Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201309000626545 Date of Approval: 22/08/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title A vital signs monitoring tool for early identification of deterioration in patients
Official scientific title The development, validation and testing of a vital signs monitoring tool for early identification of deterioration in adult surgical patients
Brief summary describing the background and objectives of the trial Background: In this study serious adverse events refer to unplanned admission to ICU, cardiac arrest without a pre-existing not-for-resuscitation order and unexpected death. Aim: in a public hospital in South Africa, to develop, validate and test the impact of implementation of a modified early warning score (MEWS)vital signs chart and training programme to improve hospital nurses' performance in early identification of postoperative physiological and clinical deterioration in adult patients.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) Cluster RCT
Disease(s) or condition(s) being studied Standard vital signs monitoring versus intervention type monitoring,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Education /Training
Anticipated trial start date 01/02/2009
Actual trial start date 01/02/2009
Anticipated date of last follow up 31/07/2010
Actual Last follow-up date 31/07/2010
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL http://www.trialsjournal.com/content/16/1/103/abstract
Secondary Ids Issuing authority/Trial register
3483 NHREC 2010/04/12 South African Human Research Electronic Application System
REC REF: 192/2009 University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
DOH-27-0713-4483 South African Department of Health, S African National CTRegistry & WITS Health Consortium
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Sequence generation for random selection of wards was unmatched. Six folded sheets of paper each of which had the name of one ward written on it were placed in a box. The first three drawn out by an independent person not associated with the study were allocated to the intervention group. Drawing sealed lots from a box and blinded to the ward names on the lots and to outcome (intervention and control trial arms) Masking/blinding used Outcome Assessors
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group MEWS training programme for nurses Twice 2 hours & 2 hours Revision of anatomy & physiology, vital signs (respiratory & heart rate, blood pressure, oxygen saturation, temperature, level of consciousness, urine output) 38
Experimental Group Implementation of the MEWS vital signs observation chart 3 months The MEWS chart replaced the standard existing vital signs chart 38
Control Group Not applicable Not applicable Not applicable Not applicable 25
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
All permanently employed nurses on day and night duty working in the six research wards. Records of patients 14 years of age and older. Had a general anaesthetic. Admitted to one of the six research wards during 1 May - 31 July 2010. Incomplete or unavailable records. 14 Year(s) 100 Year(s) Male
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes University of Cape Town Faculty of Health Sciences Human Research Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Anzio Road Cape Town 7925 South Africa
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes South African Human Research Electronic Application System - WITS (University of the Witwatersrand) Health Consortium
Ethics Committee Address
Street address City Postal code Country
8 Blackwood Avenue Parktown, Johannesburg 2193 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pre- and post-intervention test scores of nurses' knowledge by blinded independent marking Before training 3 months after training
Primary Outcome The number of patients with physiological variables recorded on the MEWS chart in intervention wards and on existing vital signs charts in control wards 3 months after the RCT commenced
Primary Outcome Nurses' responses to high and low threshold MEWS recordings in patients' notes in the intervention wards and nurses' responses to abnormal vital signs recordings on the existing chart in control wards 3 months after the RCT commenced
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Groote Schuur Hospital Drive Cape Town 7925 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
University of Cape Town Research Development Office Main Road, Mowbray Cape Town 7700 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Una Kyriacos Groote Schuur Hospital Drive, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Sue Jordan Singleton Park, Swansea University, Wales Swansea SA2 8PP United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Una Kyriacos una.kyriacos@uct.ac.za 27-21-4066410 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Jennifer Jelsma jennifer.jelsma@uct.ac.za 27-21-4066401 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Deputy Head: Postgraduate Education
Role Name Email Phone Street address
Scientific Enquiries Una Kyriacos una.kyriacos@uct.ac.za 27-21-4066410 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Lecturer
REPORTING
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