Application of a flexible visitation system in critically ill patients: A randomized clinical trial

Abstract

Objective:

To determine the feasibility of a flexible visitation system in the intensive care unit (ICU).

Methods:

A randomized, open-label, parallel group clinical trial was conducted. All patients admitted to the ICU of the Lanzhou University Second Hospital from April to June 2022 were enrolled. The enrolled patients were randomly divided into an experimental group and a control group according to a computer-generated random sequence table.

Results:

A total of 410 patients were admitted. According to the inclusion and exclusion criteria, 140 patients were included in the experimental group (flexible visitation group) and 140 in the control group (normal visitation group). The average number of visitation minutes per day between the experimental group and the control group was 24.7 versus 23.9 min (p > 0.05).Among the outcome indicators, delirium occurred in 8 (5.7%) patients in the intervention group and in 24 (17.1%) patients in the control group (p = 0.003). Five complaints (mainly pressure ulcers) were received, with one in the experimental group and the others in the control group. There were 28 cases of nosocomial infection in the experimental group and 29 cases in the control group; therefore, the incidence of nosocomial infection was 20% versus 20.7% (p = 0.882). A total of 280 questionnaires were collected, with a retrieval rate of 100%. The satisfaction of patients in the experimental group and the control group was 98.6% and 92.1%, respectively (p = 0.011). The flexible visiting system reduced the ICU length of stay (LOS). The ICU LOS of the experimental group was 6 versus 8 days for the control group (p = 0.041). However, the flexible visiting system did not reduce the hospital stay (17 vs. 19 days, p = 0.923).

Conclusion:

Conducting a flexible visitation system in ICUs could reduce the incidence of delirium in critically ill patients and improve the quality of nursing care; furthermore, the rate of nosocomial infections was not increased. These findings need to be further verified by a multicentre, large-scale clinical trial.

Introduction

In recent years, especially with the increased understanding of the pathophysiological mechanisms of critically ill patients, this young discipline has made rapid advances. However, there are also many problems. Among these issues, a visitation system is one of the problems that urgently needs to be solved. Although completely closed management can prevent and reduce the occurrence of nosocomial infection and is conducive to treating critically ill patients, it cannot meet the psychological needs of patients and their families and even increases the psychological burden of patients and their families. ¹ A visiting system can increase the sense of trust and identity between nurses and patients, play a positive role in settling disputes and contradictions, significantly promote the professional nursing level of nurses and improve the quality of nursing services. Meanwhile, a previous study ² showed that extended visits were the only protective factor for the occurrence of delirium (odds ratio (OR) 0.36; 95% confidence interval (CI) 0.17–0.74; p = 0.005). However, the nonrandomized nature of these studies limits the interpretation of the results.

Intensive care unit (ICU) visiting systems can be roughly divided into the following four models ³ : completely open (visit at any time), completely isolated (forbidden to visit), semiopen, and restricted. Each of the four visitation systems has advantages and disadvantages. The completely open visiting system places a high burden on ICU equipment and conditions, and most hospitals in China find it difficult to meet standards of care under this system, while the compliance of rules by family members is poor. In our country, ICUs generally adopt semiopen, restricted, or completely isolated visitation systems according to the patient's health status. A previous systematic review and meta-analysis ⁴ showed that a flexible visiting policy was associated with a reduced frequency of delirium (OR 0.39; 95% CI 0.22–0.69). This approach fully considers the unique characteristics of each ICU, minimizes interference with medical personnel, ensures the continuity of care of critically ill patients, and reduces nosocomial infections, but this visiting system does not fully consider the family or the patient's psychological demands, and the anxiety experienced by the patient and family can lead to a bad psychological reaction of the patient. In China, family members only need to talk with patients and, more importantly, encourage patients to build confidence to overcome the disease and play a role in psychological comfort. Simultaneously, if the patient is unable to communicate, such flexible visits can also comfort the family members. Therefore, each visit is not scheduled for a long time, and our flexible visit program is designed to make the patient feel less lonely. Therefore, the flexible visitation group can book multiple visits a day.

Previously, we studied ICU delirium, particularly the incidence and risk factors for delirium in mechanically ventilated ICU patients (Lanzhou Model).^5,6 Our findings indicated that family-centred prevention of ICU delirium should receive increased attention, but due to the equipment and conditions of ICUs in China, they cannot support open visitation. However, having a semiopen, namely, a flexible visiting system, has gradually manifested its unique advantages, but research based in China is in its infancy.^7–9 Few studies have assessed the effectiveness and safety of this type of intervention. The flexible visitation system means that patients and their families can make an appointment for visitation according to their needs during the nontreatment period, which is significantly different from the previous visitation system. In the ICU, various emergencies and changes in patients’ conditions make the previous rigid visiting system cause contradictions between doctors and patients and aggravate patients’ negative emotions, which is not conducive to patients’ rehabilitation, and some patients even suffer from ICU syndrome. Based on previous studies on ICU delirium, our research team attempted to further clarify the feasibility of a flexible visitation system in an ICU in China by designing a prospective, randomized trial and laying a theoretical foundation for the future development of flexible visitation systems.

Materials and methods

Clinical data

The data of all patients admitted to the ICU of the Lanzhou University Second Hospital from April to June 2022 were collected in the following forms: age, sex, mechanical ventilation, Acute Physiology and Chronic Health Evaluation (APACHE) II score, delirium occurrence, nosocomial infection, complaints, satisfaction questionnaire, etc.

Design

A randomized, open-label, parallel group clinical trial was performed. Complete randomization was applied in our study. First, patients were ranked according to the order of enrollment. A set of random numbers (10) was then assigned to the patients in the same order. Then, the random number column was ranked from smallest to largest, with the first five numbers for the experimental group and the last five for the control group.

This study was approved by the Ethics Committee of The Lanzhou University Second Hospital. The ethics number is 2022A-108. The clinical trial number is ChiCTR2200059093. All included patients provided informed consent forms signed by the patients or their family members.

Inclusion and exclusion criteria

Inclusion criteria included patients who had consecutive admissions and admission times > 24 h.

The exclusion criteria were as follows: delirium occurring at ICU admission; persistent coma during ICU hospitalization; and the inability to complete the confusion assessment model for ICU (CAM-ICU) scoring.

Procedures

The enrolled patients were randomly divided into the experimental group and the control group according to a computer-generated random sequence table (the random sequences were placed in an opaque sealed envelope).

Control group: Visits were allowed each day for a specified time, 16:00 to 16:30, and the visitors were required to change their clothing and wear masks and hair and shoe covers. The number of visitors was limited to three, and there were strict requirements for hand hygiene. At the end of the visit, the doctor or nurse in charge explained the illness and treatment measures to the family members.

Experimental group: In addition to the daily visit time, an appointment system was adopted. When patients or their family members had special requirements, they were allowed to visit after the patient's evaluation by doctors and nurses in charge of the patient's care.

Appointment system: A message board was placed next to the patient's bed. Family members wrote down their requested specific appointment time, the number of appointments and the reason for visiting. The doctor in charge checked the board after the set visiting time each day. The time of each visit was determined on a case-by-case basis; however, each visit did not exceed a maximum of 30 min. To ensure a safe visit, before each visit, the nurse informed the family about any important issues related to the visit.

Special situations were accommodated, such as (1) when the patient's condition changed suddenly; (2) when the patient required family members to accompany him or her; (3) when a rescue failed due to a critical condition; and (4) when family members failed to arrive during the scheduled visiting hours. Special situations were applied to both groups.

Outcomes

The primary outcome was whether delirium occurred, and the secondary outcomes were (1) whether a nosocomial infection occurred; (2) whether complaints occurred; (3) the satisfaction questionnaire; (4) ICU length of stay (LOS); and (5) length of hospital stay.

Delirium was assessed using the CAM-ICU and a hospital-developed satisfaction questionnaire. The CAM-ICU scale was assessed at 9 a.m. and 5 p.m. daily at the bedside by trained qualified nurses, and the results were recorded. The satisfaction questionnaire was conducted by the receiving nurse during an interview after the patient was admitted and was completed by the family members, reviewed by the receiving nurse and then collected and recorded. When the patient was transferred out of the ICU, the physician in charge recorded the required information in an Excel spreadsheet.

A nosocomial infection is one that occurs 48 or 72 h after admission. We included the following types of nosocomial infection: pneumonia, a bloodstream infection, and a urinary tract infection.

Complaints: We have a department for medical safety. If family members had any questions about medical activities, they could complain through the Department of Medical Safety by phone or face to face. Finally, the staff of the Medical Safety Department communicated with us.

The satisfaction questionnaire: The questionnaire was based on the ICU satisfaction questionnaire developed by the hospital. See the Supplemental materials for details.

Sample size

According to the previous treatment of patients with sepsis in our hospital, we estimated that the incidence of delirium in the control group is 20%. The power for the primary endpoint was calculated based on a two-sided t test with a significance level of 5% and was calculated using PASS software 2020 (NCSS LLC., Kaysville, UT, USA) 11 software, with a sample size of 124 participants in the experimental group and 119 participants in the control group. The trial will have more than 80% power to detect a difference between the experimental group and control group. If the rate of loss to follow-up was 10%, the sample size of the experimental group was 124÷0.9 = 137.78 participants, and the control group was 119÷0.9 = 132 participants.

Statistics

SPSS Inc. (Chicago, IL, USA) was used for statistical analysis. If the measurement data followed a normal distribution, they were expressed as the mean ± standard deviation (x ± s). The comparison between the two groups adopted the T test, and the Q–Q normal probability graph was used for normality testing. If the measurement data did not follow a normal distribution, they were represented by the median M and the quartiles (Qu, QL). The comparisons between the non-normally distributed groups were performed by the Mann‒Whitney U test or Spearman's nonparametric test. Statistical data are represented by N (%), dichotomies between the two groups were compared by Pearson's test, and ordered multiple classifications were compared by the Mann‒Whitney U test. All tests were bilateral, and p < 0.05 was defined as statistically significant.

Results

A total of 410 patients were admitted from April to June 2022. According to the inclusion and exclusion criteria, 350 patients were included (excluding 60 patients, including 29 who were younger than 18 years old, 10 who had delirium at ICU admission, and 21 who had strictly restricted visits due to their condition). However, after randomization, there were 70 patients in whom clinical staff could not assess for delirium due to depressed neurological function. Ultimately, 280 patients were included in our study. A total of 140 patients were included in the experimental group, and 140 were included in the control group (see Figure 1 for details).

Figure 1.

Flow chart. ICU: intensive care unit.

The control group had only one 30 min visit a day. The experimental group could make multiple visits a day, but the maximum time was 30 min each time. In our study, the longest visit time in the experimental group was 6 h a day, which means 12 visits were made. The average number of visitation minutes per day between the experimental group and the control group was 24.7 versus 23.9 min (p > 0.05).

The general information of the patients at admission is shown in Table 1. Delirium occurred in 8 (5.7%) patients in the intervention group and in 24 (17.1%) in the control group (p = 0.003). A total of five complaints (mainly pressure ulcers) were received, with one in the experimental group and the others in the control group. There were 28 cases of nosocomial infection in the experimental group and 29 cases in the control group; thus, the incidence of nosocomial infection was 20% versus 20.7% (χ² = 0.022, p = 0.882). A total of 280 questionnaires were collected, with a retrieval rate of 100%. The satisfaction levels of the experimental group and the control group were 98.6% and 92.1%, respectively (χ² = 6.534, p = 0.011). The flexible visiting system reduced the ICU LOS. The ICU LOS of the experimental group was 6 versus 8 days for the control group (χ² = 5.337, p = 0.041). However, it did not reduce the hospital stay (17 vs. 19 days, χ² = 1.721, p = 0.923; see Table 2 for details).

Table 1.

Baseline information.

	Experimental (n = 140)	Control (n = 140)	t/χ2	p value
Age (year)	53.29 ± 16.35	57.34 ± 12.96	−1.5	0.135
Sex (male)	93 (66.4%)	86 (61.4%)	0.759	0.384
APACHE II score	15.08 ± 4.83	14.02 ± 3.07	1.364	0.174
MV	110 (74%)	113 (73.2%)	0.198	0.656
Benzodiazepine use	22 (15.7%)	24 (17.1%)	0.552	0.493
Vasopressor use	7 (5%)	8 (5.7%)	0.074	0.879
History of dementia	2 (1.4%)	1 (0.7%)	0.187	0.744
Baseline risk of delirium (Lanzhou Model)	0.21	0.23	0.339	0.502
Alcohol use	78 (55.7%)	83 (59.3%)	0.992	.203

Lanzhou Model: Risk of delirium = 1/(1 + exp-(−1.78 + 0.001 ×Age + 0.015×APACHE-II score + 0.801×Mechanical ventilation + 0.358×Emergency operation + 0.004×Coma + 0.148×Multiple trauma + 0.353_Metabolic acidosis + 0.117×History of hypertension + 1.377×History of delirium + 0.318×History of dementia−0.57×Dexmedetomidine hydrochloride

APACHE-II: Acute Physiology and Chronic Health Evaluation; MV: mechanical ventilation.

Table 2.

Outcomes.

	Experimental (n = 140)	Control (n = 140)	χ2	p value
Complaints	0.7% (1)	2.9% (4)	1.833	0.176
Nosocomial infection	20% (28)	20.7% (29)	0.022	0.882
Delirium	5.7% (8)	17.1% (24)	9.032	0.003
Satisfaction	98.6% (138)	92.1% (129)	6.534	0.011
ICU LOS	6 (3–10)	9 (5–13)	5.337	0.041
Hospital stay	17 (7–24)	19 (9–27)	1.721	0.923

ICU LOS: intensive care unit length of stay.

Discussion

In critically ill patients, flexible visitation reduces the incidence of delirium, the severity of anxiety symptoms, and the length of ICU stay does not increase the risk of hospital-acquired infections. Simultaneously, both patients and their families were more satisfied with the flexible visitation system. We will discuss them separately as follows.

Flexible visitation reduced the incidence of ICU delirium

In this study, the incidence of delirium was 5.7% versus 17.1% in the experimental group and the control group, respectively (χ² = 9.032, p = 0.003). Compared with the routine visitation system, the incidence of delirium was significantly reduced in the experimental group, and the difference was statistically significant. Delirium, once called ICU syndrome, occurs when a patient in the ICU or a patient transferred out of the ICU appears to have reduced consciousness and confusion within a specified period of time. There is no specific treatment other than the recommended strategy of ABCDE prevention of cluster management (A: assess, prevent, and manage pain; B: both spontaneous awakening trials; C: choice of analgesia and sedation; D: delirium—assess, prevent, and manage; E: early mobility). Our previous success was based on the risk factors for ICU mechanical ventilation among patients with a delirium model ⁵ and applied it to actual clinical work. Our guidelines involved the CAM-ICU and the latest early Comfort using Analgesia, minimal Sedatives and maximal Humane care (eCASH) analgesia guidelines ¹⁰ that also stressed family-centred delirium prevention strategies. A flexible visitation system can reduce the anxiety of ICU patients admitted while they are awake and can ensure their better cooperation with treatment. However, Rosa's study ¹¹ showed that flexible visitation did not significantly reduce the incidence of delirium (18.9% vs. 20.1%, −1.7% [95% CI −6.1% to 2.7%]; p = 0.44). After careful discussion with the other authors, we concluded that these results might be because the types of patients who were included varied.

The implementation of the flexible visiting system has led to the construction of high-quality nursing services

China's 2014 requirements for high-quality nursing service evaluation rules include that hospitals should attach great importance to and support nursing work and that they perform high-quality nursing services in the ICU. ¹² Regular visiting rules allow families affected by anxiety and patients in passive states to have only a half an hour a day for visits. This can easily result in suspicion and doubt by the families,^2,13,14 but a flexible visitation system, if the clinical situation allows, can fully inform families and satisfy both the patient and their family. This system also embodies the quality of the nursing concept of “taking patients as a member of our family.” In our study, the incidence of delirium in the experimental group was significantly reduced, while satisfaction was significantly increased. The satisfaction of the experimental group was 98.6% versus 92.1% for the control group (χ² = 6.534, p = 0.011).

The flexible visiting system did not increase the incidence of nosocomial infections

At present, concern about a flexible visiting system mainly involves controlling nosocomial infections. ICU patients are in critical condition, have low immunity, undergo more invasive operations, and are prone to nosocomial infections. Frequent visits may increase the risk of nosocomial infections.^15,16 However, in practice, family members are informed in detail about the infection control measures needing attention, and their compliance is very high, which does not increase the incidence of nosocomial infections.^17,18This study's results suggest that flexible visitation does not increase the nosocomial infection rate. There were 28 cases of nosocomial infection in the experimental group and 29 cases in the control group; thus, the incidence of nosocomial infection was 20% versus 20.7%, respectively (χ² = 0.022, p = 0.882).

Conclusion

A flexible visitation system could reduce the incidence of delirium in critically ill patients and improve the quality of nursing services, and the system would not increase the incidence of nosocomial infections. However, these results need to be further verified by multicentre large clinical trials.

In conclusion, the flexible visitation system benefits more critically ill patients and improves the trust between doctors and patients. However, this visitation system needs more clinical practice to further improve. Examples include the frequency of visitation, the handling of various emergencies, and whether video visitation can be added.

Limitations

Our study has several limitations. First, our study had a small sample and was a single-centre study. Second, there was a lack of control of important covariates that may constitute risk factors for the outcomes and a lack of adjudication of infectious disease outcomes. Finally, due to the organizational characteristics of the intervention and the open-label nature of the trial, the present study is susceptible to contamination and measurement bias. Although our study is a single-centre study, it provides a theoretical basis for the development of a flexible visiting system and lays a theoretical foundation for a future large, multicentre clinical trial.

Author biographies

Hu-yong Yang, MS is an associate chief physician and mainly engaged in sepsis and ICU nursing improvement related research.

Fang Feng, MD is an associate chief physician and mainly engaged in AKI, sepsis and ICU nursing improvement related research.

Wei-wei Yang, MS is an associate chief physician and mainly engaged in sepsis and ICU nursing improvement related research.

Yu Chen, MD is an attending doctor and mainly engaged in AKI, sepsis and ICU nursing improvement related research.