Optimizing the Care, Safety and Wellness of Patients With Known Diabetes Through Laboratory Medicine and a 5-Stage Multidisciplinary Clinical Care Pathway
Zulekha Hospital Dubai | Dubai, United Arab Emirates
KEY PARTNERS/STAKEHOLDERS Magdy Allam | Mariam Younan | Mohamed Abdelhamid | Eman Yousef | Muhammad Khan
The prevalence of Diabetes Mellitus has rapidly increased over the past four decades, making it a major global healthcare challenge. Diabetes is a metabolic disorder characterized by inadequate blood glucose control, resulting in dysregulated blood glucose levels. Most cases are Type II diabetes, and may initially start with the development of insulin resistance, which begins insidiously and is associated with aging and obesity. There is an opportunity and a significant need for improving the management of these patients to stem or avoid long-term health risks.
Hyperglycemia has significant detrimental impact to multiple body organs and tissues, including the heart, the vasculature, kidneys, eyes, immune system and peripheral nerves. Diabetes is the leading cause of chronic kidney failure, a significant contributor to heart disease and a leading cause of blindness. Diabetic peripheral neuropathy developing from small nerve damage results in unrelenting pain and disrupted sensation, leading to ulcerations particularly of the heel and feet. Infections are both more common and more difficult to resolve.
Persistent hyperglycemia hastens the development of complications and need for intervention. Uncontrolled diabetics are at greatest risk. Zulekha Hospital Dubai recognized the need to improve outcomes for patients who were known diabetics and formed a multidisciplinary team to create an enhanced clinical pathway to improve management of these patients. Using the international guidelines, the team developed a 5-stage approach designed to optimize diabetic care. This facilitated better early detection of preventable diabetic complications by collaborating across departments and undertaking interventions as needed. The clinical care pathway was implemented for all patients seen in the diabetic clinic on Jan. 1, 2021.
Significant benefits resulted, including increased patient engagement – which is essential for effective diabetic management – reduced patient morbidity and decreased overall healthcare costs.
There were several important impacts on patient management, intervention and outcomes. Management of glycemic levels was improved for all monitored patients. This was measured using glycosylated hemoglobin, HbA1c, a blood measure that provides an accurate reflection of the average blood glucose across the past 90 days. Compared to the baseline levels, there was a collective decrease of 11.5% in HbA1c levels, indicating improved glycemic control. Diabetic patients became more engaged with a 30% increase in patient participation in the serial targeted and routine laboratory testing, from 70% at the start to 100% after program initiation. Implementation of the pathway enhanced the earlier detection of diabetic complications, including diabetic nephropathy (11% to 19%), retinopathy (6% to 14%) and neuropathy (14% to 36%). Significantly, diabetic foot infections were detected earlier, resulting in no amputations being required following the start of the initiative. The team realized a 4.5-fold improvement (13.8 to 3.1) in cardiovascular risk scores, which mitigated long-term risk and associated diabetic complications.
Not only were the patients more engaged, but they spread the word to other patients not involved in the program. This enhanced the value of the program and increased the hospital’s reputation throughout the community. This led Dr. Zia Ur Rahman Shah to comment, “repeated feedback across patient surveys and word of mouth of diabetic patients have consistently reinforced positive patient experiences, which have enhanced our health system’s reputation and referrals.”
The improved patient management led to both increased clinician satisfaction and clinical confidence, according to Dr. Magdy Allam, head of the endocrinology department. “Implementation of the Zulekha Hospital diabetic pathway has not only been successful for our patients but has had a positive effect on our entire endocrinology department,” Dr. Allam said. “The team is proud of our work and outcomes, as our diabetic patients receive the best possible care.”
Dr. Mohamed Elshafei, a specialist neurologist, agreed that the program had a significant impact on clinical confidence.
“The increased detection rate of neuropathy in diabetic patients … increased my confidence in preventing a further chain of potential complications, including diabetic foot infection, as neuropathy usually presents first in the chain,” Dr. Elshafei said.
This program was additionally effective at reducing hospital admissions. Prior to implementing the pathway, 4% of diabetic patients required an admission for management of an episode of moderate to severe hyperglycemia, including one patient who was admitted with diabetic ketoacidosis, a severe complication of uncontrolled blood glucose. In follow-up 10 months after implementation of the pathway, no hospital admissions were required for diabetic patients due to hyperglycemia. This led to a reduction in healthcare costs, leading Dr. Sharmila C. Jadhav to note that “closely monitoring diabetic patients … had a considerable impact on mitigating preventable adverse outcomes, with less morbidity and mortality resulting from missed early diagnosis.” Dr. Jadhav continued, “Collectively, this saves costs for the patient and the overall health ecosystem, including payers.” By recognizing the need for better management of diabetic patients and developing and implementing a program addressing this need that demonstrated measurable improvements in patient care and outcomes, Zulekha Hospital Dubai was recognized by the UNIVANTS of Healthcare Excellence program.
ALTERNATIVES
The EPA recently recommended facilities be outfitted with continuous monitoring systems, new technology that enables realtime emissions tracking that facilitates prompt responses to leaks, and with more emissions controls. The technology is not currently required under federal regulations but may provide the agency with information to guide its upcoming rulemaking.
The FDA has begun several pilot programs with the private sector to explore potential alternatives to ethylene oxide for sterilizing medical devices. They are testing methods that use carbon dioxide, nitrogen dioxide, hydrogen peroxide and radiation, for example.
The FDA oversees the device approval process, which includes plans for sterilization. The agency’s role is to assess whether devices are sufficiently sterilized without being damaged. According to an FDA webpage dedicated to ethylene oxide, it does not regulate emissions or control what types of sterilants are used in the manufacturing process.
Alternatives to EtO exist, but none are scalable using the current logistics and engineering, the University of Illinois’ Orris said. Ethylene oxide is beneficial in the manufacturing process because it can sterilize several different materials at the same time by the truckload. This enables manufacturers to pre-package surgical kits with different materials, such as metal, paper and plastic, and sterilize them in large quantities.
Other options, such as heat, steam and gamma radiation, have limits. They can’t sterilize the same range of materials as effectively, which reduces throughput and creates patient safety concerns, according to the FDA.
“What you always discover is there are always problems with the alternatives, and we have to safely handle everything. But ethylene oxide just has to go,” Orris said. “You can’t do this stuff without releasing some of it, and when you release some of it, you raise people’s risk of cancer.”
In August, the FDA concluded that the pilot programs have “shown encouraging progress with new strategies to reduce EtO emissions.” Some facilities have been able to cut emissions 20% to 35% by reducing the concentration of EtO used in the sterilization process or by transitioning certain devices to alternative methods.
ENVIRONMENTAL JUSTICE CONCERNS
By the time Becton Dickinson applied for a permit in April 2021 to operate an EtO sterilization facility in Tucson, word had spread.
The proposed site is located in an industrial park near an Amazon warehouse on the city’s southeast corner. Nearly half of the population in the surrounding census tracts are people of color, and 30% are considered low-income.
Within that same community is one of the nation’s oldest Superfund sites, a 10-squaremile area that is home to Tucson International Airport and U.S. Air Force operations. A military contractor previously dumped degreaser into the land, contaminating the groundwater with trichloroethylene, a chemical known to cause kidney cancer.
Local officials later found polyfluoroalkyl substances, or PFAS, in the water supply. Exposure to PFAS can affect fertility, childhood development and immunity, and increase the
The FDA has begun several pilot programs testing (sterilization) methods that use carbon dioxide, nitrogen dioxide, hydrogen peroxide and radiation.
risk of cancer, according to the EPA.
The area is split by an interstate highway, has several large industrial parks and a military aircraft boneyard, and houses the city’s largest power plant, according to a spokesperson with the Pima County Department of Environmental Quality. More than half of the county’s top polluters are located there.
“This gas is a known carcinogen,” Tucson resident Jessica Sampson said at the public hearing last year. “It shouldn’t be regulated. It should be banned.”
The county air quality agency said it received more feedback on Becton Dickinson’s permit application than any other before, despite it not being designated a “major” source of pollution. “People are upset that it’s being located there and feel like there may be more appropriate places to put it that aren’t near people,” a spokesperson said.
A University of Arizona environmental justice analysis prepared for Pima County found the operations would potentially cause 19 more people per 1 million to develop cancer in the neighborhoods close to the plant, well within the EPA’s allowable range.
Although the cancer risks and projected ethylene oxide concentrations within the air are expected to be much lower than those that caused plant closures in other locations, residents don’t want it, said Pima County Supervisor Adelita Grijalva (D).
“It’s a community that’s already experienced historical trauma and environmental justice issues,” said Paloma Beamer, professor of public health at the University of Arizona in Tucson and co-author of the report. “Even though the estimates look really low, it’s been hard for people in the community to understand how we would want to allow any amount of carcinogen to be emitted into our community,” Beamer said.
But sterilizer companies need the extra capacity to serve hospitals in Western states. Arizona law forbids regulations to be stricter than federal standards, unlike in California, where tougher rules are in place. Grijalva and other local officials are pushing back and questioning the purported economic benefits the plant would provide the local community. The facility will employ 40 full-time workers, according to Becton Dickinson.
“We only have so much authority,” Grijalva said. “So when we are trying to do some really significant changes and do some positive stuff, we also are dealing with the lack of environmental restrictions and oversight at the state level.”
Looser laws have funneled development of ethylene oxide plants to places such as Arizona, Arkansas, Puerto Rico and Mexico. Tucson residents question why local officials would permit air pollution in their city that is outlawed in California. It’s the same feeling of disposability that Frunk said she has felt since learning her cancer may be related to the healthcare industry: “They knew what was going on. They didn’t care,” she said.
This puts healthcare providers working to build trust with communities in an unfavorable situation, the AHA’s Foster said.
“It concerns us that people would perceive healthcare as something that is acting in any way other than to promote their health and their best life going forward. Our members run part of the healthcare system and it’s all intertwined, but communities that have jurisdiction over this land need to be thinking about these issues of justice as well,” Foster said. “We can see the health effects of pollution and other environmental concerns on the poorest of our communities. And that is simply not fair.”
The City of Tucson approved the permit in May.
“It’s a community that’s already experienced historical trauma and environmental justice issues. Even though the estimates look really low, it’s been hard for people in the community to understand how we would want to allow any amount of carcinogen to be emitted into our community.” Paloma Beamer, professor of public health at the University of Arizona in tucson