Research Article

The Impact of Health Literacy Level on Inhaler Technique in Patients With Chronic Obstructive Pulmonary Disease

Journal of Pharmacy Practice 2017, Vol. 30(1) 25-30 ª The Author(s) 2015 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0897190015585759 journals.sagepub.com/home/jpp

Collin R. Beatty, PharmD, MS1, Laura A. Flynn, PharmD2, and Tracy J. Costello, PharmD, BCPS3,4

Abstract Background: Inhaled medications are recommended as first-line treatment for chronic obstructive pulmonary disease (COPD) and can reduce exacerbations and hospitalizations. Low health literacy is associated with poor inhaler technique. Objective: This study examined whether handouts written specifically for patients with low health literacy are more effective in showing patients how to use their medications when compared to standard education materials. Methods: A prospective, experimental study was performed at a community-based hospital. Patients included in the study were admitted to the hospital with a diagnosis of COPD, taking at least 1 inhaled medication and identified as having low health literacy based on a Rapid Estimate of Adult Literacy in Medicine—Short Form. Low health literacy handouts were compared against the standard hospital educational materials for inhalers. Correct technique during each demonstration was evaluated using a standardized checklist. Results: Mean baseline scores for inhaler technique were 12.2 + 2.2 steps correct for the control group and 13.4 + 1.3 for the low health-literacy group of the 18 maximum points (P ¼ nonsignificant). The mean change in inhaler technique score for the control group was 1.0 + 1.8, while the mean change in inhaler technique score for the low health-literacy group was 2.1 + 2.7 (P ¼ .03). Keywords chronic obstructive pulmonary disease, health literacy, inhalation devices

Background Health literacy is vital for patients to acquire, process, and understand information about their health in order to make educated decisions about health care. The United States Department of Education stratifies health literacy into 4 levels: below basic, basic, intermediate, and proficient.1 Over onethird of adults in the United States have basic or below basic health literacy levels.2 Adults with basic health literary are able to read and understand written material as long as the information is presented in short, simple text using everyday language. The term below basic health literacy refers to patients who are illiterate in English or can only follow simple, concrete written instructions.1 Basic or below basic health literacy levels are correlated with increased health care costs, medication errors, and a lack of knowledge on management of chronic health conditions.1,3 Many chronic disease states are associated with complex medication regimens including hypertension, diabetes, and chronic obstructive pulmonary disease (COPD). Adherence to medication regimens is often essential to prevent complications associated with these disease states. Limited health literacy is associated with poorer comprehension of medication use and greater difficulty in interpreting medication labels and describing how to take medications.4

COPD is the fourth leading cause of death worldwide and is a significant cause of chronic morbidity and mortality.5 COPD is a progressive disease associated with an enhanced inflammatory response in the airways and lungs.5 This inflammatory response is chronic and irreversible, but pharmacologic therapy may reduce symptoms, reduce the frequency and severity of exacerbations, improve health status, and increase exercise tolerance.5 Inhaled medications are the mainstay treatment for COPD. However, up to 86% of patients with COPD improperly use their inhaled medications.6 It is important that patients with COPD understand how to properly use their inhalers to receive the full benefit of the medication.

1

CJW Medical Center, Richmond, VA, USA PGY-1 Pharmacy Resident, NorthShore University Health System, Evanston, IL, USA 3 College of Pharmacy and Health Sciences, Butler University, Indianapolis, IN, USA 4 Community Health Network, Indianapolis, IN, USA 2

Corresponding Author: Tracy J. Costello, College of Pharmacy and Health Sciences, Butler University, 4600 Sunset Avenue, Indianapolis, IN 46208, USA. Email: [email protected]; [email protected]

26 Initial therapy for COPD involves the use of a short-acting bronchodilator as needed to reduce or prevent symptoms. As symptoms and lung function worsen, long-acting b2-agonists or anticholinergic medications are added as scheduled bronchodilators to the patient’s regimen. The addition of inhaled corticosteroids is reserved for patients with severe COPD or frequent exacerbations. The combination of multiple medications is considered for patients with progressing disease or uncontrolled symptoms.5 Inhaled medications used in the treatment of COPD are available in a variety of dosage forms, including metered dose inhalers (MDIs) and dry powder inhalers (DPIs). MDIs and DPIs distribute medications to the lungs via different mechanisms and require patient activation techniques that vary from device to device. Most MDIs are operated with the same basic instructions, which include shaking the inhaler prior to use, inhaling one actuation of the inhaler with a slow, deep breath, and holding that breath for at least 10 seconds after the administered dose is delivered.7 On the other hand, DPIs are available in multiple inhaler types each of which has its own instructions for use. For example, the combination inhaler of fluticasone propionate, an inhaled corticosteroid, and salmeterol, a long-acting b2-agonist, is dispensed as a Diskus in which the dose is preloaded into the inhaler.8 In comparison, the tiotropium, a long-acting anticholinergic, is dispensed as a HandiHaler1. The HandiHaler requires the patient to place a capsule containing the medication into the inhaler and puncture the capsule before inhalation of the medication.9 Regardless of the inhaler type, all DPIs require a deep, forceful inhalation to deliver medication to the patient’s lungs. Due to the complexity of different inhaler types, patient education and understanding are important to ensure optimal medication delivery.

Need for Study Low health literacy has been linked to inferior technique in administering medications.3 Patients with limited health literacy in a primary care clinic were less likely to be able to describe how to take medications and more likely to misunderstand label instructions.3 The Agency for Healthcare Research and Quality published a systemic review that showed low health literacy is linked to poor health, higher rates of hospitalization, and more frequent use of emergency services.10 For example, Gamararian et al focused on the effect of health literacy on hypertension and diabetes of Medicare enrollees.11 Of the patients with inadequate health literacy (as defined by the Short Test of Functional Health Literacy in Adults), 47.5% incorrectly answered questions regarding the correct timing for dosing medications. Additionally, 54.3% of patients with inadequate health literacy incorrectly answered questions on how to take a medication on an empty stomach.11 The rates of incorrect answers to the same questions were lower in patients with marginal (24.4% and 33.7%) or adequate (11.5% and 15.6%) literacy.11 Mancuso and Rincon examined the influence of health literacy level on longitudinal asthma outcomes.12

Journal of Pharmacy Practice 30(1) Using bivariate analysis, they showed a statistically significant association between less health literacy and worse physical function and quality of life related to asthma.12 It is critical that patients with COPD have adequate understanding of inhaler technique so they are using their medications correctly. This study examined whether handouts written specifically for patients with low health literacy are as effective in showing patients how to use their medications when compared to standard education materials.

Study Objectives The primary objective of this study is to compare the change in patient inhaler technique scores between standard hospital medication handouts and low health literacy handouts. A secondary objective included comparing difference in patient satisfaction ratings between types of handout.

Methods A prospective, experimental study was performed at a community hospital with an average daily census of 120 patients. Patients were recruited from October 2013 to March 2014. The study included patients 18 to 89 years old with a diagnosis of COPD admitted to the hospital and who were identified as low health literate. The study excluded non-English-speaking patients, as well as those who are pregnant or prisoners. The study also excluded patients who do not manage their own medications, have plans to be discharged to another facility, or have a documented impairment in cognitive functioning. Verbal informed consent was obtained from each patient prior to the start of the study. This study was approved by the local investigational review board and received exempt status for human subject research. Waiver of documentation of informed consent was also approved. A standardized script was utilized to obtain consent, and written informed consent documents were available if requested by the study patient. The health literacy of each patient was determined using the Rapid Assessment of Adult Literacy in Medicine—Short Form (REALM-SF).13,14 REALM-SF is a word recognition test that assesses the patient’s ability to read common medical words. A score of 6 or less of the 7 correctly pronounced words identifies a patient at risk of poor literacy.14 Patients with a REALM-SF score of 6 or less were considered to have low health literacy and included in the study. Patients were randomized to receive a handout tailored to specific inhaler types and written at a low health literacy level or the standard handout used at the hospital.15 Randomization was done prior to data collection using the pencil drop method with a random number table. After giving consent, patients took a brief preassessment of simple questions related to their management of COPD. Patients were interviewed also for baseline characteristics. Next, patients were asked to demonstrate how they use their inhaler at home. Patients using more than 1 inhaler at home were asked to demonstrate use for the inhaler that contains a corticosteroid, due to the increased risk of side effects, such

Beatty et al as thrush, experienced by misuse of such products. In the instance when patients used more than 1 inhaler, but neither contained a corticosteroid, the primary investigator would randomly choose the inhaler for which the patient was asked to demonstrate use. Placebo demonstration inhalers, designated for each individual patient, were used throughout the study. Scores of appropriate use of inhalers were calculated using the Correct Use of Inhalation Medication Checklist (Appendix A). The Patient Interview and Correct Use of Inhalation Medication Checklist were adapted with permission from a standardized form previously used by Hammerlein and colleagues.16 After initial demonstration, patients received the randomly assigned handout on their demonstrated inhaler and given 15 minutes to review it. After the review period, patients were asked to demonstrate again how they should use their inhaler, based on what they read in the handout. The second demonstration was scored using the Correct Use of Inhalation Medication Checklist. Following the second demonstration, the patient took a brief postassessment.

27 Table 1. Baseline Characteristics. Control LHL (n ¼ 10) (n ¼ 13)

Characteristic

Age, mean + SD, years 69 + 11 65 + 10 Sex, female, number 3 8 Race White, number 6 8 Black, number 4 4 Unknown – 1 REALM-SF score, median (range) 5 (2-6) 5 (0-6) Duration (years) of COPD diagnosis, median 6 (1-26) 6 (1-20) (range) Duration (years) of inhaler use, median (range) 8 (1-26) 10 (1-18) Number of inhalers for COPD, median (range) 2 (1-3) 2 (1-3) Number of times instructed on inhaler use, median 1 (1-3) 1 (0-3) (range) Abbreviations: COPD, chronic obstructive pulmonary disease; LHL, low health-literacy; REALM-SF, Rapid Assessment of Adult Literacy in Medicine— Short Form; SD, standard deviation.

Table 2. Locations for Education Sessions.

Statistical Analysis Descriptive statistics, including percentages, frequencies, means, medians, and modes, were used to analyze the data. Differences between mean change in inhaler technique score between inhaler and handout types were analyzed with analysis of variance. A chi-square (w2) test was used to analyze difference in the percentage of patients who rate top scores on the patient satisfaction survey between handouts. A P value of less than 0.05 was established as statistically significant. Statistical analyses were performed using Microsoft Excel.

Results Data collection was conducted from October 1, 2013 to March 13, 2014. A total of 155 patient charts were reviewed for inclusion in the study. Eight-three patients met initial inclusion criteria but only 46 patients could be contacted before discharge. Of the 46 patients contacted, 36 gave consent to participate in the project. Thirteen patients were excluded because their REALM-SF score was greater than 6. This left 23 patients to undergo randomization. Of the patients included in the study, 10 were randomized to receive the control handout and 13 were randomized to receive a low health literacy handout. Table 1 lists the baseline characteristics of the patients included in the study. There were no statistically significant differences between groups. Previous education on inhaler use was evaluated during baseline interview. Patients reported on average 1.3 + 0.78 (median 1, range 0-3) inhaler instruction sessions prior to the study instruction and an average duration of inhaler use of 9 + 6 years (median 8, range 1-26). Table 2 shows the settings of previous educations. The most common setting for previous education was in a physician’s office, with 83% of patients reporting that they had been educated in an office. Only 1 patient could not recall previous education. Study patients

Physician office Pharmacy Other Not educated

Number

Percent

19 4 4 1

83 17 17 4

Table 3. Types of Instruction.

Oral Practical demo Guided practice Printed instruction

Number

Percent

10 16 6 4

45 73 27 18

Table 4. Medication Class.

Anticholinergic SABA LABA ICS Combination

Number

Percent

15 16 12 14 17

65 70 52 61 74

Abbreviations: ICS, inhaled corticosteroid; LABA, long-acting b agonist; SABA, short-acting b agonist.

were also asked to describe the type of instruction they had previously received (Table 3). The most common method of instruction reported by patients was a practical demonstration. About half of patients reported being verbally told how to use their inhalers. Only 6 (27%) of the 22 patients reported being educated with more than 1 method. Most patients used a combination inhaled medication (74%). The most common types of devices evaluated were fluticasone/salmeterol Diskus and various MDI. Tables 4 and 5

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Journal of Pharmacy Practice 30(1)

Table 5. Inhaler Tested.

Fluticasone/salmeterol Diskus Tiotropium HandiHaler1 Ipratropium/albuterol Respimat1 MDI

Table 6. Correct Demonstration of Technique by Step. Total

Control

8 (35%) 4 (17%) 3 (13%) 8 (35%)

2 (20%) 1 (10%) 1 (10%) 6 (60%)

LHL 6 3 2 2

(46%) (23%) (15%) (15%)

Baseline

Abbreviations: LHL, low health-literacy; MDI, metered dose inhaler.

3

Improvement in Technique from Baseline Improvement in Technique

2.5

2.1

2

1

4 5 6

*p = 0.03 7 8

1.5 1.0

0.5 0

Control

LHL

9

Figure 1. Improvement in technique score from baseline. 10 11 12 13 14 15 16

Remove locking cap Shake well before use (usually for MDI, MDI-breath, and MDI þ S) Perform steps correctly to make device ready to use (eg, pull level and attach spacer; MDI-breath, MDI þ S, and DPI) Hold device correctly Exhale normally Close lips (tightly for MDI-breath and DPI) Lean head back slightly (MDI) MDI: spray and inhale at the same time, as exception also for Jethaler1 device (DPI) MDI-breath and DPI: inhale with forceful breaths MDI þ S: release in spacer and inhale directly (

The Impact of Health Literacy Level on Inhaler Technique in Patients With Chronic Obstructive Pulmonary Disease.

Inhaled medications are recommended as first-line treatment for chronic obstructive pulmonary disease (COPD) and can reduce exacerbations and hospital...
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