Decreasing adverse events in a clinical research unit: A quality improvement project
Wednesday, June 1, 2016
Clinical research units provide a safe environment to conduct clinical trials that lead to new advancements in healthcare modalities for patients. Many regulations govern the conduct of clinical trials with human subjects, and with regulations come many ways in which research units have to report any event that is potentially related to the intervention being tested. These reports are classified as either adverse events or serious adverse event reports. An adverse event is a side effect that may be harmful and/or caused by the intervention.1
An adverse event can be either an observed event that is partially or entirely due to the intervention or totally unrelated to the intervention, but still occurring while the intervention is being tested.1 Adverse event reporting consumes time for all involved in the research process, i.e., nursing staff, principal investigators, and sponsors. The time to complete the paperwork is a cost not only to the research team, but to subjects as well. The principal investigator spends hours following up with the subject and team, determining if the adverse event was related to the intervention, and then completing documentation supporting the decision. This process, while important, can prolong the trial for weeks and may be completely unrelated to the actual intervention. Decreasing the number of adverse events, such as contact dermatitis secondary to electrocardiogram (ECG) electrodes, can also decrease the amount of time, money, and the discomfort to the participant during the conduct of research trials.
In an early Phase 1 research unit, contact dermatitis had become a problem in the Duke Clinical Research Unit (DCRU). Often, patients in telemetry units are allergic to electrode pads from ECGs or have contact dermatitis. However, this is rarely reported unless skin breakdown occurs or there is infection. However, in the early Phase 1 DCRU, contact dermatitis is not only a reportable adverse event, but also, it is uncomfortable for the research volunteer and can produce both hyperpigmentation and scarring causing their stay on the unit to be unpleasant. Contact dermatitis is common, with a prevalence in the United States of 136 per 10,000 people, according to the National Health and Nutritional Examination Survey (NHANES).2,3 Contact dermatitis presents as either an acute or chronic inflammatory reaction in response to substances that contacts with the skin.2 Acute contact dermatitis is characterized by pruritus, erythema, and vesiculation.2 The dermatitis associated with monitoring equipment placement, such as ECG pads, among the healthy adult research volunteers can be characterized as an acute, irritant contact dermatitis. Irritant contact dermatitis is caused by an external stimuli acting as an irritant that elicits a non-allergic inflammatory response.2,3 Irritant contact dermatitis represents about 80% of occupational contact dermatitis cases, which is where the most epidemiologic data regarding contact dermatitis has been reported.4 While a dearth of knowledge exists with regards to the economic impact of contact dermatitis adverse event reporting in clinical research, studies have looked at the economic burden of occupational contact dermatitis.2 In the DCRU, 35 of 80 subjects from one healthy volunteer study in a six-month period had contact dermatitis adverse events. A quality improvement step is needed to help alleviate the burden on the subjects as well as reduce costs and time of adverse event reporting when conducting research.
Evidence-literature review and synthesis
Cases of contact dermatitis from ECG electrodes were reported as early as 1986 and continue to this day. The first case report reported contact dermatitis at the Cleveland Clinic in the medical intensive care unit on an 88-year-old female.5 Patch testing and visual assessments revealed positive results to ingredients on the adhesive of the electrode itself.5 The following year, four more cases were reported using patch testing and visual assessment again, in males and females ranging from 64-80 years of age at different facilities.6 Interestingly, the agents in the adhesive were the culprits. In subsequent years of case reports, many agents in the adhesive on the back of the electrodes were found to be positive during patch testing and linked to the cases of contact dermatitis.7-13 All case reports were found in adults’ ages 30-86 years, and no comorbidities were inter-related that could have predisposed these adults to contact dermatitis. Multiple allergens associated with contact dermatitis and electrode use were brought to attention in these case reports, and the assessments used in all of these cases were patch testing and visual assessments.7-13
In 2005, a systematic review was conducted to examine the literature regarding contact dermatitis treatment and prevention in adults.14 This systematic review showed that there were a limited number of interventions that effectively prevented or treated irritant contact dermatitis; however, the evidence pointed to basic skin care of cleansing the skin with soap and water before application of any adhesive type application on skin and careful assessment of the skin.14 Similar findings from four randomized controlled trials (RCTs) concluded that the use of barrier ointments and creams did not significantly decrease the occurrence of irritant contact dermatitis and that any protection from the barrier creams was related to the amount of product applied after cleansing the skin.15-18
Overall, the evidence supports the importance of good hygiene before application of adhesives, such as electrodes, and the assessment of the skin during the time electrodes are on and after they are removed.19 It also supports the importance of not using alcohol-based cleansing products prior to application or for removal, as this has been shown to cause an increase in irritant contact dermatitis.20,21 Thus, the evidence supports the implementation of a standard skin care work instruction prior to application of ECG electrodes in healthy adult populations.
The overall goal of this quality improvement project was to implement a standard skin care work instruction for skin hygiene (cleansing) prior to the application of ECG electrodes in healthy adults. The effects of this practice change on the incidence of contact dermatitis adverse events was evaluated in healthy adults volunteering for research studies involving an ECG assessment in a general clinical research unit. The specific aims were:
- Compare the rate of contact dermatitis adverse events during a six-month interval before and after the implementation of the skin care work instruction prior to the application of ECG electrodes in healthy adults.
- Evaluate barriers to implementation of the standard skin care work instruction in healthy adults in a clinical research unit setting.
Materials and Methods
This quality improvement project utilized a two independent group design. The first group was evaluated before the implementation of a standard skin work instruction (see Appendix A) prior to the application of ECG electrodes, and the second group was evaluated after the implementation of the skin care work instruction in healthy adults who volunteered to participate in research studies involving an ECG procedure in the DCRU. The clinical outcome was the absence or presence of contact dermatitis adverse events in each healthy adult. The pre and post-implementation observation intervals were six months. The pre-implementation period was May 1, 2014, to October 31, 2014, with the education of the nursing staff on the standard skin work instruction occurring during the nursing skills week on the unit (October 15-31, 2014). All nursing staff on the unit received the education packet and team-based learning on the work instruction. The post-implementation period for the standard skin work instruction was November 1, 2014 to May 31, 2015. The project assessed absence or presence of contact dermatitis adverse events in 160 healthy adults (80 during the pre- and 80 during the post-period) who had volunteered to participate in a research study requiring ECG monitoring (≥ 4 hours).
Nursing staff were asked to assess barriers to implementation of practice change and to assess whether the skin preparation work instructions were performed during the post-implementation period. More specifically, nursing staff recorded their compliance with the new skin cleansing work instruction by documenting whether it was used with each healthy adult on the study plans used for the studies on the unit. If the work instruction was not followed, the nurse documented the reason. Adverse event reporting and standard visual assessment techniques per nursing were also used to ensure that the participants had cleansed skin prior to application of the ECG electrodes.
Data Collection Plan
Sample demographics — namely age, ethnicity, and gender — were collected for the participants assessed during the pre and post-implementation period. For each participant, the absence (0) or presence (1) of a contact dermatitis adverse event was recorded. Nurse compliance with the practice change was also collected on the nursing documentation during the post-implementation period and barriers to implementation were derived from the reasons the standard skin work instructions could not be followed as noted on the nursing documentation. Data were extracted from the records by hand.
Demographic characteristics are summarized in Table 1. Independent t-tests and Fisher’s exact tests were conducted to compare age, gender, ethnicity, and the incidence rate of adverse event contact dermatitis in pre and post-implementation groups. As shown, there were no differences between groups for demographic characteristics.
Differences in the proportion of healthy adults with contact dermatitis adverse events in the pre- and post-period were tested using a Fisher’s exact test. Post-implementation failure and barriers to implementation were summarized using number and percent. Non-directional statistical tests were conducted with the level of significance set at 0.05.
For hyperpigmentation a Fischer’s Exact test revealed a significant decrease from pre (n = 9, 11%) to post (n = 0, 0%), P = 0.011. Similarly, for contact dermatitis adverse events, there was a significant decrease in the percent of patients with that condition from pre (n = 35, 43.8%) to post (n = 4, 7.4%), P = 0.000.
Overall, the skin care work instruction decreased the incidence of contact dermatitis associated with ECG electrodes in the early Phase 1 research unit. The nursing staff stated that once the work instruction became a routine for them, it was very easy to use. However, there were several barriers to implementation at the beginning because of the time it added to obtaining an ECG due to the extra step of cleansing the skin. Although this was a barrier at the beginning, through regular practice it became just another daily routine for staff. It was easier on the research unit to make sure everyone used the work instruction because everything had to be done the same and documented for every participant. One participant out of 80 did not have the work instruction used on because he did not want his chest to be cleansed. The participant stated that he had already taken a shower. Other limitations to this quality improvement project included the differences in the two studies for which the electrodes were used. The pre-data were based on a study that spanned for 48 hours of wearing the electrodes, where as the post-data came from a study where the electrodes were only used for 24 hours. However, this just strengthened the step in the work instruction that daily removal and cleansing go skin is very important.
The team-based learning model was effective in implementing this new step in the day-to-day routine of the staff. At project initiation, the staff met to discuss their concerns and to get their questions answered about why this project was important and how to carry out the work sheet instruction. By involving everyone on the unit and letting them know the importance of decreasing the number of adverse events, not only to the integrity of the data but also to the satisfaction of the participants, everyone took ownership of the project. As previously mentioned, using a work instruction like this on units in a hospital setting where ECG electrodes are used may not be as successful as it was on the research unit due to the culture that already exists on research units. More time would be involved in following up with the staff on hospital units to make sure the work instruction was used every time electrodes were placed. However, if an inpatient-setting unit has a particular skin care issue such as contact dermatitis, perhaps a revised work instruction tailored to the particular need would be suitable in solving the problem.
- Ioannidis JPA, Evans SJW, Gøtzsche PC, et al. Better reporting of harms in randomized trials: An extension of the CONSORT statement. Ann Intern Med 2004;141:781-788.
- Cashman MW, Reutemann PA, Ehrlich A. Contact dermatitis in the United States: Epidemiology, economic impact, and workplace prevention. Dermatol Clin 2012;30:87-98.
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- Overview of dermatitis. UpToDate, 2014. Available at: http://mclibrary.duke.edu/
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- Winker R, Salameh B, Stolkovich S, et al. Effectiveness of skin protection creams in the prevention of occupational dermatitis: Results of a randomized, controlled trial. Int Arch Occup Environ Health 2009;82:653-662.
- Schliemann S, Petri M, Elsner P. Preventing irritant contact dermatitis with protective creams: Influence of the application dose. Contact Dermatitis 2014;70:19-26.
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By Ashley L. Robertson-Watson, MSN, APRN, AGACNP-BC
Barbara Turner, PhD
Julie A. Thompson, PhD and
Robert J. Noveck, MD, PhD
This article was reprinted from Research Practitioner, Volume 17, Number 2, May-June 2016.