Study protocol: a cluster randomized controlled trial of web-based decision support tools for increasing BRCA1/2 genetic counseling referral in primary care.
Ontology highlight
ABSTRACT:
SUBMITTER: Silverman TB
PROVIDER: S-EPMC6090728 | biostudies-literature | 2018 Aug
REPOSITORIES: biostudies-literature
Publications
Study protocol: a cluster randomized controlled trial of web-based decision support tools for increasing BRCA1/2 genetic counseling referral in primary care.
Silverman Thomas B TB Vanegas Alejandro A Marte Awilda A Mata Jennie J Sin Margaret M Ramirez Juan Carlos Rodriguez JCR Tsai Wei-Yann WY Crew Katherine D KD Kukafka Rita R
BMC health services research 20180813 1
<h4>Background</h4>BRCA1 and BRCA2 mutations confer a substantial breast risk of developing breast cancer to those who carry them. For this reason, the United States Preventative Services Task Force (USPSTF) has recommended that all women be screened in the primary care setting for a family history indicative of a mutation, and women with strong family histories of breast or ovarian cancer be referred to genetic counseling. However, few high-risk women are being routinely screened and fewer are ...[more]
Similar Datasets
Project description:BackgroundShared decision-making improves the quality of patient care. Unfortunately, shared decision-making is not yet common practice among vascular surgeons. Thus, decision support tools were developed to assist vascular surgeons and their patients in using shared decision-making. This trial aims to evaluate the effectiveness and implementation of decision support tools to improve shared decision-making during vascular surgical consultations in which a treatment decision is to be made.MethodsThe study design is a multicentre stepped-wedge cluster-randomised trial. Eligible patients are adult patients, visiting the outpatient clinic of a participating medical centre for whom several treatment options are feasible and who face a primary treatment decision for their abdominal aortic aneurysm, carotid artery disease, intermittent claudication, or varicose veins. Patients and vascular surgeons in the intervention group receive decision support tools that may help them adopt shared decision-making when making the final treatment decision. These decision support tools are decision aids, consultation cards, decision cards, and a practical training. Decision aids are informative websites that help patients become more aware of the pros and cons of the treatment options and their preferences regarding the treatment choice. Consultation cards with text or decision cards with images are used by vascular surgeons during consultation to determine which aspect of a treatment is most important to their patient. In the training vascular surgeons can practice shared decision-making with a patient actor, guided by a medical psychologist. This trial aims to include 502 vascular surgical patients to achieve a clinically relevant improvement in shared decision-making of 10 out of 100 points, using the 5-item OPTION instrument to score the audio-recordings of consultations.DiscussionIn the OVIDIUS trial the available decision support tools for vascular surgical patients are implemented in clinical practice. We will evaluate whether these tools actually improve shared decision-making in the consultation room. The stepped-wedge cluster-randomised study design will ensure that at the end of the study all participating centres have implemented at least some of the decision support tools and thereby a certain level of shared decision-making.Trial registrationNetherlands Trial Registry, NTR6487 . Registered 7 June 2017. URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=6487.
| S-EPMC7376920 | biostudies-literature
Project description:BackgroundChemoprevention using selective estrogen receptor modulators and aromatase inhibitors has been shown to reduce invasive breast cancer incidence in high-risk women. Despite this evidence, few high-risk women who are eligible for chemoprevention utilize it as a risk-reducing strategy. Reasons for low uptake include inadequate knowledge about chemoprevention among patients and healthcare providers, concerns about side effects, time constraints during the clinical encounter, and competing comorbidities.Methods/designWe describe the study design of a randomized controlled trial examining the effect of two web-based decision support tools on chemoprevention decision antecedents and quality, referral for specialized counseling, and chemoprevention uptake among women at an increased risk for breast cancer. The trial is being conducted at a large, urban medical center. A total of 300 patients and 50 healthcare providers will be recruited and randomized to standard educational materials alone or in combination with the decision support tools. Patient reported outcomes will be assessed at baseline, one and six months after randomization, and after their clinic visit with their healthcare provider.DiscussionWe are conducting this trial to provide evidence on how best to support personalized breast cancer risk assessment and informed and shared decision-making for chemoprevention. We propose to integrate the decision support tools into clinical workflow, which can potentially expand quality decision-making and chemoprevention uptake.Trial registrationNCT03069742.
| S-EPMC6722284 | biostudies-literature
Project description:Spatial management is a valuable strategy to advance regional goals for nature conservation, economic development, and human health. One challenge of spatial management is navigating the prioritization of multiple features. This challenge becomes more pronounced in dynamic management scenarios, in which boundaries are flexible in space and time in response to changing biological, environmental, or socioeconomic conditions. To implement dynamic management, decision-support tools are needed to guide spatial prioritization as feature distributions shift under changing conditions. Marxan is a widely applied decision-support tool designed for static management scenarios, but its utility in dynamic management has not been evaluated. EcoCast is a new decision-support tool developed explicitly for the dynamic management of multiple features, but it lacks some of Marxan's functionality. We used a hindcast analysis to compare the capacity of these 2 tools to prioritize 4 marine species in a dynamic management scenario for fisheries sustainability. We successfully configured Marxan to operate dynamically on a daily time scale to resemble EcoCast. The relationship between EcoCast solutions and the underlying species distributions was more linear and less noisy, whereas Marxan solutions had more contrast between waters that were good and poor to fish. Neither decision-support tool clearly outperformed the other; the appropriateness of each depends on management purpose, resource-manager preference, and technological capacity of tool developers. Article impact statement: Marxan can function as a decision-support tool for dynamic management scenarios in which boundaries are flexible in space and time.
| S-EPMC7317865 | biostudies-literature
Project description:BackgroundSpecialized care is crucial for severe burn injuries whereas minor burns should be handled at point-of-care. Misdiagnosis is common which leads to overburdening the system and to a lack of treatment for others due to resources shortage.ObjectivesThe overarching aim was to evaluate four decision-support tools for diagnosis, referral, and triage of acute burns injuries in South Africa and Sweden: referral criteria, mortality prediction scores, image-based remote consultation and automated diagnosis.MethodsStudy I retrospectively assessed adherence to referral criteria of 1165 patients admitted to the paediatric burns centre of the Western Cape of South Africa. Study II assessed mortality prediction of 372 patients admitted to the adults burns centre by evaluating an existing score (ABSI), and by using logistic regression. In study III, an online survey was used to assess the diagnostic accuracy of burn experts' image-based estimations using their smartphone or tablet. In study IV, two deep-learning algorithms were developed using 1105 acute burn images in order to identify the burn, and to classify burn depth.ResultsAdherence to referral criteria was of 93.4%, and the age and severity criteria were associated with patient care. In adults, the ABSI score was a good predictor of mortality which affected a fifth of the patients and which was associated with gender, burn size and referral status. Experts were able to diagnose burn size, and burn depth using handheld devices. Finally, both a wound identifier and a depth classifier algorithm could be developed with relatively high accuracy.ConclusionsAltogether the findings inform on the use of four tools along the care trajectory of patients with acute burns by assisting with the diagnosis, referral and triage from point-of-care to burns centres. This will assist with reducing inequities by improving access to the most appropriate care for patients.
| S-EPMC9246103 | biostudies-literature
Project description:BACKGROUND:Decisional tools have demonstrated their importance in informing manufacturing and commercial decisions in the monoclonal antibody domain. Recent approved therapies in regenerative medicine have shown great clinical benefits to patients. OBJECTIVE:The objective of this review was to investigate what decisional tools are available and what issues and gaps have been raised for their use in regenerative medicine. METHODS:We systematically searched MEDLINE to identify articles on decision support tools relevant to tissue engineering, and cell and gene therapy, with the aim of identifying gaps for future decisional tool development. We included published studies in English including a description of decisional tools in regenerative medicines. We extracted data using a predesigned Excel table and assessed the data both quantitatively and qualitatively. RESULTS:We identified 9 articles addressing key decisions in manufacturing and product development challenges in cell therapies. The decision objectives, parameters, assumptions, and solution methods were analyzed in detail. We found that all decisional tools focused on cell therapies, and 6 of the 9 reviews focused on allogeneic cell therapy products. We identified no available tools on tissue-engineering and gene therapy products. These studies addressed key decisions in manufacturing and product development challenges in cell therapies, such as choice of technology, through modeling. CONCLUSIONS:Our review identified a limited number of decisional tools. While the monoclonal antibodies and biologics decisional tool domain has been well developed and has shown great importance in driving more cost-effective manufacturing processes and better investment decisions, there is a lot to be learned in the regenerative medicine domain. There is ample space for expansion, especially with regard to autologous cell therapies, tissue engineering, and gene therapies. To consider the problem more comprehensively, the full needle-to-needle process should be modeled and evaluated.
| S-EPMC6315273 | biostudies-literature
Project description:The growing demand for cancer genetic services underscores the need to consider approaches that enhance access and efficiency of genetic counseling. Telephone delivery of cancer genetic services may improve access to these services for individuals experiencing geographic (rural areas) and structural (travel time, transportation, childcare) barriers to access. This cluster-randomized clinical trial used population-based sampling of women at risk for BRCA1/2 mutations to compare telephone and in-person counseling for: 1) equivalency of testing uptake and 2) noninferiority of changes in psychosocial measures. Women 25 to 74 years of age with personal or family histories of breast or ovarian cancer and who were able to travel to one of 14 outreach clinics were invited to participate. Randomization was by family. Assessments were conducted at baseline one week after pretest and post-test counseling and at six months. Of the 988 women randomly assigned, 901 completed a follow-up assessment. Cluster bootstrap methods were used to estimate the 95% confidence interval (CI) for the difference between test uptake proportions, using a 10% equivalency margin. Differences in psychosocial outcomes for determining noninferiority were estimated using linear models together with one-sided 97.5% bootstrap CIs. Uptake of BRCA1/2 testing was lower following telephone (21.8%) than in-person counseling (31.8%, difference = 10.2%, 95% CI = 3.9% to 16.3%; after imputation of missing data: difference = 9.2%, 95% CI = -0.1% to 24.6%). Telephone counseling fulfilled the criteria for noninferiority to in-person counseling for all measures. BRCA1/2 telephone counseling, although leading to lower testing uptake, appears to be safe and as effective as in-person counseling with regard to minimizing adverse psychological reactions, promoting informed decision making, and delivering patient-centered communication for both rural and urban women.
| S-EPMC4334799 | biostudies-literature
Project description:BackgroundPublic health professionals are increasingly expected to engage in evidence-informed decision making to inform practice and policy decisions. Evidence-informed decision making involves the use of research evidence along with expertise, existing public health resources, knowledge about community health issues, the local context and community, and the political climate. The National Collaborating Centre for Methods and Tools has identified a seven step process for evidence-informed decision making. Tools have been developed to support public health professionals as they work through each of these steps. This paper provides an overview of tools used in three Canadian public health departments involved in a study to develop capacity for evidence-informed decision making.MethodsAs part of a knowledge translation and exchange intervention, a Knowledge Broker worked with public health professionals to identify and apply tools for use with each of the steps of evidence-informed decision making. The Knowledge Broker maintained a reflective journal and interviews were conducted with a purposive sample of decision makers and public health professionals. This paper presents qualitative analysis of the perceived usefulness and usability of the tools.ResultsTools were used in the health departments to assist in: question identification and clarification; searching for the best available research evidence; assessing the research evidence for quality through critical appraisal; deciphering the 'actionable message(s)' from the research evidence; tailoring messages to the local context to ensure their relevance and suitability; deciding whether and planning how to implement research evidence in the local context; and evaluating the effectiveness of implementation efforts. Decision makers provided descriptions of how the tools were used within the health departments and made suggestions for improvement. Overall, the tools were perceived as valuable for advancing and sustaining evidence-informed decision making.ConclusionTools are available to support the process of evidence-informed decision making among public health professionals. The usability and usefulness of these tools for advancing and sustaining evidence-informed decision making are discussed, including recommendations for the tools' application in other public health settings beyond this study. Knowledge and awareness of these tools may assist other health professionals in their efforts to implement evidence-informed practice.
| S-EPMC4223550 | biostudies-literature
Project description:BackgroundMinistries of health in low- and middle-income countries often lack timely quality data for data-driven decision making in healthcare networks. We describe the design and implementation of decision-support electronic tools by the Ministry of Health of the State of Chiapas, in Mexico, as part of Salud Mesoamerica Initiative.MethodsThree electronic decision-support tools were designed through an iterative process focused on streamlined implementation: 1) to collect and report health facility data at health facilities; 2) to compile and analyze data at health district and central level; and, 3) to support stratified sampling of health facilities. Data was collected for five composite indicators measuring availability of equipment, medicines, and supplies for maternal and child health. Quality Assurance Teams collected data, evaluated results and supported quality improvement. Data was also analyzed at the central level and health districts for decision-making.ResultsData from 300 health facilities in four health districts was collected and analyzed (November 2014-June 2015). The first wave revealed gaps on availability of equipment and supplies in more than half of health facilities. Electronic tools provided the ministry of health officers new ways to visualize data, identify patterns and make hypothesis on root-causes. Between the first and second measurement, the number of missing items decreased, and actions performed by quality improvement teams became more proactive. In the final measurement, 89.7-100% of all health facilities achieved all the required items for each indicator.ConclusionsOur experience could help guide others seeking to implement electronic decision-support tools in low- and middle-income countries. Electronic decision-support tools supported data-driven decision-making by identifying gaps on heatmaps and graphs at the health facility, subdistrict, district or state level. Through a rapid improvement process, the Ministry of Health met targets of externally verified indicators. Using available information technology resources facilitated prompt implementation and adoption of technology.
| S-EPMC7301503 | biostudies-literature
Project description:BACKGROUND:Women with chronic medical conditions, such as diabetes and hypertension, have a higher risk of pregnancy-related complications compared with women without medical conditions and should be offered contraception if desired. Although evidence based guidelines for contraceptive selection in the presence of medical conditions are available via the United States Medical Eligibility Criteria (US MEC), these guidelines are underutilized. Research also supports the use of decision tools to promote shared decision making between patients and providers during contraceptive counseling. OBJECTIVE:The overall goal of the MiHealth, MiChoice project is to design and implement a theory-driven, Web-based tool that incorporates the US MEC (provider-level intervention) within the vehicle of a contraceptive decision tool for women with chronic medical conditions (patient-level intervention) in community-based primary care settings (practice-level intervention). This will be a 3-phase study that includes a predesign phase, a design phase, and a testing phase in a randomized controlled trial. This study protocol describes phase 1 and aim 1, which is to determine patient-, provider-, and practice-level factors that are relevant to the design and implementation of the contraceptive decision tool. METHODS:This is a mixed methods implementation study. To customize the delivery of the US MEC in the decision tool, we selected high-priority constructs from the Consolidated Framework for Implementation Research and the Theoretical Domains Framework to drive data collection and analysis at the practice and provider level, respectively. A conceptual model that incorporates constructs from the transtheoretical model and the health beliefs model undergirds patient-level data collection and analysis and will inform customization of the decision tool for this population. We will recruit 6 community-based primary care practices and conduct quantitative surveys and semistructured qualitative interviews with women who have chronic medical conditions, their primary care providers (PCPs), and clinic staff, as well as field observations of practice activities. Quantitative survey data will be summarized with simple descriptive statistics and relationships between participant characteristics and contraceptive recommendations (for PCPs), and current contraceptive use (for patients) will be examined using Fisher exact test. We will conduct thematic analysis of qualitative data from interviews and field observations. The integration of data will occur by comparing, contrasting, and synthesizing qualitative and quantitative findings to inform the future development and implementation of the intervention. RESULTS:We are currently enrolling practices and anticipate study completion in 15 months. CONCLUSIONS:This protocol describes the first phase of a multiphase mixed methods study to develop and implement a Web-based decision tool that is customized to meet the needs of women with chronic medical conditions in primary care settings. Study findings will promote contraceptive counseling via shared decision making and reflect evidence-based guidelines for contraceptive selection. TRIAL REGISTRATION:ClinicalTrials.gov NCT03153644; https://clinicaltrials.gov/ct2/show/NCT03153644 (Archived by WebCite at http://www.webcitation.org/6yUkA5lK8).
| S-EPMC5932336 | biostudies-literature
Project description:The HENVINET Health and Environment Network aimed to enhance the use of scientific knowledge in environmental health for policy making. One of the goals was to identify and evaluate Decision Support Tools (DST) in current use. Special attention was paid to four "priority" health issues: asthma and allergies, cancer, neurodevelopment disorders, and endocrine disruptors.We identified a variety of tools that are used for decision making at various levels and by various stakeholders. We developed a common framework for information acquisition about DSTs, translated this to a database structure and collected the information in an online Metadata Base (MDB).The primary product is an open access web-based MDB currently filled with 67 DSTs, accessible through the HENVINET networking portal http://www.henvinet.eu and http://henvinet.nilu.no. Quality assurance and control of the entries and evaluation of requirements to use the DSTs were also a focus of the work. The HENVINET DST MDB is an open product that enables the public to get basic information about the DSTs, and to search the DSTs using pre-designed attributes or free text. Registered users are able to 1) review and comment on existing DSTs; 2) evaluate each DST's functionalities, and 3) add new DSTs, or change the entry for their own DSTs. Assessment of the available 67 DSTs showed: 1) more than 25% of the DSTs address only one pollution source; 2) 25% of the DSTs address only one environmental stressor; 3) almost 50% of the DSTs are only applied to one disease; 4) 41% of the DSTs can only be applied to one decision making area; 5) 60% of the DSTs' results are used only by national authority and/or municipality/urban level administration; 6) almost half of the DSTs are used only by environmental professionals and researchers. This indicates that there is a need to develop DSTs covering an increasing number of pollution sources, environmental stressors and health end points, and considering links to other 'Driving forces-Pressures-State-Exposure-Effects-Actions' (DPSEEA) elements. Of interest to both researchers and decision makers should be the standardization of the way DSTs are described for easier access to the knowledge, and the identification of coverage gaps.
| S-EPMC3388451 | biostudies-literature