DNP 850 Module 3 Assignment Chapter 3 Methodology

DNP 850 Module 3 Assignment Chapter 3 Methodology

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Aspen University

DNP 850 Project Planning

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Date

Chapter 3: Methodology

The approach used in this quality improvement project is a controlled trial with two groups of participants was selected randomly. This will involve development of a diabetes management toolkit and two groups of participants; one that will receive the diabetes management toolkit whilst the other receives usual care without the toolkit. The identified components of the diabetes management toolkit may include dietary guidelines for patients with diabetes, recommendations for physical activity, medication regimens and adherence tools, as well as literacy education tools intended to improve self-management of diabetes (Kalra et al., 2020).

Patients will be conveniently enrolled from outpatient clinics in rural and urban settings and must have been diagnosed with type 2 diabetes with an A1c measurement at the baseline. Recruitment will include a process involving liaison with practitioners who will identify eligible patients for study enrollment. The A1c levels of each participant shall be taken at the initial and after completion of the intervention, which is 6 months using the toolkit.

The following produces techniques for examination and evaluation will be used by the project to assure the high effectiveness of the toolkit: First, the study will employ a monitoring system that focuses on receiving consistent data on participants’ interactions with the identified toolkit components (Kalra et al., 2020). This will include the extent to which the patients use an application on their smartphones and how often patient completes a log-in box about their diet and medicines which has to be filled throughout the day.

The participants will be administered structured questionnaires and interviews on a weekly basis, and this will help in the collection of qualitative data with respect to the experiences of the participants and any challenges incurred in the use of the toolkit (Harris & Brown, 2019). This feedback will be used to make incremental changes that will be made to the toolkit during the trial period in order to further improve the tool.

The assessment of the project will be done after analyzing the results derived from the various assessments done; both quantitative and qualitative. Using quantitative research approach, comparison of the difference in A1c in the two groups of patients: the intervention group and the control group will have comparative statistics analyzed to determine significant different and implications to clinical practice (Sharpless et al., 2021). In quantitative analysis, descriptive statistics of frequency distribution about participants’ perceptions will be analyzed thematically to explore the potential usability of the toolkit and its potential benefits. .

Project Design

The method researched and proposed for this project constitutes a quasi-experimental study with non-equivalent control groups for the purpose of assessing the medical toolkit for diabetes management (Pamungkas & Chamroonsawasdi, 2020). It is meant to be applied to patients with type 2 diabetes in order to increase glycated hemoglobin A1c levels. The patients will be randomly selected from different outpatient diabetes clinics and assigned to two groups.

The current study will have an intervention group that will be provided with the diabetes management toolkit through which they will be provided with improved dietary management, suggested physical exercise regime, medication reminders, and other educative material meant to build their diabetic handling knowledge (Smith et al., 2023). The control group will go on with their treatment as they normally would, without any extra procedures being performed on them.

Procedures for the implementation of the project will begin with the recruitment of participants who meet the inclusion criteria: patients having Type 2 diabetes and their A1c level is more than 7% (MacPherson et al., 2021). The individuals who meet the inclusion criteria will be approached and provided with detailed information about the purpose and process of the study, and upon their written consent, they will participate in the study. The toolkit is a compilation of several intervention tools that will be explained to the participants in the intervention group during the initial session and potential digital tools are demonstrated to the participants and the physical materials are distributed.

Both the intervention and the control will be followed up after one-month interval in the next six months, regularly filling A1c levels, and practices regarding diabetic management. Both groups will be followed for six months; monthly interviews will be conducted to capture changes in A1c, patterns of practice involving management of diabetes, changes in lifestyle, and medication.

Primary data collection techniques include the use of questionnaires and direct observation of the construct being measured. The primary study sample measures will be taken at baseline and at the completion of the study to compare the effectiveness of the intervention; A1c levels.

Further, demographic information, reasons for visiting clinic, and details of participant’s interaction with the toolkit and its usage of the diabetes management plan will be gathered using self-administered daily diaries and electronic logs that are integrated within the toolkit (Kim et al., 2019). The impact of the intervention will be assessed through comparing the A1c difference between the participating and non-intervention groups consequently applying statistical techniques to assess the p-value for the observed change in differences.

Instrumentation

For the project that deals with the assessment of a developed diabetes management toolkit and its impact on glycated hemoglobin (A1c) levels, the choice of instrumentation that is tools that are used in the process of data gathering will be very important because proper assessment of outcomes will require proper data collection tools. The key instruments employed will include:

The glycated hemoglobin (HbA1c) test kits will be used to determine the participant’s A1c levels before the commencement of the trial and after the 6 month intervention (Pohanka, 2021). The A1c test essentially paints the picture of the average blood sugar control in approximately three months is an important tool in managing the condition. Mobile applications for self monitoring and health management will support tracking of intake of foods, exercise, prescription compliance and monitor blood glucose levels. These applications will create a balance and provide real-time information which can accessed by both the participants and the healthcare providers in order to assess compliance and modify the treatment plan (Pohanka, 2021).

Standardized survey instruments, to obtain quantitative results on survey questions, will be used to capture participants’ level of satisfaction with the toolkit and its perceived ease of use. As mentioned, these surveys would be conducted at regular intervals throughout the study so as to assess participants’ shifts in perceptions and practices as it relates to their diabetes management. Semi-structured interviews will be designed to be held with participants with the intention of obtaining their qualitative feedback regarding the use of the toolkit and obstacles felt in the process.

These interviews will assist in further understanding the utility of the aforementioned toolkit and the differences observed between participants’ daily management of diabetes (Pohanka, 2021). Physiological monitoring devices are only for the participants who will volunteer, we may use portable monitoring devices that enable us to record physiological values of the participants like physical activity and heart rate at regular intervals (Brick et al., 2020). This data will be useful in evaluating the extent of compliance to physical activity recommendations provided under the toolkit. These instruments will be incorporated into the study in order to collect a rich set of data necessary to influence the research on the identified toolkit and the significant improvement of A 1C level among the target population of adults with type 2 diabetes.

Data Collection

The data collection for this quality improvement project aimed at assessing the utility of a diabetes management toolkit will therefore be purposive and methodical to capture every important aspect of the benefit of the toolkit on the participants’ glycated hemoglobin (A1c) and other clinical characteristics. The data collection process will involve the following components:       

• Baseline and Follow-up A1c Measurements

 Fasting A1c test will be gathered from all the participants to check on their own A1c values before getting into the study and after the 6 months trial period. These measurements will be carried out following regular set laboratory practices in order to obtain accurate and reliable results on the diabetes management tools that we develop (Brick et al., 2020).

• Digital Logging and Tracking

Intervention group will continue to engage in daily documentation of activities performed in relation with diabetes using the tools incorporated in the toolkit. This also involves noting down what the patient consumes in terms of food, activities they engage in, doses of the medications they take, and their blood glucose levels. These diaries will yield numerical data which will be useful in determining how strictly the patient has followed the diabetes management plan and the changes that adequately be expected on A1c levels.

• Surveys and Questionnaires

 In different intervals throughout the study period the participants will be prompted to fill in questionnaires and surveys in order capture data regarding participants’ satisfaction and perceived effectiveness and ease of use of the toolkit, as well as changes to the participants’ health-related quality of life if any (Brick et al., 2020). Such information will supplement the quantitative data from e-logs or glycated hemoglobin A1c levels, offering an objective view of tool effectiveness.

• Interviews

Therefore, the interview questions for the purpose of qualitative data collection will be semi structured and will be conducted mid way through and at the end of the study with some of the participants. These focused interviews will involve analysing the difficulties happened and perceived advantages of applying the toolkit in the management of diabetes by the participants. These interviews will prove to be effective in identifying some of the areas that can be focused on when developing this toolkit.

• Device Data Collection

 Wearable devices for the same participants will be utilized in order to capture objective data on physical activity and other physiological characteristics, if the participant consents (Vijayan et al., 2021). Data recorded from these devices would provide further information about the activity level of participants and how such level can affect their A1d.

Using these data collection methods in combination means that it will be possible to comprehensively determine how the diabetes management toolkit influences A1c and other important metrics related to diabetes. The applied approach to incorporating quantitative and qualitative data will also enhance our understanding of the users’ experiences and the daily practice of using a toolkit of this kind (Vijayan et al., 2021).

Data analysis methods

To evaluate the findings gathered from the study aimed at assessing the efficiency of a diabetes management toolkit, both quantitative and qualitative techniques of analysis will be used. Here are the main data analysis methods that will be used:

• Descriptive Statistics: Data analysis will commence with data summarization where an attempt will be made to describe the collected data using merely statistics that describe the values, central tendency (Terrell, 2021), and dispersion of the data collected. This includes things like calculating means, medians, standard deviations for variable that can be continuous such as the A1c levels, and frequencies, percentages where appropriate for the variables such as the adherence rates and the survey responses. This step will help determine the general concavity or convexity of the density function and the mean of the dependent variable in the intervention and more so the control group.

• Comparative Analysis: In order to compare effectiveness of diabetes management toolkit, paired T- Test of the primary outcome of this study will be performed which is the difference of A1c at baseline and at the 6-month follow up visit. The primary analysis will involve the use of independent t-tests (normal distribution) while Mann Whittney U-tests for non-normal distribution data sets will be used for comparison of differences between the two groups (Terrell, 2021). Further, there can be a usage of Analysis of Covariance (ANCOVA) to control for any deviance and equally or unequally balanced confounding variables at the baseline.

• Regression Analysis: Again, the analytical tool that shall be used to establish the relationship between the independent variables such as the extent to which participants compiled with the toolkit, their level of participation, and other demographic characteristics of the participants and the extent of change in A1c levels as the dependent variable shall be determined through multiple regression analysis. This analysis will assist in determining how specifically effective the various provided factors are for enhancing the diabetic population’s management of disease (Terrell, 2021).

• Time Series Analysis: If data is obtained over time for example data from wearable devices continuously recording data over some time then time series analysis will be used to analyze the data and determine some variance patterns (Vijayan et al., 2021). This will help in establishing whether there is a significant difference between the frequency of use of the toolkit and fluctuation in A1c levels over the period under study.

• Thematic Analysis: Interviews conducted and open-ended questions asked in the surveys will be coded thematically to determine shared patterns and stories to which the participants responded positively of the toolkit on diabetes. This type of analysis is important as it helps to identify different aspects related to usability, the benefits of the participants and possible barriers when engaging in the activity discussed, which might not be reflected by quantitative data (Vijayan et al., 2021).

• Sensitivity Analysis: To be more confident of the results that will be obtained in the study, the key assumptions and parameters that will be used to arrive at the results will be adjusted and the results regressed to check the sensitivity of the study. This will help the reviews to identify the effect of the biases to the results obtained and help to know the reliability of the results as well as its other usability in other occasions.

By using these various data analysis approaches, this study aspires to deliver an extensive and empirical assessment of whether the implementation of an accessible diabetes ‘management toolkit can increase the adult patient’s glycated hemoglobin levels with T2DM, ultimately leading to the identification of the toolkit’s feasibility and applicability.

Data Management Methods

Names and other identification details of the patients and other stakeholders involved in the study concerning the impact of a diabetes management toolkit shall be properly anonymized and secured to maintain confidentiality of the data collected throughout the data collection, storage, analysis and reporting process.

Initially, data will be extracted through several sources including self-reported A1c test results, self-monitored blood glucose records obtained from digital tracking applications and wearable devices, and questionnaires completed by participants. It is proposed that each set of data will be given an identification number in order to secure the anonymity of the participants. All specific and general data will be kept in a password protected database, with users restricted to the research team.

This will help in ensuring that the data is correct and complete as a backup will be taken frequently so as to provide back up data in case of any loss of data. Every tracking tool is normally designed with options for data validation and this will help eliminate the chances of entering incorrect figures in the system.

For example, inclusion of values for blood glucose levels higher or lower than any feasible candidates will prompt an alert confirming verification. Further, any changes made to the data will be time stamped and documented with the user involved to support enterprise-wide usability (Vijayan et al., 2021). This rigorous approach helps to mitigate risk and is a measure that helps verify that the data that is in the final analysis is sound and can be traced back to its source in the event of a query.

However, before the analysis is done, the data will be pre- processed to deal with the missing values, cleaning, and outliers observed during data cleaning phase. Qualitative data will be entered into a database to allow for coding and identification of themes, while the quantitative data shall be analyzed using statistical software with scripts and methodologies documented to allow for repeat analysis of the same if needed.

Each of the interviews conducted in this study will be recorded, then transcribed, coded, and analyzed manually and/or by using a computer aided qualitative data analysis software to enhance on thematic analysis. Because of these careful practices toward data management, the research intends to adhere to the standards of corroborated research quality and ethical practice in order to provide valid information.

Ethical Considerations

The research proposal deals with the assessment of a diabetes management toolkit, and when conducting this study, there are specific ethical issues that need to be observed to safeguard the participants and maintain the credibility of the findings (Pietilä et al., 2020). Here are the key ethical considerations for this project: Here are the key ethical considerations for this project:

Both research and control subjects must receive a permission from the researcher before joining the study. It may include the identification of the objectives and aims of the study, why people are being sought for participation, the possible risks that may arise and the potential gains of the study. Another aspect is that participants should be made aware that participation is completely voluntary and there are no repercussions for their participation if they choose to withdraw from the study at any given time without affecting future care. It is thus vital to ensure that whatever data is obtained from the participants is kept as strictly confidential as is possible.

This means that all data must be stored to the best of the available standard and only be accessible by the personnel who are assigned the right to make changes to it. In other words, we recommend that identifiable data should be removed either by anonymization or de-identification before analysis to ensure participants cannot be identified from the results (Pietilä et al., 2020).

Even though the intervention reflects common practice in diabetes care, the following intervention recommendations require precaution with patients. This is due to the closeness of following the participants to check on any adverse effects resulting from utilization of new management strategies as offered by the toolkit. Any adverse effects must be attended to immediately, and changes that may need to be made regarding the intervention for the participants’ safety must also be made.

A good record of ethical practice in cases involving research subjects is crucial in the preservation of integrity in the research outcomes. It is the process of maintaining the credibility and validity of the study through accurate data gathering, analysis, and reporting, as well as the elimination of any practices that may compromise the validity of the research results.

It is important that participants be chosen in a manner that is fair without a hint of any bias. Proper care should be taken in a way that recruitment may not be done among a particular group and that the consequent treatment and results of the study are accessible to all deserving candidates without regard to their color, gender, financial status, or station in life.

Before starting the process of conducting the research it is important to follow the principles of beneficence, which means to do good and non-maleficence that means the ability to not harm. The advantages of the diabetes management toolkit should be far more in number and significant than the disadvantages or dangers in implementing its use (Pietilä et al., 2020). It is therefore imperative that the toolkit has been designed in a way that it does in fact enhance diabetes management without increasing other important risks.

The most important rules that the researchers should adhere to during the process of their work include reporting of the methods and results and the declaration of any possible bias. This incorporates releasing the findings regardless of they being positive or negative or nonegative and thus offering sincere input in the scientific database. It is thus necessary for the researcher to address these ethical considerations with the aim of conducting the research ethically and responsibly to ensure that the research provides useful information on management of diabetes as well as safeguard and protect the rights of all participants involved in the study.

Conclusion

The potential for improvement in the current trends in diabetes treatment and the utilization of a comprehensive diabetes management toolkit in assessing the efficacy of a glycated hemoglobin (A1c) level reduction in adult patients with type 2 diabetes make the project unique and worth exploring further. This approach of providing a structured toolkit such as dietary guide, exercise regimen, medication requisites along with health education module intends to equip the patients with the requisite knowledge and management ability for the ailment.

In the course of this research, the following promising procedures of data collection and analysis have been adopted to enhance the credibility and reliability of the study. Specifically, issues of ethical consideration, and conformity with principles of informed consent, patient confidentiality, and minimizing risks, have been followed as guidelines with due consideration to protocol, thereby maintaining the credibility of the study and the rights of the participants.

The findings of this study are intended to contribute useful information on the potential benefits associated with structured management in the management of diabetes, in relation to A1c. If positive, the implications could encourage the use of such toolkits in clinical procedures and perhaps enhance clinical results for a diverse patient population. This study not only brings a value to academics as it yields findings that have been either theoretical or experimental in nature, but it is also in tune with the concept of improving the quality of life for people living with a condition like type 2 diabetes.