Cover Page - Center for Pediatric Clinical Effectiveness



Pilot Grant ProgramCPCE and PolicyLab will offer awards twice in the 2020 fiscal year through a Pilot Grant Program. The purpose of this program is to promote and support CHOP investigators in a) clinical effectiveness pilot research studies and/or b) policy-oriented health services pilot research studies that will attract external support for large-scale studies. Selected proposals will be supported for up to a maximum of $20,000 for one year. Projects should be able to be completed within one year.Key DatesApplication Deadline: Monday, March 16, 2020Anticipated Project Period: July 2020 – June 2021EligibilityFaculty and instructors from all CHOP departments and divisions are encouraged to apply. We will also consider funding research scientists, experienced research coordinators and research fellows, if (in the case of fellows) they are in their final year of fellowship transitioning to a faculty position at CHOP or there is a demonstration that their work can be completed prior to fellowship completion. Only proposals meeting the following definitions will be reviewed and considered for an award:A Pilot Study is a small study, conducted in preparation for the larger research study, in which study feasibility is tested and preliminary data are collected.And, one or both of the following:Clinical Effectiveness Research is research designed to produce evidence of what works best for treating, diagnosing and preventing disease. We are also interested in qualitative research that can inform Clinical Effectiveness Research. Descriptive studies need to clearly state how they will inform future CER studies.Policy-oriented Health Services Research is designed to study how social factors, organizational structures and processes, health systems, and personal behaviors affect access to health care, the quality and cost of health care, and person health and well-being. We are interested in health services research with a policy orientation such that a clear policy or programmatic application of the knowledge gained from the research can be identified or the study furthers a program of research that has identified specific policy targets. Policy-oriented health services research can be multidisciplinary and include a range of methods, including qualitative, descriptive research, or policy analysis. Policy encompasses institutional policy; local, state and federal public policy; and regulation. Programs include clinical, public health and social programs administered through health systems, public health entities, or government programs. All funded pilot studies are encouraged to receive peer feedback through works-in-progress sessions. Sessions are held weekly with advanced presentation sign-up coordinated through CPCE. Peer feedback opportunities will also be available through participation in a PolicyLab Portfolio.ApplicationPlease submit the application as a single Word document via email to Holly Burnside at burnsideh@email.chop.edu no later than 4:00 p.m. on the deadline date. Application components (see template, attached):Cover page, listing: Project Title, Project Director/Principal Investigator (PD/PI), Co-Investigator(s)/Mentor(s), Department/Division, Portfolio Affiliation,* DateProject Description (5-page maximum) including: Summary/Abstract, Specific Aims, Research Strategy (Significance, Innovation, and Approach), and Policy Goals**BudgetBudget JustificationReferences/Works CitedApplicant Biosketch in NIH format (5-page maximum)*Proposals submitted for review as policy-oriented health services research must identify a PolicyLab portfolio () for affiliation. ** Proposals submitted for review as policy-oriented health services research must respond to the Policy Goals prompt described below in Review Process and Selection Criteria. Of note, health services research proposals without a policy focus may also be funded if addressing comparative effectiveness questions. These do not need to address the Policy Goals prompt.BudgetBudgets must be reviewed and approved by your business manager prior to submission. Funding may not be used for investigator salary support. Staff salaries are allowable budget items. Provide a breakdown of costs by category (e.g. personnel, travel, supplies, etc.), and describe in the Budget Justification how the funds will be used and how the costs were calculated. Although projects may be funded up to a maximum of $20,000, priority will be given to projects that include a prudent spending plan. CPCE and PolicyLab will attempt to fund all requested budgets in full, but may elect to partially fund certain protocols in order to increase the number of funded proposals. Review Process and Selection CriteriaThe review process consists of 2 rounds. For Round 1, applications meeting the definitions for “clinical effectiveness research pilot studies” or “policy-oriented health services research,” and judged by the CPCE and PolicyLab Pilot Grant Steering Committee to be of sufficient quality for review, are assigned to a reviewer, critiqued and scored. For Round 2, reviewers meet in a study section to discuss the merits and limitations of the competing proposals and determine the awardee(s). Only proposals that qualify for the second round are critiqued and scored. All applicants whose proposals qualify for Round 2 will receive a copy of reviewers’ anonymized comments and scores. The review criteria, adapted from the NIH scoring system, used to score proposals follow:Significance of Study: Does the project address an important problem or a critical barrier to progress in the field?Approach: Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Are potential problems, alternative strategies, and benchmarks for success presented?Likelihood of Impact on Effectiveness of Clinical Care, Policies, or Programs: If the aims of the project are achieved, how will scientific knowledge, technical capability, clinical practice, policies, and/or programs be improved? How will successful completion of the aims change the: concepts, methods, technologies, treatments, services, or preventative interventions that drive this field? Or, how will the proposed work improve access, quality, cost, or experience of clinical care or programs?Appropriateness of Budget: Is the proposed budget and period of support appropriate in relation to the research?Likelihood of Future Research: If the aims are achieved, will the results lend themselves to future research?Innovation: Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?Overall Impact: Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the candidate to maintain a strong research program, in consideration of the previous six scored review criteria. An application does not need to be strong in all categories to have a major impact.Description of Policy Goals (Policy-focused projects): Please answer: What policy or programmatic question, issue, or knowledge gap do you ultimately hope to influence with your work? How will the proposed pilot grant activities further this goal? Who is the target audience for the study results? What are your goals for working with the PolicyLab policy and communications teams? ImpactScoreDescriptorAdditional Guidance on Strengths/weaknessesHigh1ExceptionalExceptionally strong with essentially no weaknesses 2OutstandingExtremely strong with negligible weaknesses3ExcellentVery Strong with only some minor weaknessesMedium4Very GoodStrong but with numerous minor weaknesses5GoodStrong but with at least one moderate weakness6SatisfactorySome strengths but with at least some moderate weaknessesLow7FairSome strengths but with at least one major weakness8MarginalA few strengths and a few major weaknesses9PoorVery few strengths and numerous major weaknessesProposals submitted for other awards (e.g., Foerderer) are not eligible for CPCE/PolicyLab pilot grant consideration. Studies already in progress or partially funded will not be supported. Resubmissions are by invitation only. CPCE/PolicyLab will notify applicants if their submission qualifies to be resubmitted for a future funding cycle. AwardsSuccessful applicants must show documentation of IRB submission within 30 days of award notification. Project Directors/Principal Investigators must submit a report at the end of the one-year grant period for review by the CPCE/PolicyLab Pilot Grant Steering Committee and include: project progress, expenditures and plans for disseminating results. Subsequent annual reports will be requested to include publications and extramural funding resulting from the research. Funds unspent at the end of the one-year grant period will be returned to CPCE/PolicyLab. However, requests for rollover of funds for an additional year will be considered with adequate justification. Investigative teams funded through the health services research mechanism with a policy focused project will be required to meet with the PolicyLab communications and policy teams twice during the award period, including once within 60 days of award to shape the investigator’s policy training goals and the project’s policy engagement strategy. Investigators funded through this mechanism may use funds to support attendance and travel to policy training activities such as the American Public Health Association Speak for Health Advocacy Bootcamp, Georgetown Center for Children and Families Annual Child Health Policy Conference, or AcademyHealth Policy Orientation.Additional InformationFor more information about the CPCE/PolicyLab Pilot Grant Program, please see: . Contact Holly Burnside at burnsideh@email.chop.edu with any questions about the CPCE/PolicyLab Pilot Grant Program, eligibility, or the application and submission process. Cover PageProject Title: Project Director/Principal Investigator: Dept/Div. .Co-Investigator:Dept/Div. .Co-Investigator:Dept/Div. .Portfolio Affiliation*:Date Submitted: .*Proposals submitted for review as policy-oriented health services research must identify a PolicyLab portfolio () for affiliation. Project DescriptionSummary/Abstract: (Succinct description of proposed work and relatedness to CPCE/PolicyLab mission)Specific Aims:Research Strategy:A. SignificanceB. InnovationC. ApproachD. Policy Goals**** Proposals submitted for review as policy-oriented health services research must describe their policy goals. Please answer: What policy or programmatic question, issue, or knowledge gap do you ultimately hope to influence with your work? How will the proposed pilot grant activities further this goal? Who is the target audience for the study results? What are your goals for working with the PolicyLab policy and communications teams?Budget: Amount Requested: (please break down by category e.g. personnel, travel, supplies, etc)Budget Justification:References:OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015)BIOGRAPHICAL SKETCHProvide the following information for the Senior/key personnel and other significant contributors.Follow this format for each person. DO NOT EXCEED FIVE PAGES.NAME:eRA COMMONS USER NAME (credential, e.g., agency login):POSITION TITLE:EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)INSTITUTION AND LOCATIONDEGREE(if applicable)Completion DateMM/YYYYFIELD OF STUDYNOTE: The Biographical Sketch may not exceed five pages. Follow the formats and instructions below. A.Personal StatementBriefly describe why you are well-suited for your role in the project described in this application. The relevant factors may include aspects of your training; your previous experimental work on this specific topic or related topics; your technical expertise; your collaborators or scientific environment; and your past performance in this or related fields (you may mention specific contributions to science that are not included in Section C). Also, you may identify up to four peer reviewed publications that specifically highlight your experience and qualifications for this project. If you wish to explain impediments to your past productivity, you may include a description of factors such as family care responsibilities, illness, disability, and active duty military service. B.Positions and HonorsList in chronological order previous positions, concluding with the present position. List any honors. Include present membership on any Federal Government public advisory committee.C.Contribution to ScienceBriefly describe up to five of your most significant contributions to science. For each contribution, indicate the historical background that frames the scientific problem; the central finding(s); the influence of the finding(s) on the progress of science or the application of those finding(s) to health or technology; and your specific role in the described work. For each of these contributions, reference up to four peer-reviewed publications or other non-publication research products (can include audio or video products; patents; data and research materials; databases; educational aids or curricula; instruments or equipment; models; protocols; and software or netware) that are relevant to the described contribution. The description of each contribution should be no longer than one half page including figures and citations. Also provide a URL to a full list of your published work as found in a publicly available digital database such as SciENcv or My Bibliography, which are maintained by the US National Library of Medicine.D.Research SupportList both selected ongoing and completed research projects for the past three years (Federal or non-Federally-supported). Begin with the projects that are most relevant to the research proposed in the application. Briefly indicate the overall goals of the projects and responsibilities of the key person identified on the Biographical Sketch. Do not include number of person months or direct costs. OMB No. 0925-0001/0002 (Rev. 08/12 Approved Through 8/31/2015)BIOGRAPHICAL SKETCHProvide the following information for the Senior/key personnel and other significant contributors.Follow this format for each person. DO NOT EXCEED FIVE PAGES.NAME: Hunt, Morgan CaseyeRA COMMONS USER NAME (credential, e.g., agency login): huntmcPOSITION TITLE: Associate Professor of PsychologyEDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.)INSTITUTION AND LOCATIONDEGREE(if applicable)Completion DateMM/YYYYFIELD OF STUDYUniversity of California, BerkeleyB.S05/1990PsychologyUniversity of VermontPh.D.05/1996Experimental PsychologyUniversity of California, BerkeleyPostdoctoral08/1998Public Health and EpidemiologyA. Personal StatementI have the expertise, leadership, training, expertise and motivation necessary to successfully carry out the proposed research project. I have a broad background in psychology, with specific training and expertise in ethnographic and survey research and secondary data analysis on psychological aspects of drug addiction. My research includes neuropsychological changes associated with addiction. As PI or co-Investigator on several university- and NIH-funded grants, I laid the groundwork for the proposed research by developing effective measures of disability, depression, and other psychosocial factors relevant to the aging substance abuser, and by establishing strong ties with community providers that will make it possible to recruit and track participants over time as documented in the following publications. In addition, I successfully administered the projects (e.g. staffing, research protections, budget), collaborated with other researchers, and produced several peer-reviewed publications from each project. As a result of these previous experiences, I am aware of the importance of frequent communication among project members and of constructing a realistic research plan, timeline, and budget. The current application builds logically on my prior work. During 2005-2006 my career was disrupted due to family obligations. However, upon returning to the field I immediately resumed my research projects and collaborations and successfully competed for NIH support. Merryle, R.J. & Hunt, M.C. (2004). Independent living, physical disability and substance abuse among the elderly. Psychology and Aging, 23(4), 10-22.Hunt, M.C., Jensen, J.L. & Crenshaw, W. (2007). Substance abuse and mental health among community-dwelling elderly. International Journal of Geriatric Psychiatry, 24(9), 1124-1135.Hunt, M.C., Wiechelt, S.A. & Merryle, R. (2008). Predicting the substance-abuse treatment needs of an aging population. American Journal of Public Health, 45(2), 236-245. PMCID: PMC9162292 Hunt, M.C., Newlin, D.B. & Fishbein, D. (2009). Brain imaging in methamphetamine abusers across the life-span. Gerontology, 46(3), 122-145.B. Positions and HonorsPositions and Employment1998-2000Fellow, Division of Intramural Research, National Institute of Drug Abuse, Bethesda, MD 2000-2002Lecturer, Department of Psychology, Middlebury College, Middlebury, VT 2001-Consultant, Coastal Psychological Services, San Francisco, CA 2002-2005Assistant Professor, Department of Psychology, Washington University, St. Louis, MO 2007- Associate Professor, Department of Psychology, Washington University, St. Louis, MOOther Experience and Professional Memberships1995-Member, American Psychological Association1998-Member, Gerontological Society of America1998-Member, American Geriatrics Society2000-Associate Editor, Psychology and Aging 2003-Board of Advisors, Senior Services of Eastern Missouri 2003-05NIH Peer Review Committee: Psychobiology of Aging, ad hoc reviewer2007-11NIH Risk, Adult Addictions Study Section, membersHonors2003Outstanding Young Faculty Award, Washington University, St. Louis, MO 2004Excellence in Teaching, Washington University, St. Louis, MO2009Award for Best in Interdisciplinary Ethnography, International Ethnographic SocietyC. Contribution to ScienceMy early publications directly addressed the fact that substance abuse is often overlooked in older adults. However, because many older adults were raised during an era of increased drug and alcohol use, there are reasons to believe that this will become an increasing issue as the population ages. These publications found that older adults appear in a variety of primary care settings or seek mental health providers to deal with emerging addiction problems. These publications document this emerging problem but guide primary care providers and geriatric mental health providers to recognize symptoms, assess the nature of the problem and apply the necessary interventions. By providing evidence and simple clinical approaches, this body of work has changed the standards of care for addicted older adults and will continue to provide assistance in relevant medical settings well into the future. I served as the primary investigator or co-investigator in all of these studies. Gryczynski, J., Shaft, B.M., Merryle, R., & Hunt, M.C. (2002). Community based participatory research with late-life addicts. American Journal of Alcohol and Drug Abuse, 15(3), 222-238.Shaft, B.M., Hunt, M.C., Merryle, R., & Venturi, R. (2003). Policy implications of genetic transmission of alcohol and drug abuse in female nonusers. International Journal of Drug Policy, 30(5), 46-58.Hunt, M.C., Marks, A.E., Shaft, B.M., Merryle, R., & Jensen, J.L. (2004). Early-life family and community characteristics and late-life substance abuse. Journal of Applied Gerontology, 28(2),26-37.Hunt, M.C., Marks, A.E., Venturi, R., Crenshaw, W. & Ratonian, A. (2007). Community-based intervention strategies for reducing alcohol and drug abuse in the elderly. Addiction, 104(9), 1436-1606. PMCID: PMC9000292In addition to the contributions described above, with a team of collaborators, I directly documented the effectiveness of various intervention models for older substance abusers and demonstrated the importance of social support networks. These studies emphasized contextual factors in the etiology and maintenance of addictive disorders and the disruptive potential of networks in substance abuse treatment. This body of work also discusses the prevalence of alcohol, amphetamine, and opioid abuse in older adults and how networking approaches can be used to mitigate the effects of these disorders. Hunt, M.C., Merryle, R. & Jensen, J.L. (2005). The effect of social support networks on morbidity among elderly substance abusers. Journal of the American Geriatrics Society, 57(4), 15-23.Hunt, M.C., Pour, B., Marks, A.E., Merryle, R. & Jensen, J.L. (2005). Aging out of methadone treatment. American Journal of Alcohol and Drug Abuse, 15(6), 134-149. Merryle, R. & Hunt, M.C. (2007). Randomized clinical trial of cotinine in older nicotine addicts. Age and Ageing, 38(2), 9-23. PMCID: PMC9002364Methadone maintenance has been used to treat narcotics addicts for many years but I led research that has shown that over the long-term, those in methadone treatment view themselves negatively and they gradually begin to view treatment as an intrusion into normal life. Elderly narcotics users were shown in carefully constructed ethnographic studies to be especially responsive to tailored social support networks that allow them to eventually reduce their maintenance doses and move into other forms of therapy. These studies also demonstrate the policy and commercial implications associated with these findings. Hunt, M.C. & Jensen, J.L. (2003). Morbidity among elderly substance abusers. Journal of the Geriatrics, 60(4), 45-61.Hunt, M.C. & Pour, B. (2004). Methadone treatment and personal assessment. Journal Drug Abuse, 45(5), 15-26. Merryle, R. & Hunt, M.C. (2005). The use of various nicotine delivery systems by older nicotine addicts. Journal of Ageing, 54(1), 24-41. PMCID: PMC9112304Hunt, M.C., Jensen, J.L. & Merryle, R. (2008). The aging addict: ethnographic profiles of the elderly drug user. NY, NY: W. W. Norton & plete List of Published Work in MyBibliography: . Research SupportOngoing Research SupportR01 DA942367Hunt (PI)09/01/08-08/31/16Health trajectories and behavioral interventions among older substance abusersThe goal of this study is to compare the effects of two substance abuse interventions on health outcomes in an urban population of older opiate addicts. Role: PIR01 MH922731Merryle (PI)12/15/07-11/30/15Physical disability, depression and substance abuse in the elderlyThe goal of this study is to identify disability and depression trajectories and demographic factors associated with substance abuse in an independently-living elderly population. Role: Co-InvestigatorFaculty Resources Grant, Washington University08/15/09-08/14/15Opiate Addiction DatabaseThe goal of this project is to create an integrated database of demographic, social and biomedical information for homeless opiate abusers in two urban Missouri locations, using a number of state and local data sources.Role: PICompleted Research SupportR21 AA998075Hunt (PI)01/01/11-12/31/13Community-based intervention for alcohol abuseThe goal of this project was to assess a community-based strategy for reducing alcohol abuse among older individuals.Role: PI ................
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