Readiness to Implement Symptom Management Care Pathways in Pediatric Cancer

Background: To describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation. Methods: We included 25 pediatric oncology hospitals in the United States that supported a grant submission to perform a cluster randomized trial in which the intervention encompassed care pathways for symptom management. A survey was distributed to site principal investigators to measure contextual elements related to care pathway implementation. Questions included the inner setting measures of the Consolidated Framework for Implementation Research (CFIR), study-specific potential barriers and the impact of the COVID-19 pandemic on clinical research. The Wilcoxon rank sum test was used to compare characteristics of institutions that agreed that their department supported the implementation of symptom management care pathways vs. institutions that did not agree. Results: Of the 25 sites, one withdrew because of resource constraints and one did not respond, leaving 23 institutions. Among the seven CFIR constructs, the least supported was implementation climate; 57% agreed there was support, 39% agreed there was recognition and 39% agreed there was prioritization for symptom management care pathway implementation at their institution. Most common barriers were lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Most sites reported no negative impact of the COVID-19 pandemic across research activities. Sites with fewer pediatric cancer patients were more likely to agree that staff are supported to implement symptom management care pathways (P=0.003). Conclusions: The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic was not a major barrier to clinical research activities in pediatric oncology. Clinical Trial Registration: NCT04614662


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Background Most pediatric patients receiving cancer treatments experience bothersome symptoms that are poorly documented and often not treated. [1,2] Symptom control is important as there is a strong correlation between increasing symptom burden and inferior quality of life. [1] Improving symptom control is likely to require multiple approaches including systematic symptom screening, symptom feedback to healthcare professionals and adherence to symptom management clinical practice guidelines (CPGs). [3,4] To address symptom screening, we developed the Symptom Screening in Pediatrics Tool (SSPedi), which measures the degree of bother for 15 symptoms considered most important by patients. [5][6][7] We then developed Supportive care Prioritization, Assessment and Recommendations for Kids (SPARK), which is a web-based application that consists of a symptom screening component centered on SSPedi and a supportive care CPG component. [8][9][10] To test whether SPARK can improve symptom control and quality of life for pediatric patients with cancer, we were awarded operating grants from the National Institutes of Health (1R01CA251112) and the Canadian Institutes of Health Research (PJT 169165) to perform a cluster randomized trial of 20 institutions in the United States. This trial will randomize 10 sites to intervention and 10 sites to control (usual care) groups. The intervention will include prompts to complete symptom screening three times weekly for newly diagnosed pediatric patients with cancer, symptom feedback to the primary healthcare team and adaptation of care pathways for symptom management based upon CPGs. Thus, intervention sites will need to adapt and implement evidenced-based care pathways. Planning of the trial started concurrently with the coronavirus disease pandemic (COVID-19) [11,12] thus adding potential barriers.
To begin to understand potential barriers relevant to the planned trial including care pathway implementation, we circulated a survey to sites that had committed to the trial at the grant submission stage from which the 20 participating sites would be chosen. Objectives were to describe barriers to pediatric cancer symptom management care pathway implementation and the impact of the COVID-19 pandemic on clinical research evaluating their implementation.

Methods
The study was approved by the Research Ethics Board of The Hospital for Sick Children. The sites were 25 pediatric oncology hospitals in the United States supporting a grant submission to conduct a cluster randomized trial focused on improving symptom control in pediatric cancer patients. The institutions were chosen to re ect variation in pediatric vs. mixed adult and pediatric sites and based upon previous research collaborations. One component of the intervention is the institution-speci c adaptation of symptom management care pathways that are based upon CPGs. The purposes of the baseline survey were to facilitate site selection (20 of the 25 potential sites would be chosen), to measure baseline characteristics of participating sites and to anticipate barriers and facilitators to trial conduct and care pathway implementation that could in uence implementation processes.
CPGs are statements developed to facilitate healthcare-related decisions; they are the foundations for translating evidence to clinical practice. [13] The components underpinning CPG development include a systematic review of the literature and a panel that weighs the bene ts and harms of different treatment options to arrive at recommendations. [13][14][15] Care pathways are tools that can improve CPG implementation. They can be de ned as "structured multidisciplinary care plans which detail essential steps in the care of patients with a speci c clinical problem." [16] The survey measured baseline characteristics including institution, patient and healthcare professional characteristics. In order to understand potential barriers to symptom management care pathway implementation, we used three approaches. First, we used the Consolidated Framework for Implementation Research (CFIR). [17,18] The CFIR is a conceptual framework that includes factors that may in uence intervention implementation. We focused on the inner setting measures that include the following constructs: culture, culture stress, culture effort, implementation climate, learning climate, leadership engagement and available resources. Of these constructs, implementation climate was thought to be potentially particularly important to successful implementation given its speci city to the task. Each of the questions was rated on a 5-point Likert scale consisting of 1="strongly disagree"; 2="disagree"; 3="neutral"; 4="agree"; and 5="strongly agree". We dichotomized those who agreed (score of 4 or 5) vs. those who were neutral or disagreed (score of 1, 2 or 3). We also used a second set of questions that were speci c to the proposed study and asked if the lack of the following were potential barriers to symptom management care pathway adaptation and implementation: person-time to create care pathways and champion their use; education and mentorship around care pathway use; hospital leadership support; interest from physicians; interest from allied health; information technology resources; and collaboration between different disciplines. These were rated on a 5-point Likert scale representing the degree to which they were a barrier: 1="not at all"; 2="a little"; 3="somewhat"; 4="a lot"; and 5="extreme". Third, given the timing of the COVID-19 pandemic related to full grant funding (R01 notice of award July 2020), we also asked about the impact of the pandemic across the spectrum of clinical research activities.
The primary outcomes were related to support, recognition and prioritization of symptom management care pathway implementation from the CFIR implementation climate construct. The survey was disseminated to the participating sites by email and completed in REDCap. The respondents were the site principal investigators; they could consult with other institutional personnel to facilitate survey completion.

Statistics
Descriptive statistics were used to summarize baseline characteristics and potential barriers to symptom management care pathway implementation. We compared institutional characteristics of those that agreed that their department supports, recognizes and prioritizes the implementation of symptom management care pathways vs. those that did not agree using the Wilcoxon rank sum test. Analyses were performed using R studio version 3.6.1, The R Foundation for Statistical Computing.

Results
Of the 25 sites who supported grant submission, one withdrew because of institutional resource constraints and one did not complete the survey, leaving 23 institutions included in the analysis. The survey was completed between August 5, 2020 and September 9, 2020. Table 1 describes institutional, patient and healthcare professional characteristics. Within all institutions, health care professionals create orders in the electronic health record for symptom prevention and management. The median number of new pediatric cancer patients diagnosed annually was 90 (interquartile range (IQR) 63 to 200). All institutions were described as not-for-pro t. The median number of physician full time equivalents was 9 (IQR 5 to 13).  Table 2 shows the results of the inner setting measures from the CFIR. Across most constructs, at least 70% of institutions agreed that the culture, climate, leadership and resources facilitated symptom management care pathway implementation. With respect to the implementation climate construct, less than 70% of respondents agreed or strongly agreed with the following positively framed statements: "department staff gets the support they need to implement care pathways for symptom management" (57%), "department staff gets recognition for implementing care pathways for symptom management" (39%) and "implementing care pathways for symptom management is a top priority of the department" (61%). Respondents from 35% of institutions indicated that "staff members often showed signs of stress and strain". In general, when there is agreement that change needs to happen in the department we have the necessary support in terms of: sta ng 16 70% The following are available to make implementing care pathways for symptom management work in our department: patient awareness/need 20 87% The following are available to make implementing care pathways for symptom management work in our department: provider buy-in

83%
The following are available to make implementing care pathways for symptom management work in our department: intervention team 19 83% * n -number of respondents who agreed or strongly agreed Table 3 shows additional barriers to implementing symptom management care pathways among respondents. The most common barriers (somewhat, a lot or extreme barrier) were as follows: lack of person-time to create care pathways and champion their use (35%), lack of interest from physicians (30%) and lack of information technology resources (26%). Severe barriers (a lot or extreme barrier) were rare and the most common was the lack of person-time to create care pathways and champion their use (9%). A lot or extreme barrier 1 4% Table 4 illustrates the impact of the COVID-19 pandemic on research activities at the institutions. Most sites reported no negative impact of the pandemic across research activities. The most common activities that were a lot more di cult or almost impossible were executing contracts (9%), study activation (9%) and accessing patients in person (9%). A little more di cult 9 39% A lot more di cult or almost impossible 0 0% Table 5 compares the attributes of sites that agreed that symptom management care pathway implementation was supported, recognized and prioritized vs. those that did not agree with these statements. Sites with fewer newly diagnosed cancer patients and those with fewer physician, nurse practitioner and physician assistant full time equivalents were signi cantly more likely to agree that their staff are supported. Sites with a larger percentage of black patients were signi cantly more likely to agree that their staff receives recognition for implementing symptom management care pathways and that implementation was a priority. Abbreviations: IQR -interquartile range; MD -medical doctor; DO -doctor of osteopathy * Rated on a 5-point Likert scale ranging from strongly disagree to strongly agree. Those who stated they agreed or strongly agreed were categorized as "agree"

Discussion
In this study, we found that few survey respondents anticipated challenges with supportive care implementation. However, potential barriers that were reported lay within the implementation climate construct of CFIR and were lack of support, recognition and prioritization at the participating institutions.
Lack of person-time to create care pathways and champion their use, lack of physician interest, and lack of information technology were other important potential barriers reported with respect to developing and implementing symptom management care pathways. However, the COVID-19 pandemic does not appear to be perceived as a major barrier to research conduct.
We found that unfavorable implementation climate may be a potential barrier to care pathway implementation. Other studies have also identi ed this construct as a potential problem in program implementation. [19,20] It is interesting that smaller sites reported receiving more support for care pathway implementation. It is possible that smaller sites are more likely to provide verbal and non-verbal support of initiatives in general and if this is true, identifying ways to provide this type of support across institutions could be important. Such support could include wide availability of research staff to address questions and provide educational materials. It may also be important to identify site champions who can provide this type of support locally. The nding of greater support at institutions with a greater percentage of black patients may be spurious. It also may re ect additional supports given to institutions that are minority based National Cancer Institute Community Oncology Research Program sites.
We found that the COVID-19 pandemic did not appear to be a major barrier to research conduct. This nding is in contrast to a recent meta-analysis suggesting that trial delays and cessation were common and were a direct consequence of the pandemic.
[21] Our ndings may differ because the survey was distributed later in the pandemic, when many institutions had adapted to it. Further, some institutions have made distinctions based upon whether research activities are in person vs. not in person and whether they are essential vs. not essential. Given that our trial could be conducted entirely remotely, and since some could consider this type of trial essential, respondents may have anticipated fewer barriers compared with other research studies.
The strengths of this study include the utilization of an established framework (CFIR) in addition to studyspeci c items in order to identify potential barriers to care pathway implementation. This will allow important contextual elements to be evaluated for their future relationship to implementation strategies and outcomes. Another strength is the evaluation of the impact of the COVID-19 pandemic on clinical research, a timely and important question. However, the study is limited as two institutions either dropped out or did not complete the survey; they are likely to be different than the 23 institutions that did complete the survey. In addition, these questions were mainly answered by a single individual, namely the site principal investigator. Perspectives of other healthcare professionals at the site could be different. Finally, sites agreed to provide support at the grant submission stage, suggesting they believe that symptom management is important. Thus, participating sites are likely a positively biased cohort and the "typical" site may report more barriers to care pathway implementation.

Conclusions
In conclusion, respondents at pediatric oncology institutions expected few barriers to symptom management care pathway implementation at their institutions. The most commonly reported barriers to implementation were lack of support, recognition and prioritization. The COVID-19 pandemic was not a major barrier to clinical research activities in pediatric oncology. Availability of data and materials: The datasets used or analyzed during the current study are available from the corresponding author on reasonable request.

Abbreviations
Competing interests: The authors declare that they have no competing nancial interests.