scholarly journals Practical issues regarding implementing a randomized clinical trial in a homeless population: strategies and lessons learned

Trials ◽  
2017 ◽  
Vol 18 (1) ◽  
Author(s):  
Olamide Ojo-Fati ◽  
Anne M. Joseph ◽  
Jed Ig-Izevbekhai ◽  
Janet L. Thomas ◽  
Susan A. Everson-Rose ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Lessons Learned ◽  
Homeless Population

scholarly journals When Research Meets Reality–-Lessons Learned from a Pragmatic Multisite Group-Randomized Clinical Trial on Psychosocial Interventions in the Psychiatric and Addiction Field

2012 ◽  
Vol 6 ◽  
pp. SART.S9245 ◽  
Author(s):  
Linda E. Wüsthoff ◽  
Helge Waal ◽  
Rolf W. Gråwe
Keyword(s):  
Clinical Trial ◽  
Substance Use ◽  
Randomized Clinical Trial ◽  
Substance Use Disorders ◽  
Clinical Studies ◽  
Psychosocial Interventions ◽  
Integrated Treatment ◽  
Lessons Learned ◽  
Future Research ◽  
New Challenges

Research on treatments for patients with co-occurring psychiatric and substance use disorders is of core importance and at the same time highly challenging as it includes patients that are normally excluded from clinical studies. Such research may require methodological adaptations which in turn create new challenges. However, the challenges that arise in such studies are insufficiently discussed in the literature. The aim of this methodology paper is, firstly, to discuss the methodological adaptations that may be required in such research; secondly, to describe how such adaptations created new challenges in a group-randomized clinical trial on Integrated Treatment amongst patients with co-occurring psychiatric and substance use disorders. We also discuss how these challenges might be understood and highlight lessons for future research in this field. Trial registration: NCT00447733.

scholarly journals Designing a smoking cessation intervention for the unique needs of homeless persons: a community-based randomized clinical trial

2011 ◽  
Vol 8 (6) ◽  
pp. 744-754 ◽  
Author(s):  
Kate Goldade ◽  
Guy-Lucien Whembolua ◽  
Janet Thomas ◽  
Sara Eischen ◽  
Hongfei Guo ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Smoking Cessation ◽  
Nicotine Patch ◽  
The United States ◽  
Homeless Persons ◽  
Lessons Learned ◽  
Community Advisory Board ◽  
Homeless Population ◽  
Community Based ◽  
Quit Smoking

Background Although smoking prevalence remains strikingly high in homeless populations (~70% and three times the US national average), smoking cessation studies usually exclude homeless persons. Novel evidence-based interventions are needed for this high-risk subpopulation of smokers. Purpose To describe the aims and design of a first-ever smoking cessation clinical trial in the homeless population. The study was a two-group randomized community-based trial that enrolled participants ( n = 430) residing across eight homeless shelters and transitional housing units in Minnesota. The study objective was to test the efficacy of motivational interviewing (MI) for enhancing adherence to nicotine replacement therapy (NRT; nicotine patch) and smoking cessation outcomes. Methods Participants were randomized to one of the two groups: active (8 weeks of NRT + 6 sessions of MI) or control (NRT + standard care). Participants attended six in-person assessment sessions and eight retention visits at a location of their choice over 6 months. Nicotine patch in 2-week doses was administered at four visits over the first 8 weeks of the 26-week trial. The primary outcome was cotinine-verified 7-day point-prevalence abstinence at 6 months. Secondary outcomes included adherence to nicotine patch assessed through direct observation and patch counts. Other outcomes included the mediating and/or moderating effects of comorbid psychiatric and substance abuse disorders. Results Lessons learned from the community-based cessation randomized trial for improving recruitment and retention in a mobile and vulnerable population included: (1) the importance of engaging the perspectives of shelter leadership by forming and convening a Community Advisory Board; (2) locating the study at the shelters for more visibility and easier access for participants; (3) minimizing exclusion criteria to allow enrollment of participants with stable psychiatric comorbid conditions; (4) delaying the baseline visit from the eligibility visit by a week to protect against attrition; and (5) regular and persistent calls to remind participants of upcoming appointments using cell phones and shelter-specific channels of communication. Limitations The study’s limitations include generalizability due to the sample drawn from a single Midwestern city in the United States. Since inclusion criteria encompassed willingness to use NRT patch, all participants were motivated and were ready to quit smoking at the time of enrollment in the study. Findings from the self-select group will be generalizable only to those motivated and ready to quit smoking. High incentives may limit the degree to which the intervention is replicable. Conclusions Lessons learned reflect the need to engage communities in the design and implementation of community-based clinical trials with vulnerable populations.

scholarly journals Clinical trial implementation and recruitment: Lessons learned from the early closure of a randomized clinical trial

2012 ◽  
Vol 33 (2) ◽  
pp. 291-297 ◽  
Author(s):  
Marlene H. Peters-Lawrence ◽  
Margaret C. Bell ◽  
Lewis L. Hsu ◽  
Ifeyinwa Osunkwo ◽  
Phillip Seaman ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Lessons Learned ◽  
Early Closure ◽  
Trial Implementation

scholarly journals Minimizing Defensiveness in Clinician Education about Implicit Bias: Lessons Learned from a Community‐Engaged Randomized Clinical Trial

2020 ◽  
Vol 55 (S1) ◽  
pp. 51-52
Author(s):  
J. Sabin ◽  
J. Calista ◽  
E. Dykhouse ◽  
E. Eisdorfer ◽  
A. Foiles ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Implicit Bias ◽  
Lessons Learned ◽  
Clinician Education

scholarly journals Chest computed tomography outcomes in a randomized clinical trial in cystic fibrosis: Lessons learned from the first ataluren phase 3 study

PLoS ONE ◽  
2020 ◽  
Vol 15 (11) ◽  
pp. e0240898
Author(s):  
Harm A. W. M. Tiddens ◽  
Eleni-Rosalina Andrinopoulou ◽  
Joe McIntosh ◽  
J. Stuart Elborn ◽  
Eitan Kerem ◽  
...  
Keyword(s):  
Computed Tomography ◽  
Clinical Trial ◽  
Cystic Fibrosis ◽  
Randomized Clinical Trial ◽  
Lessons Learned ◽  
Phase 3 ◽  
Chest Computed Tomography

scholarly journals Using Facebook for Large-Scale Online Randomized Clinical Trial Recruitment: Effective Advertising Strategies (Preprint)

2017 ◽  
Author(s):  
Laura Akers ◽  
Judith S Gordon
Keyword(s):  
Clinical Trial ◽  
Randomized Clinical Trial ◽  
Large Scale ◽  
Geographic Area ◽  
Lessons Learned ◽  
Online Study ◽  
Female Partners ◽  
Advertising Strategies ◽  
Support Skills ◽  
Facebook Advertising

UNSTRUCTURED Targeted Facebook advertising can be an effective strategy to recruit participants for a large-scale online study. Facebook advertising is useful for reaching people in a wide geographic area, matching a specific demographic profile. It can also target people who would be unlikely to search for the information and would thus not be accessible via Google AdWords. It is especially useful when it is desirable not to raise awareness of the study in a demographic group that would be ineligible for the study. This paper describes the use of Facebook advertising to recruit and enroll 1145 women over a 15-month period for a randomized clinical trial to teach support skills to female partners of male smokeless tobacco users. This tutorial shares our study team’s experiences, lessons learned, and recommendations to help researchers design Facebook advertising campaigns. Topics covered include designing the study infrastructure to optimize recruitment and enrollment tracking, creating a Facebook presence via a fan page, designing ads that attract potential participants while meeting Facebook’s strict requirements, and planning and managing an advertising campaign that accommodates the rapid rate of diminishing returns for each ad.

Sign in / Sign up

Export Citation Format

Share Document