Protocol for implementation of family health history collection and decision support into primary care using a computerized family health history system

<p>Abstract</p> <p>Background</p> <p>The CDC's Family History Public Health Initiative encourages adoption and increase awareness of family health history. To meet these goals and develop a personalized medicine implementation science research agenda, the Genomedical Connection is using an implementation research (T3 research) framework to develop and integrate a self-administered computerized family history system with built-in decision support into 2 primary care clinics in North Carolina.</p> <p>Methods/Design</p> <p>The family health history system collects a three generation family history on 48 conditions and provides decision support (pedigree and tabular family history, provider recommendation report and patient summary report) for 4 pilot conditions: breast cancer, ovarian cancer, colon cancer, and thrombosis. All adult English-speaking, non-adopted, patients scheduled for well-visits are invited to complete the family health system prior to their appointment. Decision support documents are entered into the medical record and available to provider's prior to the appointment. In order to optimize integration, components were piloted by stakeholders prior to and during implementation. Primary outcomes are change in appropriate testing for hereditary thrombophilia and screening for breast cancer, colon cancer, and ovarian cancer one year after study enrollment. Secondary outcomes include implementation measures related to the benefits and burdens of the family health system and its impact on clinic workflow, patients' risk perception, and intention to change health related behaviors. Outcomes are assessed through chart review, patient surveys at baseline and follow-up, and provider surveys. Clinical validity of the decision support is calculated by comparing its recommendations to those made by a genetic counselor reviewing the same pedigree; and clinical utility is demonstrated through reclassification rates and changes in appropriate screening (the primary outcome).</p> <p>Discussion</p> <p>This study integrates a computerized family health history system within the context of a routine well-visit appointment to overcome many of the existing barriers to collection and use of family history information by primary care providers. Results of the implementation process, its acceptability to patients and providers, modifications necessary to optimize the system, and impact on clinical care can serve to guide future implementation projects for both family history and other tools of personalized medicine, such as health risk assessments.</p

Protocol for implementation of family health history collection and decision support into primary care using a computerized family health history system

Background: The CDC's Family History Public Health Initiative encourages adoption and increase awareness of family health history. To meet these goals and develop a personalized medicine implementation science research agenda, the Genomedical Connection is using an implementation research (T3 research) framework to develop and integrate a self-administered computerized family history system with built-in decision support into 2 primary care clinics in North Carolina. Methods/Design: The family health history system collects a three generation family history on 48 conditions and provides decision support (pedigree and tabular family history, provider recommendation report and patient summary report) for 4 pilot conditions: breast cancer, ovarian cancer, colon cancer, and thrombosis. All adult English-speaking, non-adopted, patients scheduled for well-visits are invited to complete the family health system prior to their appointment. Decision support documents are entered into the medical record and available to provider's prior to the appointment. In order to optimize integration, components were piloted by stakeholders prior to and during implementation. Primary outcomes are change in appropriate testing for hereditary thrombophilia and screening for breast cancer, colon cancer, and ovarian cancer one year after study enrollment. Secondary outcomes include implementation measures related to the benefits and burdens of the family health system and its impact on clinic workflow, patients' risk perception, and intention to change health related behaviors. Outcomes are assessed through chart review, patient surveys at baseline and follow-up, and provider surveys. Clinical validity of the decision support is calculated by comparing its recommendations to those made by a genetic counselor reviewing the same pedigree; and clinical utility is demonstrated through reclassification rates and changes in appropriate screening (the primary outcome). Discussion: This study integrates a computerized family health history system within the context of a routine well-visit appointment to overcome many of the existing barriers to collection and use of family history information by primary care providers. Results of the implementation process, its acceptability to patients and providers, modifications necessary to optimize the system, and impact on clinical care can serve to guide future implementation projects for both family history and other tools of personalized medicine, such as health risk assessments

Sleep to Reduce Incident Depression Effectively (STRIDE): study protocol for a randomized controlled trial comparing stepped-care cognitive-behavioral therapy for insomnia versus sleep education control to prevent major depression

BACKGROUND: Prevention of major depressive disorder (MDD) is a public health priority. Strategies targeting individuals at elevated risk for MDD may guide effective preventive care. Insomnia is a reliable precursor to depression, preceding half of all incident and relapse cases. Thus, insomnia may serve as a useful entry point for preventing MDD. Cognitive-behavioral therapy for insomnia (CBT-I) is recommended as the first-line treatment for insomnia, but widespread implementation is limited by a shortage of trained specialists. Innovative stepped-care approaches rooted in primary care can increase access to CBT-I and reduce rates of MDD. METHODS/DESIGN: We propose a large-scale stepped-care clinical trial in the primary care setting that utilizes a sequential, multiple assignment, randomized trial (SMART) design to determine the effectiveness of dCBT-I alone and in combination with clinician-led CBT-I for insomnia and the prevention of MDD incidence and relapse. Specifically, our care model uses digital CBT-I (dCBT-I) as a first-line intervention to increase care access and reduce the need for specialist resources. Our proposal also adds clinician-led CBT-I for patients who do not remit with first-line intervention and need a more personalized approach from specialty care. We will evaluate negative repetitive thinking as a potential treatment mechanism by which dCBT-I and CBT-I benefit insomnia and depression outcomes. DISCUSSION: This project will test a highly scalable model of sleep care in a large primary care system to determine the potential for wide dissemination and implementation to address the high volume of population need for safe and effective insomnia treatment and associated prevention of depression. TRIAL REGISTRATION: ClinicalTrials.gov NCT03322774. Registered on October 26, 2017

The impact of a cancer Survivorship Care Plan on gynecological cancer patient and health care provider reported outcomes (ROGY Care): study protocol for a pragmatic cluster randomized controlled trial

<p>Abstract</p> <p>Background</p> <p>There is a need for improvement of information provision and post-treatment care for cancer survivors. A Survivorship Care Plan (SCP) is recommended by the American Institute of Medicine and the Dutch Health Council, which is a summary of patients' course of treatment as a formal document, and includes recommendations for subsequent cancer surveillance, management of late effects, and strategies for health promotion. Until now, evidence on the effects of implementing the SCP in clinical practice is lacking. The rationale and study design of a pragmatic cluster randomized trial, aiming to assess the impact of SCP care in routine clinical practice, is presented.</p> <p>Methods/Design</p> <p>A web-based patient registration system 'Registrationsystem Oncological GYnecology' (ROGY) is used by gynecologists in the South of the Netherlands since 2006. A personalized SCP can automatically be generated out of ROGY. In this pragmatic cluster randomized controlled trial, 12 hospitals are randomized to either 'usual care' or 'SCP care'. In patients with 'usual care', the gynecologist provides care as usual. In patients with 'SCP care', information about the tumor stage and treatment is personally discussed with the patient and a document is handed to the patient. Prospectively, all patients diagnosed with endometrial or ovarian cancer in the participating hospitals will be approached for study participation. Patients will complete questionnaires after surgery, and before additional treatment, and after 6, 12, 18 and 24 months. In addition, health care providers will be asked their opinion about implementation of SCP care. Primary outcome is defined as patient satisfaction with information provision and care. Secondary outcomes are illness perception, health-related quality of life, health care use, prevalence, course and referral rate of survivors with psychosocial distress, and health care providers' evaluation of SCP care.</p> <p>Discussion</p> <p>The ROGY Care trial will help to gain insight into the impact of SCP care on patient reported outcomes, and on the evaluation of cancer survivors and health care providers of the different elements of the SCP. Therefore, results will contribute to efforts to improve quality of care for cancer survivors.</p> <p>Trial registration</p> <p>Trial Registration: <url>http://www.ClinicalTrials.gov</url>. Identifier: <a href="http://www.clinicaltrials.gov/ct2/show/NCT01185626">NCT01185626</a></p> <p>Medical Research Ethics Committee Reference Number: NL33429.008.10 Grant Reference Number: UVT2010-4743</p

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Project HealthDesign: Rethinking the Power and Potential of Personal Health Records: Round One Final Report

Describes an initiative to develop prototypes for next-generation personal health record applications on a common platform focused on self-management for better health. Outlines grantees' prototypes for user-centered daily monitoring and lessons learned

Improving School Improvement

PREFACEIn opening this volume, you might be thinking:Is another book on school improvement really needed?Clearly our answer is yes. Our analyses of prevailing school improvement legislation, planning, and literature indicates fundamental deficiencies, especially with respect to enhancing equity of opportunity and closing the achievement gap.Here is what our work uniquely brings to policy and planning tables:(1) An expanded framework for school improvement – We highlight that moving from a two- to a three-component policy and practice framework is essential for closing the opportunity and achievement gaps. (That is, expanding from focusing primarily on instruction and management/government concerns by establishing a third primary component to improve how schools address barriers to learning and teaching.)(2) An emphasis on integrating a deep understanding of motivation – We underscore that concerns about engagement, management of behavior, school climate, equity of opportunity, and student outcomes require an up-to-date grasp of motivation and especially intrinsic motivation.(3) Clarification of the nature and scope of personalized teaching – We define personalization as the process of matching learner motivation and capabilities and stress that it is the learner's perception that determines whether the match is a good one.(4) A reframing of remediation and special education – We formulate these processes as personalized special assistance that is applied in and out of classrooms and practiced in a sequential and hierarchical manner.(5) A prototype for transforming student and learning supports – We provide a framework for a unified, comprehensive, and equitable system designed to address barriers to learning and teaching and re-engage disconnected students and families.(6) A reworking of the leadership structure for whole school improvement --We outline how the operational infrastructure can and must be realigned in keeping with a three component school improvement framework.(7) A systemic approach to enhancing school-community collaboration – We delineate a leadership role for schools in outreaching to communities in order to work on shared concerns through a formal collaborative operational infrastructure that enables weaving together resources to advance the work.(8) An expanded framework for school accountability – We reframe school accountability to ensure a balanced approach that accounts for a shift to a three component school improvement policy.(9) Guidance for substantive, scalable, and sustainable systemic changes –We frame mechanisms and discuss lessons learned related to facilitating fundamental systemic changes and replicating and sustaining them across a district.The frameworks and practices presented are based on our many years of work in schools and from efforts to enhance school-community collaboration. We incorporate insights from various theories and the large body of relevant research and from lessons learned and shared by many school leaders and staff who strive everyday to do their best for children.Our emphasis on new directions in no way is meant to demean current efforts. We know that the demands placed on those working in schools go well beyond what anyone should be asked to do. Given the current working conditions in many schools, our intent is to help make the hard work generate better results. To this end, we highlight new directions and systemic pathways for improving school outcomes.Some of what we propose is difficult to accomplish. Hopefully, the fact that there are schools, districts, and state agencies already trailblazing the way will engender a sense of hope and encouragement to those committed to innovation.It will be obvious that our work owes much to many. We are especially grateful to those who are pioneering major systemic changes across the country. These leaders and so many in the field have generously offered their insights and wisdom. And, of course, we are indebted to hundreds of scholars whose research and writing is a shared treasure. As always, we take this opportunity to thank Perry Nelson and the host of graduate and undergraduate students at UCLA who contribute so much to our work each day, and to the many young people and their families who continue to teach us all.Respectfully submitted for your consideration,Howard Adelman &amp; Linda Taylo