Healthcare Associated InfectionCaM-HAINCT04053257
Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Infections in NICU
A study testing Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs in people with Healthcare Associated Infection and Hand Hygiene, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine if use of the video camera surveillance system for HH observation and performance feedback about HH compliance rates can improve the HH compliance of HCWs and reduce healthcare-associated infections in the NICU. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Healthcare Associated Infection, Hand Hygiene, Neonatal Infection
- What is being tested?
- Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8,335 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 Jul 2019to 11 May 2021
- 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
- All HCWs working in the NICU during the study period.
Who cannot join
- Visiting patient relatives in the NICU during the study period.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Healthcare Associated Infections in Neonatal Intensive Care Unit, an Interventional Study
The purpose of this study is to determine if use of the video camera surveillance system for HH observation and performance feedback about HH compliance rates can improve the HH compliance of HCWs and reduce healthcare-associated infections in the NICU.
Read the detailed description
Hypothesis:
H1: Hand hygiene (HH) compliance monitoring using video camera surveillance and giving feedback of HH compliance rates to HCWs would effect the hand hygiene behavior of health care workers (HCW) and healthcare-associated infections (HAI).
Study design:
A video camera surveillance system is in place in all NICU rooms since 2018. The investigators designed a quasiexperimental (before-after) study.
Study site and participants:
The research will take place in NICU from July 2019 to March 2020. All nurses, attending physicians, resident physicians, environmental services staff, medical assistants work in NICU.
Control period (Before intervention):
We will observe HH behavior of HCWs using the video camera surveillance for four weeks. This will give us the baseline HH compliance rates of NICU.
The baseline HAI rates will be calculated of the 3 months before intervention.
Intervention:
We will report baseline HH compliance rates and HAI rates to HCWs during a meeting where all HCWs are present. During this meeting we will remind major infection control measures, give examples of common mistakes they made without violating personal privacy rights of HCWs and patients.
Experimental period (After intervention):
The investigators will perform HH observation for four weeks after the intervention. At the end of the observation period, feedback about the HH compliance rates, change and detailed analysis of HH compliance rates by indication, day of week, hour of the day and NICU rooms will be given during a second meeting with HCWs.
HAI rates will be calculated for period of 3 months after intervention.
Sustainability of the intervention:
We will measure HH compliance rates 12 weeks after the intervention to investigate the sustainability of our intervention.
A third meeting will be done with HCWs in the unit which the investigator give feedback about the HH compliance, HAI rates before and after the intervention periods.
Data collection:
Seven, trained HH observers will participate in the study. These observers will achieve at least 80% concordance before the study. HH compliance data will be collected using a mobile app. HH monitoring will be performed Monday through Sunday making observations from randomly selected 20 minutes lapses of morning (08:00 am - 04:59 pm), afternoon (05:00 pm - 11:59 pm) and night (00:00 am - 07:59 am) shifts of the day. All HCWs in the room during the 20 minutes observation period are monitored for HH opportunities. Each HH opportunity was stratified as compliant or noncompliant and was classified according to the three of WHO's My 5 Moments for HH as follows: (1) before touching a patient, (4) after touching a patient, and (5) after contact with the patient's environment. HH moments before an aseptic task (2) and after body fluid exposure risk (3) was not included due to low resolution of video camera surveillance system.
Compliance was calculated by dividing the total HH opportunities for each subject by the number of HH compliance × 100. Adequate materials for HH are defined using either the soap and water or alcohol-based handrub solution.
HAIs are identified and recorded by active surveillance method in NICU. HAIs are identified using CDC criteria.
Sample Size:
We used G-power program for sample size calculation. With a power of 90%, 0.05 type I error rate and anticipated HH compliance increase before and after intervention period as 10% we planned to record 538 HH opportunities for each period (1076 HH opportunities total)
- Being tested
- Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWsOther
Intervention:
We will report baseline HH compliance rates and HAI rates to HCWs during a meeting where all HCWs are present. During this meeting we will remind major infection control measures, give examples of common mistakes they made without violating personal privacy rights of HCWs and patients.
| Study group | Role | What they receive |
|---|---|---|
| Before intervention | No intervention | HH opportunities, compliant moments and HAIs recorded before the intervention |
| After intervention | Active comparator | HH opportunities, compliant moments and HAIs recorded after the intervention Receives: Other: Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total hand hygiene compliance of health care workers
By dividing the total HH opportunities for each subject by the number of HH compliance × 100
Measured: 4 weeks
Health care associated infection rate
HAI number divided by the patient days in the unit
Measured: 12 weeks
Secondary outcomes (2)
Number of HH opportunities per minute
Total number of HH opportunities divided by total HH observation minutes
Measured: 4 weeks
Hand hygiene compliance by indication
Dividing HH opportunities for each indication by HH compliance for each indication.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start29 Jul 2019
- Primary completion31 Mar 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthcare Associated InfectionStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Quasiexperimental, before and after study
- Masking
- None (open label)
- Enrolment
- 8,335 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053257
- Sponsor's protocol ID
- 09.2019.710
- Acronym
- CaM-HAI
- Status last verified
- Jul 2021
- First submitted
- 8 Aug 2019
- Last updated
- 19 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Video Camera Monitoring Feedback on Hand Hygiene Compliance and Healthcare Associated Infections in Neonatal Intensive Care Unit, an Interventional Study
- ClinicalTrials.gov ID
- NCT04053257
- Acronym / sponsor ID
- CaM-HAI / 09.2019.710
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8,335 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 12 Aug 2019 (actual)
- 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 purpose of this study is to determine if use of the video camera surveillance system for HH observation and performance feedback about HH compliance rates can improve the HH compliance of HCWs and reduce healthcare-associated infections in the NICU.
Detailed description
Hypothesis:
H1: Hand hygiene (HH) compliance monitoring using video camera surveillance and giving feedback of HH compliance rates to HCWs would effect the hand hygiene behavior of health care workers (HCW) and healthcare-associated infections (HAI).
Study design:
A video camera surveillance system is in place in all NICU rooms since 2018. The investigators designed a quasiexperimental (before-after) study.
Study site and participants:
The research will take place in NICU from July 2019 to March 2020. All nurses, attending physicians, resident physicians, environmental services staff, medical assistants work in NICU.
Control period (Before intervention):
We will observe HH behavior of HCWs using the video camera surveillance for four weeks. This will give us the baseline HH compliance rates of NICU.
The baseline HAI rates will be calculated of the 3 months before intervention.
Intervention:
We will report baseline HH compliance rates and HAI rates to HCWs during a meeting where all HCWs are present. During this meeting we will remind major infection control measures, give examples of common mistakes they made without violating personal privacy rights of HCWs and patients.
Experimental period (After intervention):
The investigators will perform HH observation for four weeks after the intervention. At the end of the observation period, feedback about the HH compliance rates, change and detailed analysis of HH compliance rates by indication, day of week, hour of the day and NICU rooms will be given during a second meeting with HCWs.
HAI rates will be calculated for period of 3 months after intervention.
Sustainability of the intervention:
We will measure HH compliance rates 12 weeks after the intervention to investigate the sustainability of our intervention.
A third meeting will be done with HCWs in the unit which the investigator give feedback about the HH compliance, HAI rates before and after the intervention periods.
Data collection:
Seven, trained HH observers will participate in the study. These observers will achieve at least 80% concordance before the study. HH compliance data will be collected using a mobile app. HH monitoring will be performed Monday through Sunday making observations from randomly selected 20 minutes lapses of morning (08:00 am - 04:59 pm), afternoon (05:00 pm - 11:59 pm) and night (00:00 am - 07:59 am) shifts of the day. All HCWs in the room during the 20 minutes observation period are monitored for HH opportunities. Each HH opportunity was stratified as compliant or noncompliant and was classified according to the three of WHO's My 5 Moments for HH as follows: (1) before touching a patient, (4) after touching a patient, and (5) after contact with the patient's environment. HH moments before an aseptic task (2) and after body fluid exposure risk (3) was not included due to low resolution of video camera surveillance system.
Compliance was calculated by dividing the total HH opportunities for each subject by the number of HH compliance × 100. Adequate materials for HH are defined using either the soap and water or alcohol-based handrub solution.
HAIs are identified and recorded by active surveillance method in NICU. HAIs are identified using CDC criteria.
Sample Size:
We used G-power program for sample size calculation. With a power of 90%, 0.05 type I error rate and anticipated HH compliance increase before and after intervention period as 10% we planned to record 538 HH opportunities for each period (1076 HH opportunities total)
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Quasiexperimental, before and after study
| Arm | Type | Receives |
|---|---|---|
| Before intervention | No intervention | –HH opportunities, compliant moments and HAIs recorded before the intervention |
| After intervention | Active comparator | Other: Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWsHH opportunities, compliant moments and HAIs recorded after the intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All HCWs working in the NICU during the study period.
Key exclusion criteria (1 listed)
- Visiting patient relatives in the NICU during the study period.
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 |
|---|---|---|
| Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWsIntervention: We will report baseline HH compliance rates and HAI rates to HCWs during a meeting where all HCWs are present. During this meeting we will remind major infection control measures, give examples of common mistakes they made without violating personal privacy rights of HCWs and patients. | Other | After intervention |
Primary outcome
Total hand hygiene compliance of health care workers
Time frame: 4 weeks
By dividing the total HH opportunities for each subject by the number of HH compliance × 100
Health care associated infection rate
Time frame: 12 weeks
HAI number divided by the patient days in the unit
2 secondary outcomes
Number of HH opportunities per minute
Time frame: 4 weeks
Hand hygiene compliance by indication
Time frame: 4 weeks
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 19 Jul 2021.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand hygiene compliance observation with video camera surveillance system and performance feedback of the HH rates to HCWs in people with Healthcare Associated Infection and Hand Hygiene, run by Marmara University at 1 site in Turkey (Türkiye).
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 1 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 19 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
Total hand hygiene compliance of health care workers (time frame: 4 weeks). The study lists 2 primary outcomes in all. 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 19 Jul 2021.