WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Project Walk Through Professor Hanne Tønnesen MD PHD & Nermin Ghith, MPH, PHD Student Shu-Ti Chiou MD PHD MSc Oliver Groene MSc PHD

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Contents Design and outcomes Methods Analyses Ethical considerations Project Organization and Economy Authorships and Publication

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Design cont. After one year The Control group begins the recognition process (= delayed start), The Intervention group (=immediate- start) continues with the recognition process.

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Randomization computerised blocks of unknown sizes stratification for each participating country performed by independent researcher

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Outcomes Frequency of health promotion services regarding –smoking –excessive alcohol use –overweight –mal-nutrition –physical inactivity

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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: )

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Inclusion criteria All kinds of clinical hospital departments are eligible; from university as well as non-university clinical hospital departments

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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.

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Trial Profile Clin Dept n = 2x44 R Intervention Data collect Control TAU 1y 2y Intervention Data collect Control Data collect Control Data collect Site Visit & Data Val RP

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Methods First step: Inclusion Agreement Allocation

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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”

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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”.

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Returning baseline package All collected data and the Quality Plan are sent to WHO-CC in Copenhagen.

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Follow-up Package Data collection similar to baseline: –Internal MR Audit –Surveys –Revised Quality Plan

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Trial Profile Clin Dept n = 2x44 R Intervention Data collect Control TAU 1y 2y Intervention Data collect Control Data collect Control Data collect Site Visit & Data Val RP

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Certificates

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Authorships & Publication Maximum one active contributor from each N/R Network will be co-author Other contributors can be acknowledged according to their work

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital 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

WHO Collaborating Centre Evidence-Based Health Promotion in Hospitals & HS Bispebjerg University Hospital Contents Design and outcomes Methods Analyses Ethical considerations Project Organization and Economy Authorships and Publication