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Trial registered on ANZCTR


Registration number
ACTRN12615000811505
Ethics application status
Approved
Date submitted
1/07/2015
Date registered
5/08/2015
Date last updated
7/07/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A nursing educational intervention for Safely Administering Medications and Managing Interruptions Pilot (SAMMI-P): a cluster randomised controlled trial (C_RCT).
Scientific title
The effectiveness of an educational intervention on safe administration of medications and the management of interruptions for nurses administering medications.
Secondary ID [1] 286930 0
Nil known
Universal Trial Number (UTN)
Trial acronym
SAMMI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interruptions to medication preparation and administration 295354 0
Condition category
Condition code
Public Health 295620 295620 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project will involve two groups - a control group and an intervention group. The practice of the control group will not differ from normal, standard medication administration practice. The intervention group will undertake an investigator-facilitated 30-60 minute education program including viewing a 20 minute DVD with details of the incidence of interruptions, behavioural strategies of managing interruptions and simulations of interruptions and panel discussion by nursing leaders on changing ward culture. A register of all nursing staff within wards will be established and attendance will be monitored.

Ward posters noting "In the interest of patient safety please do not interrupt nurses administering medications" will be placed within patient areas.
Intervention code [1] 292121 0
Behaviour
Comparator / control treatment
Education and simulation experience (intervention) compared to no education and simulation (control).
Control group
Active

Outcomes
Primary outcome [1] 295334 0
The number of interruptions (log of interruptions which occur during medication administration observed by research nurses over a one month period after delivery of the intervention) per 100 medication administration events of nurses receiving an education and simulation experience compared to nurses not receiving education.
Timepoint [1] 295334 0
Continuous assessment of interruptions (log of interruptions which occur during medication administration observed by research nurses) occurring when participant nurses administer medications over a one month period after delivery of the intervention.
Secondary outcome [1] 315374 0
The number of nurses' clinical and procedural errors (log of errors observed by research nurses over a one month period after delivery of the intervention) per 100 medication administration events where nurses undertake an education program and simulation experience compared to nurses not receiving education.
Timepoint [1] 315374 0
Continuous assessment of clinical and procedural errors (log of clinical and procedural errors which occur during medication administration observed by research nurses) occurring when participant nurses administer medications over a one month period after delivery of the intervention.
Secondary outcome [2] 316236 0
Patients' lengths of stay (assessed from electronic medical records) in the intervention wards receiving care from nurses completing the education program and simulation experience will have reduced compared to patients in the control wards over a one month period after delivery of the intervention.
Timepoint [2] 316236 0
The length of stay of patients (assessed from electronic medical records admission and discharge dates) receiving care from nurses completing the education program and simulation experience compared to patients in the control wards over a one month period after delivery of the intervention.

Eligibility
Key inclusion criteria
Nursing Unit Manager of the general medical/surgical clinical areas within major metropolitan hospitals within South Western Sydney Local health District (cluster). Critical care units are excluded from the study.

Registered and Enrolled nurses (certified to undertake medication administration) who routinely administer medications to patients.

Patients admitted to the intervention and control wards who are receiving one or more medications.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Critical care units

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster level: The study will be described through an educational program to Directors of Nursing and Nursing Unit Managers of potential medical/surgical units from major teaching hospitals within South Western Sydney Local Health District. Participant information sheets and consent forms will also fully describe the study. Four intervention and four control wards will be selected from a list of potential sites based on geographical location and being general/medical surgical units. Critical care units are excluded from the study.

To reduce the occurrence of contamination within the trial the wards that are geographically separated for the intervention and control groups and limited within each hospital will be selected. Wards will form a list. Allocation to control or intervention wards will be conducted off-site by a computer-generated randomisation process.

Nursing Unit Managers from these units will represent the cluster participant.

Nurse and patient level: In the intervention wards 75% of nurses will attend the educational intervention at the ward level. Only nurses (and coincidentally their patients) who have completed the education intervention will be requested to be observed for the intervention wards. In the control wards nurses (and coincidentally their patients) who voluntarily consent to participate will be observed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer generated randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Other design features
Parallel
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The intra-cluster correlation coefficient was used to calculate sample size. Assuming an intra-cluster coefficient of 0.05 with an average cluster (ward) size of 30 nurses per ward, it was estimated that this would result in an 80% power of detecting procedural errors from 53% (estimates range from 38 to 85%) to 25% in intervention wards. Although these estimations suggest that 8 wards in the intervention and 8 wards in the control group would be required, at this pilot only 4 wards for both the intervention and control wards are being sought. We believe that more precise estimation of the intra-cluster correlation coefficient will provide a better estimate of the requirements for the larger multicentre study.

The estimated number of 30 patients per ward was taken from separation data indicating that based an average 50-88 patients are separated from Liverpool hospital per month. It is expected that 36 medications per nurse will be observed in one hour, resulting in 30 nurses and 1080 medications being observed per ward.

Kappa statistic will be used to test inter-rater (observer) reliability.

Quantitative data analysis will be undertaken using R version 3.0.1 (R Core Team, 2013) or SPSS.
Summaries of baseline data for both clusters and individuals will be presented as tables. For observed medication administration procedural and clinical errors (number of interruptions and medication errors (procedural or clinical) per 100 medication administrations or per 100 medication events) are collected at individual patient level to analyse the intervention effect between the control and intervention wards.

At the cluster level, unpaired t-tests will be used to compare interruption rates, medication administration errors rates and patient length of stay in control and intervention wards. As this is a feasibility trail, and a small number of clusters in each arm, Wilcoxon Rank sum test may be required (violation of normality assumption). At individual level, negative binomial regression accounting for over dispersion, with generalised estimating equations allowing for within cluster correlation will be used to examine the effect of the intervention on medication administration error rates between the intervention and control wards. Analysis of patient length of stay at individual level will be analysed using negative binominal regression with generalised estimating equations allowing for within-cluster correlation.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/08/2015
Actual
14/08/2015
Date of last participant enrolment
Anticipated
30/09/2015
Actual
30/04/2016
Date of last data collection
Anticipated
31/12/2017
Actual
30/04/2016
Sample size
Target
1440
Accrual to date
Final
806
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3933 0
Liverpool Hospital - Liverpool
Recruitment hospital [2] 3934 0
Fairfield Hospital - Prairiewood
Recruitment hospital [3] 3935 0
Campbelltown Hospital - Campbelltown
Recruitment hospital [4] 3936 0
Camden Hospital - Camden
Recruitment postcode(s) [1] 9849 0
2170 - Liverpool
Recruitment postcode(s) [2] 9853 0
2176 - Prairiewood
Recruitment postcode(s) [3] 9855 0
2560 - Campbelltown
Recruitment postcode(s) [4] 9899 0
2570 - Camden

Funding & Sponsors
Funding source category [1] 291489 0
Government body
Name [1] 291489 0
Nursing and Midwifery Office, NSW Ministry of Health; SWSLHD.
Country [1] 291489 0
Australia
Primary sponsor type
Government body
Name
Centre for Applied Nursing Research, Ingham Institute, South Western Sydney Local Health District
Address
Centre for Applied Nursing Research,
Ingham Institute Applied Medical Research,
Level 3,
1 Campbell Street,
Liverpool 2170,
NSW
Country
Australia
Secondary sponsor category [1] 290166 0
University
Name [1] 290166 0
University of Western Sydney
Address [1] 290166 0
Locked Bag 7103,
Penrith,
NSW 2751
Country [1] 290166 0
Australia
Secondary sponsor category [2] 290167 0
University
Name [2] 290167 0
Australian Catholic University
Address [2] 290167 0
40 Edward Street,
North Sydney,
NSW 2060
Country [2] 290167 0
Australia
Secondary sponsor category [3] 290168 0
University
Name [3] 290168 0
Deakin University
Address [3] 290168 0
221 Burwood Highway,
Burwood,
Victoria 3125
Country [3] 290168 0
Australia
Secondary sponsor category [4] 290169 0
University
Name [4] 290169 0
University of Newcastle
Address [4] 290169 0
University Drive,
Callaghan,
NSW 2308
Country [4] 290169 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293073 0
SWSLHD Research and Ethics Office
Ethics committee address [1] 293073 0
Ethics committee country [1] 293073 0
Australia
Date submitted for ethics approval [1] 293073 0
Approval date [1] 293073 0
25/06/2015
Ethics approval number [1] 293073 0
15/047

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58166 0
Prof Maree Johnson
Address 58166 0
Australian Catholic University
40 Edward Street
North Sydney
NSW 2060
Country 58166 0
Australia
Phone 58166 0
(+612) 9739 2704
Fax 58166 0
(+612) 9739 2867
Email 58166 0
maree.johnson@acu.edu.au
Contact person for public queries
Name 58167 0
Professor Maree Johnson
Address 58167 0
Australian Catholic University
40 Edward Street
North Sydney
NSW 2060
Country 58167 0
Australia
Phone 58167 0
(+612) 9739 2704
Fax 58167 0
(+612) 9739 2867
Email 58167 0
maree.johnson@acu.edu.au
Contact person for scientific queries
Name 58168 0
Maree Johnson
Address 58168 0
Australian Catholic University
40 Edward Street
North Sydney
NSW 2060
Country 58168 0
Australia
Phone 58168 0
(+612) 9739 2704
Fax 58168 0
(+612) 9739 2867
Email 58168 0
maree.johnson@acu.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.