Discussion: The RISE RCTs will provide novel, rigorous evidence regarding the impact of remote trial methods on trial efficiency and rigor, including the degree to which these effects generalize across clinical contexts and participant characteristics. Trial registration: RCT 1 was preregistered on February 12 2025, on ClinicalTrials.gov, NCT06822049. https://clinicaltrials.gov/study/NCT06822049. (RCTs 2 and 3 will be registered prior to initiating recruitment to those trials.) Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-026-09910-1.
SN - 1745-6215
ER -