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

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project walk through

Project Walk Through

Professor Hanne Tønnesen MD PHD

Nermin Ghith, MPH, PHD Student

Shu-Ti Chiou MD PHD MSc

Oliver Groene MSc PHD

contents
Contents
  • Design and outcomes
  • Methods
  • Analyses
  • Ethical considerations
  • Project Organization and Economy
  • Authorships and Publication
design
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
design cont
Design cont.

After one year

  • The Control group begins the recognition process (= delayed start),
  • The Intervention group (=immediate-start) continues with the recognition process.
randomization
Randomization
  • computerised
  • blocks of unknown sizes
  • stratification for each participating country
  • performed by independent researcher
outcomes
Outcomes

Frequency of health promotion services regarding

  • smoking
  • excessive alcohol use
  • overweight
  • mal-nutrition
  • physical inactivity
outcomes1
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)

material
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
inclusion criteria
Inclusion criteria
  • All kinds of clinical hospital departments are eligible; from university as well as non-university clinical hospital departments
exclusion criteria
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.
trial profile

Clin Dept

n = 2x44

Intervention

Data collect

Control

TAU

R

RP

RP

Intervention

Data collect

Control

Data collect

1y

2y

Site Visit & Data Val

Control

Data collect

Site Visit & Data Val

Trial Profile
methods
Methods

First step:

  • Inclusion
  • Agreement
  • Allocation
methods baseline package
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
data collection
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”
quality plan
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”.
returning baseline package
Returning baseline package
  • All collected data and the Quality Plan are sent to WHO-CC in Copenhagen.
implementation of quality plan
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
follow up package
Follow-up Package
  • Data collection similar to baseline:
    • Internal MR Audit
    • Surveys
    • Revised Quality Plan
data validation after 1 yr
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
trial profile1
Trial Profile

Clin Dept

n = 2x44

Intervention

Data collect

Control

TAU

R

RP

RP

Intervention

Data collect

Control

Data collect

1y

2y

Site Visit & Data Val

Control

Data collect

Site Visit & Data Val

analyses
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
ethical considerations
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
project organisation
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
project organisation1
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
project economy
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
authorships publication
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
authorships publication1
Authorships & Publication
  • Maximum one active contributor from each N/R Network will be co-author
  • Other contributors can be acknowledged according to their work
authorships publication2
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
contents1
Contents
  • Design and outcomes
  • Methods
  • Analyses
  • Ethical considerations
  • Project Organization and Economy
  • Authorships and Publication