Factors related to participation decision-making in emergency surgery patients

doi:10.21203/rs.3.rs-3401444/v1

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Research Article

Factors related to participation decision-making in emergency surgery patients

https://doi.org/10.21203/rs.3.rs-3401444/v1

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Background

Patient’s shared decision-making (SDM) is an ethical standard for respecting patient autonomy.

Objectives

This study aimed to investigate the level of shared decision-making (SDM) for emergency surgery and its related factors in hospitals affiliated with the Zanjan University of Medical Sciences (Iran).

Methods

The study has a cross-sectional design. The study was performed on 306 patients candidates for emergency surgery in 2020. The research instruments included a 9-item Shared Decision-Making Questionnaire (SDM-Q-9) and an SDM-related factors questionnaire for surgery.

Results

The results showed that more than 50% of patients did not participate in the choice of emergency surgery. Among the related factors, the SDM level of the family members, the patient's marital status, and systolic blood pressure were the main predictors of the patient’s SDM for surgery (P-value < 0.05).

Conclusions

The emergency conditions of patients and the high workload of staff reduced participation in the decision-making of patients and their family members.

Patient Participation

Decision-Making

Shared

surgery

Emergencies

Informed Consent

Patient’s shared decision-making (SDM) is an ethical standard for respecting patient autonomy (1). SDM means involving the patients in the goals of care and treatment and considering their desires (2). Freely choosing and deciding on receiving health services is a part of the patient’s rights (3). One of the most critical situations for SDM is deciding about treatment and obtaining patients’ informed consent for surgery (4). Before surgery, the patient should be informed of the details, importance, risks, and consequences of the surgery and necessary advice should be given to the patient in choosing the type of treatment. Ultimately, the patient decides whether to accept or refuse a therapeutic intervention (5, 6). The patient SDM increases patients’ cooperation in the treatment process.(7). The high workload of emergency departments restricts patient autonomy, patient-centered care, and shared decision-making (SDM) of patients (8, 9). Since the condition of patients in the Emergency Department is urgent, SDM rates of the patients are likely to decrease, especially for emergency treatments and emergency surgery. Therefore, the SDM of patients and related factors has also altered in this critical situation.

Previous studies have not reported patient SDM to be favorable (9–13). Also, level of health literacy, knowledge, and education, type of decision-making required, type of disease, gender, age, race, and level of economic and social status, and the use of medical alternatives are among the essential factors in SDM of patients (5, 11, 14–16).

The conditions of the Iranian hospitals follow clinical governance. In this system, patient centralism is essential to provide quality services that meet the desired standards. In this respect, the patient rights is one of the most important axes of clinical governance (13). Factors related to SDM levels in different cultures and communities can vary (17).

this study aimed to investigate the status of shared decision-making to get informed consent in patients undergoing emergency surgery and its related factors.

3.1. Design

This descriptive cross-sectional study was performed on patients undergoing emergency surgery in hospitals affiliated to the Zanjan University of Medical Sciences (Iran) from March 24 to September 20, 2020.

3.2. Study setting

The research environment in the present study was the hospitals affiliated to the Zanjan University of Medical Sciences in the three cities of Zanjan, Abhar, and Khorramdareh (Ayatollah Mousavi, Al-Ghadir, Emdadi, and Bouali Sina hospitals). In Iran, a patient’s consent is required to perform the surgery. However, getting approval for surgery, besides the patient’s consent, is subject to the signature of a first-degree family member of the patient. Therefore, one of the most important factors influencing a patient’s SDM is the participation of the patient’s family members. Meanwhile, physicians should always provide information about the type of treatment in the presence of family members. Consent is not legal without the signature and consent of a first-degree member of the patient.

3.3 Participant and sampling

The study population consisted of patients who were candidates for emergency surgery referring to the emergency departments of hospitals of the Zanjan University of Medical Sciences. Sampling was done by convenience sampling. Inclusion criteria for patients were having emergency surgery, being alertness, being capacity for informed consent, being age over 18 years, and willingness to participate in the study. Inclusion criteria for the patients’ family members included having age over 18 years, signed the informed consent form for the patient’s surgery, and willingness to participate in the study. We excluded those patients who lost consciousness or the participants who were unwilling to continue participating in the study.

To estimate the sample size, we conducted a pilot study on 30 people. Considering the 95% confidence interval, 80% power of a test, and 0.16 relationship between fear and the level of patients’ participation, we estimated the sample size to be 304. The data from the pilot study included in the main results.

3.4. Measures

Data was collected through three questionnaires. The first questionnaire was about patient profile (i.e., age, sex, education, occupation, marital status, and address). The 9-item Shared Decision-Making Questionnaire (SDM-Q-9) was used to assess participation in obtaining informed consent for surgery. This questionnaire, introduced and validated by Kriston et al., consists of nine items that are scored on a Likert scale, from strongly disagree (0) to strongly agree (5) (18). In this tool, questions 1 to 4 (score range 0–20, score > 10 is non-participation) are related to providing information and ensuring the patient understands the information. Questions 5 and 6 (range 0–10, score less than 5 = non-participation/ score 5 and more than = participation) are related to the level of counseling in treatment decision-making. Finally, Questions 7, 8, and 9 (score range 0–15, score less than 7.5 = non-participation/ score 7.5 and more than = participation) are related to decision-making for treatment. The total score of the questionnaire ranges from 0 to 45. Scores between 0 and 22.5 were non-participation, and scores between 22.6 and 45 were considered participation. The validity and reliability of SDM-Q-9 have been confirmed in a study in Iran on 1,783 oncology patients (19). In the present study, the reliability of the SDM-Q-9 using Cronbach’s alpha method was 0.83.

The factors affecting participation in obtaining informed consent for surgery were prepared based on previous studies (5, 9, 11, 14, 16, 20, 21). These factors included the patient’s triage level, hemodynamic symptoms (heart rate, respiration, and blood pressure), hospitalization experience, length of stay in the emergency room, rush to get informed consent, type of information provided (in writing/orally), pain when getting consent, and the level of fear when getting informed consent. Also, the level of SDM of the patient’s family member (using the SDM-Q-9 questionnaire) and the level of fear of the patient’s family member when getting informed consent were influential factors.

Pain and fear were measured using the Visual Analogue Scale (VAS) (score range 0 to 10). Face validity and content validity were used to evaluate the validity of the questionnaire of factors affecting the patient SDM. The questionnaires were provided to ten experts in medical ethics, and the questionnaire’s face validity and qualitative content validity were confirmed. Inter-rater reliability was used for evaluating the reliability of the questionnaire of factors affecting the patient SDM. Subsequently, two researchers simultaneously and separately evaluated these factors in 20 patients. The kappa agreement coefficient between the two researchers was 97%.

By visiting the emergency department, the researcher identified the eligible participants. If the eligibility criteria were met, the first and third parts of the questionnaire were collected in the emergency department. For patient comfort and reducing the effect of patient clinical condition (as a confounding variable) on completing a questionnaire and increasing data accuracy, SDM-Q-9 was completed by the patient and the patient’s family member after surgery and stabilization of the patient in the surgical ward. To reduce recall bias, we provide the questionnaire to patients and family members as soon as the patient’s condition stabilized.

3.5. Data analysis

SPSS software version 22 was used for data analysis. To check the normality of the data, skewness and kurtosis of the data were examined. The skewness and kurtosis of the data were between − 2 to 2, and the data had a normal distribution. The Exclude Cases Listwise command was used to manage the missing data and remove the outliers. Next, frequency, percentage, mean, and standard deviation were used to evaluate baseline data and patient SDM status. In addition, multiple linear regression was used to predict the patient's SDM variable. Finally, multicollinearity was checked using variance inflation factor (VIF) and tolerable range for all variables included in the model. None of the independent variables was linearly related to each other. The significance level was considered less than.05.

3.6. Ethical considerations

The researcher obtained written consent from the participants (patient and patient’s family members). Participants were assured that all their information would be kept confidential and that they could leave the study at any time if they do not want to.

In this study, out of 316 participants, 7 patients were excluded due to a decreased level of consciousness. The data of three patients was not included in SPSS software due to outliers’ data. Finally, the data of 306 participants were analyzed.

This study showed that most of the participants were men, married people, people living in the city, and people with a diploma. Most patients were at triage level 3 (serious conditions that require emergency intervention) and candidates for general surgery (Table 1).

Table 1

Patient profile
Variable		N (%)
Gender	Male	175 (57.2)
Gender	Female	131 (42.8)
Education	Illiterate	28 (9.5)
	High school	58 (19)
	Diploma	105 (35)
	College education	110 (38.5)
Marital status	Single	105 (34.3)
Marital status	Married	198 (65.7)
Residence	Village	86 (28.1)
Residence	City	220 (71.9)
Job	Employed	140 (45.7)
	Retired	22 (7.2)
	Unemployed	36 (11.8)
	Housewife	68 (22.2)
	Student	38 (12.4)
Triage level	Level 1	2 (.7)
	Level 2	139 (45.4)
	Level 3	165 (53.9)
Type of surgery	Neurosurgery	76 (24.8)
	General surgery	121 (39.5)
	Urological surgery	12 (3.9)
	Orthopedic surgery	74 (24.2)
	Obstetric surgery	21 (6.9)
Inpatient experience	Yes	224 (73.2)
Inpatient experience	No	82 (26.8)

Patients had a mean age of 38.5 ± 16.1. Until the referral to the emergency department, the duration of symptoms was 89.5 minutes. The waiting time in the emergency department was 54.1 ± 41.3 minutes. The patient’s pain and fear using VAS were 6.65 ± 1.93 and 6.04 ± 2.19, respectively. The mean systolic blood pressure of patients was 113.78 ± 21.8 mm Hg, mean diastolic blood pressure of patients was 68.1 ± 11.09 mm Hg, mean pulse rate was 83.77 ± 11.07 times per minute, and mean respiratory rate was 18.98 ± 2.44 times per minute.

In this study, 185 (60.8%) patients and 184 (60.5%) patient’s family members believed that their consent was obtained in a hurry. Also, 155 (51%) patients stated that the information provided in surgery was in writing and 149 (49%) patients mentioned that the information was provided both orally and in written forms. 169 (55.6%) and 135 (44.4%) patients’ family members stated that the information in surgery was provided in written and both oral and written forms, respectively. The mean total score of SDM of patients and patient’s family members was between non-participation (Table 2). 172 (56.5%) patients and 175 (57.2%) patients’ family members reported they did not participate in the decision-making for emergency surgery. Also, 134 (43.8%) patients and 130 (42.5%) patients’ family members reported participating in treatment choice. Over 50% of patients and their family members believed SDM was in the non-participation range at all three levels (information provision, counseling, and decision making) (Table 3).

Table 2

The levels of participation in treatment decisions from the perspective of the patient and family member.
	Appropriate N (%)	Inappropriate N (%)
Information P	155 (50.7)	151 (49.3)
Information F	142 (46.4)	163 (53.3)
Consult P	137 (44.8)	169 (55.4)
Consult F	147 (48)	159 (52)
Decision making P	126 (41.2)	180 (58.8)
Decision making P	126 (41.2)	180 (58.8)

Table 3

Mean and standard deviation of the questions of the participation questionnaire for treatment decision
Question	Patient Mean ± SD	Family Mean ± SD
My doctor made clear that a decision needs to be made.	2.46 ± 1.45	2.28 ± 1.4
My doctor wanted to know exactly how I want to be involved in making the decision.	2.31 ± 1.34	2.36 ± 1.25
My doctor told me that there are different options for treating my medical condition.	2.29 ± 1.25	2.31 ± 1.23
My doctor precisely explained the advantages and disadvantages of the treatment options	2.53 ± 1.27	2.4 ± 1.2
My doctor helped me understand all the information	2.15 ± 1.28	2.16 ± 1.23
My doctor asked me which treatment option I prefer	2.15 ± 1.29	2.21 ± 1.17
My doctor and I thoroughly weighed the different treatment options.	2.18 ± 1.26	2.23 ± 1.16
My doctor and I selected a treatment option together.	2.25 ± 1.32	2.29 ± 1.23
My doctor and I reached an agreement on how to proceed.	2.29 ± 1.28	2.32 ± 1.26
Total	20.59 ± 9.4	20.69 ± 9.02
SD = Standard Deviation

A stepwise multiple regression model was used to examine the predictive variables of SDM. Fear of hospitalization was included as a dependent variable, and other factors were included as independent variables. After running the model in three steps, three variables (SDM level of a family member, patient marital status, and patient systolic blood pressure) remained. In the third step, this model’s coefficient of determination (R²) was 0.68, and the adjusted coefficient of determination (Adjusted R Square) was 0.68. Therefore, the variables used in the model could provide a good fit for the model. The results of this model showed that all three variables remaining in the model could predict changes in the SDM level of the patient (P-Value < .05) (Table 4).

Table 4. Multiple regression model to examine the predictors of participation in decision-making for treatment

Model	Unstandardized Coefficients		Standardized Coefficients	t	P-value	95.0% Confidence Interval for B		Collinearity Statistics
	Unstandardized Coefficients					Lower Bound	Upper Bound	Tolerance	VIF
	B	Beta				Lower Bound	Upper Bound	Tolerance	VIF
Constant	.24	1.81		.133	.894	-3.321	3.80
SDM family member	.86	.034	.82	25.64	.001	.79	.93	.99	1.00
Marital status	-1.52	.60	-.08	-2.52	.012	-2.706	-.33	.98	1.02
Systolic blood pressure	.031	.01	.07	2.20	.028	.003	.06	.98	1.02

P-value<.05

This study aimed to evaluate the patient’s SDM and related factors. The results showed that the patient’s SDM level in all three dimensions (information provision, counseling, and decision making) was between non-participation. Among the related factors, the SDM level of a family member, marital status, and systolic blood pressure could predict the SDM for obtaining informed consent.

This study showed that from the perspective of patients and their family members, the SDM level for obtaining informed consent for emergency surgery is low. The results of other studies have shown that most people do not participate in the decision-making of their treatment and the physician makes decisions about their treatment, which was in line with the results of our study (6, 9–11).

In the present study, emergency conditions affected the opportunity for proper notification and the time required for patient consultation and decision-making (22). COVID-19 pandemic conditions and patient overcrowding in hospitals also affected patient participation in decision-making (23). In this study, the treatment of choice (emergency surgery) was introduced to the patient, and for informed consent, information about the surgical procedure (introduction of surgery, benefits, risks, and complications) was provided to the patients and their families in writing. Therefore, in such a condition, the patients and their families had no choice but to accept the proposed treatment and were forced to sign a consent form after studying the information or hearing the staff’s explanations (doctor or nurse). In the present study, most of the related factors had no statistically significant relationship with the patient’s SDM, while in previous studies, most of the patients’ demographic characteristics (i.e., age, sex, level of education, surgical history) and type of surgery and surgical complications were related with patients’ SDMs (11, 20). One reason for this difference was the low SDM level of the patient for obtaining informed consent for surgery. In the present study, the only factors associated with SDM were the level of participation of the patient’s family members, marital status, and the patient’s systolic blood pressure (11, 20). Due to the urgency of the patient's condition, the patient's decision to choose surgical treatment depends on the opinion and decision of her/his family member. Given that, in most cases, the patients’ family member who consented to the surgery was their spouse, so both their family’s SDM level and their relationship with the patient (marital status) are predictors of the patient’s SDM for surgery.

In the present study, the only relevant physiological variable was the patient’s systolic blood pressure. Therefore, the decision-making to treat and obtain the patient’s informed consent should not be done in conditions of pain and acute physiological changes, but sometimes the patient’s autonomy is ignored to save the patient’s life (9, 22, 24).

5.1. Conclusion

The results of this study showed that the urgency of the patient’s condition and the overcrowding of the emergency department affect the SDM level for surgery and subsequent patient’s informed consent. It is known that the participation of the patient and their family members increases treatment adherence and improves patient treatment outcomes and satisfaction. Therefore, the authors suggest that nurses and physicians try to provide appropriate physical and mental conditions for greater participation of patients and their family members in decision-making about treatment, so that patient’s informed consent is legally valid. They do not have to sign an informed consent form under psychological or physical pressure. Health care staff should know that emergency conditions should not undermine patients’ rights. Nurses, in particular, have a duty to increase patients’ SDM by informing patients of their legal rights because enhancing the awareness of patients and their families about their rights causes the demand of SDM for surgery and increases the quality of services.

One of the limitations of this study was the emergency conditions of patients. Completing the SDM questionnaire of patients and their family members in the emergency department could reduce the validity of the data, so the questionnaires were completed in the surgical department and after the stability of patients’ clinical status. The results of this study are not generalizable to other decision-making situations of patients, other communities.

Acknowledgements

This article is extracted from the master’s thesis of the first author in Zanjan University of Medical Sciences. The authors wish to thank the patients participating in the study, and their families for their kind cooperation during the study.

Authors’ contributions

Study design: Nasrin Hanifi, Nasrin Bahraminejad

Data collection: Roya Mohammadi

Data analysis: Nasrin Hanifi, Roya Mohammadi

Manuscript writing: Nasrin Hanifi, Nasrin Bahraminejad, Roya Mohammadi

Conflict of Interests: There is no conflict of interest.

Ethical Approval: This study was registered with the ethical code IR.ZUMS.REC.023 in Zanjan University of Medical Sciences.

Funding/Support: There was no funding.

Informed Consent: All participants gave written informed consent to participate in the study.

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Factors related to participation decision-making in emergency surgery patients

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Version 1

Abstract

1. Background

2. Objectives

3. Method

3.1. Design

3.2. Study setting

3.3 Participant and sampling

3.4. Measures

3.5. Data analysis

3.6. Ethical considerations

4. Results

5. Discussion

5.1. Conclusion

Declarations

References

Status:

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