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
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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
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Design and outcomes
Methods
Analyses
Ethical considerations
Project Organization and Economy
Authorships and Publication