NCT04075344

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:

  1. 1.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
  2. 2.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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
67

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
3 days until next milestone

Study Start

First participant enrolled

September 2, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 29, 2020

Completed
Last Updated

September 3, 2019

Status Verified

August 1, 2019

Enrollment Period

8 months

First QC Date

August 28, 2019

Last Update Submit

August 30, 2019

Conditions

Keywords

infection control ; bacterial contamination

Outcome Measures

Primary Outcomes (1)

  • 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.

    Before and after the intervention (4 months aparts)

Secondary Outcomes (4)

  • A change of total bacterial counts on enteral milk of residents

    Before and after the intervention (4 months aparts)

  • A change of skills on the NG tube feeding among the RCHEs staff

    Before and after the intervention (4 months aparts)

  • A change of Knowledge on the NG tube feeding among the RCHEs staff

    Before and after the intervention (4 months aparts)

  • A change of total bacterial counts on 10 fingertips of RCHEs staff

    Before and after the intervention (4 months aparts)

Study Arms (2)

Experimental RCHEs staff

EXPERIMENTAL

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.

Other: Multimodal Infection control programme

Control RCHEs staff

NO INTERVENTION

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

Interventions

12 weekse educational programme with 6 sessions, 45 minutes per session will be provided to experimental group RCHEs staff

Experimental RCHEs staff

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • RCHEs do not provide NG tube feeding to residents.
  • RCHEs do not assurance the entire staff team will join the study.
  • 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.
  • RCHEs staff do not understand Chinese
  • RCHEs staff do not participate in NG tube feeding
  • (1) All residents receiving NG tube feeding in the participating homes will be included.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 20451294BACKGROUND
  • 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.

    PMID: 22682697BACKGROUND
  • 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.

    PMID: 25775048BACKGROUND
  • 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.

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Suki Ho, Msc

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study is single-blinded research, wherein the outcome assessors will be blinded to the assignment of the intervention or control groups.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Cluster randomized control trials
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 28, 2019

First Posted

August 30, 2019

Study Start

September 2, 2019

Primary Completion

April 29, 2020

Study Completion

April 29, 2020

Last Updated

September 3, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share