AOTF Health Services Research Grant Request For Application

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AOTF Health Services Research Grant 2018-2019 Request Fr Applicatin The AOTF Health Services Research Grant (HSR) is targeted t principal investigatrs wh d nt currently have substantial extramural research awards as an independent principal investigatr (e.g., NIH, R01, PCORI, Research Prgram Prject Grant, Veterans Administratin Merit Award, and Field-Initiated Prject). Typically, the principal investigatr (PI) will have a funding histry assciated with early stage, emerging, r early midcareer investigatrs that may include small research grants and training-related r mentred career awards. The PI must als have a cmmitment frm an experienced research mentr wh has an established recrd f substantial extramural grant funding, peerreviewed publicatins, and supervisin and mentring f researchers. Cntact AOTF (research@atf.rg) if yu have any questins. I. Abut the 2018-2019 Funding Pririties fr the Health Services Research grant II. Abut the Appraches: Pilt/Feasibility/Planning Grant Descriptins III. Abut the Available Awards IV. Abut the Eligibility Criteria fr Investigatrs V. Abut the Prcess and Timeline fr 2018-2019 Applicatins VI. Abut the Cmpnents f the 2018-2019 Letter f Intent and Applicatin VII. Abut the Key Review Criteria fr 2018-2019 Applicatins Grant Eligibility Frm and Letter f Intent will pen July 16, 2018. I. ABOUT THE 2018-2019 FUNDING PRIORITIES FOR HEALTH SERVICES RESEARCH A. What are the research pririties fr the 2018-2019 funding cycle? The AOTF Research Pririties were used t establish the funding pririties. The AOTF Research Pririties: Health behavirs t prevent and manage chrnic cnditins Functinal cgnitin Safety and injury preventin in hme, clinical and cmmunity settings Technlgy and envirnmental supprts in hme and cmmunity Develpment and transitins fr individuals and families Emtinal and physilgical influences Family and caregiver needs Health care experience: access, care crdinatin, utilizatin B. What are the bjectives f the AOTF Health Services Research Grant? HSR grant bjectives include but are nt limited t: Examine hw OT services are rganized and delivered within the healthcare system Explre client access t OT services Determine hw t ptimize client prvider behavirs with evidence-based tls t fster delivery f high quality care Study the impact f plices n OT delivery and quality.

II. ABOUT THE APPROACHES: PILOT/FEASIBILITY DESCRIPTIONS A. Appraches that lay the necessary grundwrk fr larger interventin studies include: Pilt studies A Pilt Study is a versin f the main study that is run in miniature t test whether the cmpnents f the main study can all wrk tgether. It is fcused n the prcesses f the main study, fr example t ensure recruitment, randmisatin, treatment, and fllw-up assessments all run smthly. It will therefre resemble the main study in many respects. In sme cases this will be the first phase f the substantive study and data frm the pilt phase may cntribute t the final analysis; this can be referred t as an internal pilt. Alternatively at the end f the pilt study the data may be analysed and set aside, a s-called external pilt. (p. 5) Pilt studies are characterized by: rigrus methdlgical cmpnents like sample size estimatin, randmizatin and cntrl grup selectin (p. 5) an explicit purpse (e.g., t test a new prcedure in preparatin fr a clinical trial ) and the criteria which lead t further studies being abandned. (p. 6) reprting f results are interpreted with cautin (p. 6) r as incnclusive, with the intentin f cnducting a further, larger study (p. 5) results that prvide infrmatin t enable a sample size calculatin in a subsequent main study. (p. 6) Feasibility studies Feasibility Studies are pieces f research dne befre a main study. They are used t estimate imprtant parameters that are needed t design the main study. Fr instance: standard deviatin f the utcme measure, which is needed in sme cases t estimate sample size, willingness f participants t be randmised, willingness f clinicians t recruit participants, number f eligible patients, characteristics f the prpsed utcme measure and in sme cases feasibility studies might invlve designing a suitable utcme measure, fllw-up rates, respnse rates t questinnaires, adherence/cmpliance rates, ICCs in cluster trials, etc. Feasibility studies fr randmised cntrlled trials may nt themselves be randmised. Crucially, feasibility studies d nt evaluate the utcme f interest; that is left t the main study..if a feasibility study is a small randmised cntrlled trial, it need nt have a primary utcme and the usual srt f pwer calculatin is nt nrmally undertaken. Instead the sample size shuld be adequate t estimate the critical parameters (e.g. recruitment rate) t the necessary degree f precisin. (p. 5) In general, feasibility studies are cnducted with mre flexible methdlgy cmpared t thse labeled 'pilt'. Fr example the term 'feasibility' has been used fr large scale studies such as a screening prgramme applied at a ppulatin level t determine the initial feasibility f the prgramme. (p. 5) AOTF Health Services Research Grant RFA Page 2 f 6

Arain, M., Campbell, M. J., Cper, C. L., & Lancaster, G. A. (2010). What is a pilt r feasibility study? A review f current practice and editrial plicy. BMC medical research methdlgy, 10(1), http://www.ncbi.nlm.nih.gv/pmc/articles/pmc2912920/ III. ABOUT THE AVAILABLE AWARDS FOR THIS HEALTH SCIENCES RESEARCH INITIATIVE HSR Pilt Study Optin #1: Includes pilt studies examining an ccupatinal therapy-related questin using data frm administrative r healthcare dataset(s) (e.g. Medicare Administrative data, Health System Electrnic Medical recrds). Funding Required: $100,000 per grant. Funding may be used t cver full-time equivalent (FTE) fr Principal Investigatr and ther key persnnel, data acquisitin csts, sftware fr data analysis, cnsultant fees, and disseminatin activities. These studies may run up t 2 years given the time necessary t purchase administrative data, clean the data, and cnduct analysis befre manuscript develpment. HSR Pilt Study Optin #2: Includes pilt studies examining a rehabilitatin questin using data frm publicly available datasets (e.g., Health and Retirement Survey, Natinal Health and Aging Trends Study, Natinal Health and Nutritin Examinatin Survey, LTCFcus). Funding Required: $50,000 per grant. Funding may be used t cver full-time equivalent (FTE) fr Principal Investigatr and ther key persnnel fr wrk and statistical cnsulting. Data sets fr these studies are free and thus wuld nt require purchasing f data r paying fr health systems IT persnal. These studies may run up t 1 year. Funds will be released n a payment schedule identified by AOTF. The grant cycle will begin n July 1 pending IRB receipt (if required) by AOTF. IV. ABOUT THE ELIGIBILITY CRITERIA FOR INVESTIGATORS A. What are the eligibility criteria fr the principal investigatr (PI)? General Persnal Criteria The PI has a terminal research degree r dctrate with advanced research training (such as cmpletin f a research fellwship). The PI is emplyed by a U.S. dmestic, public r private, nn-prfit rganizatin/institutin that is eligible t receive Fundatin research grants and will prvide assurance f its accuntability and supprt fr the prject. The PI is a U.S. citizen r nn-citizen natinal f the United States OR admitted fr permanent residence OR applied fr permanent residence. (Fr nn-citizens, the applicant rganizatin must have plicies in place t determine whether residence status r visa status will allw cmpletin f the research.) The PI has a faculty appintment r an equivalent research psitin. The PI is a credentialed OT r if nt, an OT has a majr rle in the research. AOTF Health Services Research Grant RFA Page 3 f 6

Research and Prpsed Prject Criteria The PI has a track recrd f achievements and career gals related t the prpsed prject that includes peer-reviewed publicatins. The PI des nt currently have any substantial extramural research awards (e.g. RO1, PCORI, Research Prgram Prject Grant, Veterans Administratin Merit Award, Field-Initiated Prject). Typically, the PI will have a funding histry assciated with early stage, emerging, r early midcareer investigatrs that may include small research grants and training-related r mentred career awards. The PI has a cmmitment frm an experienced research mentr wh has an established recrd f substantial extramural grant funding, peer-reviewed publicatins and supervisin and research mentring experience. The PI des nt have any cnflicts f interest. The PI is nt: An AOTF r AOTA bard r staff member An AOTF Scientific Advisry Cuncil member A bard r staff member f an IRG spnsr V. ABOUT THE PROCESS AND TIMELINE FOR 2017-2018 APPLICATIONS A. What is the prcess fr submitting an applicatin fr 2018-2019 Health Sciences Research funding? Applying fr the grant invlves several steps: The principal investigatr reviews the eligibility criteria and cmpletes the nline Grant Eligibility Frm. The nline site fr the AOTF Health Sciences Research grant pens July 16, 2018. If the principal investigatr meets all eligibility criteria n the nline Grant Eligibility Frm, immediate access will be given t the Letter f Intent (LOI). The LOI must be submitted by August 23, 2018, 11:59 CDT. The LOI is reviewed by AOTF. If the PI meets all eligibility criteria and the LOI is accepted by AOTF, applicants will be prvided with a link t the applicatin. Principal investigatrs wh are granted permissin t submit an applicatin will be ntified by September 21, 2018. Applicatin deadline: Nvember 13, 2018, 11:59 CDT. Applicants are respnsible fr all deadlines. Deadline extensins will NOT be granted. B. What is the timeline fr the 2018-2019 Health Sciences Research grant prject? July 2018 Review the research pririties, bjectives, appraches, and eligibility criteria. Begin develping the initial framewrk fr a Letter f Intent and Applicatin using infrmatin and instructins n the AOTF website. Cntact AOTF if yu have questins regarding the Interventin Research Grant prgram. (AOTF Scientific Prgrams Officer, research@atf.rg). July 16, 2018 -- Online submissin site fr Letter f Intent pens. August 2018 August 23, 2018 -- Letter f Intent deadline 11:59 p.m. CDT. AOTF Health Services Research Grant RFA Page 4 f 6

September 2018 September 21, 2018 -- Invitatins t submit an Applicatin are extended t principal investigatrs wh meet all eligibility criteria and have submitted an LOI that is accepted by AOTF. September 21, 2018 Online Applicatin site pens. Begin Applicatin. Nvember 2018 Nvember 13, 2018 -- Applicatin due 11:59 p.m. CST. February 2019 Summary statements and award ntificatins are sent t applicants. VI. ABOUT THE COMPONENTS OF THE 2018-2019 LETTER OF INTENT AND APPLICATION A. What are the cmpnents f the Letter f Intent (LOI)? Principal investigatr: persnal infrmatin and bisketch Infrmatin abut the applicant rganizatin If PI is nt an OT, include OT bisketch. Research mentr: persnal infrmatin, letter f cmmitment including mentring plan, bisketch, and mentr training table Shrt descriptin f the prpsed research prject including ratinale and imprtance t the rehabilitative sciences field. B. What are the cmpnents f the Applicatin? Principal investigatr and prject infrmatin. Spnsring institutin infrmatin. Research Plan with infrmatin n: Specific Aims including expected utcme f the study and its impact n the field f rehabiltatin. Methd. List f databases t be used. Future Implicatins. Shrt prject summary in lay language. Budget and budget justificatin. Specific aims. Letters f supprt. Literature cited. Prtectin f human subjects plan (if needed). Inclusin f wmen, minrities, and children. Cnsrtium/cntractual/cnsulting arrangements. IRB apprval letter/iacuc apprval (if needed fr research. If research requires an IRB, grant will nt begin until AOTF receives the RB). Human subjects research training certificatin fr key persnnel if needed. Appendices. Available resurces. Bigraphical sketches f c-investigatrs and ther key persnnel including rles and respnsibilities each member f the team. Overview f deliverables. AOTF Health Services Research Grant RFA Page 5 f 6

VII. ABOUT THE KEY REVIEW CRITERIA FOR 2018-2019 APPLICATIONS A. What are the key review criteria fr the 2018-2019 applicatins? Overall impact scre Significance Innvatin Apprach Envirnment Investigatr(s) Ptential fr subsequent funding -- lays the necessary grundwrk fr larger interventin studies and subsequent funding. Budget Statistical analysis AOTF Health Services Research Grant RFA Page 6 f 6