Supplemental Material for The Unintended Impact of Smoking-Risk Information on Concerns About Radon: A Randomized Controlled Trial

2018 ◽  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Risk Information ◽  
Randomized Controlled

scholarly journals Using web-based familial risk information for diabetes prevention: a randomized controlled trial

2013 ◽  
Vol 13 (1) ◽  
Author(s):  
Miranda Wijdenes ◽  
Lidewij Henneman ◽  
Nadeem Qureshi ◽  
Piet J Kostense ◽  
Martina C Cornel ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Diabetes Prevention ◽  
Controlled Trial ◽  
Familial Risk ◽  
Risk Information ◽  
Web Based ◽  
Randomized Controlled

Does providing personalized depression risk information lead to increased psychological distress and functional impairment? Results from a mixed-methods randomized controlled trial

2020 ◽  
pp. 1-9
Author(s):  
JianLi Wang ◽  
Heidi Eccles ◽  
Molly Nannarone ◽  
Norbert Schmitz ◽  
Scott Patten ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Psychological Distress ◽  
Mixed Methods ◽  
Functional Impairment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Risk Information ◽  
Control Group ◽  
Randomized Controlled ◽  
Depression Risk

Abstract Background Multivariable risk algorithms (MVRP) predicting the personal risk of depression will form an important component of personalized preventive interventions. However, it is unknown whether providing personalized depression risk will lead to unintended psychological harms. The objectives of this study were to evaluate the impact of providing personalized depression risk on non-specific psychological distress and functional impairment over 12 months. Methods A mixed-methods randomized controlled trial was conducted in 358 males and 354 females who were at high risk of having a major depressive episode according to sex-specific MVRPs, and who were randomly recruited across Canada. Participants were assessed at baseline, 6 and 12 months. Results Over 93% of participants were interested in knowing their depression risk. The intervention group had a greater reduction in K10 score over 12 months than the control group; complete-case analysis found a significant between-group difference in mean K10 change score (d = 1.17, 95% CI 0.12–2.23) at 12 months. Participants in the intervention group also reported significantly less functional impairment in the domains of home and work/school activities, than did those in the control group. A majority of the qualitative interviewees commented that personalized depression risk information does not have a negative impact on physical and mental health. Conclusions This study found no evidence that providing personalized depression risk information will lead to worsening psychological distress, functional impairment, and absenteeism. Provision of personalized depression risk information may have positive impacts on non-specific psychological distress and functioning. Trial registration ClinicalTrials.gov NCT02943876

scholarly journals Impact of personal genomic risk information on melanoma prevention behaviors and psychological outcomes: a randomized controlled trial

2021 ◽  
Author(s):  
Amelia K. Smit ◽  
Martin Allen ◽  
Brooke Beswick ◽  
Phyllis Butow ◽  
Hugh Dawkins ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Risk Information ◽  
Psychological Outcomes ◽  
Skin Cancer Prevention ◽  
European Ancestry ◽  
Polygenic Risk Score ◽  
Randomized Controlled ◽  
The Impact ◽  
Genomic Risk

Abstract Purpose We evaluated the impact of personal melanoma genomic risk information on sun-related behaviors and psychological outcomes. Methods In this parallel group, open, randomized controlled trial, 1,025 Australians of European ancestry without melanoma and aged 18–69 years were recruited via the Medicare database (3% consent). Participants were randomized to the intervention (n = 513; saliva sample for genetic testing, personalized melanoma risk booklet based on a 40-variant polygenic risk score, telephone-based genetic counseling, educational booklet) or control (n = 512; educational booklet). Wrist-worn ultraviolet (UV) radiation dosimeters (10-day wear) and questionnaires were administered at baseline, 1 month postintervention, and 12 months postbaseline. Results At 12 months, 948 (92%) participants completed dosimetry and 973 (95%) the questionnaire. For the primary outcome, there was no effect of the genomic risk intervention on objectively measured UV exposure at 12 months, irrespective of traditional risk factors. For secondary outcomes at 12 months, the intervention reduced sunburns (risk ratio: 0.72, 95% confidence interval: 0.54–0.96), and increased skin examinations among women. Melanoma-related worry was reduced. There was no overall impact on general psychological distress. Conclusion Personalized genomic risk information did not influence sun exposure patterns but did improve some skin cancer prevention and early detection behaviors, suggesting it may be useful for precision prevention. There was no evidence of psychological harm.

scholarly journals Stories to Communicate Individual Risk for Opioid Prescriptions for Back and Kidney Stone Pain: Protocol for the Life STORRIED Multicenter Randomized Clinical Trial (Preprint)

2020 ◽  
Author(s):  
Zachary F Meisel ◽  
Erica B Goldberg ◽  
Abby R Dolan ◽  
Esha Bansal ◽  
Karin V Rhodes ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Risk Communication ◽  
Acute Care ◽  
Acute Pain ◽  
Kidney Stone ◽  
Controlled Trial ◽  
Risk Information ◽  
Opioid Use ◽  
Information Sheet ◽  
Randomized Controlled

BACKGROUND Prescription opioid misuse in the United States is a devastating public health crisis; many chronic opioid users were originally prescribed this class of medication for acute pain. Video narrative–enhanced risk communication may improve patient outcomes, such as knowledge of opioid risk and opioid use behaviors after an episode of acute pain. OBJECTIVE Our objective is to assess the effect of probabilistic and narrative-enhanced opioid risk communication on patient-reported outcomes, including knowledge, opioid use, and patient preferences, for patients who present to emergency departments with back pain and kidney stone pain. METHODS This is a multisite randomized controlled trial. Patients presenting to the acute care facilities of four geographically and ethnically diverse US hospital centers with acute renal colic pain or musculoskeletal back and/or neck pain are eligible for this randomized controlled trial. A control group of patients receiving general risk information is compared to two intervention groups: one receiving the risk information sheet plus an individualized, visual probabilistic Opioid Risk Tool (ORT) and another receiving the risk information sheet plus a video narrative–enhanced probabilistic ORT. We will study the effect of probabilistic and narrative-enhanced opioid risk communication on the following: risk awareness and recall at 14 days postenrollment, reduced use or preferences for opioids after the emergency department episode, and alignment with patient preference and provider prescription. To assess these outcomes, we administer baseline patient surveys during acute care admission and follow-up surveys at predetermined times during the 3 months after discharge. RESULTS A total of 1302 patients were enrolled over 24 months. The mean age of the participants was 40 years (SD 14), 692 out of 1302 (53.15%) were female, 556 out of 1302 (42.70%) were White, 498 out of 1302 (38.25%) were Black, 1002 out of 1302 (76.96%) had back pain, and 334 out of 1302 (25.65%) were at medium or high risk. Demographics and ORT scores were equally distributed across arms. CONCLUSIONS This study seeks to assess the potential clinical role of narrative-enhanced, risk-informed communication for acute pain management in acute care settings. This paper outlines the protocol used to implement the study and highlights crucial methodological, statistical, and stakeholder involvement as well as dissemination considerations. CLINICALTRIAL ClinicalTrials.gov NCT03134092; https://clinicaltrials.gov/ct2/show/NCT03134092 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/19496

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