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Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.

ABSTRACT: PURPOSE:We describe the methods, stakeholder engagement, and lessons learned from a study comparing a video decision aid to standard educational materials on lung cancer screening decisions. METHODS:The study followed rigorous methodology standards from the Patient-Centered Outcomes Research Institute. The importance of patient-centeredness and patient/stakeholder engagement are reflected across the study's conceptualization, execution, interpretation, and dissemination efforts. Advisory groups of current and former smokers, quitline service providers, clinicians, and patient advocates were formed for the project. The study used both retrospective and prospective recruitment strategies. Randomization of patients occurred within state-based quitlines, with aggressive tracking of participants. We collected data at baseline and 1-week, 3-month and 6-months after receiving the intervention. The patient-centered outcomes included whether patients' receiving the decision aid a) felt better prepared to make a decision, b) felt more informed about the screening decision, c) had more clarity on their values regarding the benefits and harms of lung cancer screening, and d) were more knowledgeable about lung cancer screening than patients receiving the standard education materials. Exploratory outcomes included making an appointment with a health care provider to discuss screening, scheduling and completing lung cancer screening. RESULTS:We have enrolled and randomized 516 quitline patients and learned many lessons about executing the trial based on significant patient and stakeholder engagement. CONCLUSIONS:Conducting patient-centered outcomes research requires new ways of thinking and continuously checking-in with patients/stakeholders. The engagement of quitline service providers and patient advisors has been key to successful recruitment and dissemination planning. PCORI- CER-1306-03385 ClinicalTrials.gov NCT ID: NCT02286713.

SUBMITTER: Lowenstein LM

PROVIDER: S-EPMC6219628 | biostudies-literature | 2018 Sep

REPOSITORIES: biostudies-literature

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Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.

Lowenstein Lisa M LM Escoto Kamisha H KH Leal Viola B VB Bailey Linda L Bevers Therese B TB Cantor Scott B SB Cinciripini Paul M PM Jacobs Lianne E LE Esparza Angelina A Godoy Myrna C MC Housten Ashley J AJ Lin Heather H Luckett Pamela P Munden Reginald F RF Rabius Vance V Volk Robert J RJ

Contemporary clinical trials 20180720

<h4>Purpose</h4>We describe the methods, stakeholder engagement, and lessons learned from a study comparing a video decision aid to standard educational materials on lung cancer screening decisions.<h4>Methods</h4>The study followed rigorous methodology standards from the Patient-Centered Outcomes Research Institute. The importance of patient-centeredness and patient/stakeholder engagement are reflected across the study's conceptualization, execution, interpretation, and dissemination efforts. A ...[more]

PMID: 30010085

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Project description:BackgroundPhysical activity (PA) preserves mobility, but few practices screen older adults for mobility impairment or counsel on PA.Design"Promoting Active Aging" (PAA) was a mixed-methods randomized-controlled pilot, to test the feasibility and acceptability of a video-based PA counseling tool and implementation into practice of two mobility assessment tools.SettingThree primary care practices affiliated with Wake Forest Baptist Health.ParticipantsAdults aged 65 years and older who presented for primary care follow-up and were willing and able to answer self-report questions and walk 4 meters (n = 59).InterventionVideo-based PA counseling intervention versus control video, "Healthy Eating."MeasurementsPotential participants completed mobility assessments: self-report (Mobility Assessment Tool-short form (MAT-sf)) and performance based (4-meter walk test). We assessed PAA's implementation-feasibility, acceptability, and value-via interviews and surveys. Effectiveness was measured via participant attendance at a PA information session.ResultsOf 92 patients approached, 89 (96.7%) agreed to mobility assessment. Eighty-nine completed MAT-sf, and 97.8% (87/89) completed 4-meter walk test. Sixty-seven (75%) met eligibility criteria, and 59 (88%) consented to be randomized either to the PA counseling intervention (Video-PA) or to active control (Video-C). Most participants viewed the walk test positively (51/59; 86.4%). Staff reported that completion of patient surveys, MAT-sf, and videos required significant staff time and support (median = 26 minutes for all), resulting in low acceptability of MAT-sf and the videos. Attendance at a PA information session did not differ by randomization group (Video-PA = 11/29 (37.9%); Video-C = 12/30 (40%); 95% confidence interval for difference in proportion = -0.29 to 0.25).ConclusionsMobility assessment, particularly a 4-meter walk test, was feasible in primary care. Tablet-based assessment (MAT-sf) and video counseling tools, selected to reduce staff effort, instead required significant time to implement. Future work to promote PA should identify effective ways to facilitate adoption of PA in sedentary older adults that do not burden staff.

Project description:BackgroundPatients and healthcare stakeholders are increasingly becoming engaged in the planning and conduct of biomedical research. However, limited research characterizes this process or its impact.ObjectiveWe aimed to characterize patient and stakeholder engagement in the 50 Pilot Projects funded by the Patient-Centered Outcomes Research Institute (PCORI), and identify early contributions and lessons learned.DesignA self-report instrument was completed by researchers between 6 and 12 months following project initiation.ParticipantsForty-seven principal investigators or their designees (94 % response rate) participated in the study. MAIN MEASURES Self-report of types of stakeholders engaged, stages and levels of engagement, facilitators and barriers to engagement, lessons learned, and contributions from engagement were measured.Key resultsMost (83 %) reported engaging more than one stakeholder in their project. Among those, the most commonly reported groups were patients (90 %), clinicians (87 %), health system representatives (44 %), caregivers (41 %), and advocacy organizations (41 %). Stakeholders were commonly involved in topic solicitation, question development, study design, and data collection. Many projects engaged stakeholders in data analysis, results interpretation, and dissemination. Commonly reported contributions included changes to project methods, outcomes or goals; improvement of measurement tools; and interpretation of qualitative data. Investigators often identified communication and shared leadership strategies as "critically important" facilitators (53 and 44 % respectively); lack of stakeholder time was the most commonly reported challenge (46 %). Most challenges were only partially resolved. Early lessons learned included the importance of continuous and genuine partnerships, strategic selection of stakeholders, and accommodation of stakeholders' practical needs.ConclusionsPCORI Pilot Projects investigators report engaging a variety of stakeholders across many stages of research, with specific changes to their research attributed to engagement. This study identifies early lessons and barriers that should be addressed to facilitate engagement. While this research suggests potential impact of stakeholder engagement, systematic characterization and evaluation of engagement at multiple stages of research is needed to build the evidence base.

Project description:BackgroundEvidence-informed Decision-making in Nutrition and Health (EVIDENT) is an international partnership that seeks to identify information needs in nutrition and health in Africa and build local capacity in knowledge management to help translate the best available evidence into context-appropriate recommendations aligned to the priorities of decision-makers. This study evaluates the extent to which EVIDENT achieved its intended activities, documents the lessons learned and draws on these lessons learned to inform future activities of EVIDENT, as well as in evidence-informed decision-making (EIDM) in nutrition overall.MethodsPurposive and snowball sampling were used to identify participants that were either directly or indirectly involved with EVIDENT. An analytical framework of five key elements was developed to guide data collection from EVIDENT's documentation, in-depth interviews (n = 20), online surveys (n = 26) and a participatory discussion. Interviews were transcribed verbatim and coded in NVivo 11, using deductive thematic content analysis and a phenomenological approach. Online surveys were analysed using Stata 14. Data were triangulated to address both objectives under each element of the analytical framework.ResultsEVIDENT succeeded in establishing a collaborative partnership, within which it delivered four short courses in EIDM. This capacity complemented case study activities in four partner African countries where EIDM processes were implemented and assessed. Identified barriers to these processes included little experience in EIDM, difficulties in engaging stakeholders, challenging local environments (e.g. donor influence, bureaucracy, inaccessibility to scientific research, poor internet connectivity), and limited time and funding. However, EVIDENT activities were driven by a local need for EIDM, a sheer interest and commitment to the cause, and the opportunity for the Global North and South to work together and build relationships. Future activities of EVIDENT, and EIDM in nutrition overall, should focus on sustained capacity-building in EIDM processes, leadership and functional skills across the Global South, investment in stakeholder engagement, context-specific EIDM, enhanced communication and linking, and strengthening relationships with existing stakeholder organisations.ConclusionsIn its first 3 years, EVIDENT developed and strengthened partnership, capacity and visibility on EIDM in Africa. Innovative and long-term capacity-building, dedicated leadership, further stakeholder engagement and sustainable financing, are needed for future activities of EVIDENT and EIDM in nutrition.

Project description:IntroductionFor children who present to emergency departments (EDs) due to blunt head trauma, ED clinicians must decide who requires computed tomography (CT) scanning to evaluate for traumatic brain injury (TBI). The Pediatric Emergency Care Applied Research Network (PECARN) derived and validated two age-based prediction rules to identify children at very low risk of clinically-important traumatic brain injuries (ciTBIs) who do not typically require CT scans. In this case report, we describe the strategy used to implement the PECARN TBI prediction rules via electronic health record (EHR) clinical decision support (CDS) as the intervention in a multicenter clinical trial.MethodsThirteen EDs participated in this trial. The 10 sites receiving the CDS intervention used the Epic(®) EHR. All sites implementing EHR-based CDS built the rules by using the vendor's CDS engine. Based on a sociotechnical analysis, we designed the CDS so that recommendations could be displayed immediately after any provider entered prediction rule data. One central site developed and tested the intervention package to be exported to other sites. The intervention package included a clinical trial alert, an electronic data collection form, the CDS rules and the format for recommendations.ResultsThe original PECARN head trauma prediction rules were derived from physician documentation while this pragmatic trial led each site to customize their workflows and allow multiple different providers to complete the head trauma assessments. These differences in workflows led to varying completion rates across sites as well as differences in the types of providers completing the electronic data form. Site variation in internal change management processes made it challenging to maintain the same rigor across all sites. This led to downstream effects when data reports were developed.ConclusionsThe process of a centralized build and export of a CDS system in one commercial EHR system successfully supported a multicenter clinical trial.

Project description:IntroductionMany parents who choose hypospadias repair for their sons experience decisional conflict (DC) and decisional regret (DR). We previously found that parental decision-making about hypospadias surgery is a complex process characterized by cyclic information-seeking to alleviate anxiety and confusion.ObjectiveThe objective of this study was to engage parents of hypospadias patients and pediatric providers in the co-design of a decision aid (DA) prototype to facilitate shared decision-making about hypospadias surgery and address DC and DR.MethodsFrom August 2018 to January 2019, we conducted three co-design workshops with parents of hypospadias patients, pediatric urology and general pediatric providers to discuss their recommendations for a DA prototype. Activities were audio recorded and professionally transcribed. Transcripts and worksheets were analyzed by six coders using qualitative analysis to identify key aspects of a hypospadias DA desired by stakeholders. We conducted a collaborative design and prototyping session to establish key features and requirements, created a content map visualizing this work, and then developed a DA prototype.ResultsParent participants included 6 mothers and 4 fathers: 8 Caucasian, 2 African-American; median age 31 years. Providers included pediatric urology (n = 7) and general pediatric providers (n = 10): median age 47.5 years, 83.3% Caucasian, 58.3% male, 58.3% MD's and 41.7% nurse practitioners. Participants created user-friendly, interactive DA prototypes with "24/7" availability that had three key functions: 1) provide accurate, customizable, educational content, 2) connect parents with each other, and 3) engage them in a decision-making activity. The prototype consisted of five modules (Extended Summary Figure). "Hypospadias Basics" includes epidemiology and a hypospadias severity scale. "Surgery Basics" includes goals, illustrated steps, and pros/cons of surgery. "Testimonials" includes videos of parents and adolescents discussing their experiences. "Help me Decide" includes a decisional conflict scale and a decision-making activity (i.e. values clarification method). "Frequently Asked Questions" covers general hypospadias information, perioperative expectations and a review of postoperative care.DiscussionTo our knowledge, this is the first DA prototype developed for a pediatric urology condition using a human-centered design approach to engage many key stakeholders in the development process. One limitation of this study is the small population sampled, which limits generalizability and means that our findings may not reflect the views of all parents or pediatric providers involved in hypospadias decision-making.ConclusionsWe created a parent-centered hypospadias DA prototype that provides decision support in an online, interactive format. Future directions include further testing with usability experts, providers and parents.

Project description:It is widely acknowledged that health policy and management decisions rarely reflect research evidence. Therefore, it is important to determine how to improve evidence-informed decision-making. The primary aim of this systematic review was to evaluate the effectiveness of research implementation strategies for promoting evidence-informed policy and management decisions in healthcare. The secondary aim of the review was to describe factors perceived to be associated with effective strategies and the inter-relationship between these factors.An electronic search was developed to identify studies published between January 01, 2000, and February 02, 2016. This was supplemented by checking the reference list of included articles, systematic reviews, and hand-searching publication lists from prominent authors. Two reviewers independently screened studies for inclusion, assessed methodological quality, and extracted data.After duplicate removal, the search strategy identified 3830 titles. Following title and abstract screening, 96 full-text articles were reviewed, of which 19 studies (21 articles) met all inclusion criteria. Three studies were included in the narrative synthesis, finding policy briefs including expert opinion might affect intended actions, and intentions persisting to actions for public health policy in developing nations. Workshops, ongoing technical assistance, and distribution of instructional digital materials may improve knowledge and skills around evidence-informed decision-making in US public health departments. Tailored, targeted messages were more effective in increasing public health policies and programs in Canadian public health departments compared to messages and a knowledge broker. Sixteen studies (18 articles) were included in the thematic synthesis, leading to a conceptualisation of inter-relating factors perceived to be associated with effective research implementation strategies. A unidirectional, hierarchal flow was described from (1) establishing an imperative for practice change, (2) building trust between implementation stakeholders and (3) developing a shared vision, to (4) actioning change mechanisms. This was underpinned by the (5) employment of effective communication strategies and (6) provision of resources to support change.Evidence is developing to support the use of research implementation strategies for promoting evidence-informed policy and management decisions in healthcare. The design of future implementation strategies should be based on the inter-relating factors perceived to be associated with effective strategies.This systematic review was registered with Prospero (record number: 42016032947).

Project description:INTRODUCTION:Low-income, low-literacy, limited English-proficient populations have low colorectal cancer (CRC) screening rates and experience poor patient-provider communication and decision-making processes around screening. The purpose of this study was to test the effect of a CRC screening decision aid on screening-related communication and decision making in primary care visits. STUDY DESIGN:RCT with data collected from patients at baseline and immediately after the provider encounter. SETTING/PARTICIPANTS:Patients aged 50-75 years, due for CRC screening, were recruited from two safety net clinics in North Carolina and New Mexico (data collection, January 2014-September 2015; analysis, 2015). INTERVENTION:Participants viewed a CRC screening decision aid or a food safety (control) video immediately before their provider encounter. MAIN OUTCOME MEASURES:CRC screening-related knowledge, discussion, intent, test preferences, and test ordering. RESULTS:The study population (N=262) had a mean age of 58.3 years and was 66% female, 61% Latino, 17% non-Latino black, and 16% non-Latino white. Among Latino participants, 71% preferred Spanish. Compared with controls, intervention participants had greater screening-related knowledge (on average 4.6 vs 2.8 of six knowledge items correct, adjusted difference [AD]=1.8, 95% CI=1.5, 2.1) and were more likely to report screening discussion (71.0% vs 45.0%, AD=26.1%, 95% CI=14.3%, 38.0%) and high screening intent (93.1% vs 84.7%, AD=9.0%, 95% CI=2.0%, 16.0%). Intervention participants were more likely to indicate a specific screening test preference (93.1% vs 68.0%, AD=26.5%, 95% CI=17.2%, 35.8%) and to report having a test ordered (56.5% vs 32.1%, AD=25.8%, 95% CI=14.4%, 37.2%). CONCLUSIONS:Viewing a CRC screening decision aid before a primary care encounter improves knowledge and shared decision making around screening in a racially, ethnically, and linguistically diverse safety net clinic population. TRIAL REGISTRATION:This study is registered at www.clinicaltrials.gov NCT02054598.

Dataset Information

Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.

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Randomized trial of a patient-centered decision aid for promoting informed decisions about lung cancer screening: Implementation of a PCORI study protocol and lessons learned.

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