INTRODUCTION

Clinical action plans (CAPs) are patient education tools used to enhance knowledge transfer from the medical team to the patient and caregivers. First applied to the management of asthma in children, CAPs that assist in the management of several pediatric diseases have emerged over the last few years. 2021 policy statement from the American Academy of Pediatrics (AAP) supports the use of written medical instructions [emphasizing the point-of-care use of clinical action plans] initiated by the clinician for the patient at discharge. The implementation of this strategy seeks to prevent medication errors and improve clinical outcomes for children [1▪▪]. The objective of this review is to highlight the advantages and disadvantages of the CAPs available to clinicians, and to establish a roadmap for pediatricians to implement CAPs into their routine, office-based pediatric practice. 

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CASE STUDIES Case #1

You are the primary care provider who is conducting a new outpatient visit for a previously healthy 4-year-old male with a chief complaint of abdominal pain associated with 1–2 hard bowel movements in the toilet per week over the last month. The child is accompanied by his mother who states, ‘I think my son is constipated. We tried giving him more water and fiber gummies at home for a few days, but that did not help. What should we do?’.

Case #2

You are the provider conducting a chart review of an established 10-year-old patient with asthma who is scheduled to see you tomorrow for a health maintenance visit before the start of the school year. The child spends his summer living with a different parent who is geographically distanced from your clinic. You review a secure message from the parent stating that the patient has ‘visited the ER many times for asthma attacks since his last well check’.

Case #3

You are set to evaluate a 5-year-old female with Cystic Fibrosis who recently moved to the area and is new to your Cystic Fibrosis Center. The parents mentioned to the medical assistant performing the encounter screening, ‘We are concerned because our child has had worsening diarrhea and has not gained much weight in the last year’. The medical assistant completes the screening and medication reconciliation before you enter the examination room.

Clinical action plan development and assessment

A variety of strategies can be used to develop a clinical action plan; the ‘universal precautions approach’ is the most common [2–4]. Pioneered by the National Institute for Health (NIH) and the American Healthcare Research and Quality (AHRQ) groups, the ‘universal precautions approach’ applies health literacy concepts by assuming all patients are at risk for (1) having difficulty comprehending health information, (2) assessing health services, and (3) acting upon medical instructions. Low health literacy in patients and/or caregivers have been linked with higher medical resource utilization and poorer outcomes in several chronic pediatric diseases (e.g. asthma, sickle cell disease, cystic fibrosis, chemotherapy-induced nausea and vomiting, and atopic dermatitis) [5–9]. In 2018, the NIH initiated the ‘Clear & Simple’ campaign, a 5-step process that employs the ‘universal precautions approach’ in developing patient education materials. This process has been used to develop many of the clinical action plans included in this review [10]. The stepwise developmental format of the ‘Clear & Simple’ campaign facilitates the creation of clinical action plans as unique and valuable patient education tools for targeted populations. This patient-centered design flow produces CAPs that help mitigate low health literacy by facilitating symptom recognition and responsive disease self-management at home. As a result of this shared developmental process, many CAPs incorporate the Green-Yellow-Red ‘stoplight system’ framework. Alternatively, some have begun to incorporate clinical pictograms and other multimedia. These sophisticated features can enhance the CAP experience for patients and clinicians.

Once developed, a clinical action plan should undergo a series of assessments by various stakeholders prior to implementation. These assessments serve to verify the applicability of the CAP to the clinical environment. Clinical action plans should be measured for readability, with a goal less than a 6th-grade reading level). Additional quality control metrics that incorporate validated questionnaires with patients and caregivers, medical librarians, and/or clinicians should be assessed as depicted in Table 1[11]. Some CAPs contain embedded decision support elements for the clinician, such as automation (e.g., weight-based pharmacotherapy dosing). Therefore, it is important to perform safety testing of these automated CAPs using digital, low-fidelity patient simulation before implementation. Finally, clinical teams must recognize that CAPs should only be deemed ‘validated’ when they have demonstrated superiority to standard of care during the study of clinical implementation. These investigative studies can be complex, time-consuming, and the subject enrollment and study process can be lengthy which delays the publication of their findings by many years after completion of the verification process for the CAP. Because our proposed verification process measures a CAP's potential usefulness based on direct patient/caregiver and clinician feedback, we recommend these CAPs be incorporated into routine practice even in the absence of validation studies [12].

Table 1 - Summarized methods for development and assessment of clinical action plans Outcome Measures Participant Type Assessment Tools Description Comment Pictogram Validation Patient/caregiver Transparency, translucency and recall Transparency ≥85%, mean translucency score ≥5, and recall ≥85% 1. Definitions of Transparency, Translucency, and Recall Readability Readability calculator Flesch-Kincaid Grade Level (FKGL), the Automated Readability Index (ARI), The Simple Measure of Gobbledygook (SMOG) Index, the Linsear Write Formula (LWF), and the Powers-Sumner-Kearl Formula Grade level assessment of the clinical action tool Readability Composite Score was calculated using Brian Scott's ‘Readability Calculator’ Patient/caregiver perceptions Patient/caregiver Consumer Information Response Form (CIRF) Completed by respondents on follow up survey after pictogram validation to assess: comprehensibility, design quality, usefulness. Validated tool for measurement of patient perceptions of written medical information 2. Explanation of CIRF survey and calculation of overall CIRF percentile score (OCPS) Understandability and Actionability of the plan Medical Librarian Patient Education Materials Assessment Tool for Printable Materials (PEMAT-P) Completed by Medical Librarians at various institutions Valid instrument to assess the understandability and actionability of print and audiovisual materials used in patient education 3. Additional details regarding PEMAT-P Suitability Clinicians modified Suitability Assessment of Materials (SAM ) Completed by clinicians Validated tool for measurement of clinician perceptions related to patient written materials 4. Additional noteworthy details regarding us of the SAM

1. Transparency. Transparency refers to the ability of an individual to guess an image's meaning without being provided details beyond the pictogram. Transparency was evaluated by asking participants to match a picture to the appropriate text (presented in random order). We followed the American National Standards Institute (ANSI) standard for adequate transparency: correct identification of each image by at least 85% of participants.Translucency. Translucency refers to the strength of the relationship between the picture and its intended meaning. Translucency was evaluated by pairing the appropriate, key clinical text with the image and asking the participant to determine how well the illustration resembled the key clinical element based on a seven-point visual analog scale (1 = no relationship, 7 = very strong relationship). The accepted standard for translucency is a mean score of at least five.Recall. Recall involves the determination of a patient's comprehension of the image meaning using short-term memory after an appropriate distraction part. Following the translucency assessment, each participant responded to the health literacy assessment: The Newest Vital Sign (NVS). The NVS served as a distraction event which compels the participant to rely upon short-term recall memory as opposed to working memory when judging the pictogram. Recall was measured by showing participants each image one-by-one and asking respondents to reproduce the appropriate, key clinical text using a ‘free response’ textbox. The threshold for the acceptable recall is when at least 85% of the participants correctly recall the image.2. The CIRF exhibits good external validity when measuring perceptions of written patient/medical materials by nonclinicians, particularly by patients and caregivers. The CIRF rates 17 items in total using a five-point Likert scale.3. The team followed the AHRQ PEMAT-P user guide to assess the clinical action plan. All items have the answer option of ‘Agree’ (1 point), ‘Disagree’ (0 points), and ‘Not Applicable’ (questions answered with ‘Not Applicable’ are excluded when calculating points, decreasing the total possible points). The scores are tallied after the assessment of the tool by all medical librarians. The total score was divided by the total possible points and multiplied by 100 in order to report a percentage score. Higher scores correlate with greater understandability and actionability of the material.4. The modified-SAM eliminates the cultural appropriateness scale because action plans should be created for general audiences rather than a specific target population (i.e., even a visiting family member with low HL who does not ordinarily care for the patient should be able to understand and follow the plan). For the 19 judged criterion, a modified SAM scoring system (0 = not suitable, 1 = adequate, 2 = superior) is used to grade each factor. We assign a ‘superior’ rating for a factor if at least 85% of the clinicians scored the factor as a 2. The final scores (overall suitability score) for each category were then used to calculate the total SAM score. Total SAM score was calculated by dividing the sum of the assigned overall suitability scores for each factor by the total number of applicable items.

Clinical action plans benefit patients

Many features can be included in a clinical action plan that benefit patients. Primary among these is the ‘universal precautions approach’ which establishes a clear and safe patient care therapeutic communique. CAPs enhance the therapeutic alliance by relying on the Green-Yellow-Red ‘stoplight system’ framework, the Universal Medication Schedule (UMS) and other low HL elements (e.g., clinical pictograms). The Green-Yellow-Red ‘stoplight system’ is a common CAP framework that divides the plan into colored zones which correspond to worsening clinical signs and symptoms: Green for good, Yellow for Bad, Red for Worse (or similar distinction). The UMS is an AHRQ-recommended feature designed to prevent medication errors by presenting pharmacotherapy dosing frequencies using 4 specific times of day (e.g., ‘morning,’ ‘noon,’ ‘evening,’ and ‘bedtime’ instead of as the number of times per day) [1▪▪]. CAPs can also be enhanced with clinical pictograms which direct patients and/or caregivers to recignize worsening disease signs and/or to escalate pharmacotherapy care at home. Pictograms should undergo a validation process by using the concepts of transparency, translucency, and recall prior to incorporation to the CAP [see pictogram validation methods in Table 1] [13▪]. The use of validated clinical pictograms in a CAP has been associated with greater patient adherence to pharmacotherapy and improved clinical outcomes (e.g., asthma) [2,14].

Unfortunately, some CAPs present management plans using a ‘menu’ approach. Many drug dosing options are displayed with only a few options being circled, checked, or highlighted by the clinician at the time of discharge [15]. This strategy violates AHRQ principles and can present confusion to the patient and risks for harm. Recently, CAPs have been designed to contain Simple Mathematic Automated Recommendation Tools (SMART), which can leverage background, embedded Javascript coding to provide various patient-centered features. These SMART features can be used to display only the medication(s) specifically selected for the patient's personalized care plan, eliminating ambiguity. Additional patient-centered SMART features can include: pop up of quick response (QR) code, ‘Patient How To’ videos demonstrating proper use of pharmacotherapy treatments (like use of respiratory device(s) in asthma) and AHRQ-recommended teach-back video(s). The teach-back video concept broadly summarizes self-management of the disease process and enhances patient and caregiver comprehension by demonstrating how to use the clinical action plan at home. Incorporation of these evidenced-based elements into CAPs can help patients recognize, correct, and mitigate the pitfalls of chronic disease management.

Clinical action plans benefit providers in practice

Historically, clinical action plans have been patient-centered tools completed at the close of a clinical encounter. The incorporation of SMART features into clinical action plans has made it possible for CAPs to support clinicians in a high-fidelity, decision-making model which automates recommendations from clinical practice guidelines (e.g., asthma symptoms based on the 2020 NHLBI Guideline) into clinical outputs (i.e., severity of the child's asthma) [16▪].

With many common pediatric diagnoses, such as asthma and constipation, low rates of guideline-concordant care have been demonstrated; this can contribute to higher referral rates and poor outcomes [17–20]. In 2008, Wisnivesky and colleagues surveyed 202 primary care providers to identify barriers to asthma guideline adherence. They showed that overall provider guideline adherence was low (62% inhaled corticosteroid use) and that low provider self-efficacy was associated with low rates of asthma action plan use. For constipation, separate teams from Mallon, Webster, and Hawa have used clinical informatics to demonstrate that implementation of a constipation action plan can significantly alter referral patterns, acute visits, or other relevant metrics in the general pediatrics and gastroenterology clinics [19,21,22]. Thus, CAPs with SMART features equip primary care providers with state-of-the-art diagnostic and management tools at point-of-care which can enhance guideline concordance and potentially improve outcomes.

In addition, SMART features assist primary care providers in selecting and dosing appropriate pharmacotherapy (e.g, providing a warning message when a child with persistent asthma is not prescribed inhaled corticosteroid or other guideline-based recommended treatment). Anecdotally, reliance on the SMART features of a clinical action plan for constipation, which automatically outputs age/weight-based laxative doses for clean-out and maintenance laxative therapies, has been effective in the author's general pediatrics clinic [13▪]. In another example, endocrinologists have reported more rapid and standardized adrenal insufficiency care by relying on the SMART-enhanced clinical action plan for adrenal insufficiency that eliminated the tedious creation of the traditional ‘adrenal crisis’ letter [23].

Clinical action plans also can provide decision-making support in the form of SMART features that display useful handouts for certain diseases and conditions. One example is the Allergy & Asthma Network ‘Respiratory Treatments’ 2021 chart that uses a clickable (on/off) function. This concept is adaptable to other pathologies like formula options for patients with failure to thrive, reflux, or other aerodigestive disorders. SMART features represent the latest evolution for clinical action plans and could be tailored to meet the needs of various chronic disease processes in supporting guideline-concordant care [24].

Clinical action plans can incorporate less sophisticated SMART features like free-text box fields that allow for customization of the plan beyond its preprogrammed inputs (e.g., providing dietary recommendations in the management of functional abdominal pain). CAPs that boast SMART features are flexible and can accommodate formulary changes, guideline updates, or free text input when patient circumstances or clinician preference warrant deviation from these general guidelines. Most CAPs appear in a Portable Document Format (PDF) that can be completed using a free Adobe Acrobat Reader platform, which facilitates CAP implementation at various institutions with different electronic health record systems. In summary, the use of clinical action plans provides an opportunity to enhance electronic health record documentation by capturing the home care of a complex disorder in a single, summative page for written communication with patients and other clinical team members.

The real-world application of clinical action plans

Clinical action plans represent an opportunity for the entire medical team to be on the same page. For example, a SMART-enhanced clinical action plan for asthma could be opened during the patient screening portion of the visit when vitals are being collected. A medical teammate could use the tool to document asthma severity and input the patient's currently prescribed pharmacotherapy. This would provide the medical team with an opportunity to perform an automatic management check of guideline concordance prior to the physician entering the encounter. The ordering clinician would then review the clinical action plan, adjust pharmacotherapy as needed to meet guideline-concordance, and then sign the plan to lock entries. Finally, the Snipping tool feature can create a digital image of the plan to be added to the encounter documentation in the electronic health record. The completed clinical action plan would then be printed, secure-messaged to the patient, or both. Some hospital systems have successfully implemented clinical action plans that serve as bonafide medical prescriptions for either the embedded hospital or ambulatory pharmacy [25,26].

Clinical action plans can also increase relative value units (RVUs). When clinical teams complete an encounter with appropriate counseling and a clinical action plan is generated, they have an opportunity to claim this additional work using specific procedural and disposition current procedural terminology (CPT) codes. Figure 1 provides a recommended workflow to best capture additional encounter disposition CPT codes (i.e., principal care management 99424–99427 or chronic care management 99491, 99437, 99487, 99489) for chronic care when a clinical action plan is used in the outpatient setting [27,28]. Notably, these additional CPT codes can lead to a significant increase in RVU generation for that encounter. For example, a single, chronic condition encounter requiring ≥30 min of physician-driven care that is coded as 99424 would generate an additional 2.41 total nonfacility RVUs.

FIGURE 1:

Current procedural terminology (CPT) codes workflow when using a clinical action plan 1A- Principal Care Management 1B- Chronic Care Management.

There already are a variety of clinical action plans available to providers. Supplemental Figure 1 (online-only), https://links.lww.com/MOP/A65 provides a summary of the author's recommended clinical action plans discussed in the literature, many of which are accessible online for free. The author recommends the following alphabetized list of clinical action plans for these specific diagnoses or conditions:

(1) Adrenal insufficiency- Uniformed Service Adrenal Insufficiency Action Plan [23] (2) Anaphylaxis/Food allergy- Children's Hospital of Eastern Ontario (CHEO) Anaphylaxis Action Plan [26] (3) Asthma- Uniformed Service Asthma Action Plan [29] (4) Chemotherapy-induced nausea and vomiting- Uniformed Services Chemotherapy-induced Nausea and Vomiting Action Plan [30] (5) Functional constipation- Uniformed Services Constipation Action Plan [13▪,31] (6) Cyclic vomiting syndrome- Uniformed Services Cyclic Vomiting Syndrome Action Plan [15] (7) Cystic Fibrosis- Uniformed Services Cystic Fibrosis Action Plan (8) Eczema- Children's Hospital of Eastern Ontario (CHEO) Eczema Action Plan [32] (9) Headache Migraine- Pediatric Migraine Action Plan (PedMAP) [33] (10) Sickle Cell Disease-related Pain- Uniformed Services Sickle Cell Pain Action Plan [24] Future opportunities

This review has highlighted the detrimental effects that low health literacy can have on disease management and how clinical action plans can mitigate this issue. Language barriers and poor medical language interpretation represent an equally important healthcare disparity, which can lead to increased medical expenses and poor outcomes [34–37]. To combat this, we must endeavor to translate CAPs to the critical languages used by our patients. Finally, we must begin to meld the SMART features of some CAPs with the ingenuity from Webster et al.[19] to incorporate clinical action plans into the electronic health record. This could be accomplished by developing EHR-specific Application Programming Interfaces (API), which integrates a CAP within the electronic health record thereby making clinical action plan completion and recommended pharmacotherapy prescribing simultaneous.

DENOUEMENT Case #1

We have a 4-year-old male who has no alarm signs or symptoms and meets the ROME IV criteria for functional constipation [38]. The parent has attempted short-term lifestyle modifications and fiber supplementation but has not been successful. Physical examination reveals palpable stool throughout the abdomen as well as fecal streaking in the patient's underwear. In this scenario, the North American Society for Pediatric Gastroenterology, Hepatology, and Nutrition recommends disimpaction and maintenance therapy be prescribed using polyethylene glycol 3350 [39▪]. Therapy should be continued for 2 months, and symptoms of functional constipation should be resolved for at least 1 month before discontinuation of pharmacotherapy. You go to https://wrnmmc.libguides.com/pediatrics/USAP to download the constipation action plan. The plan is completed using the SMART auto-dosing for disimpaction [clean-out] and maintenance [every-day] therapies and the family watches the education video prior to leaving the clinic. The image of the plan is included in your documentation for this 30-min encounter. You rely on Fig. 1 and include the following in your encounter documentation: 99203 + 99424 + 97535.

Case #2

Your chart review for the patient prior to his clinic visit reveals that he has not refilled his low-dose inhaled corticosteroid or his rescue beta-agonist inhaler (single maintenance and reliever therapy plan) in the past 6 months. During his visit, your medical assistant performing the screening downloads the Uniformed Services Asthma Action Plan, https://wrnmmc.libguides.com/pediatrics/USAP, and uses the Asthma Severity calculator to determine that the child has Severe Persistent Asthma. Upon entering the room, you discuss symptoms with the patient and confirm the severity assessment provided by the calculator. You then select a combination of medium-dose inhaled corticosteroid (with appropriately sized spacer) and beta agonist therapies to complete the child's plan. You review what the medications will look like using the Asthma Network ‘Respiratory Treatments’ 2021 chart. After confirming no additional questions from the parent, you sign the plan and exit the room. Prior to discharge from the clinic, the registered nurse directs the family to view the education videos for the use of respiratory devices selected by the provider which automatically appeared on the plan. The image of the plan is included in your documentation for this 30-min encounter. You rely on Fig. 1 and include the following in your encounter documentation: 99214 + 99424 + 97535 + 99426.

Case #3

Prior to completing the screening process, your medical assistant downloaded and filled out the Uniformed Services Cystic Fibrosis Action Plan including entry of the child's current medications and growth data. The Pediatric Gastroenterologist and Registered dietitian nutritionist jointly enter the room. They determine that the child's defecation pattern is most consistent with steatorrhea from exocrine pancreatic insufficiency. You optimize the child's dose of proton pump inhibiter therapy, you increase the lipase meal and snack doses, and the dietician reviews the caloric goal automatically recommended by the plan. The remainder of the multidisciplinary team (including Pulmonology and Behavioral Health) complete their portion of the visit and the team jointly reviews the patient's Cystic Fibrosis Action Plan. Additional ‘if/then’ clinical scenario statements are added in plain (low literacy) language to the yellow and red zones of the plan as appropriate. The registered nurse reviews the plan with the family for comprehension and directs them to the education videos. The image of the plan is included in your documentation for this 45-min encounter. You rely on Fig. 1, documenting only for your time spent, not for the time of the other providers, and include the following in the encounter note: 99215 + 99487 + 97535 + 99490.

CONCLUSIONS

This review focused on the development, implementation, and assessment of clinical action plans into office pediatrics. Recent advancements have allowed CAPs to enhance high-value, guideline-concordant care by mitigating low health literacy for patients and providing medical teams with automated, clinical decision support. The widespread use of CAPs for various diseases has the potential to improve individualized care within the patient-centered medical home model by providing digital, low-literacy educational resources that seek to enhance proper medication use and improve medication adherence. The CAP-enhanced model has been shown to deliver more rapid and safer patient care with higher satisfaction compared with traditional approaches in both the general and subspecialty pediatric settings. In addition, RVU generation is higher when a clinical action plan is used. Thus, clinical action plans to help manage chronic pediatric diseases and conditions are warranted.

Acknowledgements

Thank you to Dr Philip L. Rogers for your constant mentorship and serving as the true example of soldier, statesman, and knightly gentleman.

Thank you to Nancy Reeves for your constant support, creativity, and teamwork.

Financial support and sponsorship

There was no funding support beyond the salary disclaimers, as above, for the completion of this project. Salary support was provided for to all authors by the United States Department of Defense.

Conflicts of interest

The authors have no financial relationships relevant to this article to disclose.

There are no prior presentations of the study data as an abstract or poster.

Disclaimer: This work was prepared as part of the official duties of Dr Reeves who is employed by the United States Army, and Department of Defense. The identification of specific products or scientific instrumentation is considered an integral part of the scientific endeavor and does not constitute endorsement or implied endorsement on the part of the author(s),DoD, or any component agency. The views expressed in this manuscript are those of the authors and do not necessarily reflect the official policy of the Department of Defense or the U.S. Government.

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Article Summary: This review focuses on the development, implementation and evaluation of clinical action plans in pediatric medicine.

REFERENCES AND RECOMMENDED READING

Papers of particular interest, published within the annual period of review, have been highlighted as:

▪ of special interest

▪▪ of outstanding interest

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