SmokingRPNCT01563575
WHO-HPH Recognition Project on Fast-Track Implementation of Clinical Health Promotion
A study testing fast-track implementation process in people with Smoking and Excessive Drinking, run by Bispebjerg Hospital at 11 sites in 11 countries.
Trial summary
The project's background is the notion that patient centred clinical health promotion has been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO describes health promotion as a key dimension of quality in hospitals, and the organization has developed standards on the topic in order… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Smoking, Excessive Drinking, Lack of Physical Activity
- What is being tested?
- fast-track implementation process
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 11 sitesin 11 countries
- Study dates
- Jan 2012to 11 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Clinical hospital departments from university hospitals
- Clinical hospital departments from non-university hospitals
Who cannot join
- Palliative care departments
- Pediatric departments
- Nursing homes
- Non-hospital departments
- Primary care facilities
Trial locations and contacts
11 sites in 11 countries.
11 sites in 11 countries
About this study
Official title: WHO-HPH Recognition Project on Fast-Track Implementation of Clinical Health Promotion - a Multi-Centre RCT
The project's background is the notion that patient centred clinical health promotion has been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO describes health promotion as a key dimension of quality in hospitals, and the organization has developed standards on the topic in order to help hospital management and staff members to assess and improve the quality of health care and thereby achieve better health for patients, staff, and community. Even so, however, health promotion is still a very implicit part of nearly all quality standards on hospitals. Moreover, assessing hospitals departments' health promotion performance is still quite an unexplored area. On this basis, this project will test a new recognition process that uses the relevant WHO-HPH tools and standards to assess performance, by way of explicit documentation and evaluation of clinical health promotion activity. The project is deigned as a RCT, with a control group that undergoes the recognition process immediately and a control group that continue usual clinical routine. Then, after one year, the control group also begins the recognition process (= delayed start), while the Intervention group (=immediate-start) continues with the recognition process. Doing this allows for a great array of measurements, and hopefully the project will then show whether the recognition process really benefits implementation of health promotion in hospitals and health services, and also, if this really generates better health gains for patients and staff. The outcome measurements will be frequency of health promotion services delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity to patients in need. Such services could for instance be motivational counselling and brief interventions, as well as intervention, rehabilitation and after treatment. Physical, mental, and social health status among patients and staff will be measured by short form (SF36).
- Conditions
- Smoking, Excessive Drinking, Lack of Physical Activity, Malnutrition, Obesity
- Being tested
- fast-track implementation process
- Keywords
- Recognition Process, Health Promotion, HPH, WHO, Hospitals, Health Services, Health Gain, Service Delivery, Quality Management
- Medical subject headings
- Smoking, Sedentary Behavior, Malnutrition, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fast-track implementation processOther
Undergo fast-track implementation process (WHO-HPH recognition Process), including: baseline data collection, quality plan, implementation for one year, follow-up data collection, revision of quality plan, external site visit and data validation
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | fast-track implementation process Receives: Other: fast-track implementation process |
| Control Group | No intervention | Continue usual routine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changed health gain of patients and staff
Change in physical, mental, and social health status among patients and staff will be measured by short form (SF36).
Measured: Baseline, after 1 year, after 2 years
Secondary outcomes (1)
Number of health promotion services delivered
Change in the frequency of health promotion services delivered on smoking, excessive alcohol use, overweight, mal-nutrition, and physical activity to smoking, excessive drinking, overweight, malnourished, and physical inactive patients. These services concern clinical health promotion activities, like motivational counselling and brief interventions, as well as intervention, rehabilitation and after treatment.
Measured: Baseline, after 1 year, after 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2012 (estimated)
- Study startJan 2012
- Primary completion11 Sep 2018
- Study completion11 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SmokingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bispebjerg Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- World Health Organization, International Network of Health Promoting Hospitals & Health Services (HPH), National HPH Network of Montreal, Canada, National HPH Network of the Czech Republic, National HPH Network of Slovenia, National HPH Network of Estonia, Regional HPH Network of Taiwan, National HPH Network of Indonesia, National HPH Network of Japan, HPH member hospitals in Denmark, HPH member hospitals in Croatia, HPH member hospitals in Malaysia, HPH member hospitals in Thailand
- Responsible party
- Principal investigator, Hanne Tonnesen, Bispebjerg Hospital
- Investigators
- Hanne Tonnesen, MD DMSc, Principal investigator, University Hospital Bispebjerg and Frederiksberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01563575
- Sponsor's protocol ID
- WHOHPHRP
- Acronym
- RP
- Status last verified
- Jun 2022
- First submitted
- 22 Mar 2012
- Last updated
- 15 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Svane JK, Chiou ST, Groene O, Kalvachova M, Brkic MZ, Fukuba I, Harm T, Farkas J, Ang Y, Andersen MO, Tonnesen H. A WHO-HPH operational program versus usual routines for implementing clinical health promotion: an RCT in health promoting hospitals (HPH). Implement Sci. 2018 Dec 22;13(1):153. doi: 10.1186/s13012-018-0848-0.
PubMed 30577871
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WHO-HPH Recognition Project on Fast-Track Implementation of Clinical Health Promotion - a Multi-Centre RCT
- ClinicalTrials.gov ID
- NCT01563575
- Acronym / sponsor ID
- RP / WHOHPHRP
- Conditions
- Smoking, Excessive Drinking, Lack of Physical Activity, Malnutrition, Obesity
- Keywords
- Recognition Process, Health Promotion, HPH, WHO, Hospitals, Health Services, Health Gain, Service Delivery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Bispebjerg HospitalUniversity, hospital or other
- Collaborators
- World Health Organization, International Network of Health Promoting Hospitals & Health Services (HPH), National HPH Network of Montreal, Canada, National HPH Network of the Czech Republic, National HPH Network of Slovenia, National HPH Network of Estonia, Regional HPH Network of Taiwan, National HPH Network of Indonesia, National HPH Network of Japan, HPH member hospitals in Denmark, HPH member hospitals in Croatia, HPH member hospitals in Malaysia, HPH member hospitals in Thailand
- Study start
- Jan 2012
- Primary completion
- 11 Sep 2018 (actual)
- Study completion
- 11 Sep 2018 (actual)
- First posted
- 27 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project's background is the notion that patient centred clinical health promotion has been shown to significantly improve both outcomes and patient safety. Accordingly, the WHO describes health promotion as a key dimension of quality in hospitals, and the organization has developed standards on the topic in order to help hospital management and staff members to assess and improve the quality of health care and thereby achieve better health for patients, staff, and community. Even so, however, health promotion is still a very implicit part of nearly all quality standards on hospitals. Moreover, assessing hospitals departments' health promotion performance is still quite an unexplored area. On this basis, this project will test a new recognition process that uses the relevant WHO-HPH tools and standards to assess performance, by way of explicit documentation and evaluation of clinical health promotion activity. The project is deigned as a RCT, with a control group that undergoes the recognition process immediately and a control group that continue usual clinical routine. Then, after one year, the control group also begins the recognition process (= delayed start), while the Intervention group (=immediate-start) continues with the recognition process. Doing this allows for a great array of measurements, and hopefully the project will then show whether the recognition process really benefits implementation of health promotion in hospitals and health services, and also, if this really generates better health gains for patients and staff. The outcome measurements will be frequency of health promotion services delivered on smoking, excessive alcohol use, overweight, malnutrition, and physical activity to patients in need. Such services could for instance be motivational counselling and brief interventions, as well as intervention, rehabilitation and after treatment. Physical, mental, and social health status among patients and staff will be measured by short form (SF36).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Other: fast-track implementation processfast-track implementation process |
| Control Group | No intervention | –Continue usual routine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical hospital departments from university hospitals
- Clinical hospital departments from non-university hospitals
Key exclusion criteria (5 listed)
- Palliative care departments
- Pediatric departments
- Nursing homes
- Non-hospital departments
- Primary care facilities
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fast-track implementation processUndergo fast-track implementation process (WHO-HPH recognition Process), including: baseline data collection, quality plan, implementation for one year, follow-up data collection, revision of quality plan, external site visit and data validation | Other | Intervention Group |
Primary outcome
Changed health gain of patients and staff
Time frame: Baseline, after 1 year, after 2 years
Change in physical, mental, and social health status among patients and staff will be measured by short form (SF36).
1 secondary outcome
Number of health promotion services delivered
Time frame: Baseline, after 1 year, after 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2022.
- Derived from this study: PubMed 30577871Svane JK, Chiou ST, Groene O, Kalvachova M, Brkic MZ, Fukuba I, Harm T, Farkas J, Ang Y, Andersen MO, Tonnesen H. A WHO-HPH operational program versus usual routines for implementing clinical health promotion: an RCT in health promoting hospitals (HPH). Implement Sci. 2018 Dec 22;13(1):153. doi: 10.1186/s13012-018-0848-0.
- Main info pageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanne Tonnesen, MD DMSc principal investigator
University Hospital Bispebjerg and Frederiksberg
11 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fast-track implementation process in people with Smoking and Excessive Drinking, run by Bispebjerg Hospital at 11 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Canada, Croatia, Czechia, Denmark, Estonia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changed health gain of patients and staff (time frame: Baseline, after 1 year, after 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01563575, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2022.