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Quantitative Study Design
Background of the Study
Diabetes is a chronic disease that affects the metabolism of glucose, which is the key physiological sugar. Type 2 diabetes occurs when the body develops resistance to the hormone insulin whose function is to lower blood glucose levels. Approximately 27 million people in the United States have type 2 diabetes, whereas 86 million have prediabetes [1]. Prediabetes is characterized by high blood glucose levels that have not reached the threshold required for the condition to be considered diabetes [1]. Recent statistics indicate that the global incidence of diabetes among adults above the age of 18 years has increased from 4.7% to 8.5% over the last 40 years [2]. Hemoglobin A1c (HbA1c) levels are useful indicators of blood glucose levels over three months. Healthy individuals without diabetes have HbA1c levels that range from 4% to 5.9% [3]. On the other hand, diabetic patients with poor blood glucose control have HbA1c levels exceeding 7%. Therefore, HbA1c levels are used to establish blood sugar control over time and are an indication of effective self-management among diabetic patients.
Group medical visit is a novel and time-effective strategy of providing care to patients with similar chronic disorders. Patients are requested to show up for these gatherings to receive care, teaching, and guidance within an empathetic group setting. Group medical visits are associated with enhanced patient self-management, which is the goal of health literacy. It is expected that group medical visits will motivate the patients to better self-care, which will translate into improved glycemic control and reduced HbA1c levels.
Significance
Diabetes is responsible for other health complications such as blindness, heart attacks, renal complications, stroke, and amputation of lower limbs. It is reported that lowering HbA1c levels by 1% reduces the likelihood of microvascular problems such as kidney failure, the diabetic eye, and nerve complications by 10% [4]. As a result, the American Diabetic Association recommends that HbA1c should be checked every six months in diabetic patients with stable blood sugar control [3]. The frequency of HbA1c testing should increase to every three months for patients who are attempting to establish unwavering blood sugar control. The management of diabetes involves adherence to medications, a healthy diet, and regular exercise. Despite this knowledge, the morbidities and mortalities associated with diabetes are on the increase due to noncompliance with medical advice. Studies indicate that patient education and healthcare staff recommendations lead to improved health outcomes [5]. Group medical visits have also been reported to improve patients’ reception and implementation of medical advice, which leads to improved outcomes [6]. There is a need to determine the impact of group medical visits on diabetes self-care and HbA1c levels. This knowledge will help to improve healthcare outcomes by enhancing the quality of life of diabetic patients. As a result, there will be significant savings on healthcare costs spent on treating the complications associated with diabetes.
Purpose of the Study
The purpose of the study is to determine the impact of group medical visits compared to individual medical visits on HbA1c levels among African Americans with type 2 diabetes mellitus.
The rationale for Selecting the Study Design
Quasi-experimental study design was chosen. Quasi-experimental research designs check for test-effect associations by establishing the consequences of an intervention on a target population. However, randomization is absent in this research design. A dependent variable, which is usually designated as X, is the anticipated outcome of implementing a specified intervention or treatment. An independent variable, conversely, is a self-determining factor that modifies a dependent variable. The independent variable may consist of different categories. Subjects are assigned to groups by the principal investigator or self-selection. The benefit of conducting a quasi-experimental study is that it is possible to conduct experiments in instances where randomization may not be feasible. In this study, the main intervention is group medical visits, which will be compared to individual visits (control). It will be necessary to assign subjects into groups based on their schedules so that they can attend group medical sessions without any inconveniences.
Research Question and Hypothesis
The research question for the study is “What is the impact of group medical visits compared to individual medical visits on HbA1c levels among African Americans with type 2 diabetes mellitus?” It is hypothesized that African Americans patients with type 2 diabetes mellitus patients who will undergo group medical visits will have lower HbA1c levels than those who will undergo individual medical visits. Therefore, the null hypothesis (H0) for the study is: there is no significant difference in mean HbA1c levels in African American patients who undergo group medical visits compared to those who undergo individual medical visits. A one-tailed alternative hypothesis will be considered.
Study Design
A pre and posttest study design of the quasi-experimental research design will be used for the study. In this design, the dependent variable is assessed before and after implementing the intervention. Baseline HbA1c data will be collected at the beginning and end of the study. The two values will be compared to determine the impact of the intervention. One benefit of the pre and posttest study design is that it is easy to ascertain that the posttest values are consequences of the intervention.
Setting
The setting of the study will be an internal medicine clinic. The clinic provides a wide range of health services such as annual physical examinations, screening for hypertension, diabetes, and other chronic diseases. The populations served at the clinic include Whites, African Americans, Latinos, and a small group of Asians.
Sampling
The study sample will include African American patients with recently diagnosed type II diabetes mellitus. The subjects will be aged between 40 and 60 years. Patients suffering from other comorbidities such as renal disease, pancreatic disease, anemia, and type 1 diabetes will be excluded from the study. Pregnant women will also be excluded from the study.
Sample Size Determination
The statistical power of a study is the likelihood of identifying a predefined clinical significance. Ideal studies should have high power, which is the likelihood of detecting a significant difference between groups. The recommended power for most research studies is 80% [7]. For this study, a medium-sized effect is desired at α=0.05. Power analysis is used to determine the appropriate sample size as shown in the equation below.
In the above equation, N is the sample size, Zα is the normal deviate at a specified level of significance (1.96 for 5% level of significance), and Z1-β is the normal deviate at 1-β% power with β% of type II error. The value of Z1-β is 0.84 at 80% power. On the other hand, r, which is the ratio of the sample size required for 2 groups is given by n1/n2. In this case, equal-sized groups are desired, therefore, r=1. σ is the pooled standard deviation, whereas d is the difference between the averages of 2 groups. Estimates of σ and d are obtained from previous studies or pilot investigations. A previous study that compared mean HbA1c levels between two groups found mean HbA1c levels of 65 and 68.3 mmol/mol and a common standard deviation of 10.05 [8]. Therefore, N= (1+1) (1.96+0.84)210.052/1* (68.3-65)2, which is equal to approximately 145. Therefore, a total of 145 subjects with 72 subjects in each group will be appropriate for the study.
Intervention
The main intervention in the study will be group medical visits. The treatment group will be divided into 6 units comprising 12 patients each. Each group visit will last 90 minutes. During the group sessions, the physician will provide hands-on care, including routine blood pressure checks, blood sugar tests, HbA1c measurement, writing prescriptions for the refill of medications, and patient education. However, patients will be allowed to share their progress and challenges briefly, after which the physician will respond to any concerns. The control group will include subjects who will undergo normal individual medical visits lasting 15 minutes each. The procedures followed during the group medical visits will also be used for the individual visits.
Measurement
Lifestyle changes will lead to changes in glycemic control hence HbA1c levels. However, since lifestyle modifications cannot be measured explicitly, the outcome variables that will be measured are HbA1c levels and body mass indices. Blood samples will be drawn from all participants and tested for HbA1c levels using the immunoturbidimetric method in the clinic’s laboratory.
Procedures
Recruitment plan
Eligible patients will be invited to participate in the study through invitation emails that will be sent at least two months before the commencement of the proposed study.
Data collection method
Blood samples will be drawn from all participants and tested for HbA1c levels at the baseline (beginning of the study). The BMI values of the subjects will also be measured at this point. The second set of measurements will be taken 3 months after the commencement of the study. The third set of measurements will be taken 6 months later.
Intervention delivery
The intervention will be delivered to the subjects during their normal medical appointments with their physicians. Subjects in each group (for the group medical visit intervention) will be scheduled for their appointment on similar days to facilitate the convergence of the groups.
Data Analysis Plan
The pretest and posttest data will be compared to determine the effectiveness of the intervention. The mean HbA1c levels and BMIs of the subjects in the intervention and control groups will be compared using paired t-tests at 0.05 level of significance. Data analysis will be conducted using SPSS version 22 software.
Study Team
The study team will consist of a group of healthcare providers such as a nurse practitioner, two physicians, and registered nurses. The role of the physician will be to provide consultation services to the patients during the individual and group medical visits. The lab technologists will be responsible for performing the HbA1c tests.
Limitations of the Study
There is no guarantee that all subjects recruited at the beginning of the study will be present at the end of the research. Some patients may abandon the investigation and complicate the data analysis. Other subjects may become uncomfortable with the group medical visits or their schedules may change during the study hence forcing them to opt-out. This attrition will be factored into the data analysis at the end of the experiment. Confounding variables are uncontrolled factors that may affect the internal validity of an investigation. In this paper, confounding variables comprise all dynamics that affect HbA1c levels in diabetic patients. They include acute and chronic blood loss (losing blood lowers the survival of erythrocytes hence decreasing HbA1c levels), hemolytic anemias, blood urea (high levels increase HbA1c levels), and pregnancy (HbA1c levels reduce in the second trimester and rise in the third trimester). Other forms of anemia alter the quaternary structure of hemoglobin, which influences its glycation rates. Consequently, HbA1c levels are likely to be higher in anemic people than normal ones.
Internal validity indicates whether the outcomes observed in an investigation are as a result of the alteration of the independent variable and not because of other factors. The internal validity of the study will be ensured by taking care of the confounding variables in the inclusion and exclusion criteria. External validity, conversely, represents the generalizability of an experiment to a specific population. It is expected that after controlling for the confounding variables, the findings will reflect the impact of group medical visits on HbA1c levels in adults with type 2 diabetes.
Ethical Considerations
Participation in the study will be voluntary. The researcher will obtain written informed consent to take part in the study. Eligible subjects will receive the consent form together with the invitation to participate in the study. The privacy of the patients will also be upheld. Since the study will involve human subjects, permission to conduct the study will be obtained from the clinic’s ethics committee.
Timeline
The entire study from the recruitment of subjects, commencement of the intervention, and measurement of outcomes will take 8 months. It will be expected that by the end of this period, the impact of group intervention on HbA1c levels in diabetic African Americans will be ascertained.
Qualitative Study
Background of the Study
Adulthood is marked by contending social, occupational, and financial burdens, which pose unique challenges for patients with type 2 diabetes. The competing priorities often lower compliance with self-care measures hence leading to poor glycemic control and related complications such as microvascular problems, extreme hypoglycemia, and ketoacidosis. Type 2 diabetes is a chronic disorder that needs constant medical follow-up and continuous self-care. Healthcare systems around the world face the challenge of increasing numbers of chronically ill patients and a reducing physician labor force, particularly in primary care [9]. As a result, policymakers are exploring new paradigms of providing primary care to enhance quality and productivity. Group medical visits are a useful strategy that can help to address the shortage of primary care physicians while ensuring that a large number of chronically-ill patients receive care. However, there is little information regarding diabetic patients’ views of group medical visits. Therefore, there is a need to conduct a qualitative study to investigate patients’ attitudes and feelings towards this therapeutic approach.
Significance
Approximately 27 million people in the United States have type 2 diabetes, whereas 86 million have prediabetes [1]. There is adequate evidence to prove that strengthening the foundation of primary health care is likely to enhance health outcomes and improve the management of chronic diseases such as type 2 diabetes [3]. Group medical visits provide an idyllic arrangement for patients with chronic diseases such as diabetes because they allow patients with similar health conditions to interact in one appointment. Group medical visits have been reported to lead to significant improvements in glycemic control as measured by HbA1c levels [6]. This improvement is attributed to social support from peers during the group sessions. Therefore, it is hypothesized that the wider application of group medical visits will have a positive effect on patient outcomes for patients with type 2 diabetes. However, to increase the effectiveness of the intervention, it is necessary to identify patients’ views on group medical visits.
Qualitative research provides an exceptional opportunity for patient experiences to guide the development of effective intermediations to improve self-care in type 2 diabetes. Social aspects of healthcare may require a thoughtful exploration, especially when dealing with complex concepts that cannot be measured easily. Therefore, qualitative studies are desired when health science researchers wish to share personal experiences, comprehend the context of health issues, clarify connections in causal theories, and when conventional quantitative statistical evaluation approaches do not match the research problem. Descriptive research can also inform future investigations by identifying testable variables.
Purpose of the Study
The purpose of the study is to analyze the experiences of African American patients with type 2 diabetes mellitus on group medical visits.
The rationale for Selecting the Study Design
A descriptive qualitative study was chosen for this investigation. Qualitative descriptive studies are meant to portray the contributors’ views accurately and are open to research in the health arena because they yield realistic responses to questions concerning people’s feelings about specific phenomena [10]. A qualitative descriptive study about the views of African Americans on group medical visits will provide an in-depth understanding of patients’ perceptions of group medical visits. This information will inform medical providers about ways of enhancing the provision of group medical care. As a result, the outcomes of patients with type 2 diabetes will be improved.
Research Question
The research question for the study is “What is it like for African American patients with type 2 diabetes mellitus to experience group medical visits?”
Study Design
A focus group approach was chosen to gather detail and perspective about adult African Americans’ experiences of group medical visits in the management of type 2 diabetes. A series of three group sessions will be conducted to appreciate the patients’ understanding and experiences of group medical visits for diabetes care. Qualitative focus groups make it possible to look into numerous experiences, viewpoints, and sentiments within a group scenery [10].
Setting
The setting of the study will be an internal medicine clinic that provides a wide range of health services such as annual physical examinations, screening for hypertension, diabetes, and other chronic diseases. The populations served at the clinic include Whites, African Americans, Latinos, and a small group of Asians.
Sampling
A purposive sampling strategy will be used to identify the participants. African American patients with type II diabetes mellitus who are aged between 40 and 60 years will be selected. Only patients who have undergone group medical visits in the past year will be included in the study. Patients with type 1 diabetes and other comorbidities will be excluded from the study.
Procedures
Recruitment plan
The study team will contact eligible subjects and invite them to take part in the study. Introductory letters will be sent to all suitable candidates and followed by individual phone calls to confirm receipt of the invitation as well as participation in the study. Groups will be formed based on the participants’ level of glycemic control, which will be determined by the patients’ HbA1c levels as measured in the most recent visit before enrollment. Participants with HbA1c levels equal to or lower than 8.5% will be placed in one group. On the other hand, patients whose HbA1c levels exceed 8.5 will be placed in a separate group. The purpose of this approach will be to attain group homogeneity to enhance compatibility, unity, an exposé in the focus groups. Additionally, having similar levels of glycemic control will ease discomfort and eliminate feelings of competition during discussions.
Data collection method
A structured focus group guide will be formulated based on a thorough literature review of medical literature about the needs of adult diabetic patients. Medical providers specialized in diabetes care will be part of the team that will develop the focus group guide. The guide will include broad, open-ended questions to provoke specifics of the group medical visit experiences from a patient’s point of view. However, there will be room for revisions of the guide after the first focus group to accommodate emerging topics. Notable focus group guide items will include experiences in group medical sessions, the impact of group sessions on self-care, barriers to group sessions, and the impact of group sessions on the perception of diabetes. The following questions will be considered in the focus group guide.
- What is your experience in the group medical visits for diabetes care?
- Can you describe some of the challenges that you have encountered during group medical visits?
Each focus group will be facilitated by the same researcher, who will see to it that the group discusses all topics included in the guide. The group facilitator will also ensure that all group participants have an opportunity to air their views. A second researcher will take field notes to capture important observations about group discussions and associations. Each focus group discussion will last 60 minutes, after which the two moderators will meet to compare notes. Also, each session will be audiotaped and transliterated word for word by three team members in 30 days after each session. A quality check will be performed to authenticate the transcripts by paying attention to the recordings.
Data Analysis Plan
A thematic analysis will be used to analyze the data collected. The study team will meet at regular intervals to examine and evaluate the data based on the tenets of thematic analysis. The first phase of data analysis will involve each team member reading all the transcripts and notes, marking, and grouping the keywords to create initial codes [10]. These codes will be discussed by the entire group to work out any inconsistencies and create the primary thematic outline. This thematic framework will then be applied to all transcripts. Qualitative data analysis software such as NVivo 8 software will then be used for further grouping and organization of the codes to determine definitive themes.
Rigor
The credibility of the findings will be ensured by the triangulation of data sources. Researcher bias will be minimized by engaging a team of experts in the development of the focus group guide, conducting focus group sessions, and data analysis.
Study Team
The study team will include the principal researcher (self), two physicians with experience in adult diabetic care, and two physician assistants. The roles of each team member are explained in the data collection method.
Limitations of the Study
One possible limitation of the study is that subjects may not be honest about their opinions. There is a likelihood of unnatural behavior when subjects know that their actions are being monitored and recorded [11]. It is also impossible to determine a cause-effect relationship through descriptive studies. As much as the patient’s identities will be kept private, confidentiality issues may arise during the focus group sessions. As a result, some subjects may not be free to express their sentiments for fear of victimization. Researcher bias may also affect the findings of the study in several ways. For instance, the points in the focus group guide may lean towards the researcher’s interests [11]. The investigator is likely to make a skewed choice about the information to capture and accentuate the outcomes. Statistical evaluation of the findings is impossible. Therefore, the findings of such a study cannot be replicated and can be interpreted differently by different people.
Ethical Considerations
Participation in the study will be voluntary. The researcher will seek the subjects’ informed consent to take participate in the study. The privacy of the patients will be upheld because their names will not be mentioned anywhere in the study. Since the study will involve human subjects, permission to conduct the research will be obtained from the clinic’s ethics committee. Participants will also receive monetary compensation for their time.
Timeline
The entire investigation from the recruitment of subjects, data collection, and data analysis will take 3 months. It will be expected that by the end of this period, the researcher will have adequate information regarding the experiences of African American patients on the use of group medical visits for the management of diabetes.
Reference List
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Kraemer HC, Blasey C. How many subjects? Statistical power analysis in research. 2nd ed. California: Sage Publications; 2015.
Kuniss N, Müller UA, Kloos C, Müller R, Starrach G, Jörgens V et al. Substantial improvement in HbA1c following a treatment and teaching programme for people with type 2 diabetes on conventional insulin therapy in an in- and outpatient setting. Acta Diabetol. 2018;55(2): 131-137.
Crisp N, Chen L. Global supply of health professionals. N Eng J Med. 2014;370(10): 950-957.
Vaismoradi M, Jones J, Turunen H, Snelgrove S. Theme development in qualitative content analysis and thematic analysis. J Nurs Ed Pract. 2016;6(5): 100.
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