The effect of improvement program on ventilator-bundle adherence and patient outcomes: A cluster-randomized trial

Registration number: NPCTR2022000018
Register By : Dejina Thapa
Registered Date : 2022/01/06
Email : dejinathapa@link.cuhk.edu.hk
Titles & IDs
Refrence Number : REF/2022/01/000077
Public Title : The effect of improvement program on ventilator-bundle adherence and patient outcomes: A cluster-randomized trial
Scientific Title : The effect of improvement program on ventilator-bundle adherence and patient outcomes: A cluster-randomized trial
Trial Acronyms :
Registration Type : Prospective
Secondary Id :
Recruitment Country : Hong Kong

Ventilator-associated pneumonia (VAP) is the most frequent device-related infection. A ventilator bundle is a group of evidence-based interventions that work together for the prevention of VAP. Studies reported nurses’ adherence to ventilator bundle is often poor and inconsistent. Researchers have postulated that tailoring implementation strategies are more effective when addressing the prospective determinants of practice. Based on the phase I findings of the study we identified the multifaceted implementation strategies to improve adherence to ventilator bundle and patient outcomes. Thus, to mitigate the VAP burden, a multifaceted implementation strategy called Ventilator-Associated Pneumonia Improvement Program (VAP-IMP) program will test the effectiveness of the VAP-IMP program. This is a cluster randomized controlled trial involving the six hospitals which are following the same protocol of implementation of the ventilator bundle. The convenience sample will be used to select the cluster. All the nurses will be enrolled to participate in the study. The nurses who have agreed and given their consent to participate will join the VAP-IMP program. The study intervention is a 6 -week program where the intervention group will receive the VAP-IMP program and the control group will carry the usual care. Adherence to the ventilator bundle is the primary outcome whereas, patient outcomes, knowledge, attitude, organizational support are the secondary outcomes. Obtaining ethical approval from the ethics committee, the study will be carried out according to the principle of ethics. Data analysis will be performed in Social Package Statistical Software (SPSS) version 26.0 with descriptive and inferential analysis, where appropriate. The findings of this proposed study will contribute to ventilator-associated pneumonia prevention and inform future research. The findings of this study will act as a preliminary step to look into areas to enhance nurses adherence. This study will inform hospital authorities for considering such strategies and improve sustainability after the study ends.

Principal Investigator (Trail coordinator for multi centric study)

Principal Investigator ( 1 )

Name
Dejina Thapa
Email
dejinathapa@link.cuhk.edu.hk
Contact No
9813470508
Designation
PhD Candidate
Orgnizational Affilation
The Chinese University of Hong Kong
Address
6/F, Rm:601, Esther lee building, The Chinese University of Hong Kong
Country
Hong Kong

Contact person (scientific query)
Name
Dejina Thapa
Email
dejinathapa@link.cuhk.edu.hk
Contact No
9813470508
Designation
PhD Candidate
Orgnizational Affilation
The Chinese University of Hong KOng
Address
Jockey Clob, Post graduate hall
Country
Hong Kong

Contact person (Public Query)
Name
Dejina Thapa
Email
dejinathapa21@gmail.com
Contact No
9813470508
Designation
PhD Candidate
Orgnizational Affilation
The Chinese University of Hong KOng
Address
6-8/F, Rm:601, Esther lee building, The Chinese University of Hong Kong
Country
Hong Kong

Contact person (Public Query)
Name
Dejina Thapa
Email
dejinathapa21@gmail.com
Contact No
9813470508
Designation
PhD Candidate
Orgnizational Affilation
The Chinese University of Hong KOng
Address
6-8/F, Rm:601, Esther lee building, The Chinese University of Hong Kong
Country
Hong Kong

Sponsor
Type
Medical/health science, University/college
Name
Dejina Thapa
Email
dejinathapa@link.cuhk.edu.hk
Contact
9813470508
Address
Jockey Clob, Post graduate hall

Recruitment Country
Country
Hong Kong

Site(s) of study
Site Address
Tribhuvan University Teaching Hospital
Contact Person Name
Professor Subhash Prasad Achanrya
Contact Person Email
drsuvash@gmail.com
Contact Person Contact
9851147242

Ethics Committees Informations
Ethics Committee
Institute review Committe
Ethics Committee Contact
9774254220
Ethics Committee Address
Nepal health research Council
Ethics Committee Email
approval@nhrc.gov.np

Approvals
Status
Approved
Date
1970-01-01

Health condition(s)
Status
Healthy human volunteers

Study type
Thesis
Yes
Type of trial
Interventional
Study Type
Others (Specify), Others (Specify),

Study Design
Allocation
randomized controlled trial
Masking
blinded (masking used)
Control
active
Assignment
Cluster
purpose
prevention, health services research
Trial Phase
N/A

Intervention and comparison
Intervention name
Ventialtor Associated Pneumonia Improvement program
Intervention details

Nurses in the intervention group will participate in the Ventilator-Associated Pneumonia Improvement Program (VAP-IMP) program, and those in the control group will continue their usual care.

VAP-IMP Program

The content of the VAP-IMP program is tailored to address the identified barriers in Phase I.

Then, the VAP-IMP program (see Figure 1) is designed to be a multifaceted intervention that includes educational workshops, disturbing handouts, ventilator care leader (VCL), reminders, audits and feedback, and rewards.

This is a 6-week program applied to three ICUs (the intervention group) to improve nurse's adherence to elements of the ventilator bundle. The duration of the study is supported by a previous study (Parisi et al., 2016) stating that a 40-day intervention program substantially improves adherence and patient outcomes.

For a period of 2-weeks: All the nurses in the intervention group will be invited to participate in an educational workshop. Handouts will also be distributed in the workshop in the first week. In the second week, the meeting will be organized with the Nurse in Charge and 2 senior nursing staff to select the VCL. VCL should be an ICU senior registered nurse certified by the Critical Care Nursing association of Nepal (CCNAN), having ≥ two years of ICU working experience. The intervention group will have three VCL, one in each of the ICU.

For a period of 4-weeks (1 month): During this one month, nurses can approach VCL if they have questions about the ventilator bundle. A weekly reminder message will be sent to the nurses. The audit will be conducted for one week and provide feedback. The reward will be provided at the end of the intervention.

The details of the intervention are described as below:

Educational workshop: At first, the educational workshop will be provided to the intervention group.

Content of the educational workshop: The content of the educational workshop is based on international guidelines and the literature review (IHI, 2012). The component of the educational intervention will be standard, while the detailed contents of the intervention will be tailored based on the needs of participants. Furthermore, this workshop aimed to fill the barriers of knowledge, attitude, and assessment skills identified in our Phase I study. Therefore, the educational workshop consists of lectures, training sessions, and training materials to support and strengthen their understanding of implementing the ventilator bundle. The workshop intended to improve the nurse’s knowledge by providing a PowerPoint presentation on the introduction of VAP, risk factors contributing to VAP, the pathophysiology of VAP, prevention of VAP, and elements of the ventilator bundle. The workshop intended to improve the nurse’s attitude by discussion through clarifying values and misconceptions of the elements of the ventilator bundle. The workshop intended to improve the nurse’s assessment practices by a clinical demonstration, practical exercise, return demonstration, and provision of handouts. Additionally, participants will be encouraged to actively participate in group discussions and exchange ideas and problems concerning the implementation of the ventilator bundle.

Delivery format: The Principal Investigator (Ph.D. student) will deliver the workshop. The number of participants in the workshop will be limited to no more than 30 to ensure effective interaction between the interveners and the participants. The educational workshop will be face-to-face, conducted in 9 repeated sessions that last for 3 hours each. It will be conducted three sessions per week to facilitate the attendance of nurses working on different shifts. The educational workshop is arranged in accordance with the official time release. If the participants are unable to attend the scheduled sessions, then they will be invited to join in another session that could fit their schedule. Therefore, the educational workshop required 1 week to complete.

Handouts

The handouts will be developed from guideline recommendations (Powell et al., 2015; Summers et al., 2009) to facilitate the nurse’s understanding of the details of the ventilator bundle. The handout will serve as a reminder and reference to improve the knowledge and practice of the participants about the ventilator bundle. The handouts contain information about the brief description of ventilator-associated pneumonia and elements of the ventilator bundle and hand hygiene. Each element of the ventilator bundle and hand hygiene is illustrated step-by-step through a photograph and textual description. To facilitate accessibility, each nurse will get the handouts in the workshop. The handouts will also be provided to the nurses who are on continuous night duty or on leave. These handouts will also be placed in nursing rooms and ICU desks.

Ventilator Care Leader (VCL).

VCL are experts in caring for ventilated patients and implementing the ventilator bundle. After 2 weeks of the educational workshop, VCL will provide on-site consultation to the nurses working in ICU during work. Other than on site-consultation, VCL will also conduct a 1-hour weekly session for four weeks. It will be conducted every Saturday afternoon. It will be implemented in a small group approach (i.e., 4-8 nurses). In this, nurses are volunteer to join the group. In the session, there will be an interaction between nurses and VCL. Nurses can ask questions, express difficulty or suggestions for improvements regarding the implementation of ventilator bundle from nurses. VCL will attempt to address the difficulties and brainstorm strategies to solve the identified problem in order to enhance adherence to the ventilator bundle elements in practice.

Reminder.

After the educational workshop, nurses in the intervention group will receive weekly text messages for four weeks, further, to sustain the influence of the educational workshop on participants. The message will be sent via Viber, the most commonly used social media, from the PI. A Viber group will be formed (i.e. 3 groups for 3 ICUs). The short message will be sent as a reminder to nurses to use the ventilator bundle. In the Viber group, nurses are also encouraged to raise questions about the ventilator bundle and the PI will respond to questions. All questions will be addressed similarly to the responses agreed by VCLs.

Audit and feedback.

A Cochrane Review by Ivers et al. (2012) suggested that an audit and verbal feedback could effectively improve the rates of adherence to recommended practices among health care professionals. After the workshop workshops and during the four weeks (1 month) period for VCL interventions, the audit will be conducted for one week to measure adherence to the ventilator bundle. PI will conduct all audits in the intervention group (i.e., 3ICUs). The PI spends one shift (morning or evening) in the ICU each day, observing the nurse's performance with the ventilator bundle. The PI will observe the performance for six days and record the adherence to the checklist. The PI will also provide prompt feedback to the nurses on duty if any improper practices on the implementation of the ventilator bundle on the nurses’ side were identified. On the seventh day, immediate verbal feedback on the adherence to the ventilator bundle will be provided. For the feedback, PI will convene a 30-minute meeting with the nursing in-charge and ICU coordinator to discuss the adherence rates. The successes, failures, and critical issues encountered will be discussed during the meeting. In addition, the nurses will receive feedback on the adherence rate through text messages. Following the completion of the audit in one ICU, the PI will move on to the next ICU and repeat a similar process. Therefore, it will take 3 weeks to complete the audit and feedback in the intervention group.

Reward.

A reward will be linked to the one-week audit reportto provide positive reinforcement of the desired behaviour (Scott et al., 2021). The nurses will be rewarded (a small bottle of hand sanitizer and an appreciation certificate) on the day of the feedback (i.e., meeting with the nursing in charge). As the previous study (Thaqafy et al., 2014) showed, the 71% adherence showed a significant improvement in decreasing VAP rate, mortality, and ICU length of stay; thus, we have set the achievement of 70% adherence as a criterion for the reward.

Comparison name
Control group This study will not use a placebo as the control arm but instead will compare the effectiveness with usual care.
Comparison details

In the control group, the ventilator bundle is already in use. Patients in the control group are supposed to receive care similar to that received by them in daily practice. In daily practice, nurses implement the ventilator bundle. The nurses in the control group will not receive the VAP-IMP program.


Eligibility (Inclusion criteria)
Age Group
Please refer to inclusion details below
Gender
Both
Detail

Cluster eligibility criteria and recruitment.

Those ICUs that admit adult patients will be included and follow the same guidelines of the ventilator bundle. ICU that exclusively admits cardiac patients will be excluded.

Nurses eligibility criteria

All nurses working in the recruited ICUs will be included.

Patient eligibility criteria

Patients aged over 18 years old and are placed on mechanical ventilation for ≥48 hours. The rationale of using 48 hours as a cut-off point because pneumonia develops within 48 hours is less likely to be confirmed as VAP (Centre for Disease Control and Prevention, 2021).

Exclusion Detail

Exclusion criteria

Pediatric patients and patients with Acute Physiology and Chronic Health Evaluation (APACHE II) score ≥40 (Le Gall et al., 1984). Patients with an APACHE-II score ≥40 are more likely to develop complications due to his/her own severity of illness (Le Gall et al., 1984).

Sample Size
Nurses: All the nurses in recruited ICUS will be requested to participate. It is expected that the intervention would detect a 62% reduction. By using the power analysis software PASS 16 (NCSS, Kaysville, US), we anticipate that 986 ventilator days per gr
Enrollment Date
2022-04-10
Completion Date
2022-09-30
Enrollment Status
recruiting