Objectives: The purpose of this study was determination of the effect of designed clinical pathway map on clinical care outcomes in patients with acute coronary syndrome.
Method (Design): This study is randomized trial with test and control group with pretest and posttest design. 30 patients with acute coronary syndrome disease randomized to test and control groups after admission to CCU. In two groups at first in hospitalization time and after stabilization of patient condition anxiety and depression are measured. Then, in test group the clinical pathway map presented to patients while in control group the patients cared by routing method. In discharge time variable such as anxiety, depression, satisfaction and hospitalization periods measured again.
Participant: Samples of research are patients over 30 years old, consciousness and literate that had acute coronary syndromes and can understand the clinical pathway. Also, the illiterate patients or those with threatening life condition exclude from study.
Intervention: Using clinical pathway map for test group and routine care method for control group.
Main outcomes measures: Patient’s anxiety, depression, satisfaction and hospitalization duration in CCU.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202235134N5
Registration date:2012-03-17, 1390/12/27
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-03-17, 1390/12/27
Registrant information
Name
Ali Fakhr-Movahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 23 3365 4192
Email address
Alimovi49@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Semnan University of Medical Sciences
Expected recruitment start date
2012-02-29, 1390/12/10
Expected recruitment end date
2012-08-31, 1391/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of designed clinical pathway map on clinical care outcomes in patient with acute coronary syndrome
Public title
Effect of clinical pathway on clinical care outcomes in acute coronary syndrome
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Speech to Persian language in sample research; consciousness; patients over 30 years old, consciousness and literate that had acute coronary syndromes and can understand the clinical pathway.
Exclusion criteria:
Unwillingness or canceling from sample research; life threatening condition; death of sample research; illiteracy patients or patient cannot percepts the clinical pathway; patients with problematic MI (pulmonary edema, hemodynamic alteration, life threatening arrhythmia and cardiogenic shock)
Age
From 30 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical board of Semnan University of Medical Sciences
Street address
Department of Research and Technology, Dept Headquarters, Basij Blvd
City
Semnan
Postal code
Approval date
2012-02-12, 1390/11/23
Ethics committee reference number
90/144313
Health conditions studied
1
Description of health condition studied
Unstable angina, Acute myocardial infarction
ICD-10 code
I20.0 ، I2
ICD-10 code description
Unstable angina, Acute myocardial infarction
Primary outcomes
1
Description
anxiety
Timepoint
pretest and posttest
Method of measurement
hospital anxiety and depression scale
2
Description
depression
Timepoint
pretest and posttest
Method of measurement
hospital anxiety and depression scale
3
Description
patient satisfaction
Timepoint
posttest
Method of measurement
patient satisfaction instrument
4
Description
hospitalization period in cadiac critical care unit
Timepoint
posttest
Method of measurement
counting the days in CCU
Secondary outcomes
empty
Intervention groups
1
Description
in test group: Presentation of clinical pathway map
Category
Other
2
Description
in control group: routine caring method
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Semnan Fatemieh hospital
Full name of responsible person
Dr. Nobakht
Street address
17 Shahrivar Blvd.
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Semnan University of Medical Sciences
Full name of responsible person
Dr. Raheb Ghorbani
Street address
Departement of Research and Techonology of Semnan Universiy of Medical Sciences, Basij Bvld.
City
Semnan
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, Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Ali Fakhr-Movahedi
Position
Nursing PhD / Assistant professor and faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Nursing and Allied Health Faculty, 5 Kilometer, Damghan road.
City
Semnan
Postal code
Phone
+98 23 1335 4192
Fax
Email
alimovi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Fakhr-Movahedi
Position
Nursing PhD / Assistant professor and faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Nursing and Allied Health Faculty, 5 Kilometer, Damghan road.
City
Semnan
Postal code
Phone
+98 23 1335 4192
Fax
Email
alimovi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Ali Fakhr-Movahedi
Position
Nursing PhD / Assistant professor and faculty member
Other areas of specialty/work
Street address
Semnan University of Medical Sciences, Nursing and Allied Health Faculty, 5 Kilometer, Damghan road.
City
Semnan
Postal code
Phone
+98 23 1335 4192
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)