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Intervention Zambia Rural L&D Infection Study
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Postpartum Infection Neonatal Infection | Other: Bundled L&D Infection Prevention Interventions | Not Applicable |
The total duration of the intervention phase is estimated to be 4 months. During this time, the investigators will collaborate with the healthcare workers (HCWs) at each study site and the district pharmacist.
The study team will visit each site separately and administer the training modules on-site during the first month of the research until all of the modules have been completed for all of the Labor and Delivery (L&D) staff, which usually consist of about 2-3 people. A quiz will be administered before and after the training session to assess change in knowledge after the training.
SMS reminders will be sent every weekday to promote best infection control practices in the L&D. Posters will also be posted for visual reminders of best practices around the health center.
After the initial training, each health centers will be visited twice a month by a study team member to assess alcohol rubs (AHR) stock, gather feedback and comments, and evaluate postpartum maternal and neonatal infectious complications and hospital outcomes. Infection and outcome data will be shared with each site monthly. About 2 months after initial training, a refresher education and training course will be held at each study site. A quiz will be administered before and after the refresher course to assess knowledge.
The investigators will collaborate with the district pharmacy for production and distribution of AHR. The pharmacists will receive training on how to combine and mix the hand rub components per WHO guidelines, and test batches will be made prior to distribution to study sites to ensure familiarity of the pharmacy staff with its production. Quality control with an alcoholmeter will be performed with the alcohol ingredient and with the finished product, as per World Health Organization (WHO) recommendation. Afterwards, the head pharmacist will be consulted biweekly by study team member to document AHR production, budget, distribution, and any other issues.
Endline data collection will occur 12 weeks after initiation of intervention implementation. During data collection period, a study team member will meet with a L&D floor administrator in a private setting at a time convenient to the administrator to go through the questionnaire portion of the ICAT together.
Eligible pregnant women will primarily be recruited and consented outside the facility in the waiting area where they congregate prior to admission for delivery. Women who are consented will be given a "consent card" in addition to a copy of the consent form. This card will state that they have previously consented to the study, and can then be presented once they are admitted for delivery. A member of the research team will accompany the primary care provider during their provision of care and patient contact during first, second, and third stages of labor to observe, assess and document infection control behaviors and practices by the providers, using the ICAT.
A retrospective review of the logbook will be done to assess for rates of postpartum maternal and neonatal infectious complication and outcomes for participants.
During the endline data collection, an anonymous, self-administered survey will be administered to the study site HCWs to assess the knowledge, attitudes and practices of the study site HCWs towards the implemented study interventions.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Health Services Research |
| Official Title: | Prevention of Neonatal and Maternal Infection During Labor and Delivery in Rural Healthcare Sites in Zambia - Intervention Phase |
| Actual Study Start Date : | April 11, 2019 |
| Actual Primary Completion Date : | August 16, 2019 |
| Actual Study Completion Date : | September 16, 2019 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Preventing L&D Infections
Low-cost bundled L&D infection prevention interventions will be implemented, including education, visual reminders, feedback, and alcoholic hand rub supply. Infection control practices and child delivery outcomes will be assessed after implementation of these interventions.
|
Other: Bundled L&D Infection Prevention Interventions
The following bundle of infection prevention interventions will be implemented at each study site for 12 weeks: Education: 2 day module of Infection Prevention and Control (IPC) training and education at the beginning of the period, with specific information pertaining to labor and delivery. A refresher course will be administered at week 6. Feedback: Monthly feedback sessions detailing IPC practices Reminders: Visual poster reminders on hand hygiene and daily SMS reminders on best practices for peripartum and postnatal care. Alcohol Hand Rub (AHR) supply: Provision of AHR, produced by WHO standards and guides in collaboration with district pharmacy |
- Infection control practices assessed by Infection Control Assessment Tool (ICAT) score [ Time Frame: 12 weeks ]A survey including 98 questions detailing infection control practices in the L&D. It includes questions on facility, Infection Prevention and Control (IPC) program, general IPC, hand hygiene, L&D practices, and postpartum care practices. The scores from each question on the survey will be summed for the ICAT score for each health center. Maximum score is 140 points and minimum score is 0 points, with higher score indicating better infection control practices. Of the 98 questions, 34 questions are duplicated in an observation tool in order to corroborate the accuracy of survey information by direct observation. The observation tool includes topics on supplies in the L&D and healthcare worker behaviors during childbirth. ICAT was developed by the Rational Pharmaceutical Management plus Infection Control Project team in 2009.
- Number of mothers with postpartum maternal infection from medical records [ Time Frame: 12 weeks ]A mother will be counted as having postpartum maternal infection if women they have one or more of the following:sepsis, endometritis (puerperal infection), mastitis, urinary tract infection (UTI), cellulitis, and other unspecified infections documented in the medical records (ie logbook review of maternal admission, delivery, and postnatal registries).
- Number of newborns with postpartum neonatal infection from medical records [ Time Frame: 12 weeks ]A newborn will be counted as having postpartum neonatal infection if they have one or more of the following:sepsis, pneumonia, meningitis, UTI, omphalitis, and others unspecified infections documented in the medical records (ie logbook review of maternal admission, delivery, and postnatal registries).
- Rates of maternal hospital outcome categories from medical records [ Time Frame: 12 weeks ]Categories for maternal hospital outcomes include: 1) full recovery, 2) delayed discharge, 3)transfer, 4) death, and 5) no information. Information collected from logbook review of maternal admission, delivery, and postnatal registries will be assessed and the counts in each category will be divided by the total number of mothers.
- Rates of neonatal hospital outcomes from medical records [ Time Frame: 12 weeks ]Categories for neonatal hospital outcomes include: 1) full recovery, 2) delayed discharge, 3)transfer, 4) death, and 5) no information. Information collected from logbook review of maternal admission, delivery, and postnatal registries will be assessed and the counts in each category will be divided by the total number of newborns.
- HCW attitudes towards infection control interventions from an anonymous survey [ Time Frame: 12 weeks ]Summed scores from an anonymous survey designed by the investigators will be used to assess HCW (healthcare workers') attitudes towards each aspects of the interventions and the program as a whole. The survey has 28 Likert scale questions (responses range from 1 to 5 and the summed score from 28 to 140). Higher scores indicate more positive HCW attitudes toward the interventions.The survey also includes a section for any open-ended comments for each of the interventions.
| Ages Eligible for Study: | 15 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for observation:
- Women of age > 15 in early first stage of labor (cervical dilation ≤ 6cm) at the study sites during the study period
- If woman is 15 to 17 must have a guardian present
- Planned vaginal delivery
- Any healthcare workers providing direct patient care to women delivering at the study sites during study period
Exclusion Criteria for observation:
- Any eligible woman who presents past the early first stage of labor (cervical dilation > 6cm)
- Woman under 18 years old without a guardian present
Inclusion criteria for logbook review:
- Women who delivered their baby at the study sites during the study period
- Newborns who were born at the study sites during the study period
| Zambia | |
| Mangunza Rural Health Facility | |
| Choma, Southern Province, Zambia | |
| Masuku Mission Rural Health Facility | |
| Choma, Southern Province, Zambia | |
| Mbabala Rural Health Facility | |
| Choma, Southern Province, Zambia | |
| Mochipapa Rural Health Facility | |
| Choma, Southern Province, Zambia | |
| Simakutu Rural Health Facility | |
| Choma, Southern Province, Zambia | |
| Study Director: | Davison Hamer, MD | Boston University School of Public Health, Center for Global Health |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | January 14, 2019 | ||||
| First Posted Date ICMJE | January 18, 2019 | ||||
| Last Update Posted Date | November 13, 2019 | ||||
| Actual Study Start Date ICMJE | April 11, 2019 | ||||
| Actual Primary Completion Date | August 16, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Infection control practices assessed by Infection Control Assessment Tool (ICAT) score [ Time Frame: 12 weeks ] A survey including 98 questions detailing infection control practices in the L&D. It includes questions on facility, Infection Prevention and Control (IPC) program, general IPC, hand hygiene, L&D practices, and postpartum care practices. The scores from each question on the survey will be summed for the ICAT score for each health center. Maximum score is 140 points and minimum score is 0 points, with higher score indicating better infection control practices. Of the 98 questions, 34 questions are duplicated in an observation tool in order to corroborate the accuracy of survey information by direct observation. The observation tool includes topics on supplies in the L&D and healthcare worker behaviors during childbirth. ICAT was developed by the Rational Pharmaceutical Management plus Infection Control Project team in 2009.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intervention Zambia Rural L&D Infection Study | ||||
| Official Title ICMJE | Prevention of Neonatal and Maternal Infection During Labor and Delivery in Rural Healthcare Sites in Zambia - Intervention Phase | ||||
| Brief Summary | This is the intervention phase of a study to investigate the impact of low-cost bundled interventions on improving the infection control practices in the labor and delivery units in rural healthcare settings in Zambia. A baseline observational phase of the health care providers' infection control procedures was done. In this intervention phase, low-cost bundle of interventions, including health care provider education, behavior feedback, visual and Short Message Service (SMS)/text message reminders, and provision of alcoholic hand rubs, will be implemented at 5 study sites. 12 weeks after the initiation of interventions, endline data will be collected. The data from endline after interventions will be compared with baseline data from observational phase to detect changes in infection control practices at each study site after the interventions. | ||||
| Detailed Description |
The total duration of the intervention phase is estimated to be 4 months. During this time, the investigators will collaborate with the healthcare workers (HCWs) at each study site and the district pharmacist. The study team will visit each site separately and administer the training modules on-site during the first month of the research until all of the modules have been completed for all of the Labor and Delivery (L&D) staff, which usually consist of about 2-3 people. A quiz will be administered before and after the training session to assess change in knowledge after the training. SMS reminders will be sent every weekday to promote best infection control practices in the L&D. Posters will also be posted for visual reminders of best practices around the health center. After the initial training, each health centers will be visited twice a month by a study team member to assess alcohol rubs (AHR) stock, gather feedback and comments, and evaluate postpartum maternal and neonatal infectious complications and hospital outcomes. Infection and outcome data will be shared with each site monthly. About 2 months after initial training, a refresher education and training course will be held at each study site. A quiz will be administered before and after the refresher course to assess knowledge. The investigators will collaborate with the district pharmacy for production and distribution of AHR. The pharmacists will receive training on how to combine and mix the hand rub components per WHO guidelines, and test batches will be made prior to distribution to study sites to ensure familiarity of the pharmacy staff with its production. Quality control with an alcoholmeter will be performed with the alcohol ingredient and with the finished product, as per World Health Organization (WHO) recommendation. Afterwards, the head pharmacist will be consulted biweekly by study team member to document AHR production, budget, distribution, and any other issues. Endline data collection will occur 12 weeks after initiation of intervention implementation. During data collection period, a study team member will meet with a L&D floor administrator in a private setting at a time convenient to the administrator to go through the questionnaire portion of the ICAT together. Eligible pregnant women will primarily be recruited and consented outside the facility in the waiting area where they congregate prior to admission for delivery. Women who are consented will be given a "consent card" in addition to a copy of the consent form. This card will state that they have previously consented to the study, and can then be presented once they are admitted for delivery. A member of the research team will accompany the primary care provider during their provision of care and patient contact during first, second, and third stages of labor to observe, assess and document infection control behaviors and practices by the providers, using the ICAT. A retrospective review of the logbook will be done to assess for rates of postpartum maternal and neonatal infectious complication and outcomes for participants. During the endline data collection, an anonymous, self-administered survey will be administered to the study site HCWs to assess the knowledge, attitudes and practices of the study site HCWs towards the implemented study interventions. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Other: Bundled L&D Infection Prevention Interventions
The following bundle of infection prevention interventions will be implemented at each study site for 12 weeks: Education: 2 day module of Infection Prevention and Control (IPC) training and education at the beginning of the period, with specific information pertaining to labor and delivery. A refresher course will be administered at week 6. Feedback: Monthly feedback sessions detailing IPC practices Reminders: Visual poster reminders on hand hygiene and daily SMS reminders on best practices for peripartum and postnatal care. Alcohol Hand Rub (AHR) supply: Provision of AHR, produced by WHO standards and guides in collaboration with district pharmacy |
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| Study Arms ICMJE | Experimental: Preventing L&D Infections
Low-cost bundled L&D infection prevention interventions will be implemented, including education, visual reminders, feedback, and alcoholic hand rub supply. Infection control practices and child delivery outcomes will be assessed after implementation of these interventions.
Intervention: Other: Bundled L&D Infection Prevention Interventions
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Actual Enrollment ICMJE |
37 | ||||
| Original Estimated Enrollment ICMJE |
35 | ||||
| Actual Study Completion Date ICMJE | September 16, 2019 | ||||
| Actual Primary Completion Date | August 16, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria for observation:
Exclusion Criteria for observation:
Inclusion criteria for logbook review:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 15 Years and older (Child, Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Zambia | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03809741 | ||||
| Other Study ID Numbers ICMJE | H-38261 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Boston University | ||||
| Study Sponsor ICMJE | Boston University | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| PRS Account | Boston University | ||||
| Verification Date | November 2019 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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