SepsisNCT02069028
Effectiveness of Different Interventions for Implementing Surviving Sepsis Campaign (SSC) Guidelines on Compliance and Mortality: Systematic Review and Meta-analysis
An observational study of Sepsis and Septic, run by King Abdullah International Medical Research Center.
Trial summary
This is a systematic review and Meta-Analysis of interventions for implementation of Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Sepsis, Septic, Septicemia
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Feb 2014to Sep 2014
- Phase
- Observational
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Research articles
Who may be able to join
- Any study or data
- assessing any intervention method for implementing SSC guidelines in regards to compliance and mortality,
- has a comparison group,
- reported data on sepsis resuscitation bundle compliance and mortality
Who cannot join
- Any study used other than SSC guidelines in sepsis management will be excluded.
About this study
This is a systematic review and Meta-Analysis of interventions for implementation of Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction
Read the detailed description
The implementation of the sepsis resuscitation bundle recommended by the SSC guidelines has been shown to increase compliance and reduce mortality in several settings. Different implementation strategies have been utilized, including education, posters, reminders, audit and feedback, paper-based and electronic sepsis screening tools, clinical pathway and sepsis response teams. Different studies showed a considerable variation effect on compliance and mortality.It has been suggested that implantation strategies vary in there effect from low impact for human-based interventions such as education and training, rules and policies, reminders, checklists and double checks, however, reaching high effect for system based interventions like automation and computerization and forcing function. However, this has not been studied in relation to the implementation of SSC bundle. As such, many projects continue to invest on low-impact interventions with modest change in compliance and mortality. Multiple interventions were adopted by different centers worldwide to implement SSC guidelines. These interventions vary on their level of compliance and outcomes. The effectiveness of intervention if system oriented is more effective than human oriented. The hierarchy of effectiveness assigning forcing function intervention on the top of the pyramid and the training and education on the bottom.
The investigators hypothesize that interventions system based interventions are more likely to be more effective in improving the compliance with sepsis resuscitation bundle and in improving mortality.
The aim of this study is to assess the effectiveness of different interventions for implementation of Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction.
- Conditions
- Sepsis, Septic, Septicemia
- Keywords
- surviving sepsis campaign, sepsis, septic, septicemia, mortality, compliance
- Medical subject headings
- Sepsis, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Low intensity intervention | human oriented interventions with less consideration to the system based act including, but not limited to, education, training, sepsis profile and posters with protocol algorithms. | |
| Intermediate intensity intervention | interventions that lie in between human oriented and system oriented Including, but not limited to, sepsis protocols, daily audits, feedback and clinical pathway | |
| High intensity intervention | system based interventions with less involvement of human effect including, but not limited to, electronic alert systems and sepsis response team. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surviving Sepsis Campaign (SSC) Guidelines Compliance and Mortality
Measured: 2002 - 2014 (12 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Observational
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King Abdullah International Medical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Yaseen Arabi, King Abdullah International Medical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02069028
- Sponsor's protocol ID
- 0
- Status last verified
- Feb 2014
- First submitted
- 20 Feb 2014
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Different Interventions for Implementing Surviving Sepsis Campaign (SSC) Guidelines on Compliance and Mortality: Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT02069028
- Acronym / sponsor ID
- 0
- Conditions
- Sepsis, Septic, Septicemia
- Keywords
- surviving sepsis campaign, sepsis, septic, septicemia, mortality, compliance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- King Abdullah International Medical Research CenterUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 21 Feb 2014 (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.
This is a systematic review and Meta-Analysis of interventions for implementation of Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction
Detailed description
The implementation of the sepsis resuscitation bundle recommended by the SSC guidelines has been shown to increase compliance and reduce mortality in several settings. Different implementation strategies have been utilized, including education, posters, reminders, audit and feedback, paper-based and electronic sepsis screening tools, clinical pathway and sepsis response teams. Different studies showed a considerable variation effect on compliance and mortality.It has been suggested that implantation strategies vary in there effect from low impact for human-based interventions such as education and training, rules and policies, reminders, checklists and double checks, however, reaching high effect for system based interventions like automation and computerization and forcing function. However, this has not been studied in relation to the implementation of SSC bundle. As such, many projects continue to invest on low-impact interventions with modest change in compliance and mortality. Multiple interventions were adopted by different centers worldwide to implement SSC guidelines. These interventions vary on their level of compliance and outcomes. The effectiveness of intervention if system oriented is more effective than human oriented. The hierarchy of effectiveness assigning forcing function intervention on the top of the pyramid and the training and education on the bottom.
The investigators hypothesize that interventions system based interventions are more likely to be more effective in improving the compliance with sepsis resuscitation bundle and in improving mortality.
The aim of this study is to assess the effectiveness of different interventions for implementation of Surviving Sepsis Campaign guidelines and their impact on compliance and mortality reduction.
Study design
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low intensity intervention | – | –human oriented interventions with less consideration to the system based act including, but not limited to, education, training, sepsis profile and posters with protocol algorithms. |
| Intermediate intensity intervention | – | –interventions that lie in between human oriented and system oriented Including, but not limited to, sepsis protocols, daily audits, feedback and clinical pathway |
| High intensity intervention | – | –system based interventions with less involvement of human effect including, but not limited to, electronic alert systems and sepsis response team. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Research articles
Key inclusion criteria (4 listed)
- Any study or data
- assessing any intervention method for implementing SSC guidelines in regards to compliance and mortality,
- has a comparison group,
- reported data on sepsis resuscitation bundle compliance and mortality
Key exclusion criteria (1 listed)
- Any study used other than SSC guidelines in sepsis management will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Surviving Sepsis Campaign (SSC) Guidelines Compliance and Mortality
Time frame: 2002 - 2014 (12 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Septic, run by King Abdullah International Medical Research Center.
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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 21 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Surviving Sepsis Campaign (SSC) Guidelines Compliance and Mortality (time frame: 2002 - 2014 (12 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Feb 2014.