Construction and Effect Evaluation of Integrated Care Model for Pulmonary Infection in Stroke Patients With Tracheotomy
Primary Purpose
Stroke, Pulmonary Infection
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
integrated care model
Sponsored by
About this trial
This is an interventional other trial for Stroke
Eligibility Criteria
Inclusion Criteria:
- Non-acute stroke patients diagnosed by MRI or CT who meet the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases";
- Those who meet the diagnostic criteria for pulmonary infection;
- Age ≥18 years old;
- Tracheotomy patients who have been off the ventilator or do not need mechanical ventilation;
- Patients who can cooperate with the research and sign the informed consent.
Exclusion Criteria:
- Patients whose vital signs are unstable and may be transferred to ICU for treatment in the future;
- Patients with malignant tumors or other infectious diseases.
Sites / Locations
- The Second People's Hospital of ShenzhenRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
control group
intervention group
Arm Description
Implement routine nursing such as: routine oral nursing, tracheostomy, dressing change, sputum suction nursing, oral education, etc.
Implement comprehensive nursing models such as: admission risk assessment, personalized oral care based on beck oral score, aspiration prevention, airway care, diversified health education
Outcomes
Primary Outcome Measures
Clinical Pulmonary Infection Score
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
Clinical Pulmonary Infection Score
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
Secondary Outcome Measures
Beck Oral Assessment Score(BOAS),modified
The scale includes five items: lips, gums and oral mucosa, tongue, teeth, and saliva to evaluate the oral hygiene status and functional status. Each item is scored with 1 to 4 points, and the total oral hygiene score is 5 to 20 points. The higher the score, the worse the oral hygiene.
Beck Oral Assessment Score(BOAS),modified
The scale includes five items: lips, gums and oral mucosa, tongue, teeth, and saliva to evaluate the oral hygiene status and functional status. Each item is scored with 1 to 4 points, and the total oral hygiene score is 5 to 20 points. The higher the score, the worse the oral hygiene.
Zarit Caregiver Burden Interview, ZBI
The scale mainly includes 2 dimensions (personal burden and responsibility burden), a total of 22 items, each item is divided into 5 grades according to the severity of the burden, expressed on a scale of 0-4, 0 means never, 4 means almost often. The total score of the scale is 0-88 points, and the higher the score, the heavier the burden of care.
Zarit Caregiver Burden Interview, ZBI
The scale mainly includes 2 dimensions (personal burden and responsibility burden), a total of 22 items, each item is divided into 5 grades according to the severity of the burden, expressed on a scale of 0-4, 0 means never, 4 means almost often. The total score of the scale is 0-88 points, and the higher the score, the heavier the burden of care.
EuroQol-5 Dimension, EQ-5D
he Chinese version of the European five-dimensional health scale (EuroQol-5 Dimension, EQ-5D), EQ-5D is a commonly used scale to measure health-related quality of life. The scale is divided into 2 parts: the EQ-5D health description system and the EuroQol-Visual Analogue Score (EQ-VAS). The EQ-5D health description system includes 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression, and each dimension contains 3 levels: no difficulty, some difficulty, and extreme difficulty. The EQ-VAS uses a score of 0 to 100 to evaluate a patient's current health status, with 100 representing the "best health status in my mind" and 0 representing the "worst health status in my mind".
EuroQol-5 Dimension, EQ-5D
he Chinese version of the European five-dimensional health scale (EuroQol-5 Dimension, EQ-5D), EQ-5D is a commonly used scale to measure health-related quality of life. The scale is divided into 2 parts: the EQ-5D health description system and the EuroQol-Visual Analogue Score (EQ-VAS). The EQ-5D health description system includes 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression, and each dimension contains 3 levels: no difficulty, some difficulty, and extreme difficulty. The EQ-VAS uses a score of 0 to 100 to evaluate a patient's current health status, with 100 representing the "best health status in my mind" and 0 representing the "worst health status in my mind".
Full Information
NCT ID
NCT05505487
First Posted
May 14, 2022
Last Updated
August 15, 2022
Sponsor
Shenzhen Second People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05505487
Brief Title
Construction and Effect Evaluation of Integrated Care Model for Pulmonary Infection in Stroke Patients With Tracheotomy
Official Title
Construction and Effect Evaluation of Integrated Care Model for Pulmonary Infection in Stroke Patients With Tracheotomy
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 7, 2022 (Actual)
Primary Completion Date
May 7, 2026 (Anticipated)
Study Completion Date
May 7, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Second People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
To understand the occurrence of pulmonary infection in stroke patients with tracheotomy, and to clarify the current situation of clinical nursing.
Construct a standardized, systematic and scientific integrated care model to control the severity of pulmonary infection in non-acute stroke patients with simple tracheotomy.
To evaluate the clinical application effect of integrated care model of pulmonary infection in stroke patients with tracheotomy.
Detailed Description
1. Research content This study involves two parts: construction and effect evaluation.
The construction link includes: retrospective analysis of patient data, clinical observation, literature review, expert consultation, and pre-experiment.
Effect evaluation: The integrated care model was applied to the clinic, and the patients' CPIS score, Beck oral score, ZBI caregiver burden score, EQ-5D score and hospitalization cost were collected to evaluate the effect of the model.
2. The grouping method Convenience sampling method was used to select patients with simple tracheotomy for non-acute stroke who were admitted to the Department of Rehabilitation Medicine of Shenzhen Second People's Hospital as the research object, and the patients before the implementation of the integrated care model(May-July 2022) were set as the control group , the patients after the implementation of the integrated care model (August-October 2022) were set as the intervention group.
3. Sample Size Estimation
This study is a quasi-experimental study, and the main outcome indicator is the control of pulmonary infection (CPIS score). Therefore, the sample size estimation method of the group design quantitative data sample mean is adopted.
Based on the results reported in similar research literature, the authors assumed that the CPIS scores of the control group and the intervention group were 3.9±1.5 and 2.8±1.1, respectively. Set β=0.1, power (Power=1-β)=90%, two-sided α=0.05 at the significance level, and the sample size of each group was 32 cases after calculation by G-power3.1 software. According to the 20% dropout rate, the final sample size of each group was 40 cases, and there were 80 cases in the two groups.
4. Statistical analysis Using Excel and IBM SPSS Statistics 26.0 software for double entry and analysis, the measurement data that conformed to the normal distribution were expressed as the mean ± standard deviation, and the t test was used for comparison between groups; the measurement data that did not conform to the normal distribution were expressed as the median and four The number of quantiles was expressed, and the rank-sum test was used for comparison between groups. The count data were expressed as frequency and percentage, and the chi-square test was used for comparison between groups. The difference was statistically significant with p<0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke, Pulmonary Infection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study is a quasi-experimental study; no equal control design
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control group
Arm Type
No Intervention
Arm Description
Implement routine nursing such as: routine oral nursing, tracheostomy, dressing change, sputum suction nursing, oral education, etc.
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Implement comprehensive nursing models such as: admission risk assessment, personalized oral care based on beck oral score, aspiration prevention, airway care, diversified health education
Intervention Type
Other
Intervention Name(s)
integrated care model
Intervention Description
The interventions in this study were to implement basic patient care only and did not involve any invasive procedures. On the basis of routine nursing, the content of nursing intervention was integrated, and a standardized nursing model was formed for clinical application to control the severity of pulmonary infection in patients with simple tracheotomy in the non-acute phase of stroke.
Primary Outcome Measure Information:
Title
Clinical Pulmonary Infection Score
Description
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
Time Frame
Within 1 week of admission
Title
Clinical Pulmonary Infection Score
Description
The scale mainly includes 7 indicators of body temperature, white blood cell count, tracheal secretions, oxygenation, chest X-ray, progress of pulmonary exudation, and microbial culture of tracheal aspirates, each with 0 to 2 points, with a total score of 12 If the score is less than 6, the lung infection is considered to be controlled.
Time Frame
3 weeks after admission
Secondary Outcome Measure Information:
Title
Beck Oral Assessment Score(BOAS),modified
Description
The scale includes five items: lips, gums and oral mucosa, tongue, teeth, and saliva to evaluate the oral hygiene status and functional status. Each item is scored with 1 to 4 points, and the total oral hygiene score is 5 to 20 points. The higher the score, the worse the oral hygiene.
Time Frame
Within 1 week of admission
Title
Beck Oral Assessment Score(BOAS),modified
Description
The scale includes five items: lips, gums and oral mucosa, tongue, teeth, and saliva to evaluate the oral hygiene status and functional status. Each item is scored with 1 to 4 points, and the total oral hygiene score is 5 to 20 points. The higher the score, the worse the oral hygiene.
Time Frame
3 weeks after admission
Title
Zarit Caregiver Burden Interview, ZBI
Description
The scale mainly includes 2 dimensions (personal burden and responsibility burden), a total of 22 items, each item is divided into 5 grades according to the severity of the burden, expressed on a scale of 0-4, 0 means never, 4 means almost often. The total score of the scale is 0-88 points, and the higher the score, the heavier the burden of care.
Time Frame
Within 1 week of admission
Title
Zarit Caregiver Burden Interview, ZBI
Description
The scale mainly includes 2 dimensions (personal burden and responsibility burden), a total of 22 items, each item is divided into 5 grades according to the severity of the burden, expressed on a scale of 0-4, 0 means never, 4 means almost often. The total score of the scale is 0-88 points, and the higher the score, the heavier the burden of care.
Time Frame
3 weeks after admission
Title
EuroQol-5 Dimension, EQ-5D
Description
he Chinese version of the European five-dimensional health scale (EuroQol-5 Dimension, EQ-5D), EQ-5D is a commonly used scale to measure health-related quality of life. The scale is divided into 2 parts: the EQ-5D health description system and the EuroQol-Visual Analogue Score (EQ-VAS). The EQ-5D health description system includes 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression, and each dimension contains 3 levels: no difficulty, some difficulty, and extreme difficulty. The EQ-VAS uses a score of 0 to 100 to evaluate a patient's current health status, with 100 representing the "best health status in my mind" and 0 representing the "worst health status in my mind".
Time Frame
Within 1 week of admission
Title
EuroQol-5 Dimension, EQ-5D
Description
he Chinese version of the European five-dimensional health scale (EuroQol-5 Dimension, EQ-5D), EQ-5D is a commonly used scale to measure health-related quality of life. The scale is divided into 2 parts: the EQ-5D health description system and the EuroQol-Visual Analogue Score (EQ-VAS). The EQ-5D health description system includes 5 dimensions: mobility, self-care, activities of daily living, pain or discomfort, anxiety or depression, and each dimension contains 3 levels: no difficulty, some difficulty, and extreme difficulty. The EQ-VAS uses a score of 0 to 100 to evaluate a patient's current health status, with 100 representing the "best health status in my mind" and 0 representing the "worst health status in my mind".
Time Frame
3 weeks after admission
Other Pre-specified Outcome Measures:
Title
hospital costs
Description
Collection of treatment expenses during hospitalization of patients through the hospital electronic medical record system
Time Frame
≥3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Non-acute stroke patients diagnosed by MRI or CT who meet the diagnostic criteria of the "Chinese Guidelines for the Prevention and Treatment of Cerebrovascular Diseases";
Those who meet the diagnostic criteria for pulmonary infection;
Age ≥18 years old;
Tracheotomy patients who have been off the ventilator or do not need mechanical ventilation;
Patients who can cooperate with the research and sign the informed consent.
Exclusion Criteria:
Patients whose vital signs are unstable and may be transferred to ICU for treatment in the future;
Patients with malignant tumors or other infectious diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yan Gao, Ph.D
Phone
+8613660367430
Email
gaoyanluoyang@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yan Gao, Ph.D
Organizational Affiliation
Shenzhen Second People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Second People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518035
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ph.D
Phone
+8613660367430
Email
gaoyanluoyang@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Contact the principal investigator for data if necessary
Learn more about this trial
Construction and Effect Evaluation of Integrated Care Model for Pulmonary Infection in Stroke Patients With Tracheotomy
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