Project Walk Through

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Project Walk Through
Professor Hanne Tønnesen MD PHD   Nermin Ghith,
MPH, PHD Student Shu-Ti Chiou MD PHD MSc Oliver
Groene MSc PHD
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Contents

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

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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

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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.

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Randomization

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

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Outcomes

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

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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
• N2x4010 drop outs 2x44

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Inclusion criteria

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

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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.

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Trial Profile
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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

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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

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Trial Profile
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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

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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