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Impact of a Lung Cancer Screening Information Film on Informed Decision-making: A Randomized Trial.

ABSTRACT: Rationale: Lung cancer screening has the potential to save lives, but it also carries a risk of potential harms. Explaining the benefits and harms of screening in a way that is balanced and comprehensible to individuals with various levels of education is essential. Although a shared decision-making approach is mandated by the Centers for Medicare & Medicaid Services, there have been no randomized studies to evaluate the impact of different forms of lung screening information. Objectives: To evaluate the impact of a novel information film on informed decision-making in individuals considering participating in lung cancer screening. Methods: A subset of participants from LSUT (Lung Screen Uptake Trial) were randomly allocated either to view the information film and receive a written information booklet or to receive the booklet alone. The primary outcome was the objective knowledge score after intervention. Secondary outcomes included subjective knowledge, decisional conflict, final screening participation, and acceptability of the materials. Univariate and multivariate analyses were performed to determine differences in pre- and postintervention knowledge scores in both groups and between groups for the primary and secondary outcomes. Results: In the final analysis of 229 participants, both groups showed significantly improved subjective and objective knowledge scores after intervention. This improvement was greatest in the film + booklet group, where mean objective knowledge improved by 2.16 points (standard deviation [SD] 1.8) compared with 1.84 points (SD 1.9) in the booklet-alone group (β coefficient 0.62; confidence interval, 0.17-1.08; P = 0.007 in the multivariable analysis). Mean subjective knowledge increased by 0.92 points (SD 1.0) in the film + booklet group and 0.55 points (SD 1.1) in the booklet-alone group (β coefficient 0.32; CI, 0.05-0.58; P = 0.02 in the multivariable analysis). Decisional certainty was higher in the film + booklet (mean 8.5/9 points [SD 1.3], group than in the booklet-alone group (mean 8.2/9 points [SD 1.5]). Both information materials were well accepted, and there were no differences in final screening participation rates between groups. Conclusions: The information film improved knowledge and reduced decisional conflict without affecting lung-screening uptake. Clinical trial registered with clinicaltrials.gov (NCT02558101).

SUBMITTER: Ruparel M

PROVIDER: S-EPMC6543473 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:BackgroundLung cancer screening (LCS) is recommended for individuals at high risk due to age and smoking history after a shared decision-making conversation. However, little is known about best strategies for incorporating shared decision-making, especially in a busy primary care setting.ObjectiveTo develop a novel tool, Lung Cancer Assessment of Risk and Education (LungCARE) to guide LCS decisions among eligible primary care patients.DesignPilot cluster randomized controlled trial of LungCARE versus usual care.ParticipantsPatients of providers in a university primary care clinic, who met criteria for LCS.InterventionProviders were randomized to LungCARE intervention or control. LungCARE participants completed a computer tablet-based video assessment of lung cancer educational needs in the waiting room prior to a primary care visit. Patient and provider both received a summary handout of patient concerns and responses.Main measuresAll eligible patients completed baseline interviews by telephone. One week after the index visit, participants completed a follow-up telephone survey that assessed patient-physician discussion of LCS, referral to and scheduling of LCS, as well as LCS knowledge and acceptability of LungCARE. Two months after index visit, we reviewed patients' electronic health records (EHRs) for evidence of a shared decision-making conversation and referral to and receipt of LCS.Key resultsA total of 66 participants completed baseline and follow-up visits (34: LungCARE; 32: usual care). Mean age was 65.9 (± 6.0). Based on EHR review, compared to usual care, LungCARE participants were more likely to have discussed LCS with their physicians (56% vs 25%; p = 0.04) and to be referred to LCS (44% vs 13%; p < 0.02). Intervention participants were also more likely to complete LCS (32% vs 13%; p < 0.01) and had higher knowledge scores (mean score 6.5 (± 1.7) vs 5.5 (± 1.4; p < 0.01).ConclusionsLungCARE increased discussion, referral, and completion of LCS and improved LCS knowledge.Clinical trial registrationNCT03862001.

Project description:ImportanceLung cancer screening with low-dose computed tomography lowers lung cancer mortality but has potential harms. Current guidelines support patients receiving information about the benefits and harms of lung cancer screening during decision-making.ObjectiveTo examine the effect of a patient decision aid (PDA) about lung cancer screening compared with a standard educational material (EDU) on decision-making outcomes among smokers.Design, setting, and participantsThis randomized clinical trial was conducted using 13 state tobacco quitlines. Current and recent tobacco quitline clients who met age and smoking history eligibility for lung cancer screening were enrolled from March 30, 2015, to September 12, 2016, and followed up for 6 months until May 5, 2017. Data analysis was conducted between May 5, 2017, and September 30, 2018.InterventionsParticipants were randomized to the PDA video Lung Cancer Screening: Is It Right for Me? (n = 259) or to EDU (n = 257).Main outcomes and measuresThe primary outcomes were preparation for decision-making and decisional conflict measured at 1 week. Secondary outcomes included knowledge, intentions, and completion of screening within 6 months of receiving the intervention measured by patient report.ResultsOf 516 quit line clients enrolled, 370 (71.7%) were younger than 65 years, 320 (62.0%) were female, 138 (26.7%) identified as black, 47 (9.1%) did not have health insurance, and 226 (43.8%) had a high school or lower educational level. Of participants using the PDA, 153 of 227 (67.4%) were well prepared to make a screening decision compared with 108 of 224 participants (48.2%) using EDU (odds ratio [OR], 2.31; 95% CI, 1.56-3.44; P < .001). Feeling informed about their screening choice was reported by 117 of 234 participants (50.0%) using a PDA compared with 66 of 233 participants (28.3%) using EDU (OR, 2.56; 95% CI, 1.72-3.79; P < .001); 159 of 234 participants (68.0%) using a PDA compared with 110 of 232 (47.4%) participants using EDU reported being clear about their values related to the harms and benefits of screening (OR, 2.37; 95% CI, 1.60-3.51; P < .001). Participants using a PDA were more knowledgeable about lung cancer screening than participants using EDU at each follow-up assessment. Intentions to be screened and screening behaviors did not differ between groups.Conclusions and relevanceIn this study, a PDA delivered to clients of tobacco quit lines improved informed decision-making about lung cancer screening. Many smokers eligible for lung cancer screening can be reached through tobacco quit lines.Trial registrationClinicalTrials.gov identifier: NCT02286713.

Project description:INTRODUCTION:It is increasingly considered important that people make an autonomous and informed decision concerning colorectal cancer (CRC) screening. However, the realisation of autonomy within the concept of informed decision-making might be interpreted too narrowly. Additionally, relatively little is known about what the eligible population believes to be a 'good' screening decision. Therefore, we aimed to explore how the concepts of autonomous and informed decision-making relate to how the eligible CRC screening population makes their decision and when they believe to have made a 'good' screening decision. METHODS:We conducted 27 semi-structured interviews with the eligible CRC screening population (eighteen CRC screening participants and nine non-participants). The general topics discussed concerned how people made their CRC screening decision, how they experienced making this decision and when they considered they had made a 'good' decision. RESULTS:Most interviewees viewed a 'good' CRC screening decision as one based on both reasoning and feeling/intuition, and that is made freely. However, many CRC screening non-participants experienced a certain social pressure to participate. All CRC screening non-participants viewed making an informed decision as essential. This appeared to be the case to a lesser extent for CRC screening participants. For most, experiences and values were involved in their decision-making. CONCLUSION:Our sample of the eligible CRC screening population viewed aspects related to the concepts of autonomous and informed decision-making as important for making a 'good' CRC screening decision. However, in particular the existence of a social norm may be affecting a true autonomous decision-making process. Additionally, the present concept of informed decision-making with its strong emphasis on making a fully informed and well-considered decision does not appear to be entirely reflective of the process in practice. More efforts could be made to attune to the diverse values and factors that are involved in deciding about CRC screening participation.

Project description:BackgroundShared decision making (SDM) is a widely recommended yet unproven strategy for increasing colorectal cancer (CRC) screening uptake. Previous trials of decision aids to increase SDM and CRC screening uptake have yielded mixed results.PurposeTo assess the impact of decision aid-assisted SDM on CRC screening uptake.DesignRCT.Setting/participantsThe study was conducted at an urban, academic safety-net hospital and community health center between 2005 and 2010. Participants were asymptomatic, average-risk patients aged 50-75 years due for CRC screening.InterventionStudy participants (n=825) were randomized to one of two intervention arms (decision aid plus personalized risk assessment or decision aid alone) or control arm. The interventions took place just prior to a routine office visit with their primary care providers.Main outcome measuresThe primary outcome was completion of a CRC screening test within 12 months of the study visit. Logistic regression was used to identify predictors of test completion and mediators of the intervention effect. Analysis was completed in 2011.ResultsPatients in the decision-aid group were more likely to complete a screening test than control patients (43.1% vs 34.8%, p=0.046) within 12 months of the study visit; conversely, test uptake for the decision aid and decision aid plus personalized risk assessment arms was similar (43.1% vs 37.1%, p=0.15). Assignment to the decision-aid arm (AOR=1.48, 95% CI=1.04, 2.10), black race (AOR=1.52, 95% CI=1.12, 2.06) and a preference for a patient-dominant decision-making approach (AOR=1.55, 95% CI=1.02, 2.35) were independent determinants of test completion. Activation of the screening discussion and enhanced screening intentions mediated the intervention effect.ConclusionsDecision aid-assisted SDM has a modest impact on CRC screening uptake. A decision aid plus personalized risk assessment tool is no more effective than a decision aid alone.Trial registrationThis study is registered at www.clinicaltrials.govNCT00251862.

Project description:The conflicting recommendations for prostate cancer (PCa) screening and the mixed messages communicated to the public about screening effectiveness make it critical to assist men in making informed decisions.To assess the effectiveness of 2 decision aids in helping men make informed PCa screening decisions.A racially diverse group of male outpatients aged 45 to 70 years from 3 sites were interviewed by telephone at baseline, 1 month, and 13 months, from 2007 through 2011. We conducted intention-to-treat univariate analyses and multivariable linear and logistic regression analyses, adjusting for baseline outcome measures.Random assignment to print-based decision aid (n?=?628), web-based interactive decision aid (n?=?625), or usual care (UC) (n?=?626).Prostate cancer knowledge, decisional conflict, decisional satisfaction, and whether participants underwent PCa screening.Of 4794 eligible men approached, 1893 were randomized. At each follow-up assessment, univariate and multivariable analyses indicated that both decision aids resulted in significantly improved PCa knowledge and reduced decisional conflict compared with UC (all P <.001). At 1 month, the standardized mean difference (Cohen’s d) in knowledge for the web group vs UC was 0.74, and in the print group vs UC, 0.73. Decisional conflict was significantly lower for web vs UC (d?=?0.33) and print vs UC (d?=?0.36). At 13 months, these differences were smaller but remained significant. At 1 month, high satisfaction was reported by significantly more print (60.4%) than web participants (52.2%; P?=?.009) and significantly more web (P?=?.001) and print (P?=?.03) than UC participants (45.5%). At 13 months, differences in the proportion reporting high satisfaction among print (55.7%) compared with UC (49.8%; P?=?.06) and web participants (50.4%; P?=?.10) were not significant. Screening rates at 13 months did not differ significantly among groups.Both decision aids improved participants’ informed decision making about PCa screening up to 13 months later but did not affect actual screening rates. Dissemination of these decision aids may be a valuable public health tool.clinicaltrials.gov Identifier: NCT00196807.

Project description:BackgroundThe "Just-in-time Information" (JIT) librarian consultation service was designed to provide rapid information to answer primary care clinical questions during patient hours. This study evaluated whether information provided by librarians to answer clinical questions positively impacted time, decision-making, cost savings and satisfaction.Methods and findingA randomized controlled trial (RCT) was conducted between October 2005 and April 2006. A total of 1,889 questions were sent to the service by 88 participants. The object of the randomization was a clinical question. Each participant had clinical questions randomly allocated to both intervention (librarian information) and control (no librarian information) groups. Participants were trained to send clinical questions via a hand-held device. The impact of the information provided by the service (or not provided by the service), additional resources and time required for both groups was assessed using a survey sent 24 hours after a question was submitted. The average time for JIT librarians to respond to all questions was 13.68 minutes/question (95% CI, 13.38 to 13.98). The average time for participants to respond their control questions was 20.29 minutes/question (95% CI, 18.72 to 21.86). Using an impact assessment scale rating cognitive impact, participants rated 62.9% of information provided to intervention group questions as having a highly positive cognitive impact. They rated 14.8% of their own answers to control question as having a highly positive cognitive impact, 44.9% has having a negative cognitive impact, and 24.8% with no cognitive impact at all. In an exit survey measuring satisfaction, 86% (62/72 responses) of participants scored the service as having a positive impact on care and 72% (52/72) indicated that they would use the service frequently if it were continued.ConclusionsIn this study, providing timely information to clinical questions had a highly positive impact on decision-making and a high approval rating from participants. Using a librarian to respond to clinical questions may allow primary care professionals to have more time in their day, thus potentially increasing patient access to care. Such services may reduce costs through decreasing the need for referrals, further tests, and other courses of action.Trial registrationControlled-Trials.com ISRCTN96823810.

Project description:BackgroundEliciting patient preferences within the context of shared decision making has been advocated for colorectal cancer (CRC) screening, yet providers often fail to comply with patient preferences that differ from their own.PurposeTo determine whether risk stratification for advanced colorectal neoplasia (ACN) influences provider willingness to comply with patient preferences when selecting a desired CRC screening option.DesignRandomized controlled trial.Setting/participantsAsymptomatic, average-risk patients due for CRC screening in an urban safety net health care setting.InterventionPatients were randomized 1:1 to a decision aid alone (n= 168) or decision aid plus risk assessment (n= 173) arm between September 2012 and September 2014.OutcomesThe primary outcome was concordance between patient preference and test ordered; secondary outcomes included patient satisfaction with the decision-making process, screening intentions, test completion rates, and provider satisfaction.ResultsAlthough providers perceived risk stratification to be useful in selecting an appropriate screening test for their average-risk patients, no significant differences in concordance were observed between the decision aid alone and decision aid plus risk assessment groups (88.1% v. 85.0%,P= 0.40) or high- and low-risk groups (84.5% v. 87.1%,P= 0.51). Concordance was highest for colonoscopy and relatively low for tests other than colonoscopy, regardless of study arm or risk group. Failure to comply with patient preferences was negatively associated with satisfaction with the decision-making process, screening intentions, and test completion rates.LimitationsSingle-institution setting; lack of provider education about the utility of risk stratification into their decision making.ConclusionsProviders perceived risk stratification to be useful in their decision making but often failed to comply with patient preferences for tests other than colonoscopy, even among those deemed to be at low risk of ACN.

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Impact of a Lung Cancer Screening Information Film on Informed Decision-making: A Randomized Trial.

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