Two for one : A self-management plan coupled with a prescription sheet for children with asthma

1Clinical Research on Childhood Asthma; 2Department of Pediatrics, University of Montreal; 3Division of Allergy and Clinical Immunology; 4Division of Pediatric Emergency Medicine, Department of Pediatrics, Montreal Children’s Hospital, McGill University Health Centre; 5Division of Pediatrics, Research Centre, CHU Sainte-Justine, Montreal, Quebec; 6Division of Pediatric Emergency Medicine, Department of Pediatrics, Children’s Hospital for Eastern Ontario, Ottawa, Ontario; 7Quebec Network for Asthma and COPD Education, Department of Pharmacy, Centre de Santé et de Services Sociaux de la Vieille Capitale, Quebec City, Quebec Correspondence: Dr Francine M Ducharme, Department of Pediatrics, CHU Sainte-Justine, Room 7939, 3175 Cote Sainte-Catherine, Montreal, Quebec H3T 1C5. Telephone 514-345-4931 ext 4398, fax 514-345-4822, e-mail francine.m.ducharme@umontreal.ca FM Ducharme, F Noya, D McGillivray, et al. Two for one: A self-management plan coupled with a prescription sheet for children with asthma. Can Respir J 2008;15(7):347-354.

N ational and international guidelines (1-3) recommend the use of a written self-management plan for all patients with asthma.In the context of a comprehensive asthma education and medical follow-up program, action plans clearly improve asthma morbidity (4)(5)(6).Yet, the ownership of a selfmanagement plan by Canadian patients remains disappointingly low, ranging from 8% to 11% in children and adults with asthma (7,8).Clearly, the delivery of written self-management plans requires additional time and effort on the part of physicians, particularly when the instructions are hand-written on a blank piece of paper (9).
Although most health professionals recognize the advantages of self-management plans, they have limited knowledge of what to include in the plan to optimize care and communication with ©2008 Pulsus Group Inc.All rights reserved

ORIGINAL ARTICLE
patients (10).According to the standard definition (2), a written self-management plan should focus on the management of exacerbations.Yet, daily anti-inflammatory therapy is the most effective strategy to prevent exacerbations (11).Contrary to common practice, there is little evidence that step-up therapy with inhaled corticosteroids reduces the severity of exacerbations compared with maintaining a stable dose (12)(13)(14).The evidence suggests that maintenance therapy should constitute the cornerstone of a self-management plan for most children and adults.While the amount of information provided in the plan is positively related to its perceived relevance by patients (15), few studies have focused on identifying key elements of an effective self-management plan (16).
The objectives of the present study were to develop a unique written self-management plan for children, adolescents and adults based on scientific evidence and expert opinion, to test the self-management plan for clarity and perceived relevance in children and their parents, and to create a suitable design that facilitates its adoption by health care professionals.

Item generation
To identify key elements to include in the self-management plan, the Cochrane Airways Group Clinical Trials Register was searched for review articles and randomized controlled trials testing asthma self-management plans in children, published until March 2006.Adult and pediatric self-management plans were solicited from published randomized controlled trials whenever available, from educators of the 90 Quebec asthma education centres of the Quebec Network of Asthma and COPD (Réseau québécois de l'asthme et de la MPOC), and from our international consultant committee.These consultants represented different health care professionals (physicians, pharmacists, nurse educators), specialties (pediatrics, adult and pediatric respiratory medicine, emergency medicine, nursing), practice settings (community and academic), and various geographic regions in Quebec and outside Canada (United Kingdom, France and Australia); they provided extensive feedback on the first prototype and the final version of the selfmanagement plan.

Item reduction
To identify key elements to include in, and trivial or confusing elements to remove from, the self-management plan, a questionnaire was mailed to 129 educators at the 90 asthma education centres across Quebec; there was no repeat mailing for nonresponders.The questionnaire solicited feedback on the following aspects of an ideal action plan: overall format, general messages and language, self-assessment, recommendations and asthma control zones.The educators rated the importance of each item on a Likert scale of 1 (not important) to 5 (very important).Item scores that averaged 4 or more were considered to be important and selected for inclusion; items that averaged 3.5 or more were considered to be desirable, and included whenever possible.

Item presentation and scaling
The layout and presentation were inspired from adult and pediatric self-management plans, review articles and recommendations from the international consultants.The design was guided by the specific intention of coupling the self-management plan with a prescription.
Testing for clarity Design: Between May and August 2005, a survey of a convenience sample of children and their parents, who were approached in the emergency department, asthma and respiratory clinics, and hospital wards of the Montreal Children's Hospital (Montreal, Quebec), was conducted.The study was approved by the Scientific and Institutional Review Boards of the Montreal Children's Hospital.Informed consent was obtained from parents and children seven years of age or older.Study participants: Participants included children aged one to 17 years (and their parents) who presented with asthma (or suspected asthma, which was supported by current ownership of asthma medication) and with adequate French or English language skills.Children were excluded if they had a chronic pulmonary disease (ie, bronchopulmonary dysplasia or cystic fibrosis) or were too sick to complete the interview.Procedure: Clarity and perceived relevance were tested with cognitive interviews in children aged seven to 17 years and their parents, as well as in parents of children aged one to six years.Specifically, participants were instructed to read aloud the selfmanagement plan so that words or elements that were problematic could be identified.Because of the time constraints of the recruitment setting, feedback on the clarity and relevance of the overall format (layout and graphics) was prioritized.Depending on the allotted time, feedback on one or more of the following sections was requested: general messages and language, self-assessment of asthma control, asthma control zones and nonpharmacological recommendations.Finally, the selfmanagement plan was completed with fictitious instructions, and interviewees were probed with scenarios and questions to ensure understanding.Aiming for a grade 2 elementary reading level (seven years of age), the self-management plan was tested in school-aged children and adolescents, and parents were specifically asked about the suitability of the self-management plan for themselves as potential patients.Several iterative versions were developed until clarity and perceived relevance was achieved in 85% of participants.Using the back-translation technique, the French and English versions were simultaneously designed.

Statistics
Based on the elaboration of previous instruments (each in French and English) (17), it was estimated that the feedback from 30 to 50 children and 50 to 75 parents on iterative versions would be required to achieve 85% clarity and perceived relevance on the final version.Clarity and perceived relevance were reported as proportions.Medians were reported with interquartile range (25th to 75th percentile).

Instrument development
Five sources of information guided the development of the initial version of the self-management plan.First, three Cochrane reviews of randomized controlled trials examining the efficacy of self-management plans were identified (16,18,19); two reviews (16,19) specifically identified key characteristics associated with an effective plan.The superiority of symptombased over peak flow-based action plans (19) led to the primary use of symptoms to describe the three control zones (16) in our action plan, with optional peak flow values.Second, a survey of nurses involved in childhood asthma care in the United Kingdom identified characteristics of asthma action plans that promoted self-management in school-aged children, which inspired our first prototype (20).Third, with a response rate of 42%, the survey of the Quebec asthma educators allowed us to prioritize the items perceived to be most important (Table 1).Fourth, the layout, presentation and description of the asthma control zones were inspired by a collection of action plans tested in trials or used in Quebec or abroad, and were revised with the feedback of the international consultant committee.Finally, the self-management plan was conceived in a way that applied to children, adolescents and adults; could be printed in triplicate, combining a prescription, a medical chart copy and the take-home action plan to facilitate its dispensing by physicians; and could be used in both clinics and acute care settings.The first prototype to be tested met almost all recommendations.

Testing for clarity
Of the 122 children approached, 112 were eligible.With a participation rate of 87%, 97 children and parents were interviewed on one or more of the five sections (Figure 1); 38 patients tested the French model, and 59 patients tested the English model.The characteristics of the patients are depicted in Table 2.The median age of the children was nine years, with four completed years of school.One-third of mothers and fathers had a high school education or less.Only 25% of the children had previously seen or had a self-management plan, with less than 3% currently using one.Most parents (86%) perceived their child's asthma as being well controlled, a perception shared by 56% of children old enough to answer.However, 50% of children presented at least two criteria indicative of poor asthma control.
Comments and suggestions were elicited from participants for three iterative versions before the final version.Table 3 illustrates the clarity and perceived relevance of the third version, as well as the overall score with all versions combined.An overwhelming proportion of subjects endorsed the concepts of traffic light colours, achievable asthma control, ability to lead a healthy and active life, and the five nonpharmaceutical recommendations.The concept of asthma chronicity was reworded without the word 'chronic', because two-thirds of children did not understand the word.Finally, 30% of participants remained confused with the terms 'holding chamber' and/or 'spacer', preferring the use of the commercial names, which could not be avoided; space constraints impeded the substitution of these terms with a picture.

Treatment of comorbidities
Endorsed items were rated for their importance on a Likert scale of 1 (not important) to 5 (very important): items rated 4 or more were considered important for inclusion in the self-management plan; those that averaged 3.5 to 3.9 were considered desirable and were included whenever possible; while items rated lower than 3.5 were considered not important.RQAM Réseau québécois de l'asthme et de la MPOC (Quebec Network of Asthma and COPD) With regard to self-assessment of asthma control, the use of a modified version of the validated Asthma Quiz for Kidz (17) was endorsed by the majority of participants (Figure 2).The title, the description and the instructions of each control zone were overwhelmingly clear (Table 3).The proportion of patients who rated as important the opportunity to record their personal symptoms, decreased from 88% (version 1) to 14% (version 3); this space was thus removed.Of interest, 78% of patients expressed a wish for a matching calendar to record symptoms and medications.
With regard to the potential need for distinct self-management plans for children, adolescents and adults, 97% of the 80 parents and the 22 asthmatic adolescents surveyed endorsed the action plan for their personal use, and specifically its language, layout and criteria for asthma control.With 15% of parents requesting fewer graphics, the final version retained only smiley faces and traffic light colours to serve as a unique selfmanagement plan for all age groups.
Although the initial intention was to develop a unique selfmanagement plan for use in both clinics and acute care settings, most participants were confused by the unfilled sections (ie, unfilled red section for clinic patients; unfilled green and yellow sections for those treated in the acute care setting).Because physicians also shared this confusion, two self-management plans, one for each setting, were created and harmonized with each other.The self-management plan used in clinics focuses on the maintenance of asthma control (green zone) and the appropriate measures to take in case of deterioration (yellow zone) (Figure 2).The plan conceived for the acute care setting focuses on the treatment following an unscheduled medical consultation for acute asthma.Both are available in English and French versions.
The concept of coupling the self-management plan with a prescription was endorsed by l'Ordre des pharmaciens du Québec, because the plan adhered to prescription guidelines by providing space for the date, physician's name, signature and license number, as well as a copy of the plan for the medical chart.It is available as a triplicate document; the prescription is the first copy, a replica of the self-management plan for the medical chart is the second copy, and the self-management plan for the patient is the third copy.
More than 88% of the participants perceived the final version of the self-management plan as relevant, with no difference across age groups (one to six years, seven to 12 years, 13 to 17 years).This final version achieved more than 85% clarity and perceived relevance for almost all of its components, with the few exceptions mentioned above.With minor modifications, the final version was approved for use in children and adults by the Conseil du Médicament under the recommendation of the experts from its advisory groups and by international consultants; it was endorsed by the Quebec Network of Asthma and COPD (Réseau québécois de l'asthme et de la MPOC), and various provincial stakeholders.

DISCUSSION
In an iterative process, we developed and tested two written asthma self-management plans for use in clinics and acute care settings, respectively.We used the back-translation technique to develop the French and English versions simultaneously.The control zones were defined by symptoms identified through a literature review and confirmed by patient interviews.The self-management plans were based on a prototype elaborated from surveys of asthma educators from the United  Previous experience with a written action plan, % Ever seen or ever had one 26 24 Current ownership 16 5 Current use 0 5 Self-described asthma symptomatology, % Nonparticipants (13%)

Participants n=97
Self-assessment of asthma control n=64

General messages and language n=22
Asthma control zones, n=27 Under control (green), n=27 Not well controlled (yellow), n=25 Out of control (red), n=24

Nonpharmaceutical recommendations n=27
Figure 1) The selection of participants Kingdom and Quebec.The versions were revised until 85% clarity and perceived relevance were obtained.After feedback and revision, the final version was approved by the Direction scientifique du suivi et de l'usage optimal of the Conseil du Médicament and its committees, our international consultant committee and expert groups.These self-management plans transcend the traditional concept of former self-management plans by putting emphasis on preventive management; facilitating self-assessment by linking the asthma quiz and control zones; including a prescription and a medical chart copy; applying to children, adolescents and, most likely, adults; being available in French and English; and conveying the five basic concepts of the Canadian Asthma Consensus, namely, control of the environment, adherence to treatment, self-assessment and self-management, regular medical follow-up and asthma education.
The plan promotes the self-assessment of asthma control using symptoms and self-management (using three colour zones), two concepts overwhelmingly endorsed by patients.These decisions are supported by methodologically strong Cochrane reviews.Indeed, a pediatric review stressed the greater effectiveness of symptom-based over peak flow-based action plans for reducing emergency department visits (19).Gibson and Powell (16) associated the use of four or less action points to lower asthma morbidity in adults.The proposed action plan calls for regular self-assessment using a modified version of the validated Asthma Quiz for Kidz (17).The modified Asthma Quiz shares many similarities with a validated adult questionnaire that used the same five criteria and cut-off value of one, as an indicator of poor control (21).The yellow zone description, linked but not limited to the Asthma Quiz, serves to identify an acute loss of control, thus allowing rapid therapeutic adjustment.These criteria are in tune with most published and unpublished written self-management plans (16,(22)(23)(24).They were approved by expert groups and endorsed by an overwhelming majority of participants who interestingly,   The self-management plan for the acute care setting will be available on request declined the option of adding other symptoms.These plans were also developed to facilitate self-management in children, adolescents and adults through a second-grade language level that is clear but not infantile, attractive graphics and format, clear links between self-assessment and self-management instructions, simple fill-in-the-blank recommendations for medications, and the five steps to maintain asthma control described on the verso of the action plan.
To our knowledge, this is the first published written action plan for use at discharge following an acute care visit.In this busy setting, where physicians (25) and patients (26) tend to adhere poorly to standard discharge recommendations, our intent was to clearly identify the acute care visit as a treatment failure, reverse the perception of asthma as an episodic condition (27), and create an opportunity to initiate adequate longterm asthma management.
Three features were intended to facilitate the dispensing of the self-management plan by physicians and asthma educators, namely, the use of the fill-in-the-blank method to reduce the amount of writing, the design as an educational tool, and the coupling of the self-management plan with a prescription.Whether use of these specific self-management plans will improve the quality of physicians' recommendation for, and patients' compliance with, maintenance therapy, asthma education and medical follow-up, beyond that observed with existing plans, remains to be tested.
We recognize the following limitations of the present study.Space constraints have compelled us to remove some items, such as instructions on how to use the inhaler device and a description of the role of each medication; experience will allow us to validate or invalidate these removals.Although 80 parents were specifically asked to give their perspective as potential users of the plan, we have not tested the plan in a large number of asthmatic adults.Self-management plans may need to be revised over time, because knowledge progresses in the recognition and treatment of loss of asthma control.A matching calendar of symptoms has been solicited by most participants as a means to facilitate the use of the action plan.
The generalizability of the present study results merits careful consideration.Although conducted in a pediatric university hospital, the participants appeared to be comparable with several population-based surveys in Canada in terms of the disconnection between actual and perceived asthma control, underuse of daily preventive medication and low ownership of action plans (8,28).Finally, the self-management plan has yet to be tested for its effectiveness in promoting self-management and self-assessment in clinics and acute care settings in various populations, including adults.
The proposed self-management plans are based on probing data, as well as recommendations from local and international physicians, nurses and educators.They were revised with patients in an iterative way until more than 85% clarity and perceived relevance was obtained.These plans are offered as tools to facilitate self-assessment, self-management and communication between patients and health care professionals (physicians, pharmacists, asthma educators) (29).
Asthma self-management plan coupled with a prescription Can Respir J Vol 15 No 7 October 2008 349

*
This validated six-item questionnaire reports the number of indicators of poor asthma control, namely day and night symptoms, rescue beta 2 -agonist use, exercise limitation in the preceding seven days, as well as absenteeism and exacerbation in the preceding month Approached n=122 Not eligible (8%) No asthma, n=3 Major health problem, n=1 Insufficient language skills, n=2 Refusal to answer screening questions, n=4 Eligible n=112 Asthma self-management plan coupled with a prescription Can Respir J Vol 15 No 7 October 2008 351

Figure 2 )
Figure2) English (A) and French (B) versions of the self-management plan for clinics.The left panel represents the recto (the pharmacy copy), and is reproduced in triplicate format with the second copy for the medical chart and the third copy for the patient.The right panel represents the verso of the written action plan, and comprises general messages about asthma, the purpose of the action plan and the five steps to maintain asthma control.The self-management plan for the acute care setting will be available on request

TABLE 1
Rating of items for inclusion in the self-management plan based on a survey of Quebec asthma educators

TABLE 3
Clarity and perceived relevance of items in the self-management plan *Values are presented as per cent of patients who answered yes; † Values are presented as per cent of patients who answered important or somewhat important; ‡ For acute care version only