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