Quality Improvement project to study the impact of clinical pharmacist in diabetic management of admitted cardiac patients

doi:10.21203/rs.3.rs-1947531/v1

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Quality Improvement project to study the impact of clinical pharmacist in diabetic management of admitted cardiac patients

https://doi.org/10.21203/rs.3.rs-1947531/v1

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Diabetes is a fast-growing chronic disease worldwide. Associated with high morbidity, mortality, and cost. Glycemic control in diabetic patients is a demanding issue and requires partnership with health care professionals. the clinical pharmacist has a positive contribution through a range of extended services to optimize diabetic management and improve patients outcome.

Objectives: This study aims to investigate the role of the clinical pharmacist in the glycemic management of admitted diabetic cardiac patients at King Fahad Medical City.

Method: This is a prospective, cohort study carried out at King Salman Cardiac Center of King Fahad Medical City, cardiac Patients admitted at the cardiac centerfrom October 2018 to October 2020 were randomly assigned to intervention (n= 500) or control group (n=500). Patients were recruited either in the intervention group ( group covered by a clinical pharmacist ) or the control group ( group not covered by a clinical pharmacist ). Follow-up started concurrently with data collection, Glycosylated hemoglobin (HbAC ), fasting blood glucose (FBG),and frequency of hypoglycemic episodes at baseline , and then 6 months after clinical pharmacist intervention

Results:

HbAC levels were reduced in both groups. For the intervention group, HbAC reduction was (8.5 from10.2 , SD= 2.2 ) , (p= 0.04 ). For the control group, HbAC reduction was 9.05 from 9.95 , SD= 1.95 , (p= 0.05) , FBG was decreased in intervention group by 29 mg\dl compared to non-statistical significant by 9 mg\dl decrease in control group . Both the t-test indicated that the HbAC difference was statistically significant.

Conclusions: Clinical pharmacist has a positive impact on monitoring diabetes in admitted cardiac patients.

HbAC

Diabetes

All-cause mortality

Hospitalization

Coronary heart disease

Stroke

Hypoglycemia

prevention

Treatment Outcome

Knowledge

Clinical pharmacist

Pharmaceutical care

FBG

HbAC

cardiac

in-patients

medication adherence

FBGs

The patients’ health outcomes could be improved by proper diagnosis and management of diabetic symptoms among hospitalized cardiac patients that can save the cost of the healthcare system.

Study Contribution/Value

Study determines the role of clinical pharmacist in diabetic management of admitted cardiac patients .
The study has also identified the gap in current assessment, diagnosis, and management of diabetic among cardiac patients and the need for clinical pharmacist interventions to get the therapeutic HbA1c .

Practical Implications on the field of Study

Proper and early intervention of clinical pharmacist in diagnosis and treatment of diabetic in hospitalize cardiac patients will help in getting the therapeutic HbA1C and cost-saving of the health care system and improve quality of life for those populations

Diabetes mellitus is a fast- growing disease and is associated with significant complications, , and health care costs. The International Diabetes Federation (IDF) Diabetes Atlas, 2019, provides the following informations :- one in 11 adults have diabetes (463 million), nearly half of adults with diabetes are undiagnosed ( 232 million ), one in five adults seven births are affected by gestational diabetes, 542,000 children have type 1 diabetes, and a person dies from diabetes every 6 seconds. Of those people with diabetes, three-quarters (75%) live in low- and middle-income countries.- ( Saeedi,2019 )( Williams, 2019) Adults with diabetes have a threefold increased risk of suffering heart disease or stroke compared to patients without diabetes. The microvascular and macrovascular complications of diabetes make it the main cause of renal disease, heart disease, and amputation . ( Cade, 2008)

Optimizing therapy in patients with diabetes is a difficult multi-task requiring considerable contribution between clinical pharmacists, diabetic educators, and treating physician teams. The goal is to improve glycemic control and improve medication adherence without adverse effects of medication. In hospitalized cardiac patients with diabetes, optimal glycemic control is necessary to avoid adverse effects. Insulin therapy is currently the primary medication recommended for hospitalized patients . ( Hughes, 2017).

This is a prospective, randomized controlled study carried out at King Salman Cardiac Center of King Fahad Medical City, our sample haswas cardiac Patients admitted at the cardiac center from October 2018 to October 2020 who were randomly assigned to intervention by a clinical pharmacist (n= 500 ) or control group taking usual care by treating team (n=500). the study was approved by the Institutional Review Board (IRB) committee of King Fahad Medical City. A sample size of 450 patients in each research arm would be enough (ß = 0.20 and α = 0.05) to detect a difference in HbAC, FBG, and differences in hypoglycemic episodes. Patients were recruited either in the intervention group ( group covered by the clinical pharmacist ) or the control group ( group not covered by a clinical pharmacist ). Follow-up started concurrently with data collection, Glycosylated hemoglobin (HbAC ) fasting blood glucose (FBG), and frequency of hypoglycemic episodes at baseline, the patients' medical records were reviewed by the clinical pharmacist to obtain all needed information. Data analysis was performed using the SPSS software version ( 21 ).

and after 6 months. During the admission demographic data, history of diabetes and diabetes assessment, anti-diabetic medications and adherence to medications, diabetes lifestyle adherence were recorded.

Inclusion criteria:

Male or female ≥ 18 years.
Patients who have been admitted to cardiac center and have diabetes.
Patient is willing to participate in the study and provides written informed consent to his participation.

Exclusion criteria:

Pregnant women.
Patient who refuses diabetic medication initiation.
Patient with dementia or cognitive impairment.

Patients were randomly allocated either as intervention or as a control group after providing a consent form, data were collected from patients by the clinical pharmacist including demographics, medical history, current diabetic medications used, adherence to diabetic medications, lifestyle adherence, and baseline data for HbAC %, fasting blood glucose (FBG). Data were obtained from medical files, patients themselves, or by the accompanied caregiver.

Intervention group :

For patients in the intervention group, the clinical pharmacist collaborated with a physician in the management of diabetic patients .during the first interview of patients and after collecting essential data, the clinical pharmacist recommendations regarding insulin therapy were discussed with their responsible physician, these recommendations were (based on American Diabetic Association 2018. All FBG, HbAC , and percentage of hypoglycemia \patient\month for all patients were recorded at baseline, and 6 months after discharge. We defined hypoglycemia as having any point-of-care test glucose value <70 mg/dL in any of the daily evaluations.

The clinical pharmacist explained to the patients the clinical course of the disease including signs and symptoms, prescribed the recommended goals of glycemic control, justified the role of insulin and other hypoglycemic medications in their diabetes management, educate the patients about the appropriate use of antidiabetic and the importance of adherence, educated the patients about sign and symptoms of hypo and hyperglycemia and the way to deal with them, educated the patients about lifestyle changes including smoking cessation, diet, and exercise in collaborative with diabetic educators. Provided the patients with manual sugar-checking devices and explain when and how to use them and provide diabetic sheet records which were used to adjust the doses of diabetic medications. The patients were asked to monitor their blood glucose several times a day.

Control group

Patients in the control group received their usual care from the clinic team in cardiac wards not covered by clinical pharmacists. Also, they were provided with a self-check device they were asked to record their FBG each month and to record hypoglycemic episodes if any.

Outcome measures at baseline and after 6 months:

Glycosylated hemoglobin HbAC (HbAC). (Primary outcome)
Fasting blood glucose (FBG). (Secondary outcome)
Frequency of hypoglycemic episodes. (secondary outcome).

Data analysis :

Data analysis using SPSS version 21 A – p-the value of less than 0.5 is considered significant. A suitable type of test was considered according to the variable type. An Independent t-testwas used to compare the mean of HbAC and FBG in both control and intervention group . PS matching provided a 1:1 matched sample of 400 patients per cohort

Out of 1114 patients who were approached, 1000 patients were recruited, 500 patients in each group; patients' selection charts are shown in Figure 1. Eight patients were lost ingfollow-up (4 from the control group and 4 from the intervention group) as they did not return back and lost contact. Sample selection for this study was a convenience sample, 496 patients with diabetes admitted to a cardiac center were compared with 496 patients in a pharmacist-managed diabetes group (intervention group) between October 2018 to October 2020. Results of nine hundred ninety-two medical records were reviewed in this study (n=496 for each group). The baseline demographic and clinical characteristics of the study participants are presented in Table 1 and Table 2.

a --twoThe mean age of the participants was (54 ± 9.8) years in the intervention group and ( 54.5 ± 6.9 ) in the control group. More than 50 % of our study sample was obese, 58% in the intervention group and 53 % in the control group were obese with a BMI of 30 and above. (Table 1 ) The majority of the participants had hypertension about (70.1 %)in the intervention group and ( 68 %) in the control group, more than half (60.1 %) had dyslipidemia and (62.3% ) in the control group, ( 51.2 % ) in the intervention group and (53.6%) in the control group had ischemic heart disease. (Table 1 )

The patients had diabetes for a mean of ( 13.5 ± 7.4) years in the intervention and a mean of ( 12.9 ± 7.1) years in the control group. Hemoglobin HbAC measured at baseline was 9.8 ± 1.2 in the intervention group and 9.6± 1.1 in the control group. (Table 2 )

HbAC:

HbAC levels were reduced in both groups. For the intervention group, HbAC reduction was 16 % ( 8.5 from 10.2 , SD= 2.2 , (p=0.04 ). For the control group, HbAC reduction was 9 %, 9.10 from 9.95, SD= 1.95, (p= 0.05 ) . . Both the t-test indicated that the HbAC difference was statistically significant. (Figure 2) (Table 4 )

FBGs :

Mean FBGs at baseline was 164 ± 54 in the intervention group and 161 ± 51 in the control group. Intervention group FBG decreased statistically significantly by 29 mg\dl compared to non-statistical significant by 9 mg\dl decreases in the control group. (Figure 3)(Table 4 )

Hypoglycemia :

Percentage of hypoglycemic episodes\patient compared at baseline and after 6 months, there was a statistically insignificant difference in hypoglycemic episodes frequency between the two groups (p-value = 0.65 ) in the intervention group and p-value 0.09 in the control group, with a mean of ( 0.9 ) episodes per patient \ month in the intervention group and ( 1.1) \patient\month in the control group.

A list of changes made in the intervention and control group was listed in table 3.

Table 1. Demographic characteristics (N= 992 )

Control (%)†	Intervention (%)†	Total (%)*	Parameter
496	496	992	Research group, N
295 201	301 195		Gender, N (%): Male Female
56.5+\_6.9	54+\- 9.8		Age (years), mean (SD)
19.8 % 38.3 % 29.4% 12.5 %	16.3 % 32.7 % 36.7 % 14.3%		Body mass category Kg\m², N (%) Normal Overweight Obese Morbid obesity
22.2 % 17.9% 18.1% 19 % 22.4% 0.4%	21.6% 20.2% 16.5% 19.7% 21.6% 0.4 %		Education level, N (%) Illiterate Primary Secondary High school Bachelor Post-graduated
9 %	11 %		Smoking, N (%) Current smoker
337(68%)	349(70.1%)		Hypertension , BP ≥130\80
309(62.3%)	301(60.1%)		Dyslipidemia
266(53.6%)	254(51.2%)		Ischemic heart disease
349(70.3%)	312(62.9%)	Normal Renal function	Renal function
147(29.7%)	184(37.1%)	Impaired renal function Creatinine clearance ≤ 60ml\min\1.73m²	Renal function

Table 2. DM assessment (N= 965)

Control ( % )	Intervention ( %)	Parameter
12.9 (7.1 )	13.5(7.4 )	DM duration (years), mean (SD)
9.95 (1.25)	10.2 (1.2)	Baseline HbAC, mean (SD)
161(51) 8.9(2.8)	164(54) 9.1 (3)	Baseline FBG mean (SD)
1.4\patient\month	1.3 \patient\month	Baseline Hypoglycemic episodes \patient \month

Table 3. Medications changes during admission :

Control Group	Intervention group	Medication
29(5.8% )	89(18%)	Adding Insulin
32(6.5 %)	105(21.2%)	Adding another anti-diabetic medication
45 (9.6 %)	201(40.5%)	Change in the medication doses

Table 4. Outcomes measured (Changes from baseline)

Mean (SD)		N=992 (496 intervention, 496 control)
Control group	Intervention
10.2	9.95	At enrollment	Mean HbAC%
8.5	9.5	After 6 months
0.05	0.04	Change P-value
161	164	At enrollment	Mean FBG
155	135	After 6 months
0.45	0.05	Change P-Value
1.4\patient\month	1.3 /patient /month	At enrollment /Admission Hypoglycemic episode/day	Frequent of hypoglycemia
1.1\patient\month	0.9/patient/day	After 6 months
0.09 Non statistical significant	0.065 Non statistical significant	Change p-value

Table 5: Adherence to medication in the intervention group :

Using the Medication Adherence Report Scale (MARS-5) Scale

Good adherence	188 ( 37.9 %)
Bad adherence	308( 62.9% )

Diabetes mellitus has been recognized as a demanding disease that requires urgent attention from all health care providers to address its prevalence and related complications. It is considered as a top 10 cause of death globally. ( Oguntibeju, (2019).) Poor control and hyperglycemia lead to many complications resulting in increased mortality, morbidity, increased utilization of the health care system, reduced quality of life, and life expectancy. (American diabetes, 2017) (American diabetes association, 2020 )

The prevalence of diabetes mellitus (DM), in Saudi Arabia, is growing. One-fourth of adult is affected by diabetes, which is further predicted to rise to more than double by the year 2030. ( Alzaheb, 2018 ). Also nearly half of diabetes exhibited a low level of functional health literacy had low diabetes self-management. (Almigbal, 2019). The American Diabetes Association (ADA) recommended an HBAC goal of less than 7% for most adults with diabetes. ( ( Skyler, J.,2009 )

Despite the availability of diabetes care clinical practice guidelines, diabetes is poorly managed resultto resulting in complications and unnecessary costs (Nazir, M., 2018). A hospital-based cross-sectional study among randomly selected 258 type 2 diabetic adults concluded that 70.8% had a poor status of glycaemic control, educational level and longer duration of diabetes were significantly associated with increased odds of poor glycaemic control. (Abera, 2022 ). In the UK Prospective Diabetes Study (UKPDS), newly diagnosed with type 2 diabetes followed for 10 years, with intensive control (median HBAC 7.0%) was found to reduce the overall microvascular complication rate by 25%, uncontrolled glucose levels were associated with substantial mortality and cardiovascular disease. ( Navarro-Pérez,2018) (Manley, S. 2003). Uncontrolled diabetes is associated with cardiovascular disease (CVD). Which leads to significant morbidity and premature mortality, the greatest cause of death in people with diabetes is CVD, good glycaemic control decreases the cardiovascular risk by 42%, 60 % with an intensive reduction of HbAC. ( American Diabetes Association, 1999 ) ( Genuth, S., 2006 ) ( Skyler, J.,2009 )

Our findings showed that more than 20 % of our patients are illiterate, the mean duration of diabetes is more than 13 years and the mean HbAC is more than 9 . with a mean HBAC of more than 9 most of our cardiac patients had uncontrolled diabetic, about 37 % of our intervention group have impaired renal function - Creatinine clearance less than 60 ml\min, all of uncontrolled diabetic and impaired renal function increase the cardiovascular risk and complication. More than 60 % of our diabetic, cardiac patients had poor adherence to their medications. (Table 5 ) With more duration of diabetic disease cardiovascular risk increases and that is clear with more than 12 years of diabetic duration in our cardiac patients.Our intervention group showed that about 21 % need adding another drug, 18 % need Insulin to be added, 40.5% of our patients needed a change in doses, more than 60 % had poor medication adherence and more than 21 % were illiterate. ( Figure 4 ) These results highlight the need for a multidisciplinary approach to the management of patients focusing on associated factors identified for poor glycemic control to maintain good glycemic control and improve outcomes, our findings from our study and previous studies showed that the clinical Pharmacist as a member of a multidisciplinary team has important roles in diabetes management to achieve the goal of treatment, decrease mortality and morbidity, improve quality of life, and delay complication by education, counseling on drug, disease, diet, exercise, smoking cessation and lifestyle modification, self-management, an assessment and adjustment of anti-diabetic medications, identifying and solving drug-related problems in co-operation with physician and other diabetes health care team. (Figure 5 ) All of these interventions helped in improving glycemic control, provided the more advanced diabetes services as pharmacists reviewed the patient’s drug re-fill history and identified poor adherence, and helped in identifying the barriers to medication taking in diabetic patients

In this study and all other studies, it was proven that the intervention was successful in achieving the goals of HbAC in diabetes patients and reducing the complications, improving diabetes self-management and adherence to diabetic medication. Therefore, integrating the clinical pharmacists into a health care team had shown to be effective in improving the outcomes in diabetic patients. (Demoz, 2018) (Van Dril, 2019)( Kharjul,2018) (Powers,2020) ( Willens , 2011) . The American Diabetes Association Standards and the International Diabetes Federation (IDF) recognize pharmacists as one responsible for teaching self-management practices, reviewing the treatment plan, optimizing medication therapy, promoting adherence to medication and blood glucose monitors, referring diabetic patients to other healthcare services when needed which help in decrease health care cost and utilization. (Dickinson, ,2019) (El Hajj,,2018 ). A study by Presley, 2019 concluded that clinical pharmacists have a role in diabetes care to enhance medication adherence. ( Presley,2019) In this study about 63 % of our patients had bad medication adherence, involving of clinical pharmacist in patients care can improve adherence by patients counseling and explain the importance of medication and the importance of good glycemic control to the patients

In the hospital, both hyperglycemia and hypoglycemia are associated with adverse outcomes, inpatient goals should include the shortest safe stay, prevention of both hyperglycemia and hypoglycemia, promote and preventing complications. Implementation of a clinical pharmacist in glycemic control of hospitalized, postoperative patients led to safer practice and better quality of glycemic care, and lower hypoglycemic episodes. According to the standards of medical care in Diabetes—2021, Collaborative, multidisciplinary teams are the best practice to provide care for people with chronic conditions such as diabetes to facilitate adherence and patients’ self-management ( American Diabetes Association, 2019) ( Mularski, 2012 ) ( American Diabetes Association,2021) (Butt,2016) ( Warrington,2012). The results of our study are most similar to a study by Abuloha S. (2016); and Katherine Fukunaga, 2020 which showed that a clinical pharmacist has a role in monitoring diabetic patients and decreasing HbAC however their study focused on the role of clinical pharmacist in Insulin management in an out-patient setting. (Abuloha,2016) ( Fukunaga, 2020) (Hughes ,2017) (Alsuwayni,2020)

In our study, HbAC , and FBG were significantly reduced with pharmacists’ interventions compared with usual care. In our study the patients did not get the therapeutic target of HbAC and FBG, patients were followed for six months but with time clinical pharmacists' interventions would help patients meet the target of their treatment.

Limitation of the study :

Our study is open study design (not blinded). Performance bias in both groups was likely in this study.

Clinical pharmacist As a part of a multidisciplinary team has a positive impact on monitoring diabetes in admitted cardiac patients, to achieve the goal of treatment, decrease mortality and morbidity, improve quality of life, and delay complications. Clinical pharmacists’ interventions are more effective than usual care in decreasing HbAC levels, and decreasing FBG in admitted, diabetic cardiac patients.

Ethics approval and consent to participate :

The research had been approved ; IRB registration number with King Abdulaziz for Science and Technology , King Saudi Arabia (KACST , KSA ) : H-01-R-012 . IRB registration Number with Office of Human Research Protection (OHRP/NIH ) , USA :IRB 00010471, Approve Number Federal Wide Assurance NIH , USA : FWA 00018774 , IRB Log No : 19-135 – 03/03/2019 .

All methods were performed in accordance with Declaration of Helsinki guidelines and regulations .

Ethics approval and consent to participate’ section :

Consent for participation :

the informed consent has been obtained from all participants in “All participitants had been signed a consent form to participitate under the supervision of KFMC- research center “ .

Consent for publication :

Not applicable

Availability of data and materials :

All data are available upon request from the main author , Sanaa Mekdad .

Competing interests :

All authors have no conflict of interest .

Funding :

The research had not been funded .

Authors' contributions :

All authors contributed to the conceptual design of the study, data collection, analysis of results and reaching a mutual understanding on the conclusions .

S.M. Contributed in writing the abstract , statistical analysis and manuscript writing .L.A. Contributed in data collection , data analysis , manuscript reviewing .

Acknowledgements : We would like to show our gratitude to cardiology department of KFMC for sharing their wisdom with us during this research .

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No competing interests reported.

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