Parkinson's disease (PD) is a neurodegenerative disorder characterized by tremor, bradykinesia, rigidity, and postural instability. Degeneration of dopamine-producing neurons results in PD impairments to motor function (Cheron et al., 2017). Levodopa remains the gold standard treatment for PD symptom management; however, the long-term use of oral levodopa is associated with the development of significant complications including motor and nonmotor fluctuations and dyskinesias. Device-aided treatments such as levodopa-carbidopa intestinal gel (LCIG) infusion may be an option for patients with advanced PD on long-term oral levodopa treatment with motor and nonmotor complications. Continuous infusion of LCIG is delivered via a percutaneous endoscopic gastrostomy tube with a jejunal extension (PEG-J) connected to a portable pump. This allows for more consistent plasma levodopa levels, improving motor and nonmotor fluctuations due to prolonged use of oral levodopa. However, complications associated with the tube and peristomal site are common (Fernandez et al., 2015; Lang et al., 2016).
A number of device-associated adverse events (AEs) have been reported in the literature; however, appropriate management protocols have not been discussed in detail. A 7-year analysis of patients with PD on LCIG therapy in 2012 found that 12 of 59 patients developed peristomal infection, and 55 of 59 patients had problems related to the tubing or infusion device (Zibetti et al., 2014). A retrospective multicenter observational study also showed that 74 of 102 patients experienced at least one tube and/or peristomal AE such as tube dislocation, kinking, occlusion, peristomal granulation, and infection (Yamashita et al., 2021). An expert consensus document on the clinical management of continuous infusion of LCIG recommended a multidisciplinary team approach to management with patient and caregiver education as a priority (Garcia et al., 2016). Given the common occurrence of minor complications, it is imperative that patients are educated on how to properly manage and prevent cutaneous and intraluminal stoma-site complications.
Background
In partnership with a customer service support program in the community, there is an existing process in which patients are screened for eligibility for both LCIG and the PEG-J insertion, given education about the PEG-J and pump, and received follow-up phone calls to see how they are managing. Although an overview on stoma-site care is provided before and after PEG-J insertion, there is no routine stoma assessment for early identification of stoma complications. Inconsistencies in the availability of resources in the community to provide support and variability in the practice and skill of healthcare practitioners can also affect timely treatment of stoma-site complications.
The absence of standardized patient education for tube site care and maintenance is concerning. The PEG tubes enable patients to receive nutritional support, hydration, and medication treatment at home. However, this places responsibility on the patients, their caregivers, and their local care team who may not have access to educational materials or have the experience in dealing with PEG complications (Martin, Blomberg, & Lagergren, 2012). If patients do not know how to care for their tube or do not have access to resources with expertise in PEG management for assessment, cutaneous and intraluminal stoma-site complications can occur. These complications leakage, hypergranulation, blockages, infection, or buried bumper syndrome (Ojo, Keaveney, Wang, & Feng, 2019). The occurrence of these clinical problems can negatively affect one's quality of life through pain, infection, and interruption of therapy. Lack of education, ongoing support, and the development of complications can also result in increased healthcare utilization through outpatient, inpatient, and emergency department visits.
In an urban academic outpatient clinic, the clinical team recognized the need to improve care for this patient population. Specifically, the team identified an opportunity to enhance patient education on stoma-site care and PEG maintenance and timely access to stoma care resources in the community and developed a quality improvement (QI) initiative. The objective of this QI initiative was to create a standardized education and assessment pathway to enhance self-care and reduce stoma-site and tube complications.
Methods
The QI initiative took place in an outpatient clinic within an urban academic teaching hospital from October 2018 to December 2019. A proposal outlining the components of the project was submitted to the hospital's research ethics board (REB) for review; the team was given a formal waiver of REB approval requirement.
A retrospective chart review of 50 consecutive patients who received LCIG infusion by PEG-J between January 2015 and September 2018 was conducted. Data collection was limited to date of PEG insertion, documented date and type of stoma-site complication, and date of PEG exchanges. Stoma-site complications were defined as pain, erythema, exudate, itching, rash, pressure injury, and hypergranulation. First mention of complication was measured as the time from initial PEG-J insertion or the most recent PEG-J system exchange. No patient identifiers were collected; instead, patients were assigned a number sequentially in the order the charts were accessed.
Intervention
A review of literature was conducted prior to chart review and implementation of interventions but found no clear guidelines on routine follow-up for percutaneous endoscopic gastrostomy tubes. Using the "Enhanced Recovery After Surgery: Best Practice Guideline for Care of Patients With a Fecal Diversion" (Miller, Pearsall, Johnston, Frecea, & McKenzie, 2017) as a model, a pathway was created to provide education and conduct stoma assessments at set points postinsertion and ongoing. Preoperative assessments were conducted by the gastroenterologist. Preoperative stoma-site markings were not included as PEG tube siting is determined by transillumination of the stomach during initial insertion.
A team was formed consisting of clinic nurses specializing in the management of patients on LCIG infusion; advanced practice nurses specializing in wound, ostomy, and continence; and physician partners in gastroenterology and neurology to evaluate the standard of care and conduct a review of existing PEG tube care resources. Patient education material was created specific to caring and maintaining the PEG-J system used for LCIG therapy. Principles of site care and maintenance focused on routine hygiene, keeping the external bumper within 0.5-1 cm from skin level and utilizing secondary securement to minimize excessive tube movement. Education was delivered to both patients and their caregivers and community partners. Community services such as home care and the customer service support program were engaged to reinforce the same care principles.
Using a rapid-cycle improvement model, the patients receiving LCIG therapy via PEG-J were placed prospectively on the standardized education and assessment pathway. This pathway comprised patient education on stoma-site care and tube maintenance and routine stoma assessment by a nurse specializing in wound, ostomy, and continence (NSWOC). Patients who were new to LCIG therapy were placed on the pathway at the time of PEG-J insertion and received patient education and stoma assessment by an NSWOC at set points: postinsertion Day 1, within 1 month during drug titration, and at each subsequent visit with the movement disorders clinic nurse (MDC RN). In keeping with the principle of patient-centered care, the stoma assessment was incorporated into the existing MDC clinic follow-up schedule and ad hoc to minimize unnecessary time and travel on the patient's part. A significant percentage of patients lived remotely. Those with preexisting PEG-J tubes were placed prospectively into the same pathway during their next contact with the MDC RN.
Evaluation
Stoma assessments were conducted at postinsertion Day 1, during titration, and at each subsequent movement disorders clinic visit. Incidences of stoma-site complications were determined in relation to the time from most recent PEG-J insertion or exchange.
At the end of the study period, a survey link seeking feedback was sent out electronically using an online survey platform. The survey was sent out to all 40 patients actively receiving LCIG therapy via PEG-J seeking feedback on the impact of the NSWOC on the patient experience. It was optional and anonymous.
Results
The study period was more than 14 months. Forty patients receiving LCIG therapy via PEG-J were seen according to the standardized assessment and education pathway totaling 104 visits. Half of the patients seen had their first visit with the NSWOC more than 1 year post PEG-J insertion. Only 10 visits did not have an assessment by the NSWOC due to vacation and sick days. All 40 patients received standardized education in the form of verbal teaching and a patient education pamphlet.
Baseline data revealed that 66% of patients (33/50) had documented stoma-site complications, half of which occurred within the first 6 months. Notably, six patients had documented complications within the first 4 weeks, requiring two counts of oral antibiotics and two counts of topical antibiotics.
Thirteen of 40 patients had no stoma complications (32.5%). After the implementation of the standardized education and assessment pathway, stoma-site complications within the first 9 months decreased. Review of baseline data yielded 20 incidences of stoma-site complications compared with six incidences postpathway. A decrease in incidences within the first month of insertion from six to one is also of significance (Table 1).
Baseline information on types of stoma-site complications was limited by the patient's description. The most common complications identified were excess tissue growth (hypergranulation), redness (erythema), and rash (Table 2). After comparison of pre- and postpathway implementation data, reports of rash and erythema decreased. Formation of excess tissue growth was mostly delayed to after the 1-year mark (Table 3).
A survey seeking feedback on the impact of the NSWOC was sent electronically by the MDC RN to all patients receiving LCIG therapy. Twelve surveys were completed with a response rate of approximately 25%; two surveys were removed because they had not interacted with the stoma nurse. Eight out of 10 respondents agreed that having access to a stoma nurse was very helpful and helped increase confidence in their ability to care for their PEG-J tube and site. All 10 respondents indicated that after receiving education, they experienced less degree of worry in their ability to manage their PEG-J tube (Table 4).
Discussion
The PEG-J Site Assessment Pathway was created to coincide with routine follow-up appointments with the MDC RN. During this QI project, the NSWOC was able to attend greater than 90% of patient visits to provide stoma-site assessment and patient education. Peristomal skin care and tube maintenance and securement were reviewed with the clinic patients. When site complications developed, a treatment plan was created with plans for follow-up.
In both baseline and postintervention groups, more stoma-site complications were observed after 1 year postinsertion. The most common type of site complication was hypergranulation, followed by erythema. Upon review, contributing factors to site complications included dyskinesia, failure to minimize movement of tube within the stoma tract, heat, moisture, suspected biofilm, and varying practices in site cleansing. Routine PEG-J-site assessments and the standardization of education given by the NSWOC have resulted in identification of risk factors and early identification and timelier treatment of stoma-site complications. The MDC RNs also reported anecdotal decrease in urgent phone calls from clinic patients regarding stoma-site concerns.
Key limitations included inconsistencies in frequency of follow-up visits. This may be due in part to remote areas of residence, or length of time that they have been on LCIG therapy. With the observed long periods of time between clinic visits, up to a year, frequency and timing of stoma assessments varied by patient. Depending on the neurologist, some patients may not receive active clinic nurse involvement. The team needs to bridge this gap by ensuring active multidisciplinary team involvement for all patients on LCIG therapy.
Conclusion
As PD progresses, fluctuations in motor and nonmotor complications such as dyskinesia, changes in posture, dementia, and autonomic dysfunction occur. Those receiving intraduodenal LCIG infusions as part of their disease management have the added responsibility of maintaining their PEG-J system and their stoma site to ensure patency and uninterrupted therapy. This can be a source of anxiety. The implementation of a standardized education and assessment pathway provides the opportunity for routine assessment, early identification, and timely management of stoma complications. Moreover, it provides patients with the ongoing education to support independence while they are receiving intraduodenal LCIG infusion via PEG-J tube. This increases self-confidence in the management of their medical device, thus improving quality of care and quality of life.
The standardized education and assessment pathway has resulted in improved satisfaction from patients and caregivers. Increased confidence in self-management also allows patients to socialize more, not being home bound due to pain, malodor, or drainage. It has resulted in the reduction of stoma complications, use of home care resources, and unnecessary use of advanced wound care products. The number of times a patient or family member contacts the clinical team regarding a stoma problem decreased, reducing the frequency of urgent telephone and clinic visits. These changes improved health outcomes have increased healthcare staff satisfaction.
An important next step to this initiative is to incorporate this practice into institutional policy so that those fully or partially dependent for care will also receive the benefit. This will ensure consistency in nursing practice, focusing on prevention and reinforcement of care principles, as opposed to responding to a problem. This may lead to decrease in unnecessary radiation exposure for "tube checks" and decreased unnecessary use of antimicrobials.
This project demonstrated positive results in skin care and self-management in a patient population that is elderly with multiple comorbidities requiring some level of assistance. A reduction in the incidence of stoma-site complications in a population with unique vulnerabilities suggests that this pathway and practice can be applicable in different practice settings. This method can be replicated and applied to other types of gastric tubes and patient groups.
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