Healthcare-associated InfectionsNCT02244905
Trial of Positive Deviance in Inpatient Wards to Reduce Hospital Infections
A study testing Positive Deviance in people with Healthcare-associated Infections, run by University of Texas Southwestern Medical Center.
Trial summary
Healthcare-associated infections (HAI) are a significant public health burden. Even with existence of recommendations on technical strategies to prevent these infections, there is a need for strategies to increase staff engagement within the local organizational and cultural context. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Healthcare-associated Infections
- What is being tested?
- Positive Deviance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16,876 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Aug 2014
- 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
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For Intervention: All staff members employed in the study wards assigned to the intervention arm.
- For Primary Outcome Assessment:
- All patients admitted to any of the six study wards included in the study over the 24-month study period.
Who cannot join
- -None
About this study
Healthcare-associated infections (HAI) are a significant public health burden. Even with existence of recommendations on technical strategies to prevent these infections, there is a need for strategies to increase staff engagement within the local organizational and cultural context. Positive deviance is one such approach that engages people in improvement efforts. Positive Deviance is based on the observation that in every community there are certain individuals or groups whose uncommon behaviors and strategies enable them to find better solutions to problems than their peers, while having access to the same resources and facing similar or worse challenges. In the proposed study, the investigators plan to test the effectiveness of using positive deviance based horizontal infection prevention approach to achieve overall reduction of HAIs among hospital inpatients. The investigators hypothesized that a broad and horizontal approach to reduce opportunities for acquisition of nosocomial pathogens using PD will lead to greater reduction of HAI among hospital inpatients compared to standard-of-care infection control approach. The investigators objective was to test the investigators hypothesis and evaluate whether there is greater decline in rate of HAI in the experimental group of wards compared to the control group of wards.
Read the detailed description
Objective: To evaluate whether positive deviance (PD) based horizontal infection prevention approach will result in a higher rate of decline in incidence density of patients with HAI (central line-associated bloodstream infection, healthcare-associated pneumonia, catheter-associated urinary tract infection, or Clostridium difficile infection) per 1000 patient days per month in the intervention wards compared to control wards.
Design: A cluster randomized controlled trial was conducted over a period of 24 months. Six medical wards were randomized and positive deviance intervention was randomly allocated to one of the two groups of three wards each. The baseline, intervention and follow-up periods were 6, 9 and 9 months respectively.
Setting: A public safety-net major teaching hospital in United States.
Participants: The ward staffs participated in the intervention.
Intervention: Key components of the intervention were invitation to participate voluntarily, open-ended dialogues with staff members to discover barriers and seek solutions to prevent HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions generated. Staffs of all six wards were asked to voluntarily participate in a modified hospital survey of patient safety climate (HSOPSC) and a social network survey at 6, 15, and 24 months.
Statistical analysis: Statistical methods used were time series modeling, summary of frequencies, Chi-square or Fisher's exact for testing difference in proportions and t-test.
- Conditions
- Healthcare-associated Infections
- Being tested
- Positive Deviance, Standard-of-Care Infection Control approach
- Keywords
- Positive Deviance, Infection Control, Healthcare-Associated Infections, Staff Engagement, Cluster Randomized Controlled Trial
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Positive DevianceBehavioural
The recipients of the Positive Deviance intervention are the staff members of the three wards in the intervention arm, while the outcomes are measured among the patients receiving care in the three wards in the intervention arm. Key components of the intervention were invitation to participate voluntarily, open-ended dialogues with staff members to discover barriers and seek solutions to prevent HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions generated.
Standard-of-Care Infection Control approachOther
Standard-of-Care Infection Control approach
| Study group | Role | What they receive |
|---|---|---|
| Positive Deviance Intervention Arm | Experimental | Three hospital wards received Positive Deviance intervention. Receives: Behavioral: Positive Deviance; Other: Standard-of-Care Infection Control approach |
| Control Arm | Other | Three hospital wards randomized to control arm received the Standard-of-Care Infection Control approach. Receives: Other: Standard-of-Care Infection Control approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of HAI per 1000 patient-days per month.
The primary study outcome is the incidence density of HAI [a composite of central line associated bloodstream infection (CLABSI), hospital-acquired pneumonia (HAP), catheter-associated urinary tract infection (CAUTI) and C.difficile infection (CDI)] per 1000 patient-days per month.
Measured: 24 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startAug 2011
- Primary completionMar 2013
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare-associated InfectionsStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16,876 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pranavi Sreeramoju, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244905
- Sponsor's protocol ID
- STU 072011-079
- Other IDs
- Grant # 137911
- Status last verified
- Mar 2020
- First submitted
- 15 Sep 2014
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial of Positive Deviance in Inpatient Wards to Reduce Hospital Infections
- ClinicalTrials.gov ID
- NCT02244905
- Acronym / sponsor ID
- STU 072011-079
- Conditions
- Healthcare-associated Infections
- Keywords
- Positive Deviance, Infection Control, Healthcare-Associated Infections, Staff Engagement, Cluster Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16,876 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Mar 2013 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 19 Sep 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.
Healthcare-associated infections (HAI) are a significant public health burden. Even with existence of recommendations on technical strategies to prevent these infections, there is a need for strategies to increase staff engagement within the local organizational and cultural context. Positive deviance is one such approach that engages people in improvement efforts. Positive Deviance is based on the observation that in every community there are certain individuals or groups whose uncommon behaviors and strategies enable them to find better solutions to problems than their peers, while having access to the same resources and facing similar or worse challenges. In the proposed study, the investigators plan to test the effectiveness of using positive deviance based horizontal infection prevention approach to achieve overall reduction of HAIs among hospital inpatients. The investigators hypothesized that a broad and horizontal approach to reduce opportunities for acquisition of nosocomial pathogens using PD will lead to greater reduction of HAI among hospital inpatients compared to standard-of-care infection control approach. The investigators objective was to test the investigators hypothesis and evaluate whether there is greater decline in rate of HAI in the experimental group of wards compared to the control group of wards.
Detailed description
Objective: To evaluate whether positive deviance (PD) based horizontal infection prevention approach will result in a higher rate of decline in incidence density of patients with HAI (central line-associated bloodstream infection, healthcare-associated pneumonia, catheter-associated urinary tract infection, or Clostridium difficile infection) per 1000 patient days per month in the intervention wards compared to control wards.
Design: A cluster randomized controlled trial was conducted over a period of 24 months. Six medical wards were randomized and positive deviance intervention was randomly allocated to one of the two groups of three wards each. The baseline, intervention and follow-up periods were 6, 9 and 9 months respectively.
Setting: A public safety-net major teaching hospital in United States.
Participants: The ward staffs participated in the intervention.
Intervention: Key components of the intervention were invitation to participate voluntarily, open-ended dialogues with staff members to discover barriers and seek solutions to prevent HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions generated. Staffs of all six wards were asked to voluntarily participate in a modified hospital survey of patient safety climate (HSOPSC) and a social network survey at 6, 15, and 24 months.
Statistical analysis: Statistical methods used were time series modeling, summary of frequencies, Chi-square or Fisher's exact for testing difference in proportions and t-test.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive Deviance Intervention Arm | Experimental | Behavioral: Positive Deviance, Other: Standard-of-Care Infection Control approachThree hospital wards received Positive Deviance intervention. |
| Control Arm | Other | Other: Standard-of-Care Infection Control approachThree hospital wards randomized to control arm received the Standard-of-Care Infection Control approach. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- For Intervention: All staff members employed in the study wards assigned to the intervention arm.
- For Primary Outcome Assessment:
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| Positive DevianceThe recipients of the Positive Deviance intervention are the staff members of the three wards in the intervention arm, while the outcomes are measured among the patients receiving care in the three wards in the intervention arm. Key components of the intervention were invitation to participate voluntarily, open-ended dialogues with staff members to discover barriers and seek solutions to prevent HAI, discussion of outcomes, and encouragement to prioritize and implement the solutions generated. | Behavioural | Positive Deviance Intervention Arm |
| Standard-of-Care Infection Control approachStandard-of-Care Infection Control approach | Other | Control Arm, Positive Deviance Intervention Arm |
Primary outcome
Number of HAI per 1000 patient-days per month.
Time frame: 24 Months
The primary study outcome is the incidence density of HAI [a composite of central line associated bloodstream infection (CLABSI), hospital-acquired pneumonia (HAP), catheter-associated urinary tract infection (CAUTI) and C.difficile infection (CDI)] per 1000 patient-days per month.
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 17 Mar 2020.
Related trials for Healthcare-associated Infections
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Initial and Subsequent Healthcare-Associated Infections in Intensive Care Patients
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Prospective Healthcare-Associated Links in Transmission of Nontuberculous Mycobacteria
Cystic Fibrosis, Nontuberculous Mycobacterial Pulmonary Infection
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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.
Pranavi Sreeramoju, MD principal investigator
University of Texas Southwestern Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Positive Deviance in people with Healthcare-associated Infections, run by University of Texas Southwestern Medical 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 3 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: finished, as of the sponsor's last update on 17 Mar 2020. 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?
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?
Number of HAI per 1000 patient-days per month. (time frame: 24 Months). 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 17 Mar 2020.