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The effect of using critical care service team in comparison to routine care on mortality of acutely ill patients in general wards

Protocol summary

Summary
Delivering timely, safe, and optimal care to patients is an unalienable obligation of a health system and its workers; sub-optimal care, as a rule, ends up with deteriorating conditions for patients. This is certainly the case in general hospital wards, where an increasing number of acutely ill patients (AIP) are admitted. Failing to identify and manage AIPs may lead to catastrophic outcomes. Implementing a Critical Care Service (CCS), aimed at timely identification and management of AIPs, was an approach to overcoming these shortcomings. An evaluation study is designed to explore the potential impact of CCS in 13 medical-surgical wards in an Iranian University Hospital during the 72-week period. The study design is a Stepped-Wedge Cluster Randomized Controlled Trial. The study include, for each ward, an unexposed to the intervention phase, a training phase, and an exposed to the intervention phase during which the ward go through a transition phase of adopting the intervention (CCS). All patients care for during the unexposed; training and exposed to the intervention phases are included as unexposed, training, and exposed respectively. Burn, cardiac surgery, pediatric and neonatal will exclude from the study. The CCS team is nurse-led, and the CCS team members have responsibility for training and assisting the ward staff in caring for the AIPs. The primary outcomes are CPRs and mortality, and the secondary outcomes are length of stay and admission to intensive care unit. The outcomes in two phases will be compared, when the ward patients receive routine care and later on when the CCS will be implemented in the wards.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201107187053N1
Registration date: 2015-07-07, 1394/04/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-07-07, 1394/04/16
Registrant information
Name
Alireza Jeddian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2101
Email address
jeddian@mohme.gov.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tehran University of Medical Sciences
Expected recruitment start date
2010-07-17, 1389/04/26
Expected recruitment end date
2012-01-17, 1390/10/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of using critical care service team in comparison to routine care on mortality of acutely ill patients in general wards
Public title
The effect of using critical care service team on mortality of acutely ill patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: The role of CCS is to deliver care in the non-critical care units of general hospital wards and all patients who will admit to these wards were included in the trial. Exclusion criteria are burn;cardiac surgery; pediatric and neonatal patients .
Age
From 18 years old to 120 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Assigning the participating wards to the intervention was at random

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran university of medical sciences
Street address
Ghods St., Keshavarz Blvd, Tehran
City
Tehran
Postal code
1417653761
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
89-01-37-10612

Health conditions studied

1

Description of health condition studied
Acutely Ill Patients
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Number of deaths
Timepoint
during three phases of recieving routtine care, while on training and while recieving intervention
Method of measurement
Physician’s certification of death

2

Description
Number of Cardio-pulmonary resucitations
Timepoint
during three phases of recieving routtine care, while on training and while recieving intervention
Method of measurement
A CPR call that was made for the patient (was called code 145 in study setting) and completed CPR forms in the medical records of the patient

Secondary outcomes

1

Description
Length of stay
Timepoint
during three phases of recieving routtine care, while on training and while recieving intervention
Method of measurement
Total days of patients hospitalization according to the hospital information system

2

Description
Admission to ICU
Timepoint
during three phases of recieving routtine care, while on training and while recieving intervention
Method of measurement
Number of patient who will admit to the ICU from general wards (medical and surgical)

Intervention groups

1

Description
The intervention group: In this study the intervention group will receive the critical care service (CCS). The steps of intervention will be training of ward nurses, admitting acutly ill patients (AIPs) under the care of CCS and management and follow up of CCS patients. These steps explain in detail as below: 1- Training of ward nurses : Because ward nurses are the first step in the CCS process, an additional 8-week period of training is provided for them before starting the intervention on each ward. During this stage identifying the acutely ill patients , the process of CCS and patients care will explained to ward staff. 2- Admitting AIPs under the care of CCS: Patients can come under the care of the CCS in one of three ways: a) patients who met the criteria (for example: high blood presssure ( are referred by the ward staff to the CCS team; b) patients will discharge from ICU; and c) the CCS team can actively identify patients in the wards. Ward nurses will identify patients requiring intervention by the CCS based on the standard criteria. The ward nursing staff will report any changes in systolic blood pressure, respiratory rate, heart rate, urinary output, body temperature, level of consciousness and any other general concerns about the patient’s condition to the shift’s head nurse. They will continue to observe the patients for 30 minutes, and if there is no improvement; they will inform the CCS team. Then the CCS team will attend the patient’s bedside. The patient’s care is taken over by the CCS team if the patient has a acute condition. If the patient is assess and find not to need CCS (those with no acute condition), they are given the same treatments as other patients in wards. Also, list of patients, who are transfer from ICUs to general wards, is taken from supervisors in each shift and pass to the CCS team. Following these patients are visit by CCS team members and place in CCS team service. 3- Management and follow up of CCS patients: After admitting patients to CCS, immediate evaluations are carried out and decisions are made for their management. Methods for patients’ management are applied to CCS patients, as will describe below: a) Active intervention: In these situations, team members are responsible for patients’ critical care, such as airway suction, changes in patients’ position, oxygen therapy, and consultation with physicians about patient care. b) Training of ward staff: Medical staffs, particularly wards nurses, are trained in patient care. This include appropriate airway management, suction, oxygen therapy, changing the patient’s position, endotracheal tube care, working with a ventilator and regulating its settings based on the patient’s needs. The team members give practical tutoring to the staff on the correct performance of these procedures. c) Training and active intervention: This method is a combination of previous methods. After intervention, haemodynamically stable patients are observed for 72hours and then discharge from CCS if they recover. If not, another intervention is decided upon. Patients who remain ill and unstable, or whose conditions cause concern, are transferred to ICU if there are any empty beds available. If not, the intervention is continued on general wards.
Category
Treatment - Other

2

Description
Control group: This group will recieve routine ward care and usual practices vis-a-vis urgent patient situaions
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Alireza Jeddian
Street address
Shariati Hospital, Jalal alahmad, North Kargar,Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar Fotouhi
Street address
Ghods St, Keshavarz Boulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Alireza Jeddian
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2101
Fax
Email
jeddian@mohme.gov.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran university of Medical Sciences
Full name of responsible person
Alireza Jeddian
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
+98 21 8490 2101
Fax
Email
jeddian@mohme.gov.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
tehran University of Medical Sciences
Full name of responsible person
Alireza Jeddian
Position
MD
Other areas of specialty/work
Street address
Shariati Hospital
City
Tehran
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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