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.: PACTR201406000838118 Date of Approval: 02/06/2014
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title An early warning score (EWS) system for recognition of clinical deterioration: RCT in two hospitals
Official scientific title Testing the effectiveness of a modified early warning score (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) (¿2 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)
Disease(s) or condition(s) being studied Standard vital signs monitoring versus intervention type monitoring
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/07/2014
Actual trial start date 01/08/2014
Anticipated date of last follow up 30/09/2014
Actual Last follow-up date 31/08/2014
Anticipated target sample size (number of participants) 612
Actual target sample size (number of participants) 306
Recruitment status Closed to recruitment,follow-up continuing
Publication URL
Secondary Ids Issuing authority/Trial register
UCT HREC/REF:337/2014 NHREF 3779 SANCTR DOH-27-0614-4779
nil known UCT HREC 825/2014
UCT HREC 825/2014
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 trials unit, Swansea. Random allocation of the 2ospitals is to either the intervention trial arm or control trial arm. This means that the 3 wards in each hospital will also have been randomised to that trial arm. The trialist in the Swansea clinical trials unit was given codes for the 2 participating hospitals and had to randomly allocate these to either the intervention or control trial arm using a random table. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Randomisation will be undertaken electronically in the clinical trials unit, Swansea. Random allocation of the 2ospitals is to either the intervention trial arm or control trial arm. This means that the 3 wards in each hospital will also have been randomised to that trial arm. The trialist in the Swansea clinical trials unit was given codes for the 2 participating hospitals and had to randomly allocate these to either the intervention or control trial arm using a random table. Masking/blinding used
Parallel: different groups receive different interventions at same time during study Randomised Randomisation will be undertaken electronically in the clinical trials unit, Swansea. Random allocation of the 2ospitals is to either the intervention trial arm or control trial arm. This means that the 3 wards in each hospital will also have been randomised to that trial arm. The trialist in the Swansea clinical trials unit was given codes for the 2 participating hospitals and had to randomly allocate these to either the intervention or control trial arm using a random table. Masking/blinding used Outcome Assessors
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 + implementation of the SBAR communication tool 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 and those whose clinical records are unavailable Incomplete records (not including 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 UCT 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 NHREC + SANCTR
Ethics Committee Address
Street address City Postal code Country
8 Blackwood Avenue Johannesburg 2193 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 SANCTR National Department of Health
Ethics Committee Address
Street address City Postal code Country
Civitas Building, Corner Andries and Struben Streets Pretoria 0001 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. 1 month
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
New Somerset Hospital Portswood Road Cape Town 8051 South Africa
Victoria Hospital Wynberg Hill Road Cape Town 7824 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 27 21 4066410 Anzio Roac, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Senior Lecturer
Role Name Email Phone Street address
Public Enquiries Delva Shamley delva.shamley@uct.ac.za 0743775287 Anzio Road, Observatory
City Postal code Country Position/Affiliation
Cape Town 7925 South Africa Deputy Director, Clinical Research Centre
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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