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Project Walk Through

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Project Walk Through Professor Hanne T nnesen MD PHD & Nermin Ghith, MPH, PHD Student Shu-Ti Chiou MD PHD MSc Oliver Groene MSc PHD – PowerPoint PPT presentation

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Title: Project Walk Through


1
Project Walk Through
Professor Hanne Tønnesen MD PHD   Nermin Ghith,
MPH, PHD Student Shu-Ti Chiou MD PHD MSc Oliver
Groene MSc PHD
2
Contents
  • Design and outcomes
  • Methods
  • Analyses
  • Ethical considerations
  • Project Organization and Economy
  • Authorships and Publication

3
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

4
Design cont.
  • After one year
  • The Control group begins the recognition process
    ( delayed start),
  • The Intervention group (immediate-start)
    continues with the recognition process.

5
Randomization
  • computerised
  • blocks of unknown sizes
  • stratification for each participating country
  • performed by independent researcher

6
Outcomes
  • Frequency of health promotion services regarding
  • smoking
  • excessive alcohol use
  • overweight
  • mal-nutrition
  • physical inactivity

7
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)
8
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
  • N2x4010 drop outs 2x44

9
Inclusion criteria
  • All kinds of clinical hospital departments are
    eligible from university as well as
    non-university clinical hospital departments

10
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.

11
Trial Profile
12
Methods
  • First step
  • Inclusion
  • Agreement
  • Allocation

13
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

14
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

15
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.

16
Returning baseline package
  • All collected data and the Quality Plan are sent
    to WHO-CC in Copenhagen.

17
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

18
Follow-up Package
  • Data collection similar to baseline
  • Internal MR Audit
  • Surveys
  • Revised Quality Plan

19
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

20
Trial Profile
21
Certificates
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
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

24
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

25
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

26
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

27
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

28
Authorships Publication
  • Maximum one active contributor from each N/R
    Network will be co-author
  • Other contributors can be acknowledged according
    to their work

29
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

30
Contents
  • Design and outcomes
  • Methods
  • Analyses
  • Ethical considerations
  • Project Organization and Economy
  • Authorships and Publication
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