Effect of Opt-In vs Opt-Out Framing on Enrollment in a COVID-19 Surveillance Testing Program: The COVID SAFE Randomized Clinical Trial.
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ABSTRACT:
SUBMITTER: Oakes AH
PROVIDER: S-EPMC8176333 | biostudies-literature | 2021 Jun
REPOSITORIES: biostudies-literature
Publications
Effect of Opt-In vs Opt-Out Framing on Enrollment in a COVID-19 Surveillance Testing Program: The COVID SAFE Randomized Clinical Trial.
Oakes Allison H AH Epstein Jonathan A JA Ganguly Arupa A Park Sae-Hwan SH Evans Chalanda N CN Patel Mitesh S MS
JAMA network open 20210601 6
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Project description:INTRODUCTION: Since 2008, the Singapore Ministry of Health (MOH) has expanded HIV testing by increasing anonymous HIV test sites, as well as issuing a directive to hospitals to offer routine voluntary opt out inpatient HIV testing. We reviewed this program implemented at the end of 2008 at Tan Tock Seng Hospital (TTSH), the second largest acute care general hospital in Singapore. METHODS AND FINDINGS: From January 2009 to December 2010, all inpatients aged greater or equal than 21 years were screened for HIV unless they declined or were not eligible for screening. We reviewed the implementation of the Opt Out testing policy. There were a total of 93,211 admissions; 41,543 patients were included based on HIV screening program eligibility criteria. Among those included, 79% (n = 32,675) opted out of HIV screening. The overall acceptance rate was 21%. Majority of eligible patients who were tested (63%) were men. The mean age of tested patients was 52 years. The opt out rate was significantly higher among females (OR: 1.5, 95%CI: 1.4-1.6), aged >60 years (OR: 2.3, 95%CI: 2.2-2.4) and Chinese ethnicity (OR: 1.7, 95%CI:1.6-1.8). The false positive rate of the HIV screening test is 0.56%. The proportion of patients with HIV infection among those who underwent HIV screening is 0.18%. All 16 confirmed HIV patients were linked to care. CONCLUSION: The default opt-in rate of inpatient HIV testing was low at Tan Tock Seng Hospital, Singapore. Efforts to address individual HIV risk perception and campaigns against HIV stigma are needed to encourage more individuals to be tested for HIV.
| S-EPMC3321033 | biostudies-other
Project description:To safely reopen schools and businesses, widespread surveillance testing for Covid-19 will be necessary. We quickly designed and implemented a surveillance testing program that remotely enrolls participants, uses automated bidirectional text message communications, incorporates symptom monitoring, and automatically reports test results. Summary To manage the Covid-19 pandemic, a multi-stakeholder group at Penn Medicine recognized a need to implement a surveillance testing program for its faculty, staff, and students. Such a program would help to identify asymptomatic, presymptomatic, or mildly symptomatic cases that would otherwise go undetected, and could monitor for spread of possible vaccine-resistant viral variants. Covid SAFE (Screening Assessment for Exposure) was designed to leverage separate but existing tools and resources at the health system to accomplish this goal. The data provided by Covid SAFE have allowed health system leadership to make informed decisions about resumption of research and reopening of campus while providing the community with reassurances about their safety. Their experience, having enrolled more than 4,000 participants and conducted more than 25,000 tests, can be used as a framework for other institutions to develop and launch their own programs.
| S-EPMC7924814 | biostudies-literature
Project description:BackgroundUnder opt-out organ donation policies, individuals are automatically considered to have agreed to donate their organs in the absence of a recorded opt-out decision. Growing evidence suggests that the language used within organ donation campaigns influences donor intentions and decision-making.PurposeAs awareness campaigns to promote opt-out consent in the UK are ongoing, the objectives of this study were to investigate the effect of language and message framing used in opt-out organ donation campaigns on donor intentions and psychological reactance.MethodsIndividuals from Scotland and England (N = 1,350) completed this online experiment. Participants were randomized to view one of four messages, designed in the format of a newspaper article, which described the upcoming opt-out system. This followed a 2 × 2 design whereby the degree of threatening language (high threat vs. low threat) and message framing (loss vs. gain) of the newspaper article was experimentally manipulated. Measures of intention (pre-exposure and postexposure) and postmessage reactance (threat to freedom and anger and counter-arguing) were obtained.ResultsA mixed analysis of variance revealed a significant Group × Time interaction on donor intentions; post hoc analysis revealed that intentions significantly decreased for individuals exposed to the High threat × Loss frame article but significantly increased for those exposed to the High threat × Gain frame article.ConclusionsIn campaigns to promote opt-out legislation, high-threat language combined with loss-frame messages should be avoided. If high-threat language is used, gain-frame messaging that highlights the benefits of organ donation should also be incorporated.
| S-EPMC8691393 | biostudies-literature
Project description:Purpose of reviewImproving HIV testing uptake is essential to ending the HIV pandemic. HIV testing approaches can be opt-in, opt-out or risk-based. This systematic review examines and compares the uptake of HIV testing in opt-in, opt-out and risk-based testing approaches.Recent findingsThere remain missed opportunities for HIV testing in a variety of settings using different approaches: opt-in (a person actively accepts to be tested for HIV), opt-out (a person is informed that HIV testing is routine/standard of care, and they actively decline if they do not wish to be tested for HIV) or risk-based (using risk-based screening tools to focus testing on certain individuals or sub-populations at greater risk of HIV). It is not clear how the approach could impact HIV test uptake when adjusted for other factors (e.g. rapid testing, country-income level, test setting and population tested). We searched four databases for studies reporting on HIV test uptake. In total, 18,238 records were screened, and 150 studies were included in the review. Most studies described an opt-in approach (87 estimates), followed by opt-out (76) and risk-based (19). Opt-out testing was associated with 64.3% test uptake (I2 = 99.9%), opt-in testing with 59.8% (I2 = 99.9%) and risk-based testing with 54.4% (I2 = 99.9%). When adjusted for settings that offered rapid testing, country income level, setting and population tested, opt-out testing had a significantly higher uptake (+ 12% (95% confidence intervals: 3-21), p = 0.007) than opt-in testing. We also found that emergency department patients and hospital outpatients had significantly lower HIV test uptake than other populations.
| S-EPMC9508204 | biostudies-literature
Project description:ImportanceOptimal strategies for population-based outreach for breast cancer screening remain unknown.ObjectiveTo evaluate the effect on breast cancer screening of an opt-out automatic mammography referral strategy compared with an opt-in automated telephone message strategy.Design, setting, and participantsThis pragmatic randomized clinical trial was conducted from April 2022 to January 2023 at a single Veterans Affairs (VA) medical center. Participants were female veterans aged 45 to 75 years who were eligible for breast cancer screening and enrolled in VA primary care.InterventionVeterans were randomized 1:1 to receive either an automatic mammography referral (opt-out arm) or an automated telephone call with an option for mammography referral (opt-in arm).Main outcomes and measuresThe primary outcome was completed mammography 100 days after outreach. Secondary outcomes were scheduled or completed mammography by 100 days after outreach and referrals canceled if mammography was not scheduled within 90 days. Both intention-to-treat analyses and a restricted analysis were conducted. The restricted analysis excluded veterans who were unable to be reached by telephone (eg, a nonworking number) or who were found to be ineligible after randomization (eg, medical record documentation of recent mammography).ResultsOf 883 veterans due for mammography (mean [SD] age, 59.13 [8.24] years; 656 [74.3%] had received prior mammography), 442 were randomized to the opt-in group and 441 to the opt-out group. In the intention-to-treat analysis, there was no significant difference in the primary outcome of completed mammography at 100 days between the opt-out and opt-in groups (67 [15.2%] vs 66 [14.9%]; P = .90) or the secondary outcome of completed or scheduled mammography (84 [19%] vs 106 [24.0%]; P = .07). A higher number of referrals were canceled in the opt-out group compared with the opt-in group (104 [23.6%] vs 24 [5.4%]; P < .001). The restricted analysis demonstrated similar results except more veterans completed or scheduled mammography within 100 days in the opt-out group compared with the opt-in group (102 of 388 [26.3%] vs 80 of 415 [19.3%]; P = .02).Conclusions and relevanceIn this randomized clinical trial, an opt-out population-based breast cancer screening outreach approach compared with an opt-in approach did not result in a significant difference in mammography completion but did lead to substantially more canceled mammography referrals, increasing staff burden.Trial registrationClinicalTrials.gov Identifier: NCT05313737.
| S-EPMC10495926 | biostudies-literature
Project description:Background: Enrollment in smoking cessation trials remain sub-optimal. The aim of this analysis was to determine the effectiveness of a modified Zelen's design in engaging hospitalized patients who smoke in a pragmatic OPT-IN versus OPT-OUT tobacco treatment trial. Methods: At bedside, clinical staff screened smokers for eligibility, randomized eligible into study arms, and delivered the appropriate treatment approach. Study staff called randomized patients at one-month post-discharge, debriefed patients on the study design, and collected consent to participate. We used frequencies and percentages for categorical variables and means and standard deviations for quantitative variables to describe the characteristics of those who consented and were enrolled versus those who did not enroll. We also compared the characteristics of participants who consented and those who were reached and explicitly refused consent at one-month follow-up. We used the Cohen's d measure of effect size to evaluate differences. Results: Of the 1,000 randomized, 741 (74.1%) consented to continue in the study at one-month follow-up. One hundred and twenty-seven (12.7%) refused consent and 132 (13.2%) were unreachable. Cohen's d effect size differences between those who consented/enrolled (n = 741) and those who were not enrolled (n = 259) were negligible (<0.2) for age, gender, race/ethnicity, and most forms of insurance. The effect size was small for Medicaid (0.36), and other public insurance (0.48). After excluding those unreached at 1 month (12.7%), there were medium Cohen's d effect size differences between those who consented to participate (n = 741) and those who explicitly refused (n = 127) with respect to age (0.55) and self-pay or no insurance (0.51). There were small to negligible effect size differences with respect to sex, race/ethnicity, and other forms of health insurance. Conclusions: The modified Zelen's design resulted in successful enrollment of most participants who were initially randomized into the trial, including those not motivated to quit.
| S-EPMC9195495 | biostudies-literature
Project description:ImportanceTobacco use causes 7 million deaths per year; most national guidelines require people who use tobacco to opt in to care by affirming they are willing to quit. Use of medications and counseling is low even in advanced economy countries.ObjectiveTo evaluate the efficacy of opt-out care vs opt-in care for people who use tobacco.Design, setting, and participantsIn Changing the Default (CTD), a Bayesian adaptive population-based randomization trial, eligible patients were randomized into study groups, treated according to group assignment, and debriefed and consented for participation at 1-month follow-up. A total of 1000 adult patients were treated at a tertiary care hospital in Kansas City. Patients were randomized from September 2016 to September 2020; final follow-up was in March 2021.InterventionsAt bedside, counselors screened for eligibility, conducted baseline assessment, randomized patients to study group, and provided opt-out care or opt-in care. Counselors and medical staff provided opt-out patients with inpatient nicotine replacement therapy, prescriptions for postdischarge medications, a 2-week medication starter kit, treatment planning, and 4 outpatient counseling calls. Patients could opt out of any or all elements of care. Opt-in patients willing to quit were offered each element of treatment described previously. Opt-in patients who were unwilling to quit received motivational counseling.Main outcomes and measuresThe main outcomes were biochemically verified abstinence and treatment uptake at 1 month after randomization.ResultsOf a total of 1000 eligible adult patients who were randomized, most consented and enrolled (270 [78%] of opt-in patients; 469 [73%] of opt-out patients). Adaptive randomization assigned 345 (64%) to the opt-out group and 645 (36%) to the opt-in group. The mean (SD) age at enrollment was 51.70 (14.56) for opt-out patients and 51.21 (14.80) for opt-out patients. Of 270 opt-in patients, 123 (45.56%) were female, and of 469 opt-out patients, 226 (48.19%) were female. Verified quit rates for the opt-out group vs the opt-in group were 22% vs 16% at month 1 and 19% vs 18% at 6 months. The Bayesian posterior probability that opt-out care was better than opt-in care was 0.97 at 1 month and 0.59 at 6 months. Treatment use for the opt-out group vs the opt-in group was 60% vs 34% for postdischarge cessation medication (bayesian posterior probability of 1.0), and 89% vs 37% for completing at least 1 postdischarge counseling call (bayesian posterior probability of 1.0). The incremental cost-effectiveness ratio was $678.60, representing the cost of each additional quit in the opt-out group.Conclusions and relevanceIn this randomized clinical trial, opt-out care doubled treatment engagement and increased quit attempts, while enhancing patients' sense of agency and alliance with practitioners. Stronger and longer treatment could increase cessation.Trial registrationClinicalTrials.gov Identifier: NCT02721082.
| S-EPMC9972241 | biostudies-literature
Project description:BackgroundHepatitis C (HCV) is the most common infectious disease among people who inject drugs (PWID). Engaging PWID in harm reduction services, such as syringe service programs (SSPs), is critical to reduce HCV and HIV transmission. Additionally, testing for HIV and HCV among PWID is important to improve diagnosis and linkage to care. On March 1, 2018, Florida's only legal SSP implemented bundled opt-out HIV/HCV testing at enrollment. We aimed to examine the differences in HIV/HCV testing uptake before and after the implementation of the opt-out testing policy.MethodsMultivariable logistic regression was used to assess predictors of accepting HIV/HCV tests, controlling for opt-in and opt-out policy. Monthly estimates of the percent of participants accepting an HIV test, HCV test, or both were generated. Interrupted Time Series (ITS) analysis evaluated the immediate policy impact on level of uptake and trend in uptake over time for bundled HIV/HCV testing before and after the opt-out testing policy.ResultsThe total study period was 37 months between December 2016-January 2020 with 512 SSP participants 15 months prior and 547 SSP participants 22 months after implementation of bundled HIV/HCV opt-out testing. Significant predictors of accepting both HIV/HCV tests were cocaine injection (aOR = 2.36), self-reported HIV positive status (aOR = 0.39) and self-reported HCV positive status (aOR = 0.27). Based on the ITS results, there was a significant increase in uptake of HIV/HCV testing by 42.4% (95% CI: 26.2%-58.5%, p < 0.001) immediately after the policy change to opt-out testing.ConclusionBundled opt-out HIV/HCV testing substantially increased the percentage of SSP clients who received HIV and HCV rapid tests at enrollment into the program, and the effect remained stable across the 22 months post opt-out testing policy. Future investigation must assess PWID-level perspective of testing preferences and examine whether this testing approach improves HIV/HCV detection among PWID previously unaware of their status.
| S-EPMC8814936 | biostudies-literature
Project description:BACKGROUND: Early diagnosis of human immunodeficiency virus (HIV) allows for appropriately timed interventions with improved outcomes, but HIV screening among asymptomatic persons and the general population in Singapore remains low. In 2008, Singapore's Ministry of Health implemented HIV voluntary opt-out screening (VOS) for hospitalised adults. We evaluated the outcome of VOS and surveyed reasons for its low uptake in our institution. METHODS: We assessed the outcomes of the VOS programme from January 2010 to December 2013 at National University Hospital, a 1081-bed tertiary hospital in Singapore. We also examined reasons for opting-in and opting-out using an interviewer-administered structured questionnaire in a representative sample in January 2013. RESULTS: 107,523 patients fulfilled VOS criteria and were offered HIV screening, of which 5215 (4.9%) agreed to testing. 4850 (93.1%) of those who opted-in had an HIV test done. Three (0.06%) tested positive for HIV. 238 patients (14.2%) were surveyed regarding reasons for opting-in or out of VOS. 21 (8.8%) had opted-in. Patients who opted-in were likely to be younger, more educated and reported having more regular sexual partners. Type of housing, number of casual sexual partners, sexual orientation, intravenous drug use, condom use and previous sexually transmitted infection were not associated with deciding to opt-in/out. Patients' most common reasons for opting-out were: belief that they were at low risk (50.2%), belief that they were too old (26.8%), cost (6.9%) and aversion to venepuncture (6.5%). The most common reason for opting-in was desire to know their HIV status (47.6%). CONCLUSION: The success of an HIV-VOS program is largely determined by test uptake. Our study showed that the majority of eligible VOS patients opted-out of HIV screening. Given the considerable cost and low yield of this programme, more needs to be done to better equip patients in self-risk assessment and opting in to testing.
| S-EPMC4303265 | biostudies-other
Project description:RationaleVaccination uptake is a major strategy to prevent infection with SARS-CoV-2 and curb the transmission of COVID-19. However, many people remain unwilling to receive the COVID-19 vaccine.ObjectiveUsing default nudges, the present study examines (a) whether opt-out policy and its improvements could increase intention and attitude to get vaccinated and (b) whether these default effects differ across diverse risk-perception groups.MethodAn online experiment with 1926 unvaccinated Chinese respondents was conducted in February 2021. We measured willingness to be vaccinated after informing opt-in policy, standard opt-out policy, and its five improvements (opt-out education, opt-out opportunity, opt-out social norm, opt-out feedback, and opt-out opportunity). Risk perception of the pandemic of COVID-19 and vaccination were also measured.Results(a) Opt-out policy and its improvement (except the opt-out transparency) increased intentions to be vaccinated. Policies with a vaccination default did not weaken people's attitude toward policy and policymakers compared with the opt-in policy, but participants in the transparent improvement group reported lower freedom of choice than those in the opt-out group. (b) Further latent profile analysis revealed four classes underlying risk perception: risk exaggerators, risk deniers, disease-specific risk perceivers, and vaccine-specific risk perceivers. But there was no conclusive evidence that the effect of risk perception differs as a function of defaults.ConclusionsThese findings provide new psychological evidence for formulating more targeted vaccination policies and highlight the importance of risk perception to understand vaccination intentions.
| S-EPMC9217684 | biostudies-literature