Clinical trial NCT05505487: 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
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Pulmonary Infection
Lead sponsor: Shenzhen Second People's Hospital
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a quasi-experimental study; no equal control design
Primary purpose: OTHER

Brief summary: 1. To understand the occurrence of pulmonary infection in stroke patients with tracheotomy, and to clarify the current situation of clinical nursing.
2. Construct a standardized, systematic and scientific integrated care model to control the severity of pulmonary infection in non-acute stroke patients with simple tracheotomy.
3. 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.

1. The construction link includes: retrospective analysis of patient data, clinical observation, literature review, expert consultation, and pre-experiment.
2. 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

1. 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.
2. 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.

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.

Primary outcomes:
measure: Clinical Pulmonary Infection Score
timeFrame: Within 1 week of admission
measure: Clinical Pulmonary Infection Score
timeFrame: 3 weeks after admission
Secondary outcomes:
measure: Beck Oral Assessment Score(BOAS)，modified
timeFrame: Within 1 week of admission
measure: Beck Oral Assessment Score(BOAS)，modified
timeFrame: 3 weeks after admission
measure: Zarit Caregiver Burden Interview, ZBI
timeFrame: Within 1 week of admission
measure: Zarit Caregiver Burden Interview, ZBI
timeFrame: 3 weeks after admission
measure: EuroQol-5 Dimension， EQ-5D
timeFrame: Within 1 week of admission
measure: EuroQol-5 Dimension， EQ-5D
timeFrame: 3 weeks after admission
Other outcomes:
measure: hospital costs
timeFrame: ≥3 weeks
Locations:
city: Shenzhen
country: China
facility: The Second People's Hospital of Shenzhen
state: Guangdong
Study officials:
affiliation: Shenzhen Second People's Hospital
name: Yan Gao, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: