Ophthalmic Epidemiology

ISSN: 0928-6586 (Print) 1744-5086 (Online) Journal homepage: http://www.tandfonline.com/loi/iope20

Impact of a Brief Educational Intervention on Glaucoma Persistence: A Randomized Controlled Clinical Trial Fawzia Djafari, Mark R. Lesk, Charles-Édouard Giguère, Ghada Siam & Ellen E. Freeman To cite this article: Fawzia Djafari, Mark R. Lesk, Charles-Édouard Giguère, Ghada Siam & Ellen E. Freeman (2015) Impact of a Brief Educational Intervention on Glaucoma Persistence: A Randomized Controlled Clinical Trial, Ophthalmic Epidemiology, 22:6, 380-386, DOI: 10.3109/09286586.2015.1083036 To link to this article: http://dx.doi.org/10.3109/09286586.2015.1083036

Published online: 14 Dec 2015.

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Date: 12 January 2016, At: 11:39

Ophthalmic Epidemiology, 12 2015; 22(6): 380–386 ! Taylor & Francis Group, LLC ISSN: 0928-6586 print / 1744-5086 online DOI: 10.3109/09286586.2015.1083036


Impact of a Brief Educational Intervention on Glaucoma Persistence: A Randomized Controlled Clinical Trial

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Fawzia Djafari1, Mark R. Lesk1,2, Charles-E´douard Gigue`re1, Ghada Siam1, and Ellen E. Freeman1,2 1

Research Centre, Maisonneuve-Rosemont Hospital, Montreal, Quebec, Canada and 2Department of Ophthalmology, Universite´ de Montre´al, Montreal, Quebec, Canada

ABSTRACT Purpose: To determine whether two sessions of a glaucoma educational intervention resulted in better persistence to glaucoma eye drop therapy compared to normal care. Methods: A total of 165 patients newly diagnosed with glaucoma who required eye drop therapy were recruited into a randomized clinical trial from the glaucoma clinic at Maisonneuve-Rosemont Hospital in Montreal, Canada. Patients were randomized to either an immediate intervention or normal care. The intervention consisted of two 60–90 minute sessions of education on glaucoma and its management, given in a small group format by a non-practicing ophthalmologist. Persistence to glaucoma medication was examined for 1 year by the use of Hospital medical records and by pharmacy claims records from the Re´gie de l’assurance maladie du Que´bec (Quebec Health Insurance Program). A questionnaire was administered, and medication possession ratio calculated. The primary outcome was persistence, defined as having medication available at least 75% of the time. Secondary outcomes included eye drop instillation technique and perception of the importance of eye drop therapy. Results: The intervention group achieved better persistence to eye drop therapy, as 77% of controls and 89% of people receiving the intervention were persistent (p = 0.049). The intervention also resulted in better eye drop instillation technique (p50.001) and greater perception of the importance of eye drop therapy (p50.001). Conclusions: Brief instructional sessions offered to newly diagnosed glaucoma patients can result in better persistence rates over 1-year follow-up. Strategies to permanently offer these types of initiatives should be considered. Keywords: Adherence, education, glaucoma, medication, medication possession ratio, persistence, trial


Adherence can be a problem in glaucoma, because patients must often take daily eye drops despite not noticing any benefit to their vision and despite frequent side effects.5–13 For example, in previous research, we found that 28% of people with glaucoma were not persistent to therapy as defined as having taken 575% of their prescribed medication according to pharmaceutical claims data.14 Efforts have been made to design and evaluate interventions to improve glaucoma adherence with

In people diagnosed with open-angle glaucoma, progression of the disease is common despite treatment.1 Consistent risk factors for glaucoma progression include older age, black race, higher intraocular pressure (IOP) at diagnosis, and thinner central corneal thickness.2 Poor adherence to glaucoma therapy may also be a risk factor and may be modifiable.3,4

Received 18 July 2014; Revised 26 March 2015; Accepted 28 March 2015; Published online 7 December 2015 Correspondence: Ellen Freeman, PhD, Hoˆpital Maisonneuve-Rosemont, Recherche Ophtalmologie, CSA, RC, F131, 5415 Boulevard de l’Assomption, Montre´al, QC, H1T 2M4, Canada. E-mail: [email protected]


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Educational Intervention on Glaucoma Persistence mixed success.15–19 Interventions have included patient education sessions, written information, medication reminders, eye drop instillation training, and individualized adherence plans. Adherence and persistence were measured in different ways including electronic monitoring devices, pharmacy claims data, and self-report. Our objective was to determine whether two group educational sessions plus one-on-one eye drop instillation training would improve persistence to glaucoma therapy as measured by pharmacy claims data in a cohort of newly diagnosed patients. The intervention was developed according to the Health Belief Model, which was developed in the 1950s and has been used in numerous clinical trials.16,20–22 In this theoretical model, health behavior is influenced by (1) perceived susceptibility to the disease, (2) perceived severity of the disease, (3) perceived benefits of treatment, and (4) perceived barriers to action.16 We felt this model was particularly relevant to a disease like glaucoma which is often asymptomatic at the beginning and which requires daily treatment. We designed our educational intervention to target these four areas. Our hypothesis was that persistence would be improved and that patients would better understand their disease in the intervention group.


adhered to the tenets of the Declaration of Helsinki. The trial has been registered at http://www.clinicaltrials.gov (registration number NCT02097979). The Consolidated Standards of Reporting Trials (CONSORT) guidelines for reporting on nonpharmacologic trials were followed.23

Recruitment and Randomization From July 2007 until December 2011 a researcher approached eligible patients to determine their interest in participating in the study. Participants were asked for their help in evaluating a glaucoma education class and were told that there were two arms of the study; one in which they would receive the class right away and one in which they would receive the class later. It was not possible to mask the participants with this type of design. Interested participants signed the informed consent form and were randomized. A simple draw from a concealed container was used to assign participants to either the intervention or the normal care group. Participants in the intervention group were given an appointment to come back to the hospital for the group intervention. Participants in the normal care group were told they could receive the group intervention at the end of the study.

MATERIALS AND METHODS Study Design and Population


A randomized controlled clinical trial was conducted in newly diagnosed (51 month) glaucoma patients at Maisonneuve-Rosemont Hospital in Montreal, Canada. Half of the participants were randomized to receive the intervention and half were randomized to receive normal care (they received the intervention at the conclusion of the study). Normal care consists of very minimal instruction (52 minutes) regarding glaucoma, eye drop usage, instillation, and adherence. Inclusion criteria included a diagnosis of glaucoma requiring IOP-lowering eye drop therapy, prescription drug insurance through the Re´gie de l’assurance maladie du Que´bec (RAMQ; Quebec Health Insurance Program) throughout the course of the study, and the ability to speak and understand French. In the province of Quebec, everyone must be covered by prescription drug insurance. The RAMQ provides prescription drug insurance for those people not eligible for a private plan, for those people under 65 years with no private insurance, and for those receiving last-resort financial assistance. There were three sources of data for this study; a questionnaire, medical records, and RAMQ prescription drug claims data. Follow-up was for 1 year. Written informed consent was obtained from all participants. Approval was obtained from the Ethics Committee of Maisonneuve-Rosemont Hospital and the research

Small groups of about 10 people were gathered for two 60–90 minute educational sessions on glaucoma in a classroom at Maisonneuve-Rosemont Hospital. Participants were invited to sessions and they chose the sessions that were most convenient for them. The sessions were led by a non-practicing ophthalmologist who underwent extensive training before conducting the sessions. The training was conducted to ensure that the material was delivered at about an eighth grade level and at an appropriate speed and clarity. The two sessions usually occurred within 2 weeks of each another. A Microsoft PowerPoint presentation was given that included video segments. Subjects that were covered included the anatomy of the eye, how high IOP can damage the optic nerve head and retina, what glaucoma is, the different stages and types of glaucoma, how glaucoma is monitored, how IOPlowering medications work, how IOP-lowering medications improve visual function outcomes in glaucoma, side effects of glaucoma drops, how to instill drops, how to remember to put in drops, the relationship between glaucoma drops and visual survival, and alternate treatments (laser, surgery). During the section on eye drops, there was a break during which each patient received one-on-one teaching on how to properly instill drops without touching the eye or using unnecessary drops. The


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382 F. Djafari et al. content of the intervention was developed with reference towards the Health Belief Model and in consultation with other local ophthalmologists interested in patient education.16 For example, the content addressed severity of the disease, benefits of treatment, and barriers to adherence, which are theorized to affect individual health behavior (i.e. taking eye drops as prescribed). Questions were encouraged. Attendance at the intervention was noted.

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Questionnaire and Assessment of Eye Drop Technique A single interviewer-administered questionnaire was given at the end of the study to all participants. This questionnaire has been used previously.14 Due to logistical difficulties, the person collecting the questionnaire data was not masked as to intervention group assignment. Questions were included on demographics, systemic comorbidities, ocular medications, eye drop practices and difficulties, and glaucoma knowledge. The instructor rated the ability of the participant to put eye drops in the eye taking into account the number of drops that were used and whether contact with the lid or conjunctiva occurred. Potential ratings included good, fair, and bad. We created a composite score on the perception of the importance of glaucoma eye drop therapy using the following four questions; (1) do you think glaucoma is a serious disease?, (2) do you believe that your treatment will be effective?, (3) do you think your drops can lower the pressure in your eyes?, and (4) do you think your drops can help to preserve vision? Answers of no or do not know were given 0 points and answers of yes were given 1 point. Scores were summed and the composite score ranged from 0–4.

medication possession ratio (MPR) was calculated as the sum of days of prescription supply divided by the number of days in which a prescription was required.14 Each person gave consent to contact the RAMQ to obtain pharmaceutical claims for all glaucoma medications. Data were collected on the date of purchase, and the name, dose, and class of the medicine. Data on the number of days of medication available per bottle were taken from the Friedman and colleagues6 and Rylander and Vold24 studies with the minimum value used. For the numerator of MPR, we calculated how many days of medication were available using RAMQ data. For the denominator of MPR, we calculated the number of days that medication was prescribed in the medical chart. Most people required medication for the entire year of follow-up but some people stopped medication due to having glaucoma filtering surgery. We excluded people who died during follow-up or who had a large number of medication switches which made it too difficult to determine adherence from claims data. We took into account whether drops were needed for one or both eyes. If a participant was on multiple medications, we calculated a single mean MPR for all medications. We then dichotomized the MPR so that those having medication less than 75% of the days were defined as non-adherent, as we did previously in Djafari and coauthors.14

Outcomes The primary outcome of the study was persistence of at least 75%. Secondary outcomes included the rating of the eye drop instillation technique (at the second educational session) and a composite score on the perception of the importance of glaucoma eye drop therapy (as measured at the end of the study).

Medical Chart Review Sample Size Calculation At the end of the follow-up period, information was obtained on the prescribed eye drop therapy for each patient for each eye, whether the patient had undergone glaucoma filtering surgery, whether the patient had died or was no longer being followed, the most recent visual field mean deviation in the better eye using the Humphrey Visual Field Analyzer 24-2 Swedish Interactive Threshold Algorithm (SITA) standard program (Carl Zeiss Meditec, Inc., Dublin, CA).

We assumed that 72% of the control group would be persistent as was seen in our previous work.14 We assumed the intervention would result in a rate of persistence of 90%. Given these assumptions, a 5% type 1 error rate, and a sample size of 83 in each group, our study had 85% power (PS: Power and Sample Size Calculation, version 3.0).32

Statistical Analysis Pharmaceutical Claims and Calculation of Medication Possession Ratio All participants understood that we would be monitoring their pharmacy claims data for 1 year. The

Demographic characteristics were compared between the intervention and control groups. A chi-square test was used to determine whether persistence differed between the intervention and control groups. Multiple logistic regression was used to examine all factors Ophthalmic Epidemiology

Educational Intervention on Glaucoma Persistence


Randomized (n=207)

Allocation Allocated to intervention (n=102) Received allocated intervention (n= 100) Did not receive (patient withdrawal, n=2)

Allocated to control (n= 105) Received control intervention (n=101) Did not receive (patient withdrawal, n=4)

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Follow-Up Lost to follow-up (n=1) • Unreachable (n=1)

Lost to follow-up (n=6) • Patients died (n=4) • Revised diagnosis – No glaucoma (n=1) • Patient had Alzheimers (n=1) Analysis

Analyzed (n= 84) Excluded from analysis (n=15 ) • Not covered by RAMQ (n=1) • Do not have RAMQ drug coverage (n=12) • Medical chart not available (n=2)

Analyzed (n= 81) Excluded from analysis (n= 14) • Not covered by RAMQ (n=1) • Do not have RAMQ drug coverage (n=9) • Medical chart not available (n=4)

FIGURE 1. Flow chart indicating patients included and excluded from analyses of educational intervention on glaucoma medication adherence, Montreal, Canada. RAMQ, Re´gie de l’assurance maladie du Que´bec (Quebec Health Insurance Program).

associated with persistence. Ordinal regression was used to examine the factors associated with the secondary outcomes; eye drop instillation technique and perception of the importance of glaucoma eye drop therapy. The proportional odds assumption was checked. Intention-to-treat analysis was carried out. A p value 50.05 was considered statistically significant.

RESULTS A total of 207 people with primary open-angle glaucoma consented to participate in the study and gave approval to request their RAMQ pharmacy claim records. Of that group, six patients withdrew from the study, seven were lost to follow-up, and 29 were excluded from analysis due to missing data (Figure 1). Reasons for the missing data included lack of RAMQ medical coverage (n = 2), lack of RAMQ drug coverage (n = 21), and missing hospital medical charts (n = 6). Data from 165 people were analyzed (80%). We examined the characteristics of the 20% who did not have complete data compared to those who did. Those without complete data were not different to !

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those with complete data in terms of age, sex, or treatment assignment (p40.05). Baseline characteristics of the intervention and control groups are shown in Table 1. Although there were no statistically significant differences between the groups, the control group was older, more likely to be male, and less likely to live alone than the intervention group (p40.05). Attendance at the two intervention sessions was perfect as everyone in the intervention group attended both sessions. There were no adverse events reported during the followup. Participants in the intervention group were more likely to be persistent than participants in the control group. As shown in Table 2, 89% of the intervention group and 77% of the control group were persistent (p = 0.049). The effect of the intervention was stronger after adjusting for age, which was somewhat imbalanced between the intervention and control group (odds ratio, OR, 3.06, 95% confidence interval, CI, 1.27–7.93). In a multiple logistic regression model (Table 3), we looked at other factors associated with persistence. Older people were more likely to have better persistence (OR 1.04, 95% CI 1.00–1.08). Also, people who had a greater number of chronic diseases

384 F. Djafari et al. TABLE 1. Characteristics of randomized groups for study of educational intervention on glaucoma medication adherence, Montreal, Canada.

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Intervention (n = 84) Age, mean (SD) years Sex, n (%) Female Male Ethnic origin, n (%) Caucasian Non-Caucasian Education, n (%) 5High school High school Living alone, n (%) No Yes Number of chronic diseases, mean (SD) Number of glaucoma medications, mean (SD) Visual field deviation in better eye, mean (SD)

TABLE 3. Factors associated with glaucoma medication persistence after educational intervention in a multiple logistic regression model, Montreal, Canada.

Control (n = 81)

66.5 (10.7)

68.5 (11.1)

55 (56.1) 29 (43.3)

43 (43.9) 38 (56.7)

68 (50.0) 16 (55.2)

68 (50.0) 13 (44.8)

16 (37.2) 68 (55.0)

22 (62.8) 59 (45.0)

48 (46.2) 36 (59.0) 0.70 (0.74)

56 (53.8) 25 (41.0) 0.88 (0.84)

1.73 (0.83)

1.89 (1.04)

3.69 (4.87)

4.02 (5.86)

Intervention status Control group Intervention group Age Sex Male Female Ethnicity Caucasian Non-Caucasian Education 5High school High school Living alone No Yes Number of glaucoma medications Number of chronic diseases


95% CI

1.00 3.95 1.04

Reference 1.54–11.10 1.00–1.08

1.00 1.62

Reference 0.63–4.20

1.00 0.53

Reference 0.18–1.63

1.00 0.56

Reference 0.14–1.92

1.00 0.47 1.47 1.91

Reference 0.17–1.24 0.88–2.77 1.01–3.95

OR, odds ratio; CI, confidence interval.

SD, standard deviation. TABLE 4. Glaucoma eye drop instillation technique grade by educational intervention group, Montreal, Canada. TABLE 2. Effect of educational intervention on glaucoma medication persistence as measured by pharmaceutical prescriptions, Montreal, Canada. Treatment assignment Control group Intervention group

Eye drop instillation technique

Intervention, %

Control, %

2 p value

33.3 51.9 14.8

6.8 68.9 24.3

0.0002 – –


Adherent, %

 p value

77 89

0.049 –

were more likely to have better persistence (OR 1.91, 95% CI 1.01–3.95). The other variables in the model were not statistically significant. The intervention also had an effect on our two secondary outcomes. People in the intervention group had higher scores on eye drop instillation technique than people in the control group (p = 0.0002; Table 4). This effect remained after age-adjustment (OR 3.18, 95% CI 1.64–6.38). Participants in the intervention group also had higher scores on the questions regarding the importance of glaucoma eye drop therapy (p50.0001; Table 5). This effect also remained after age adjustment (OR 4.33, 95% CI 2.30–8.31).

DISCUSSION Two educational sessions on eye drop therapy for glaucoma resulted in better persistence to glaucoma eye drop therapy; 89% of people in the intervention group had medication available at least 75% of the time. These sessions also resulted in a better eye drop instillation technique and greater perception of the

Good Fair Bad

importance of glaucoma eye drop therapy than that found in our control group. A thorough health economic analysis is beyond the scope of our project. However, it seems that this intervention would be very cost effective to implement. If the two classes were offered every month at the hospital, it would require 3 hours of time from a research nurse or non-practicing ophthalmologist making about $25/hour. This would only come to $900/year and yet these classes could provide valuable information to 120 people/year. If only one of those 120 people avoided visual impairment because of the classes, this would save $10,573 dollars to the healthcare system per year.25 Greater amounts for caregiving costs and lost productivity may also be saved. We created our intervention based on the Health Belief Model, which states that a person will take a health-related action if that person (1) feels that a negative health outcome can be avoided (e.g. blindness), (2) expects that by taking the recommended action, the negative health condition can be prevented (e.g. the drops will prevent blindness), and (3) believes that he or she can take the recommended Ophthalmic Epidemiology

Educational Intervention on Glaucoma Persistence


TABLE 5. Perception of importance of glaucoma eye drop therapy by educational intervention group, Montreal, Canada. Perception of importance of glaucoma eye drop therapy

Intervention, %

Control, %

2 p value

64.3 25.0 4.8 6.0

32.1 18.5 30.9 18.5

50.0001 – – –

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Excellent (4 positive answers) Good (3 positive answers) Moderate (2 positive answers) Low (0–1 positive answer)

health action (e.g. the person feels confident that he or she can succeed in taking the eye drops regularly and without too much discomfort). According to a 2013 Cochrane review, six previously published randomized controlled trials examining educational interventions have been conducted with three reporting significant improvements in glaucoma adherence and persistence.15,16 For example, Okeke and co-workers found that an educational intervention that included advice on overcoming barriers and phone call reminders resulted in a 19% improvement in adherence compared to only a 5% improvement in controls, where adherence was measured by use of the travoprost dosing aid.26 Also, Gray and colleagues found that individualized patient care resulted in significantly more prescriptions filled for glaucoma eye drops compared to usual care.27 By contrast, Muir and co-workers, who used pharmacy claims data in 127 patients in the Veterans Administration Medical Center, did not find a significant improvement in persistence although they saw a non-significant trend in that direction.28 Glanz and coauthors also did not find a significant effect of intervention on glaucoma persistence using pharmacy claims data.18 Other studies used either electronic medication devices29 or self-report.30 The intervention in our study is very similar to that used in a feasibility study of 19 glaucoma patients in England.31 Our study had several strengths. We used the randomized controlled trial design to reduce confounding and to minimize bias. We took advantage of prior research that had estimated the number of eye drops available in each bottle per day. We relied on pharmacy claims data to examine persistence rather than relying on self-report which can overestimate adherence. A limitation of using pharmacy claims data is that a person may fill a prescription but not take the medicine. Also, participants knew that we were monitoring their claims data so this monitoring may have improved their prescription refill behavior. However, this monitoring lasted for an entire year so, in our opinion, it is unlikely that the effect of being monitored would have lasted the entire year. Furthermore, people with poor eye drop instillation technique use more eye drops and therefore might refill their prescription more often which would overestimate their persistence. Another limitation is that our follow-up period was only 1 year so we do not know if the protective effect will be maintained !

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over time. Also, only one person delivered the intervention so we could not assess whether there were differences in the effect of the intervention depending on who was teaching it. Finally, our secondary outcomes were assessed by an unmasked interviewer who delivered the questionnaire, which could have led to problems with interviewer bias and social desirability bias, and the questionnaire and assessment of the eye drop instillation technique were not validated. In conclusion, we have demonstrated that two short and easy-to-offer educational sessions increased persistence to glaucoma eye drop therapy in newly diagnosed glaucoma patients. This intervention should be generalizable to glaucoma patients with mild to moderate vision loss who can speak and understand French. Health insurers, eye care clinicians, pharmacists, and hospitals should consider ways in which this type of education can be given to all new glaucoma patients.

DECLARATION OF INTEREST The authors report no conflicts of interest. The authors alone are responsible for the content and writing of the paper. This study was funded by a grant from Pfizer Canada (NRA6110029). The funding organization had no role in the design or conduct of this research.

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Ophthalmic Epidemiology

Impact of a Brief Educational Intervention on Glaucoma Persistence: A Randomized Controlled Clinical Trial.

To determine whether two sessions of a glaucoma educational intervention resulted in better persistence to glaucoma eye drop therapy compared to norma...
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