Dataset Information

Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial.

ABSTRACT:

Importance

Guidelines recommend shared decision-making prior to initiating lung cancer screening (LCS). However, evidence is lacking on how to best implement shared decision-making in clinical practice.

Objective

To evaluate the impact of an LCS Decision Tool (LCSDecTool) on the quality of decision-making and LCS uptake.

Design, setting, and participants

This randomized clinical trial enrolled participants at Veteran Affairs Medical Centers in Philadelphia, Pennsylvania; Milwaukee, Wisconsin; and West Haven, Connecticut, from March 18, 2019, to September 29, 2021, with follow-up through July 18, 2022. Individuals aged 55 to 80 years with a smoking history of at least 30 pack-years who were current smokers or had quit within the past 15 years were eligible to participate. Individuals with LCS within 15 months were excluded. Of 1047 individuals who were sent a recruitment letter or had referred themselves, 140 were enrolled.

Intervention

A web-based patient- and clinician-facing LCS decision support tool vs an attention control intervention.

Main outcome and measures

The primary outcome was decisional conflict at 1 month. Secondary outcomes included decisional conflict immediately after intervention and 3 months after intervention, knowledge, decisional regret, and anxiety immediately after intervention and 1 and 3 months after intervention and LCS by 6 months.

Results

Of 140 enrolled participants (median age, 64.0 [IQR, 61.0-69.0] years), 129 (92.1%) were men and 11 (7.9%) were women. Of 137 participants with data available, 75 (53.6%) were African American or Black and 62 (44.3%) were White; 4 participants (2.9%) also reported Hispanic or Latino ethnicity. Mean decisional conflict score at 1 month did not differ between the LCSDecTool and control groups (25.7 [95% CI, 21.4-30.1] vs 29.9 [95% CI, 25.6-34.2], respectively; P = .18). Mean LCS knowledge score was greater in the LCSDecTool group immediately after intervention (7.0 [95% CI, 6.3-7.7] vs 4.9 [95% CI, 4.3-5.5]; P < .001) and remained higher at 1 month (6.3 [95% CI, 5.7-6.8] vs 5.2 [95% CI, 4.5-5.8]; P = .03) and 3 months (6.2 [95% CI, 5.6-6.8] vs 5.1 [95% CI, 4.4-5.8]; P = .01). Uptake of LCS was greater in the LCSDecTool group at 6 months (26 of 69 [37.7%] vs 15 of 71 [21.1%]; P = .04).

Conclusions and relevance

In this randomized clinical trial of an LCSDecTool compared with attention control, no effect on decisional conflict occurred at 1 month. The LCSDecTool used in the primary care setting did not yield a significant difference in decisional conflict. The intervention led to greater knowledge and LCS uptake. These findings can inform future implementation strategies and research in LCS shared decision-making.

Trial registration

ClinicalTrials.gov Identifier: NCT02899754.

SUBMITTER: Schapira MM

PROVIDER: S-EPMC10469267 | biostudies-literature | 2023 Aug

REPOSITORIES: biostudies-literature

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Publications

Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial.

Schapira Marilyn M MM Hubbard Rebecca A RA Whittle Jeff J Vachani Anil A Kaminstein Dana D Chhatre Sumedha S Rodriguez Keri L KL Bastian Lori A LA Kravetz Jeffrey D JD Asan Onur O Prigge Jason M JM Meline Jessica J Schrand Susan S Ibarra Jennifer V JV Dye Deborah A DA Rieder Julie B JB Frempong Jemimah O JO Fraenkel Liana L

JAMA network open 20230801 8

<h4>Importance</h4>Guidelines recommend shared decision-making prior to initiating lung cancer screening (LCS). However, evidence is lacking on how to best implement shared decision-making in clinical practice.<h4>Objective</h4>To evaluate the impact of an LCS Decision Tool (LCSDecTool) on the quality of decision-making and LCS uptake.<h4>Design, setting, and participants</h4>This randomized clinical trial enrolled participants at Veteran Affairs Medical Centers in Philadelphia, Pennsylvania; Mi ...[more]

PMID: 37647070

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Project description:BackgroundThe United States Preventive Services Task Force (USPSTF) issued recommendations for older, heavy lifetime smokers to complete annual low-dose computed tomography (LDCT) scans of the chest as screening for lung cancer. The USPSTF recommends and the Centers for Medicare and Medicaid Services require shared decision making using a decision aid for lung cancer screening with annual LDCT. Little is known about how decision aids affect screening knowledge, preferences, and behavior. Thus, we tested a lung cancer screening decision aid video in screening-eligible primary care patients.MethodsWe conducted a single-group study with surveys before and after decision aid viewing and medical record review at 3 months. Participants were active patients of a large US academic primary care practice who were current or former smokers, ages 55-80 years, and eligible for screening based on current screening guidelines. Outcomes assessed pre-post decision aid viewing were screening-related knowledge score (9 items about screening-related harms of false positives and overdiagnosis, likelihood of benefit; score range = 0-9) and preference (preferred screening vs. not). Screening behavior measures, assessed via chart review, included provider visits, screening discussion, LDCT ordering, and LDCT completion within 3 months.ResultsAmong 50 participants, knowledge increased from pre- to post-decision aid viewing (mean = 2.6 vs. 5.5, difference = 2.8; 95% CI 2.1, 3.6, p < 0.001). Preferences across the overall sample remained similar such that 54% preferred screening at baseline and 50% after viewing; however, 28% of participants changed their preference (to or away from screening) from baseline to after viewing. We assessed screening behavior for 36 participants who had a primary care visit during the 3-month period following enrollment. Eighteen of 36 preferred screening after decision aid viewing. Of these 18, 10 discussed screening, 8 had a test ordered, and 6 completed LDCT. Among the 18 who preferred no screening, 7 discussed screening, 5 had a test ordered, and 4 completed LDCT.ConclusionsIn primary care patients, a lung cancer screening decision aid improved knowledge regarding screening-related benefits and harms. Screening preferences and behavior were heterogeneous.Trial registrationThis study is registered at www.clinicaltrials.gov . NCT03077230 (registered retrospectively,November 22, 2016).

Project description:Bisphosphonates can reduce fracture risk in patients with osteoporosis, but many at-risk patients do not start or adhere to these medications. The aims of this study are to: (1) preliminarily evaluate the effect of an individualized 10-year osteoporotic fracture risk calculator and decision aid (OSTEOPOROSIS CHOICE) for postmenopausal women at risk for osteoporotic fractures; and (2) assess the feasibility and validity (i.e., absence of contamination) of patient-level randomization (vs. cluster randomization) in pilot trials of decision aid efficacy.This is a protocol for a parallel, 2-arm, randomized trial to compare an intervention group receiving OSTEOPOROSIS CHOICE to a control group receiving usual primary care. Postmenopausal women with bone mineral density T-scores of <-1.0, not receiving bisphosphonate therapy, and receiving care at participating primary care practices in and around Rochester, Minnesota, USA will be eligible to participate in the trial. We will measure the effect of OSTEOPOROSIS CHOICE on five outcomes: (a) patient knowledge regarding osteoporosis risk factors and treatment; (b) quality of the decision-making process for both the patient and clinician; (c) patient and clinician acceptability and satisfaction with the decision aid; (d) rate of bisphosphonate use and adherence, and (e) trial processes (e.g., ability to recruit participants, collect patient outcomes). To capture these outcomes, we will use patient and clinician surveys following each visit and video recordings of the clinical encounters. These video recordings will also allow us to determine the extent to which clinicians previously exposed to the decision aid were able to recreate elements of the decision aid with control patients (i.e., contamination). Pharmacy prescription profiles and follow-up phone interviews will assess medication start and adherence at 6 months.This pilot trial will provide evidence of feasibility, validity of patient randomization, and preliminary efficacy of a novel approach--decision aids--to improving medication adherence for postmenopausal women at risk of osteoporotic fractures. The results will inform the design of a larger trial that could provide more precise estimates of the efficacy of the decision aid.Clinical Trials.gov Identifier: NCT00578981.

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: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:ImportanceDevelopmental delays and disabilities are common in children. Research has indicated that intervention during the early years of a child's life has a positive effect on cognitive development, social skills and behavior, and subsequent school performance.ObjectiveTo determine whether a computerized clinical decision support system is an effective approach to improve standardized developmental surveillance and screening (DSS) within primary care practices.Design, setting, and participantsIn this cluster randomized clinical trial performed in 4 pediatric clinics from June 1, 2010, through December 31, 2012, children younger than 66 months seen for primary care were studied.InterventionsWe compared surveillance and screening practices after adding a DSS module to an existing computer decision support system.Main outcomes and measuresThe rates at which children were screened for developmental delay.ResultsMedical records were reviewed for 360 children (180 each in the intervention and control groups) to compare rates of developmental screening at the 9-, 18-, or 30-month well-child care visits. The DSS module led to a significant increase in the percentage of patients screened with a standardized screening tool (85.0% vs 24.4%, P < .001). An additional 120 records (60 each in the intervention and control groups) were reviewed to examine surveillance rates at visits outside the screening windows. The DSS module led to a significant increase in the percentage of patients whose parents were assessed for concerns about their child's development (71.7% vs 41.7%, P = .04).Conclusions and relevanceUsing a computerized clinical decision support system to automate the screening of children for developmental delay significantly increased the numbers of children screened at 9, 18, and 30 months of age. It also significantly improved surveillance at other visits. Moreover, it increased the number of children who ultimately were diagnosed as having developmental delay and who were referred for timely services at an earlier age.Trial registrationclinicaltrials.gov Identifier: NCT01351077.

Dataset Information

Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial.

Importance

Objective

Design, setting, and participants

Intervention

Main outcome and measures

Results

Conclusions and relevance

Trial registration

Publications

Lung Cancer Screening Decision Aid Designed for a Primary Care Setting: A Randomized Clinical Trial.

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