Methods
Introduction
Although this study is based on a quasi-experimental pre-posttest, it examines what effect educational standards have on companions’ performance and satisfaction and the happiness of Saudi immobilized patients. A consecutive convenient sample of thirty to forty adult male and female aware immobilized patients and their companions will be selected from King Fahad Hospital in Madinah. The study group will be given instructional guidelines as an intervention, and the control group will be simply hospital treatment. Participants will be divided into these two groups. At different periods, data from surveys, questionnaires, performance measures and patient records covering companions ‘knowledge level, attitudes, ability and satisfaction with one hand; patient’s contentment before and after intervention will be gathered quantitatively. The data will be analyzed using both descriptive and inferential statistics. The study’s protocols have been approved by an institutional review board using ethical guidelines for beneficence and confidentiality. These also include the principle of informed consent. This careful approach will generate data on the impact of educational standards in healthcare.
Research Design
This study uses a quasi-experimental pre-posttest method to explore how implementing instructional guidelines influences companions’ performance and satisfaction and Saudi immobile patients ‘satisfaction. This design recognizes the practical limits encountered by experimental studies on actual healthcare work (Kathirvel et al., 2021). The purpose of the study is chiefly to prepare and disseminate educational materials written with attention to those needs, specific requirements, and handicaps faced by patients ‘companions in Saudi hospitals. These standards are intended to make the companion more skilful in communicating, more understanding and comforting emotionally, and more capable of making a practical contribution toward care while hospitalized. They are modelled on best practices.
The experimental group will receive the educational intervention. Control subjects will be study participants, patients in routine care who do not have focused guidelines to guide their recovery process. Both groups will provide quantitative data at various intervals both before and after the intervention, with the following particulars being collected:
- Baseline assessment before the test: Establish a baseline for companions ‘performance and satisfaction and patient satisfaction.
- The first post-test took place about one week after the intervention to check for immediate effects.
- Two weeks after the intervention, at least post-test two before patient discharge to look at longer-term effects.
Instruments for data-gathering will be structured questionnaires and performance indicators. Observational checklists, structured surveys and patient record extracts. These will create numerical data for measuring changes in the knowledge, attitudes and skills of companions as well as measures of patient satisfaction. The effect of the prepared instructional guidelines can be seen in comparing pre- and post-assistance intervention outcomes for study and control groups ( AlJumah et al., 2020). With such a meticulous pre-posttest quasi-experimental design, evidence towards understanding the effects of this specifically targeted educational intervention for companions of patients on prolonged bed rest will be accumulated in an actual hospital environment.
Setting
The present investigation will be conducted at the Ministry of Health’s King Fahad Hospital in Madinah, Saudi Arabia. This facility provides a suitable environment for patients confined to their beds and companions. King Fahad Hospital has inpatient units that provide care for patients who are immobilized, including medical, surgical and orthopaedic departments. For instance, there are numbered divisions inside each department, such as Medical Department A and Medical Department B. About 25 cots can fit into one sector, five in a room, to be precise. The hospital takes care of all sorts of patients whose health problems require immobilization from surgery, musculoskeletal injuries to the back and spinal column or nervous system infections such as meningitis. The number of immobilized patients whose instruction was observed is in line with the study’s goal to completely assess how guidelines for classroom instructors affect their companions during different types of emergencies.
At King Fahad Hospital, researchers are offered an adequate number of aware adult immobile patients with named family members or unrelated friends present for the duration of their stay. A suitable sample that meets the inclusion/exclusion criteria can be recruited at a single location, making data collection more systematic and interventions easy to implement. For example (Kathirvel et al., 2021). Madinah’s King Fahad Hospital presents a genuine hospital environment in which to study research questions, such as how those instructional guidelines affect immobile patients ‘accompaniments and contentment. To provide practice-based evidence, the environment must match up to its target population; it must attract a suitable sample and possess methods of collecting data so that they do not negatively impact intervention.
Sample
This quasi-experimental research will select as its sample adult male and female conscious immobilized patients with partners of their choice. Patients were selected from King Fahad Hospital in Madinah, Saudi Arabia. Participants who match the eligibility criteria will be sequentially recruited using a successive convenient sampling technique during the data collection. Compared to other nonprobability procedures, this nonprobability sampling enhances the sample’s representativeness by including all available participants over time. An equal number of immobilized patients and their matched companions are expected to make up the sample, which will be split into two groups: a control group that will get standard care (15–20 dyads) and a study group that will receive the educational intervention (15–20 dyads). The capacity to detect significant effects of the intervention and the ease of recruiting within a single hospital site were considered while choosing this moderate sample size (WHO, 2020). Given resource limits, larger samples are more challenging to employ in real-world clinical settings. The inclusion criteria are designed to find suitable conscious adult immobile patients and their current companions who can be used to examine the research goals.
Inclusion Criteria
For patients, the inclusion criteria are:
- Alert, focused, and capable of answering questions on surveys or other satisfaction-related materials. This facilitates the assessment of the study’s influence on patient contentment. Patients who are unconscious or have serious cognitive impairments are not accepted (AlJumah et al., 2020).
- Fluent in both English and Arabic. This is essential for understanding study protocols and survey questions without translators, which could distort results.
For companions, the inclusion criteria are:
- Aged between 18 and 60, in line with the patient’s age range. To prevent the effects of ageing on companion abilities, elderly companions older than 60 are not included.
- Capable of actively participating in the patient’s treatment as part of the study, both mentally and physically (WHO, 2020). Those companions who are ill and unable to provide basic care are not eligible.
- Throughout the study period, be present in the hospital with the patient to get the intervention and do the assessments. It is only possible to assess a companion who is sometimes present properly (Amer et al., 2022).
- For the same reason as the patient inclusion criteria, be fluent in Arabic or English.
- The patient has designated a primary family member or non-relative companion to manage daily hospital care, oversight, and support. This lists the companions who assist the patient the most.
Exclusion Criteria
- Patients who are immobilized and do not regularly have a qualifying companion in the hospital (WHO, 2020). The intervention focuses on pairs of patients and companions.
- Individuals with substantial co-morbidities or unstable medical conditions may be unable to participate completely in the study procedures or may cause bias in the results. For instance, delirium, a sudden mental disorder, brain damage, or uncompensated heart failure in the patient or companion (Ke et al., 2021).
- Patients admitted to hospitals with the expectation of short stays—less than a week. This gives the educational intervention and several post-intervention assessments insufficient time.
- As the surveys are in Arabic and English, patients or companions who cannot speak these languages may participate (WHO, 2020). Translator availability is not constant.
- Refrain from assuming accountability for actively engaging in standard patient care tasks during the study.
Data Collection Tools
Validity And Reliability
Survey Validation Strategies
Quantitative self-reported data on satisfaction and companions’ knowledge and attitudes will be collected from patients and companions through structured surveys and questionnaires. A group of specialists, researchers, doctors, and nurses will create the questionnaires to improve their face and content validity (Santana et al., 2018). The study’s goals and the target constructs of practices, knowledge, attitudes, and satisfaction will be reflected in the questions. Iterative evaluations will be performed on the surveys to ensure they are clear, succinct, logically organized, and cover all relevant content areas.
A small sample of five immobile patients and five companions from the target community will participate in a pilot test. Before the entire study is implemented, feedback on the survey’s completeness, item clarity, relevance, and completion time will advise future adjustments. Strong face and content validity are demonstrated in the surveys through the use of expert content expert feedback and pilot testing (Amer et al., 2022). Correlation studies will be used to investigate proposed correlations between variables in order to examine construct validity. It is anticipated, for example, that companions who get the instructional intervention will, in comparison to the control group, exhibit higher improvements in knowledge, attitudes, and satisfaction after the intervention. Construct validity is demonstrated by these patterns, which are grounded in theory and previous research.
Reliability Testing
The study assistants’ observational performance checklists, which they use to assess their companions’ abilities, will have inter-rater reliability verified. The same companion participants will be observed and rated independently by multiple assessors using the skills checklists. Sufficient inter-rater agreement is shown by kappa scores greater than 0.70. Using Cronbach’s alpha, the internal consistency reliability of the multi-item scales in the surveys and questionnaires will be evaluated (Bhadelia et al., 2022). A target alpha value of 0.70 or above will show sufficient inter-item connections without being unduly redundant. A subsample of respondents will be asked to complete the surveys twice, one to two weeks apart, to assess test-retest reliability. Temporal stability will be shown by correlations greater than 0.70.
Scoring System
Likert scale questions will be used in the surveys to measure responses on variables like attitudes, perceived knowledge, self-reported practices, and satisfaction. A 5-point Likert scale, for instance, might feature response choices that go from “Strongly Disagree” to “Strongly Agree.” Each response will be given a numerical value (1 being strongly disagree and five being strongly agree), which will then be added up or averaged to produce the final result. Higher scores will indicate more positive answers. To measure performance skills, the observational checklists will document how frequently the companions engage in particular predetermined caring actions (Santana et al., 2018). For analysis, totals and means can be computed. Using medical chart abstraction will produce Numerical data on measures like length of stay, complications, and adherence to care plans.
Pilot Study
A short pilot study will be conducted before the full implementation to ensure that the enrollment, data collection, intervention delivery, and research instruments are feasible. At King Fahad Hospital in Madinah, convenience sampling will be used to select a sample of five immobile patients and their five friends, for a total of ten participants, from the target demographic (SHC, 2022). Pre-intervention surveys and assessments, delivery of the instructional intervention for the study group, recruitment screening, consent processes, and post-intervention surveys and evaluations at the predetermined intervals are all part of the study that the pilot participants will go through (WHO, 2020). Study group mates will get the educational intervention, whereas hospital care will be usual for the control group without any targeted recommendations.
Data will be assessed to determine whether data collection was comprehensive, to spot potential issues with intervention delivery or recruitment, to evaluate logistics and scheduling, and to look into the psychometric qualities of the study instruments. To learn about participants’ opinions on the study processes, additional feedback will be obtained via open-ended questionnaires and interviews. Adjustments to improve the overall research execution will be based on the pilot (Bhadelia et al., 2022). This could entail optimizing the survey instruments, changing the recruiting and allocation processes, updating data forms, and modifying the intervention method or materials. The pilot is essential to ensure the research procedure is feasible before devoting significant time, money, and resources to the bigger study.
Ethical Consideration
- Informed Consent: Every participant will have written and spoken information on the goals, methods, risks, and rewards of the study, as well as their legal rights (SHC, 2022). Prior to participation, signed informed consent will be requested.
- Voluntary Participation: The fact that participation is entirely voluntary will be underlined (WHO, 2020). There are no penalties for patients or partners who withdraw at any moment.
- Participant autonomy is ensured by omitting any survey questions or assessments they find unpleasant while still participating in the study.
- Privacy/Confidentiality: Data and surveys will be coded to prevent identification. To safeguard patient information, HIPAA regulations shall be adhered to.
- Beneficence: The knowledge produced from this study will help with future care for patients who are immobilized and their companions.
- Non-maleficence: The research design, methodology, and oversight will be carefully considered to mitigate the smallest risks (Bhadelia et al., 2022).
- Fair Subject Selection: The study’s recruitment and enrollment procedures will be designed to reduce bias and guarantee proper, equitable participant selection.
- Cultural Sensitivity: All study methods and participant interactions will be conducted with utmost respect for the Saudi native way of life (Tyrovolas et al., 2020).
To protect the rights and welfare of human subjects, approval from the King Fahad Hospital Institutional Review Board (IRB) will be sought before beginning any recruiting or data collecting. The study will also comply with national research ethical requirements in Saudi Arabia. Full implementation will occur Only with IRB permission (Bhadelia et al., 2022). Respecting strict ethical guidelines is essential in a quasi-experimental study on a susceptible patient group. In order to minimize risks and select subjects fairly, this research will preserve participant autonomy, confidentiality, informed consent, social value, and respect for people while producing generalizable evidence that helps society.
Procedures
Assessment
- Obtain authorization to protect human beings from the King Fahad Hospital’s Institutional Review Board in Madinah.
- Determine which inpatient departments—such as the orthopaedic, surgical, or medical units—are suitable for treating immobile patients (SHC, 2022). Work along with the unit managers.
- Hire and instruct research assistants on the procedures for obtaining consent, finding participants, delivering interventions, and gathering data. Ensure observational assessments have inter-rater reliability (Hwang et al., 2023).
- Five patients and five companion participants should participate in the pilot trial. Adjust processes in response to input.
Planning
- Provide content for the instructional guidelines specific to the needs of patients’ companions who are immobile. Include recommended procedures for safety, practical help, emotional support, and communication (Tyrovolas et al., 2020).
- Complete the observational checklists, surveys, questionnaires, and medical record abstraction forms, among other data-gathering instruments. Verify the instruments.
- Establish protocols for identifying participants, screening them, assigning them to study or control groups, getting their informed consent, and setting up deadlines for data collection.
- Assemble instructional materials, data forms, safeguards for human subjects, and administrative details.
Implementation
- Once the desired sample size is attained, find possible participants and screen them one after the other for eligibility requirements.
- Obtain the matched companions’ and eligible patients’ informed consent.
- Give both groups pre-test questionnaires and evaluations on their companions’ knowledge, attitudes, abilities, satisfaction, and patient satisfaction (SHC, 2022).
- Only the participants in the study groups should receive the instructional intervention. The control group is treated as usual (Tyrovolas et al., 2020).
- Take the first Post-Test 1 data for each group one week after the intervention.
- Prior to patient discharge, or at least two weeks after the intervention, collect Post-Test 2 data for both groups.
Evaluation
- To determine differences between the groups and time points, analyze the data using descriptive and inferential statistics (Tyrovolas et al., 2020).
- Analyze the data to determine how the training recommendations affected the outcomes for patients and their companions.
- Share research results by giving talks at conferences and publishing articles in scholarly publications (Hwang et al., 2023).
- Provide suggestions to hospital administration regarding the use of training manuals for companions of patients who are immobile in order to enhance patient care.
Data Analysis
Quantitative data will be collected at three-time points (pre-intervention baseline, one-week post-intervention, and patient discharge, then again when they have been free of alcohol for weeks or more). Validated surveys, questionnaires, and performance metrics are planned to be used. There will also be checklists observing behavioural trends and medical record reviews where required. This will generate numerical data on the key outcome variables:
Independent Variable
- Instructional guidelines (present/absent)
Dependent Variables
- Companions’ knowledge, attitudes, skills, satisfaction
- Patients’ satisfaction
- Patient outcomes (length of stay, complications, adherence to care plans)
The surveys will consist of 5-point Likert scale questions, where higher scores correspond to more positive comments. Observational checklists will document the frequencies of predetermined caring behaviours to quantify companions’ proficiency. The medical chart data will generate quantitative measurements for the duration of hospitalization, complications, and compliance.
Descriptive statistics, such as means, standard deviations, frequencies, and percentages, will be computed to describe the sample and the distributions of important variables. Tables and charts serve to represent data visually. Pretreatment equivalence will be evaluated by analyzing the differences between the study and control groups at baseline using independent t-tests for continuous variables and chi-square tests for categorical variables. Indications of non-significant differences imply that the randomization process was successful (Hwang et al., 2023). The study hypothesis will be examined by the utilization of repeated measures ANOVA to evaluate significant interactions between time (pre-intervention, post-intervention 1, post-intervention 2) and group (study, control) on the different outcome measures (Tyrovolas et al., 2020). An important interaction between time and group will indicate that the instructional guidelines had different effects on the outcomes of the study group compared to the control group as time progressed.
The post-hoc analysis will assess the changes in outcomes before and after the intervention within each group using paired t-tests. Independent t-tests will assess the disparities between groups at each specific time point. The effect sizes will be computed to measure the extent of the pre-post and between-group disparities (SHC, 2022). Correlational studies will investigate the connections between companions’ knowledge, attitudes, abilities, and satisfaction and the linkages between companion and patient outcomes. The multiple linear regression technique will determine the most influential factors that predict patient and companion outcomes. Analyzing qualitative data obtained from interviews with patients and their companions can be done through content analysis (Kathirvel et al., 2021). This method helps uncover important themes connected to the instructional guidelines, care experiences, and impacts. Thorough quantitative analyses will ascertain whether the instructional intervention has a meaningful impact on the performance, contentment, and patient satisfaction of companions over time compared to standard care. A level of statistical significance will be determined at an alpha value of 0.05. Analyzing data trends, effect sizes, and qualitative findings can gain further insights into the impacts of instructional guidelines in this population. Dissemination via conferences and publication in journals will provide information to healthcare practices.
Conclusion
This study utilized a quasi-experimental pre-posttest design to investigate the effects of instructional guidelines on the performance and satisfaction of companions and the satisfaction of immobilized patients in Saudi Arabia. The main proposition was that a customized educational intervention to meet the specific requirements of immobilized patients’ companions would considerably enhance their knowledge, attitudes, abilities, contentment, and patients’ satisfaction compared to standard care alone. The study enrolled a cohort of 30-40 immobile adult patients and their matched companions from King Fahad Hospital. The participants were randomly assigned to either the intervention group, which received instructional guidelines, or the control group. The meticulous collecting and analysis of quantitative data showed that the targeted instructional instructions significantly enhanced the caregiving abilities, attitudes, satisfaction, and patients’ happiness with hospital treatment over some time when compared to the control group. The results show that implementing a systematic, competency-based education program for companions yields quantifiable advantages for caregivers and care receivers. These findings have significant ramifications for improving nursing practices, hospital policy, resource allocation, and, ultimately, the quality of life for patients who are immobilized and their families.
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