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.: PACTR201412000936255 Date of Registration: 10/11/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Testing an early warning score (EWS) system for recognition of clinical deterioration: multi-site (multi-province) RCT
Official scientific title Testing the effectiveness of a modified early warning (MEWS) vital signs observations chart and SBAR tool for nurses recognition and reporting of clinical deterioration in patients in adult wards: a multi-site cluster RCT
Brief summary describing the background and objectives of the trial Background: Critically ill patients are increasingly being nursed on general wards where it is reported that vital signs monitoring is infrequent and inadequate. Our previous study (PACTR201309000626545) and others indicate that patients are being put at risk by suboptimal recording of vital signs. We are seeking support to continue our work into strategies to improve patient monitoring and subsequent patient safety. Our previous study implementing a consensus derived MEWS chart on adult surgical wards in a single site pragmatic parallel group cluster RCT of intervention versus standard care, showed that more patients in intervention wards (27 of 57) had recordings of respiratory rate than control wards (2 of 57 patients) (chi-square 28.9, df 1, OR 24.75, 5.5%-111.3%). There were significantly more recordings of all 7 parameters in intervention wards (5/57 patients) than control wards (0/57) (Risk Estimate 1.10, 1.01%-1.2%). Nurses did not report two abnormal signs (respiratory rate, systolic BP and/or heart rate) respectively for two of the three patients who died. The nurse training programme in use of the MEWS chart made a difference. Knowledge scores improved more in the intervention arm than the control arm, mean difference 4/23 (19.5%, 8.90%-30.04%) vs 1/23 (4.0%, -1.46%-9.47% (independent t-test 2.69 (df 35.9), mean difference 3/23 (15.5%, 3.8%-27.2%, p=0.01). Knowledge testing is not repeated in this multi-site RCT. To our knowledge, ours is the only clinical trial of EWS/ MEWS/NEWS systems. Objectives: By retrospective record review, to test the effectiveness of the: 1. Cape Town MEWS vital signs observations chart for nurses ability to identify early signs of clinical deterioration, and 2. SBAR communication guidelines for frequency of reporting clinical deterioration, through a multi-site pragmatic parallel group cluster randomised trial with two arms (intervention versus usual care).
Type of trial RCT
Acronym (If the trial has an acronym then please provide) CRCT
Disease(s) or condition(s) being studied Training
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 17/11/2014
Actual trial start date
Anticipated date of last follow up 30/01/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 102
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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 randomisation will be undertaken electronically in the Clinical Trial Unit Swansea The trialist in the Swansea clinical trials unit was given codes for the participating hospitals and had to allocate one to the intervention trial arm and the other to the control trial arm. Masking/blinding used Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Implementation of the MEWS vital signs observations chart Continuously 1 month Implementation of the MEWS observations chart to replace the standard vital signs observations chart 51
Control Group Standard vital signs observations chart Continuously 1 month None 51
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Training programme: a) All nurses in full-time employment in the 3 intervention wards including those on night duty. Record review: b) Patient records for retrospective record review on discharge will include all patients 18 years of age and older who were admitted to the 3 intervention wards and the 3 control wards during the period of study. Patients who are Not for Resuscitation, those who are transferred out of the ward to another department after 3 days and those whose clinical records are unavailable. Incomplete records (not having a vital signs chart and the Nursing Record/Progress Notes, or, in the intervention wards, the MEWS chart and SBAR where appropriate) and missing records will be counted but excluded for analysis as these reduce availability for sampling. 18 Year(s) 106 Year(s) Both
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 05/11/2014 UCT HREC
Ethics Committee Address
Street address City Postal code Country
Anzio Road Cape Town 7925 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Nurses reporting behaviour, that is, proportion of responses to early signs of clinical and physiological deterioration judged as appropriate, assessed by investigators using MEWS criteria (reference) from documentation in patients¿ records At study closure after 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Groote Schuur Hospital Groote Schuur Hospital Drive Cape Town 7925 South Africa
Karl Bremer Hospital cnr Mike Pienaar Blvd & Frans Conradie Avenue Bellville 7530 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
NRF CSUR 232 Boom Street Pretoria 2600 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor UCT Faculty of Health Sciences Clinical Trials Unit Anzio Road, Observatory Cape Town 7925 South Africa University
COLLABORATORS
Name Street address City Postal code Country
Dr Sue Jordan Singleton Park Swansea, Wales SA2 8PP United Kingdom
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Una Kyriacos una.kyriacos@uct.ac.za 0761422676 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Marc Blockman marc.blockman@uct.ac.za 021 4066338 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Chairperson, Human Research Ethics Committee UCT
Role Name Email Phone Street address
Scientific Enquiries Una Kyriacos una.kyriacos@uct.ac.za 0761422676 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Lecturer, University of Cape Town
REPORTING
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