Culturally Specific Evaluation of Inhaler Techniques in Asthma

Design

The research applied both qualitative and quantitative methods, including a full participatory approach. The study was conducted at a university-based pulmonary medicine clinic. It was approved by the University of British Columbia Office of Research Ethics and was registered at ClinicalTrials.gov. All subjects signed a written consent form in their native language before the study.

Study Participants

We enrolled subjects who had a physician diagnosis of asthma, used asthma medications daily, were ≥21 y old, had immigrated to Canada within the past 5 y, resided in Vancouver during the study period, and spoke Mandarin, Cantonese, or Punjabi. A convenience sampling method was applied, and 167 adults with asthma were recruited, of whom 35 participated in the development of the educational videos and pamphlets, 40 participated in initial focus group sessions to review and comment on the educational materials and the study design and procedures, and the remaining 87 subjects participated in the educational intervention (85 completed all study assessments). The 75 subjects who participated in either focus groups or the development of educational materials were not invited to participate in the study intervention (Fig. 1). All study participants were identified and directly recruited from the collaborating physicians' clinics.

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Fig. 1.

Flow chart.

Since we had 4 groups in the study, we needed a total of 6 comparisons between the 4 groups. To guarantee an overall type-1 error of .05, each comparison needed to be carried out at (approximately) a type-1 error of .01 (2-sided). This means that each comparison would have identified as significant a difference between the 2 group means of d(t) = 1.05 SD, at a power of approximately 80%.

Measurements

Due to the absence of a validated assessment questionnaire in the target languages, a new measurement tool was developed by the study team as an integral part of this study. The developed instrument was pilot-tested with a number of subjects with asthma and validated (in terms of face and content validation) by participants' and professionals' inputs. Subjects' skills specific to the appropriate use of inhalers were assessed by direct observation. Participants were asked to demonstrate the use of an inhaler and to describe the steps they were taking in doing so. The measure was the percentage of correct steps in inhaler use, applying standard checklists.^21,22 For participants using ≥2 inhalers, the success rate was the percentage of correct steps taken across all inhalers. Scoring for these questions was from 0 to 9, with a 0 score meaning the subject missed all the necessary steps for inhaler use and a 9 score meaning the subject used all 9 steps of the inhaler technique appropriately. The 9 steps were: (1) shake device (metered-dose inhaler); (2) load the inhaler; (3) breathe out away from inhaler; (4) put the inhaler in mouth behind teeth; (5) breathe in deeply; (6) hold breath for 5–10 s; (7) breathe out from nose; (8) wait for 60 s before taking the second puff, if needed; and (9) recap and rinse mouth, if needed. The study questionnaire was designed using the Canadian Thoracic Society guidelines.²³ This instrument also included 5 practical outcome items to assess subjects' understanding of and adherence to their physician's instructions. For instance, we asked the participants: “Imagine your doctor has instructed you to take 2 inhalations twice daily in the morning and evening (approximately 12 h apart). Also, continue to use your reliever inhaler on an as-needed basis. Can you explain in your own words what this instruction means to you”? Scores for these questions were 0 and 1, with a score of 0 meaning the subject incorrectly answered and a score of 1 meaning that the subject correctly answered the questions.

Education Materials Development

Based on 4 preliminary patient-oriented focus group sessions conducted in 2008 as well as an earlier systematic review with regard to the relationship between health literacy and asthma outcome in ethnic minority groups,^20,24,25 we developed 2 sets of educational videos (physician-led and community videos) and pictorial pamphlets for each community. The culturally specific educational materials, 2 videos and one pamphlet, used as interventions in this study were developed by this research team using a community-based participatory approach that actively involved subjects from the Greater Vancouver Chinese and Punjabi communities in their development and testing. To ensure that the content of materials was equivalent across all 3 languages, we developed the written materials (control pictorial pamphlet) in English first and then asked professional community-based translators to translate the information, as well as provide back-translation, to the 3 target languages. The same content was used to develop the videos. In designing our videos, we elected to create 2 versions to allow for a comparison of the effect of instructions provided by lay people (subjects and home caregivers) or physicians and to explore whether any added advantage arose from exposure to both sources of information. In the community video, subjects and caregivers role-played a scenario, offering opinions and narratives about asthma and its management in short (12–14-min) videos. The physician-led video was relatively long (25 min) and provided clinical information about asthma symptoms, medication techniques, and self-management strategies. Well-known physicians from the same ethnic background who had previous experience in educating patients via video format were invited to the study who then volunteered to perform in the physician-led videos. Content for the community videos and physician-led videos was similar, with the only difference being that one was provided by the lay community. Cultural beliefs and practices from the 3 target ethnicity communities were also applied in the community videos. The correct way of using inhalers was performed by respiratory educators from the target communities at the end of both the physician-led and community videos. All materials were produced in Mandarin, Cantonese, and Punjabi. More information on the development of our asthma educational materials can be found in our previous articles.^24–26 Links to the copyrighted videos and educational illustrations are provided in the online supplementary materials at http://www.rcjournal.com.

Intervention Procedures

The study intervention lasted for 10 months. The baseline assessment (pretest) preceded the intervention; the postintervention assessment occurred immediately following the intervention (1 month after the baseline assessment); and a subsequent assessment (follow-up test) occurred 3 months following intervention. Data collection was conducted by trained bilingual facilitators, who were blinded to the study hypothesis. After the initial pretest interviews, 87 subjects were randomly assigned to one of 4 study groups, and of these, 85 completed the study. The intervention consisted of a single exposure to educational materials. Group 1 (n = 22) was assigned the physician-led video; Group 2 (n = 21) watched the community video; Group 3 (n = 20) watched both videos; and Group 4 (n = 22) served as the control group and read the pamphlet. Subjects watched the video(s) or read the pamphlet a single time, at a location of their choice (clinic or home). The study team was not blind to the subject group assignment. We also involved a family member who normally took care of the subject at home (the immediate caregiver at the home) in the interviews and learning process across the study groups. The attendance of the immediate caregiver provided the subject with a feeling of support when completing the interview as well as helping to clarify or elaborate on the subject's responses to the questions. Subjects were not permitted to keep the videos or pamphlets until the end of the study.

At all 3 in-person interviews, subjects were asked to demonstrate how they used their inhalers, and this was verified by 2 observers (the facilitator and study coordinator). In addition, they were asked to also talk through the steps, explaining in their own words what they were doing, as if they were teaching a friend or family member how to use the inhaler. Other questions included whether they had ever received instructions demonstrating inhaler use, and if yes, by whom (eg, their doctor, a pharmacist, an asthma educator, or another health professional) and whether the demonstration was accompanied by print material or another medium. The bilingual facilitators received training on how to conduct interviews and the educational intervention and how to address community challenges and concerns regarding asthma self-management. They were encouraged not to dismiss traditional practices of community members but to integrate them. The study coordinator attended all interviews to reduce the likelihood of observational errors and took notes of subjects' comments and demonstrations of inhaler techniques during the interviews. The combined notes were reviewed at the end of each interview for clarity, precision, and necessary adjustment.

Statistical Analysis

Analyses were completed using SAS 17 (SAS Institute, Cary, North Carolina). We added up the Mandarin and Cantonese subjects in one group as “Chinese” to compare the objectives of interest with the “Punjabi” subjects. The outcomes of interest were (1) participants' ability to use inhalers (assessed through observation) and (2) understanding of physicians' instructions on asthma therapy (self-reported medication adherence). Analysis of variance was used to compare the effect of the educational materials on key outcomes across the 4 study groups. Analysis of covariance was used to adjust outcomes for age, sex, and educational level and to compare the pamphlet and video methods.