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Project Walk Through

Project Walk Through. Professor Hanne Tønnesen MD PHD &  Nermin Ghith, MPH, PHD Student Shu-Ti Chiou MD PHD MSc Oliver Groene MSc PHD. Contents. Design and outcomes Methods Analyses Ethical considerations Project Organization and Economy Authorships and Publication. Design.

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Project Walk Through

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  1. Project Walk Through Professor Hanne Tønnesen MD PHD &  Nermin Ghith, MPH, PHD Student Shu-Ti Chiou MD PHD MSc Oliver Groene MSc PHD

  2. Contents • Design and outcomes • Methods • Analyses • Ethical considerations • Project Organization and Economy • Authorships and Publication

  3. Design • An RCT with hospital departments allocated to one of the two groups • Undergo the Recognition Process immediately = Intervention group • Continue their usual routine = Control group

  4. Design cont. After one year • The Control group begins the recognition process (= delayed start), • The Intervention group (=immediate-start) continues with the recognition process.

  5. Randomization • computerised • blocks of unknown sizes • stratification for each participating country • performed by independent researcher

  6. Outcomes Frequency of health promotion services regarding • smoking • excessive alcohol use • overweight • mal-nutrition • physical inactivity

  7. Outcomes • Physical, mental, and social health status by Short Form Health Survey (SF36) • patients • staff (McHorney, Colleen A.; Ware, John E.; Raczek, Anastasia E. Med Care 1993; 31: 247-263)

  8. Material • 2 x 44 clinical hospital departments • Minimal relevant difference 30% in delivery of HP services • P-2 basic HP deliveries of 40% • P-1 expected HP deliveries of 70% • N=2x40+10% drop outs = 2x44

  9. Inclusion criteria • All kinds of clinical hospital departments are eligible; from university as well as non-university clinical hospital departments

  10. Exclusion criteria • Palliative care departments, paediatric departments, nursing homes, non-hospital departments, and primary care facilities • WHO-HPH standards and tools are not validated for these clinical activities.

  11. Clin Dept n = 2x44 Intervention Data collect Control TAU R RP RP Intervention Data collect Control Data collect 1y 2y Site Visit & Data Val Control Data collect Site Visit & Data Val Trial Profile

  12. Methods First step: • Inclusion • Agreement • Allocation

  13. Methods – Baseline Package • CD Rom • Project description, Action plan and Time schedule tailored for the participating department • Manual (a written form and a video) and material for collection of data • Case report files (CRF): documents, forms for internal MR Audit, Patient and Staff Surveys • Inspiration material for Quality Plan

  14. Data collection • Copies of Policies, Guidelines, and Programs etc (translated into English) • signed by Head of Dept, H/HS Coordinator and N/R Coordinator - see “Data Form” • Internal Audit of 50 consecutive medical records (from the month prior to inclusion) • see “MR Audit Form” • Survey for patients and staff • see “SF-36 + Additional forms”

  15. Quality plan • Use baseline results • Clear milestones • Action plan and Time line for implementation in the following 12 months • The Hospital/HS Management, the Head of Department as well as the N/R and H/HS Coordinators sign the plan • See “Manual”.

  16. Returning baseline package • All collected data and the Quality Plan are sent to WHO-CC in Copenhagen.

  17. Implementation of Quality Plan • Implement Quality Plan over 12 months according to Milestones, Action plan and Time line • Minor adjustments often necessary according to changes in hospital structure, patient groups, staff etc in order to reach the Milestones

  18. Follow-up Package • Data collection similar to baseline: • Internal MR Audit • Surveys • Revised Quality Plan

  19. Data validation after 1 yr • Only after receiving all materials at WHO-CC in Copenhagen • Visit to confirm the data from internal MR audit and surveys results • Interviews with staff and patients • External audit of 50 randomly selected MR

  20. Trial Profile Clin Dept n = 2x44 Intervention Data collect Control TAU R RP RP Intervention Data collect Control Data collect 1y 2y Site Visit & Data Val Control Data collect Site Visit & Data Val

  21. Certificates

  22. Analyses • ITT by an external researcher • Frequency of health promotion services delivered • Fishers’ Exact Test • Physical, mental, and social health status are scored using the SF-36 • Mann-Whitney Test

  23. Ethical considerations • Scientific Ethical Committee in the Danish Capital Region (International trials) • Danish Data Protection Agency (International trials) • Data Security and Confidentiality • Departments will be anonymised • Only the research team have access • Patients and staff surveys carried out in accordance with hospital guidelines • Patients and staff data are anonymous (without PIN) at collection

  24. Project Organisation • WHO-CC research team and International Supervisors • Responsible for research quality, data analysis and scientific writing • National/Regional and H/HS Coordinators from HPH Networks • Responsible for supporting project • Hospital Managements and Heads of participating departments • Responsible for driving the project, collecting data and implement QP

  25. Project Organisation • Approved by the Copenhagen University as a part of the PHD study for Nermin Ghith • Supervised by • Hanne Tønnesen MD PHD • Shu-Ti Chiou MD PHD MSc • Oliver Groene MSc PHD • Study incorporated in MoU between WHO and HPH

  26. Project Economy • Hospitals & Departments and Networks secure own resources related to participation • Resources, office facilities etc. for the PHD student are covered by • WHO-CC, Bispebjerg University Hospital • Health Science, Faculty of Medicine Lund University

  27. Authorships & Publication • Main results will be included in the PHD of Nermin Ghith, who will draft the main paper(s) under supervision • National/Regional Networks and participating Hospitals/Departments can publish own data together with research team • Authorship follows the Vancouver Criteria

  28. Authorships & Publication • Maximum one active contributor from each N/R Network will be co-author • Other contributors can be acknowledged according to their work

  29. Authorships & Publication • Publication of the research results in International scientific journals • Further dissemination in clinical, scientific and public forums as well as media including WHO and HPH Network websites

  30. Contents • Design and outcomes • Methods • Analyses • Ethical considerations • Project Organization and Economy • Authorships and Publication

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