Joining the Project: What does it involve?

Transcription

1 Joining the Project: What does it involve? Principal Investigator Prof Hanne Tønnesen MD PHD PHD Student Jeff Kirk Svane MA (DK) Supervisor Shu-Ti Chiou MD PHD MSc (TW) Advisor Oliver Groene MSc PHD (UK)

2 Trial Profile Clin Dept n = 2x44 Data collect I Data collect Site Visit & Data Val R 1y TAU Data collect

3 Trial Profile Clin Dept n = 2x44 Data collect I Data collect Site Visit & Data Val R 1y 2y TAU Data collect I Data collect Site Visit & Data Val

4 Material 2 x 44 clinical hospital departments Power calculation 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

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

6 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.

7 Steps 1. Include, agree, allocate 2. Baseline package 3. Internal Audit, Surveys & Quality Plan 4. Return package 5. Implementation 6. Follow-up package 7. Int Audit, Surveys + Rev Q Plan + Return package 8. Site visit & certification

8 Certificates

9 Ethical considerations Scientific Ethical Committee (DK) Danish Data Protection Agency (International trials) Data Security and Confidentiality Patients and staff surveys carried out in accordance with hospital guidelines Patients and staff data are anonymous (without PIN) at collection

10 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 Sciences, Faculty of Medicine Lund University

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

12 Timeline Incl, Agree, Allocate Baseline Package mo I II III IV I II III IV I II III IV I 2 1 Int Audit + Q Plan 2 Return Package 1 Implementation 12 Follow-up Package Int Audit + Rev Quality Plan + Return package Site Visit + certificate Year 1 Year 2 Year 3

13 Welcome! We look forward to the fruitful collaboration Video Clip on inclusion, agreement and allocation (example from Czech Republic)

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15 Methods Baseline Package Online Package Project description, Action plan and Time schedule tailored for the participating department Manual 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

16 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 indicators

17 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.

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

19 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

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

21 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

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 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

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

25 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: )

26 Randomization computerised blocks of unknown sizes stratification for each participating country performed by independent researcher

27 Authorships & Publication Main results will be included in the PHD of Jeff Kirk Svane, 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 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