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Effect of a Infection Control Program on the Reduction of Bacterial Contamination on NG Tube Feeding in RCHEs

Primary Purpose

Infection, Bacterial

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Multimodal Infection control programme
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Infection, Bacterial focused on measuring infection control ; bacterial contamination

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion criteria of RCHEs:

The investigator will search the Hong Kong Social Welfare Department website to determine which RCHEs should be invited based on the following inclusion criteria:

  1. Chinese facilities licensed under The Hong Kong Social Welfare Department;
  2. provision of NG tube feeding service to elders;
  3. provision of nursing care services to elders by RNs, ENs, HWs, and PCW;
  4. government subsidisation [either subvented homes operated by non-government organisations (NGOs) or private homes participating in an Enhanced Bought Place Scheme (EBPS), EA1]; and
  5. consent to participate and assurance that the entire staff team will join the study.

Exclusion criteria of RCHEs:

  1. RCHEs do not provide NG tube feeding to residents.
  2. RCHEs do not assurance the entire staff team will join the study.

Inclusion Criteria of Residential care home staff: :

  1. RCHEs staff members (RNs, ENs, HWs, and PCWs) who participate in the daily care of residents at the selected RCHEs.
  2. RCHEs staff can read Chinese and speak Cantonese.

Exclusion criteria of Residential care home staff::

  1. RCHEs staff do not understand Chinese
  2. RCHEs staff do not participate in NG tube feeding

Inclusion criteria of residents:

(1) All residents receiving NG tube feeding in the participating homes will be included.

Exclusion Criteria of residents:

  1. Residents in whom NG tube feeding is assisted by relatives or caregivers other than RCHE staff members.
  2. Residents with presence of transmission-based precautions, such as airborne, contact, or droplet contamination will be excluded.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental RCHEs staff

    Control RCHEs staff

    Arm Description

    Experimental RCHEs staff will received a multimodal ICP regarding the NG tube feeding. Knowledge and skills of NG tube feeding will be measured before and after the multimodal ICP. In addition, 10 fingertips of RCHEs staff, enteral milk and NG tube hubs of residents will be taken for bacterial counts before and after the intervnetion.

    No multimodal ICP will be offered to the staff of control RCHEs.

    Outcomes

    Primary Outcome Measures

    A change of total bacterial counts on NG tube hubs
    A sampling will be taken to the residents' NG tube hubs for the measuring the total bacterial counts (cfu/ml) to investigate if there will have any changes after 4 months. NG tube feeding contamination occurs when the total bacterial count in enteral milk exceeds10 to the power 4 colony-forming units per millilitre (cfu/ml) (Borges, Campos, Cardoso, Andre, & Serafini, 2010). Therefore total bacterial counts of NG tube hubs exceed 10 to the power 4 cfu/ml is considered contamination.

    Secondary Outcome Measures

    A change of total bacterial counts on enteral milk of residents
    A sampling will be taken to the enteral milk of residents for the measuring the total bacterial counts (cfu/ml) to investigate if there will have any changes after 4 months. Total bacterial counts of enteral milk exceeds 10 to the power 4 cfu/ml is considered contamination.
    A change of skills on the NG tube feeding among the RCHEs staff
    RCHEs staff 's skills on NG tube feeding will be assessed by outcomes assessors to investigate if there will have any changes after 4 months. Investigator will use "Skill Assessment form regarding NG tube feeding" which was developed by Ho et al. (2012). This form comprises 32 items regarding NG tube feeding procedure. One point will be awarded for each requirement achieved by the RCHE staff member. The total maximum score is 32 points, and a higher score indicates better NG tube feeding skills. The content validity of this assessment is 0.86, and the test-retest reliability is 0.82.
    A change of Knowledge on the NG tube feeding among the RCHEs staff
    RCHEs staff will be required to complete the knowledge questionnaire regarding the NG tube feeding to investigate if there will have any changes after 4 months. The investigator will use "self-administered questionnaire regarding knowledge about NG tube feeding" which was developed by Ho et al. (2012). This questionnaire comprises 20 true/false items, and each correct answer is given one point. The total maximum score is 20 points, and a higher score indicates better knowledge in the area of infection control related to NG tube feeding. The content validity index of this questionnaire is 1.0, and the test-retest reliabilty is 0.84.
    A change of total bacterial counts on 10 fingertips of RCHEs staff
    A sampling will be taken to the 10 fingertips of RCHEs staff for the measuring the total bacterial counts (cfu/ml) to investigate if there will have any changes after 4 months. Total bacterial counts of 10 fingertips exceed 10 to the power 4 cfu/ml is considered contamination.

    Full Information

    First Posted
    August 28, 2019
    Last Updated
    August 30, 2019
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04075344
    Brief Title
    Effect of a Infection Control Program on the Reduction of Bacterial Contamination on NG Tube Feeding in RCHEs
    Official Title
    Effect of a Multimodal Infection Control Program on the Reduction of Bacterial Contamination on Nasogastric Tube Feeding for Elderly Persons in Residential Care Home
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 2, 2019 (Anticipated)
    Primary Completion Date
    April 29, 2020 (Anticipated)
    Study Completion Date
    April 29, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Septicaemia is a potential complication of nasogastric (NG) tube feeding contamination (Leanne, 2014; Anderton, 2000) and a major cause of morbidity and mortality in residential care home for elders ( RCHEs) (Leanne, 2014). Although health workers (HWs) and personal care workers (PCWs) are responsible for NG tube feeding and direct care to the residents who are fed by NG tube feeding under supervision of registered nurses (RNs) and enrolled nurses (ENs) in RCHEs, HWs and PCWs unfortunately receive limited training regarding infection control (Ho et al., 2012; NICE, 2012; Duckro et al., 2009; Bankhead et al., 2009). A multimodal ICP could reduce the incidence of NG tube feeding contamination by improving the knowledge and skills of RCHE staff members regarding NG tube feeding (Ho et al., 2012). However, because the intervention described by Ho et al. (2012) was not administered in a randomised manner, potential confounders that could affect the outcomes of interest were not adjusted. To overcome that limitation, the proposed work will establish a well-designed multimodal ICP and explore the effectiveness of this intervention in terms of enhancing the knowledge and skills regarding NG tube feeding of RCHE staff members and consequently reducing NG tube feeding contamination after adjusting for potentially important baseline factors. The proposed research objectives are as follows: To explore the effectiveness of a multimodal ICP for reducing bacterial contamination, as measured by the total bacterial counts on NG tube hubs and fingertips on both hands of RCHEs staff, as well as in enteral milk; and To investigate the effectiveness of a multimodal ICP for improving the knowledge and skills of RCHEs staff members regarding infection control measures during NG tube feeding in RCHEs setting.
    Detailed Description
    In nasogastric tube (NG tube) feeding, a tube is used to transport enteral nutrition to the stomach through the nose (Mosby's Medical Dictionary, 2009). This feeding modality is widely used in the geriatric population, especially for patients with cognitive impairment and oral feeding problems in a residential care home settings (Rowat, 2015). Approximately 3.5% of residents in a Hong Kong residential care home for elders (RCHE) were reported to use NG tubes for long-term feeding (Leung et al., 2000). Contamination of the NG tube hub, defined as the connection port between the NG tube and enteral feeding administration set, is considered a risk factor for the acquisition and transmission of microorganisms (Matlow et al., 2005). NG tube hubs can serve as reservoirs for microorganismal colonisation. For example, enteral milk contamination results from bacterial spread in contaminated tube hubs (Matlow et al., 2005; Donskey, 2004). Accordingly, NG tube feeding contamination occurs when the total bacterial count in enteral milk exceeds 10 to the power 4 colony-forming units per millilitre (cfu/ml) (Borges, Campos, Cardoso, Andre, & Serafini, 2010). NG tube feeding contamination is a serious issue, with potential complications including mortality, septicaemia, bacteraemia, diarrhoea, and pneumonia (Leanne, 2014 & Anderton, 2000). Previous research indicates that insufficient knowledge about infection control and poor NG tube feeding skills among RCHE staff would result in the passive transport of bacteria from contaminated tube hubs to enteral feed (Ho et al., 2012; National Institute for Health & Clinical Excellence, 2012; Duckro, Blom, Lyle, Weintein, & Hayden, 2009; Bankhead, Boullata, & Brantley, 2009). Additionally, Ho et al. (2012) demonstrated a strong relationship between the number of total bacterial counts on the fingertips of RCHE staff, NG tube hubs of the residents, and enteral milk. In Hong Kong, registered nurses (RNs), enrolled nurses (ENs), health workers (HWs), and personal care workers (PCWs) provide daily nursing care services to residents of RCHEs. Specifically, HWs and PCWs provide direct care, such as NG tube feeding, to residents under the supervision of RNs and ENs. However, PCWs and HWs hold low levels of knowledge and skills related to NG tube feeding (Ho et al., 2012; Annette, Bourgault, Weaver, Swartz, & O'Dea, 2007; Howell, 2002) and receive minimal education on infection control during the care of residents with NG tubes (Hong Kong St. John Ambulance, 2016). Accordingly, the inadequate skills of RCHE staff in terms of NG tube feeding could lead to bacterial contamination (Leanne, 2014; Anderton, 2000). Despite the above evidence, no previous study has described NG tube feeding practices used at local RCHEs in Hong Kong. Some international studies have revealed that RCHE staff members do not use non-touch techniques when connecting administration sets to the residents' NG tube hubs (Beattie & Anderton, 1998). Annette et al. (2007) reported that RCHE staff members unnecessarily disconnected NG tube feeding systems while repositioning residents and changing linens. Moreover, although 60-ml syringes are widely recommended for the prevention of multi-decanting procedures when administrating milk and medications (Roberts et al., 2007; Bowers, 2000), a previous study found that RCHE staff members repeatedly used 20-ml syringes during milk and medication decanting procedures (Annette et al., 2007). NICE (2012) advised the use of sterile water to flush all feeding tubes. However, in one study, RCHE staff used non-boiled water during NG tube feeding in elderly residents (Allen, 2015). These poor skills increase the risk of bacterial growth in NG tube feeding systems (NICE, 2012 & Ho et al., 2102). A previous study reported a relationship among NG tube hub contamination, NG tube feeding contamination, and insufficient NG tube feeding knowledge and skills held by RCHE staff members (Ho et al., 2012). Therefore, a comprehensive literature search was conducted to explore the effects of an infection control education programme on NG tube feeding contamination in RCHEs. Four studies conducted at RCHEs in the United States (Michigan), Europe (Northern Ireland and France) and Hong Kong satisfied the literature search objectives (Mody, Krein, Saint, Min, Montoya & Lansing, 2015; Ho et al., 2012; Kathleen, Gavazzi, Bar-Hen, Carrat, de Wazieres, & Lejeune, 2012; Baldwin, Gilpin, Tunney, Kearney, Crymble, & Cardwell, 2010). These four studies featured several common characteristics of teaching contents, including the provision of a multimodal infection control programme (ICP) regarding hand hygiene education, the proper use of personal protective equipment, and medical device (NG tube) care to RCHE staff. The studies utilised a combination of multimodal strategies with varied multimodal ICP contents. Here, 'multimodal' is defined as the involvement of several modes of activities, whereas 'strategy' is defined as a plan of action intended to accomplish a specific goal (Free Dictionary Oxford, 2016). Therefore, a multimodal strategy is needed to improve infection control practice (Pittet et al., 2000). The proposed multimodal ICP will have a duration of 12 weeks to ensure the sustainability of knowledge and skills. Six 45-minute sessions will be provided at 2-week intervals. In this study, the investigator would explore the effectiveness of the multimodal ICP in the reduction of the total bacterial counts on the NG tube hubs, enteral millk of the residents and the 10 fingertips of the RCHEs staff by increasing the knowledge and skills of the NG tube feeding among RCHEs staff with the multimodal ICP.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Infection, Bacterial
    Keywords
    infection control ; bacterial contamination

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cluster randomized control trials
    Masking
    Outcomes Assessor
    Masking Description
    This study is single-blinded research, wherein the outcome assessors will be blinded to the assignment of the intervention or control groups.
    Allocation
    Randomized
    Enrollment
    67 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental RCHEs staff
    Arm Type
    Experimental
    Arm Description
    Experimental RCHEs staff will received a multimodal ICP regarding the NG tube feeding. Knowledge and skills of NG tube feeding will be measured before and after the multimodal ICP. In addition, 10 fingertips of RCHEs staff, enteral milk and NG tube hubs of residents will be taken for bacterial counts before and after the intervnetion.
    Arm Title
    Control RCHEs staff
    Arm Type
    No Intervention
    Arm Description
    No multimodal ICP will be offered to the staff of control RCHEs.
    Intervention Type
    Other
    Intervention Name(s)
    Multimodal Infection control programme
    Intervention Description
    12 weekse educational programme with 6 sessions, 45 minutes per session will be provided to experimental group RCHEs staff
    Primary Outcome Measure Information:
    Title
    A change of total bacterial counts on NG tube hubs
    Description
    A sampling will be taken to the residents' NG tube hubs for the measuring the total bacterial counts (cfu/ml) to investigate if there will have any changes after 4 months. NG tube feeding contamination occurs when the total bacterial count in enteral milk exceeds10 to the power 4 colony-forming units per millilitre (cfu/ml) (Borges, Campos, Cardoso, Andre, & Serafini, 2010). Therefore total bacterial counts of NG tube hubs exceed 10 to the power 4 cfu/ml is considered contamination.
    Time Frame
    Before and after the intervention (4 months aparts)
    Secondary Outcome Measure Information:
    Title
    A change of total bacterial counts on enteral milk of residents
    Description
    A sampling will be taken to the enteral milk of residents for the measuring the total bacterial counts (cfu/ml) to investigate if there will have any changes after 4 months. Total bacterial counts of enteral milk exceeds 10 to the power 4 cfu/ml is considered contamination.
    Time Frame
    Before and after the intervention (4 months aparts)
    Title
    A change of skills on the NG tube feeding among the RCHEs staff
    Description
    RCHEs staff 's skills on NG tube feeding will be assessed by outcomes assessors to investigate if there will have any changes after 4 months. Investigator will use "Skill Assessment form regarding NG tube feeding" which was developed by Ho et al. (2012). This form comprises 32 items regarding NG tube feeding procedure. One point will be awarded for each requirement achieved by the RCHE staff member. The total maximum score is 32 points, and a higher score indicates better NG tube feeding skills. The content validity of this assessment is 0.86, and the test-retest reliability is 0.82.
    Time Frame
    Before and after the intervention (4 months aparts)
    Title
    A change of Knowledge on the NG tube feeding among the RCHEs staff
    Description
    RCHEs staff will be required to complete the knowledge questionnaire regarding the NG tube feeding to investigate if there will have any changes after 4 months. The investigator will use "self-administered questionnaire regarding knowledge about NG tube feeding" which was developed by Ho et al. (2012). This questionnaire comprises 20 true/false items, and each correct answer is given one point. The total maximum score is 20 points, and a higher score indicates better knowledge in the area of infection control related to NG tube feeding. The content validity index of this questionnaire is 1.0, and the test-retest reliabilty is 0.84.
    Time Frame
    Before and after the intervention (4 months aparts)
    Title
    A change of total bacterial counts on 10 fingertips of RCHEs staff
    Description
    A sampling will be taken to the 10 fingertips of RCHEs staff for the measuring the total bacterial counts (cfu/ml) to investigate if there will have any changes after 4 months. Total bacterial counts of 10 fingertips exceed 10 to the power 4 cfu/ml is considered contamination.
    Time Frame
    Before and after the intervention (4 months aparts)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion criteria of RCHEs: The investigator will search the Hong Kong Social Welfare Department website to determine which RCHEs should be invited based on the following inclusion criteria: Chinese facilities licensed under The Hong Kong Social Welfare Department; provision of NG tube feeding service to elders; provision of nursing care services to elders by RNs, ENs, HWs, and PCW; government subsidisation [either subvented homes operated by non-government organisations (NGOs) or private homes participating in an Enhanced Bought Place Scheme (EBPS), EA1]; and consent to participate and assurance that the entire staff team will join the study. Exclusion criteria of RCHEs: RCHEs do not provide NG tube feeding to residents. RCHEs do not assurance the entire staff team will join the study. Inclusion Criteria of Residential care home staff: : RCHEs staff members (RNs, ENs, HWs, and PCWs) who participate in the daily care of residents at the selected RCHEs. RCHEs staff can read Chinese and speak Cantonese. Exclusion criteria of Residential care home staff:: RCHEs staff do not understand Chinese RCHEs staff do not participate in NG tube feeding Inclusion criteria of residents: (1) All residents receiving NG tube feeding in the participating homes will be included. Exclusion Criteria of residents: Residents in whom NG tube feeding is assisted by relatives or caregivers other than RCHE staff members. Residents with presence of transmission-based precautions, such as airborne, contact, or droplet contamination will be excluded.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suki Ho, Msc
    Phone
    +85292509712
    Ext
    +85292509712
    Email
    sukki.ho@polyu.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Suki Ho, Msc
    Phone
    +85227666548
    Ext
    +85292509712
    Email
    1155074185@link.cuhk.edu.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Suki Ho, Msc
    Organizational Affiliation
    Chinese University of Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    20451294
    Citation
    Baldwin NS, Gilpin DF, Tunney MM, Kearney MP, Crymble L, Cardwell C, Hughes CM. Cluster randomised controlled trial of an infection control education and training intervention programme focusing on meticillin-resistant Staphylococcus aureus in nursing homes for older people. J Hosp Infect. 2010 Sep;76(1):36-41. doi: 10.1016/j.jhin.2010.03.006. Epub 2010 May 7.
    Results Reference
    background
    PubMed Identifier
    22682697
    Citation
    Chami K, Gavazzi G, Bar-Hen A, Carrat F, de Wazieres B, Lejeune B, Armand N, Rainfray M, Hajjar J, Piette F, Rothan Tondeur M. A short-term, multicomponent infection control program in nursing homes: a cluster randomized controlled trial. J Am Med Dir Assoc. 2012 Jul;13(6):569.e9-17. doi: 10.1016/j.jamda.2012.04.008. Epub 2012 Jun 7.
    Results Reference
    background
    PubMed Identifier
    25775048
    Citation
    Mody L, Krein SL, Saint S, Min LC, Montoya A, Lansing B, McNamara SE, Symons K, Fisch J, Koo E, Rye RA, Galecki A, Kabeto MU, Fitzgerald JT, Olmsted RN, Kauffman CA, Bradley SF. A targeted infection prevention intervention in nursing home residents with indwelling devices: a randomized clinical trial. JAMA Intern Med. 2015 May;175(5):714-23. doi: 10.1001/jamainternmed.2015.132. Erratum In: JAMA Intern Med. 2015 Jul;175(7):1247.
    Results Reference
    background
    PubMed Identifier
    22765960
    Citation
    Ho SS, Tse MM, Boost MV. Effect of an infection control programme on bacterial contamination of enteral feed in nursing homes. J Hosp Infect. 2012 Sep;82(1):49-55. doi: 10.1016/j.jhin.2012.05.002. Epub 2012 Jul 4.
    Results Reference
    result

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    Effect of a Infection Control Program on the Reduction of Bacterial Contamination on NG Tube Feeding in RCHEs

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