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Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial.

ABSTRACT: The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focused, telephone-based patient navigation on adherence to CT-based lung cancer screening in an urban safety-net population. 340 adults who meet standard eligibility for lung cancer screening (age 55-77years, smoking history?30 pack-years, quit within 15years if former smoker) are referred through an electronic medical record-based order by physicians in community- and hospital-based primary care settings within the Parkland Health and Hospital System in Dallas County, Texas. Eligible patients are randomized to usual care or patient navigation, which addresses adherence, patient-reported barriers, smoking cessation, and psycho-social concerns related to screening completion. Patients complete surveys and semi-structured interviews at baseline, 6-month, and 18-month follow-ups to assess attitudes toward screening. The primary endpoint of this pragmatic trial is adherence to three sequential, prospectively defined steps in the screening protocol. Secondary endpoints include self-reported tobacco use and other patient-reported outcomes. Results will provide real-world insight into the impact of patient navigation on adherence to CT-based lung cancer screening in a medically underserved population. This study was registered with the NIH ClinicalTrials.gov database (NCT02758054) on April 26, 2016.

SUBMITTER: Gerber DE

PROVIDER: S-EPMC7066861 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature

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Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial.

Gerber David E DE Hamann Heidi A HA Santini Noel O NO Abbara Suhny S Chiu Hsienchang H McGuire Molly M Quirk Lisa L Zhu Hong H Lee Simon J Craddock SJC

Contemporary clinical trials 20170705

The National Lung Screening Trial demonstrated improved lung cancer mortality with annual low-dose computed tomography (CT) screening, leading to lung cancer screening endorsement by the United States Preventive Services Task Force and coverage by the Centers for Medicare and Medicaid. Adherence to annual CT screens in that trial was 95%, which may not be representative of real-world, particularly medically underserved populations. This pragmatic trial will determine the effect of patient-focuse ...[more]

PMID: 28689056

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Project description:Importance:While the proportion of adults who smoke cigarettes has declined substantially in the past decade, socioeconomic disparities in cigarette smoking remain. Few interventions have targeted low socioeconomic status (SES) and minority smokers in primary care settings. Objective:To evaluate a multicomponent intervention to promote smoking cessation among low-SES and minority smokers. Design, Setting, and Participants:For this prospective, unblinded, randomized clinical trial conducted between May 1, 2015, and September 4, 2017, adults 18 years and older who spoke English, smoked 10 or more cigarettes per day in the past week, were contemplating or preparing to quit smoking, and had a primary care clinician were recruited from general internal medicine and family medicine practices at 1 large safety-net hospital in Boston, Massachusetts. Interventions:Patients were randomized to a control group that received an enhancement of usual care (n = 175 participants) or to an intervention group that received up to 4 hours of patient navigation delivered over 6 months in addition to usual care, as well as financial incentives for biochemically confirmed smoking cessation at 6 and 12 months following enrollment (n = 177 participants). Main Outcomes and Measures:The primary outcome determined a priori was biochemically confirmed smoking cessation at 12 months. Results:Among 352 patients who were randomized (mean [SD] age, 50.0 [11.0] years; 191 women [54.3%]; 197 participants who identified as non-Hispanic black [56.0%]; 40 participants who identified as Hispanic of any race [11.4%]), all were included in the intention-to-treat analysis. At 12 months following enrollment, 21 participants [11.9%] in the navigation and incentives group, compared with 4 participants [2.3%] in the control group, had quit smoking (odds ratio, 5.8; 95% CI, 1.9-17.1; number needed to treat, 10.4; P < .001). In prespecified subgroup analyses, the intervention was particularly beneficial for older participants (19 [19.8%] vs 1 [1.0%]; P < .001), women (17 [16.8%] vs 2 [2.2%]; P < .001), participants with household yearly income of $20 000 or less (15 [15.5%] vs 3 [3.1%]; P = .003), and nonwhite participants (21 [15.2%] vs 4 [3.0%]; P < .001). Conclusions and Relevance:In this study of adult daily smokers at 1 large urban safety-net hospital, patient navigation and financial incentives for smoking cessation significantly increased the rates of smoking cessation. Trial Registration:clinicaltrials.gov Identifier: NCT02351609.

Project description:BackgroundLittle research has directly compared the effectiveness of implementation strategies in any setting, and we know of no prior trials directly comparing how effectively different combinations of strategies support implementation in community health centers. This paper outlines the protocol of the Study of Practices Enabling Implementation and Adaptation in the Safety Net (SPREAD-NET), a trial designed to compare the effectiveness of several common strategies for supporting implementation of an intervention and explore contextual factors that impact the strategies' effectiveness in the community health center setting.Methods/designThis cluster-randomized trial compares how three increasingly hands-on implementation strategies support adoption of an evidence-based diabetes quality improvement intervention in 29 community health centers, managed by 12 healthcare organizations. The strategies are as follows: (arm 1) a toolkit, presented in paper and electronic form, which includes a training webinar; (arm 2) toolkit plus in-person training with a focus on practice change and change management strategies; and (arm 3) toolkit, in-person training, plus practice facilitation with on-site visits. We use a mixed methods approach to data collection and analysis: (i) baseline surveys on study clinic characteristics, to explore how these characteristics impact the clinics' ability to implement the tools and the effectiveness of each implementation strategy; (ii) quantitative data on change in rates of guideline-concordant prescribing; and (iii) qualitative data on the "how" and "why" underlying the quantitative results. The outcomes of interest are clinic-level results, categorized using the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework, within an interrupted time-series design with segmented regression models. This pragmatic trial will compare how well each implementation strategy works in "real-world" practices.DiscussionHaving a better understanding of how different strategies support implementation efforts could positively impact the field of implementation science, by comparing practical, generalizable methods for implementing clinical innovations in community health centers. Bridging this gap in the literature is a critical step towards the national long-term goal of effectively disseminating and implementing effective interventions into community health centers.Trial registrationClinicalTrials.gov, NCT02325531.

Project description:ImportanceAccessing specialty care continues to be a persistent problem for patients who use safety-net health systems. To address this access barrier, hospital systems have begun to implement electronic referral systems using eConsults, which allow clinicians to submit referral requests to specialty clinics electronically and enable specialty reviewers to resolve referrals, if appropriate, through electronic dialogue without an in-person visit.ObjectiveMeasure the effect of implementing an eConsult program on access to specialty care.Design setting and participantsUsing an interrupted time series design with data from 2016 to 2020, this study analyzed 50 260 referral requests submitted during the year before and the year after eConsult implementation at 19 New York City Health + Hospitals (NYC H+H) specialty clinics that spanned 7 NYC H+H hospital facilities and 6 unique specialties.ExposuresReferral request was submitted to a specialty clinic in the year following eConsult implementation.Main outcomes and measuresMain outcomes included the fraction of referral requests resolved without an in-person visit following eConsult implementation; and, among requests triaged to have an in-person visit, the fraction of referrals with a successfully scheduled appointment, mean wait time to a specialty appointment, and the fraction of referral requests with a completed specialty visit. Changes associated with eConsult implementation were estimated using multivariate linear regression adjusting for patient age, gender, and specialty clinic fixed effects.ResultsAcross 19 NYC H+H specialty clinics, 26 731 referral requests were submitted in the year before and 23 529 referrals were submitted in the year after eConsult implementation. Following eConsult implementation, 13% of all requests were resolved electronically. Among requests requiring a follow-up visit, the fraction with an appointment successfully scheduled increased by 15.8%, from 66.5% to 82.3% (P < .001). The mean time to an appointment decreased from 61.0 days pre-eConsult to 54.1 days post-eConsult, an adjusted 8.2-day shorter wait time (or 13.3% reduction) following eConsult adoption (P < .001). The percentage of referrals with a completed follow-up visit with a specialist within 90 days of the request did not change (38.4% vs 37.9%, P = .07). Changes in outcomes were mitigated during months when most clinics underwent an electronic health record transition after implementing eConsult.Conclusions and relevanceIn this quality improvement study, implementation of eConsults at a large multi-specialty safety-net system was associated with improvements in appointment scheduling rates and wait times. Despite an additional electronic health record transition, eConsults are a promising health care delivery tool for increasing access to specialty care.

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Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial.

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Patient navigation for lung cancer screening in an urban safety-net system: Protocol for a pragmatic randomized clinical trial.

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