Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Project Walk Through Professor Hanne Tønnesen MD PHD & Nermin Ghith, MPH, PHD Student Shu-Ti Chiou MD PHD MSc Oliver Groene MSc PHD Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Contents • • • • • • Design and outcomes Methods Analyses Ethical considerations Project Organization and Economy Authorships and Publication Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Design cont. After one year • The Control group begins the recognition process (= delayed start), • The Intervention group (=immediatestart) continues with the recognition process. Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Randomization • • • • computerised blocks of unknown sizes stratification for each participating country performed by independent researcher Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Outcomes Frequency of health promotion services regarding – smoking – excessive alcohol use – overweight – mal-nutrition – physical inactivity Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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) Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Inclusion criteria • All kinds of clinical hospital departments are eligible; from university as well as non-university clinical hospital departments Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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. Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Trial Profile Clin Dept n = 2x44 RP R Intervention Control Data collect TAU RP Intervention Data collect Control 1y Data collect Site Visit & Data Val Control 2y Data collect Site Visit & Data Val Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Methods First step: • Inclusion • Agreement • Allocation Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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” Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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”. Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Returning baseline package • All collected data and the Quality Plan are sent to WHO-CC in Copenhagen. Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Follow-up Package • Data collection similar to baseline: – Internal MR Audit – Surveys – Revised Quality Plan Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Trial Profile Clin Dept n = 2x44 RP R Intervention Control Data collect TAU RP Intervention Data collect Control 1y Data collect Site Visit & Data Val Control 2y Data collect Site Visit & Data Val Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Certificates Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Authorships & Publication • Maximum one active contributor from each N/R Network will be co-author • Other contributors can be acknowledged according to their work Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre 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 Bispebjerg University Hospital Evidence-Based Health Promotion in Hospitals & HS WHO Collaborating Centre Contents Design and outcomes Methods Analyses Ethical considerations Project Organization and Economy Authorships and Publication