Randomized Controlled Trial Evaluating Pictogram

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Oct 25, 2011 - The Annals of Pharmacotherapy □. 2011 November ... The use of pictograms on medication vials as a means of improving patients' understanding of ... Paul's Hospital ambulatory pharmacy meet with clinical pharmacists ...
Adherence

Randomized Controlled Trial Evaluating Pictogram Augmentation of HIV Medication Information Kyle Wilby, Carlo A Marra, Jack H da Silva, Maja Grubisic, Stephanie Harvard, and Larry D Lynd

ntiretroviral therapy for the management of HIV typically requires the BACKGROUND: Antiretroviral therapy for the management of HIV typically requires chronic use of 3 or more medications the chronic use of 3 or more medications. As such, patients with HIV are required taken at least once daily.1 As such, pato manage complex dosing schedules and are at risk of multiple potential adverse tients with HIV are required to manage effects. The use of pictograms on medication vials as a means of improving complex dosing schedules and are at risk patients’ understanding of medication information has been shown to positively of multiple potential adverse effects. The influence understanding and adherence compared to those using text alone. successful treatment of HIV depends on OBJECTIVE: To determine whether pictograms (Pharmaglyph) increase patient recall of targeted information associated with HIV medications and whether patients can strict adherence to treatment regimens, interpret the intended meaning of pictograms that they had not seen previously. and some evidence suggests that poor METHODS: A randomized, controlled trial was conducted in HIV-positive patients knowledge of HIV medication regimens, aged 19 years or older who were receiving a new prescription for an antiretroviral including knowledge related to dosing medication from the ambulatory pharmacy at St. Paul’s Hospital in Vancouver, and adverse effects, is associated with British Columbia, Canada. Participants were randomized to receive either lower adherence.2,3 pictogram-enhanced medication information or standard counseling. At the first In general, it is recommended that infollow-up visit, each patient’s recall of the medication information was evaluated, and differences between groups were compared. formation regarding medication dosing and adverse effects be communicated efRESULTS: Eighty-two subjects were randomized, 40 to the intervention group and 42 to the control arm. The mean (SD) number of HIV medications was nearly fectively to patients to improve adherequal between the intervention and control groups: 3.0 (1.5) and 3.1 (1.4), ence and reduce the risk of adverse respectively. After a mean of 34 days, 33 patients in the intervention arm and 39 events.4 Despite this, the majority of pain the control arm completed the study. The majority (88%) of the targeted pieces tients report that information provided of information in the intervention group were correctly identified at follow-up, with prescription medications is difficult compared to only 2% in the control group (Fisher exact test; p < 0.0001). to comprehend.5 Accordingly, rates of CONCLUSIONS: Pictograms improve the recall of targeted medication information misunderstanding of medication inforamong patients receiving antiretroviral therapy for HIV management; however, this appears to be dependent on the fact that these patients received a verbal mation are high among patients,6-12 parexplanation of each pictogram prior to use. ticularly those with complex treatment 7,8,13 KEY WORDS: counseling, HIV, medication information, pictograms, symbols. regimens. Ann Pharmacother 2011;45:1378-83. The use of pictograms on medication vials as a means of improving patients’ Published Online, 25 Oct 2011, theannals.com, DOI 10.1345/aph.1Q091 understanding of medication information, including dosing and adverse effects,14-17 has been shown to positively or symbols compared to those using text alone.14,16,17 Alinfluence understanding and adherence,15 and patients rethough the US Pharmacopeia has produced a series of picport greater satisfaction with labels that include pictograms tograms aimed at enhancing medication information,18 there is evidence to suggest that patients may prefer locally developed pictograms.14 Author information provided at end of text.

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Pharmaglyphs (Pharmaglyph Corp., Richmond, British Columbia, Canada; www.pharmaglyph.com) are locally developed pictograms developed with the objective of enhancing medication-specific information for patients. They have been designed to communicate information regarding dosage instructions and adverse effects by including a pictogram on the medication vial label. This specific type of pictogram was chosen for this study based on local availability and applicability to our study center. We are unaware of any other study or communication system that has used these pictograms in a public setting. We conducted a randomized controlled trial to examine the effectiveness of pictograms in communicating HIV medication information to patients. The objectives of this study were to determine whether pictograms increase patient recall of targeted information associated with their HIV medications (ie, dosing instructions and adverse effects) and whether patients can interpret the intended meaning of pictograms that they have not seen previously without assistance. Methods STUDY SETTING AND PARTICIPANTS

HIV-positive patients receiving antiretroviral medications were recruited from the ambulatory pharmacy at St. Paul’s Hospital in Vancouver, British Columbia, Canada. St. Paul’s Hospital is a 440-bed tertiary care center and a major teaching and referral hospital affiliated with the University of British Columbia. The ambulatory pharmacy at St. Paul’s Hospital is the main Vancouver dispensary for HIV medications, which patients in British Columbia receive at no cost through a provincial drug benefit program. Patients who receive HIV medications through the St. Paul’s Hospital ambulatory pharmacy meet with clinical pharmacists approximately every 4-8 weeks for medication counseling and information and to renew their prescriptions. Patients were eligible for inclusion in the trial if they were aged 19 years or older and were filling a prescription for a new HIV medication (ie, initiating antiretroviral therapy or changing a prescription). Patients receiving medication refills without changes to their prescription were ineligible. Five pharmacists in the ambulatory care pharmacy participated in the study and were trained in protocols prior to its initiation. All participating pharmacists provided care to both treatment and control patients. Two pharmacists were on call for the study and participants were encouraged to phone them with any questions regarding their medications at any time. These pharmacists were trained to answer questions in the best interests of the patient while limiting the potential for bias by avoiding specific references to the pictograms. The pharmacists were further instructed to document all patients’ questions and their responses. theannals.com

Translators were available for patients for whom English is a second language. Informed consent was obtained from each patient prior to enrollment. Following their informed consent, patients were randomized to the intervention or control group, using a computer-generated randomization table. The study was approved by the University of British Columbia Behavioral Research Ethics Board and was conducted between December 5, 2008, and March 31, 2010. SELECTION OF TARGETED MEDICATION INFORMATION

For each HIV medication dispensed, 1 or 2 pieces of targeted information from the medication information routinely reviewed with patients for which a pictogram had been developed were identified. One piece of targeted information (eg, dosing instructions) was chosen for drug formulations with 1 or 2 active ingredients (ie, single- or double-entity products) and 2 pieces of targeted information were chosen for combination products containing more than 2 active ingredients (eg, dosing instructions and 1 adverse effect). Products were limited to 1 or 2 pieces of targeted information, as we were aiming for 2-5 pieces of targeted information per patient between all medications for analysis, and limiting the total number of stickers on any vial is consistent with usual pharmacy practice. A list of all targeted information paired with specific medications is shown in Table 1. To show as many pictograms as possi-

Table 1. Selected Examples of Targeted Information for HIV Medications Abacavir

Avoid alcohol

Abacavir/lamivudine

May cause rash

Atazanavir

Take with meals

Darunavir

May cause headache

Didanosine

Take on an empty stomach

Efavirenz

May cause confusion

Efavirenz/tenofovir/ emtricitabine

May cause confusion; take with water

Etravirine

May cause rash

Lamivudine

Caution driving

Lamivudine/zidovudine

Caution driving

Lopinavir/ritonavir

May cause changes in fat composition

Nelfinavir

May cause liver toxicity

Nevirapine

Follow special dosing instructions

Raltegravir

May cause diarrhea

Ritonavir

May cause nausea/vomiting

Stavudine

May cause peripheral neuropathy

Tenofovir

Take with water

Tenofovir/emtricitabine

May cause diarrhea

Zidovudine

May cause nausea/vomiting

Zidovudine/lamivudine/ abacavir

May cause rash; avoid alcohol

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ble to patients in the intervention arm, once a piece of targeted information (and its associated pictogram) was paired with 1 medication, it was not selected for a second medication unless no alternative was available. INTERVENTION AND CONTROL PROCEDURES

Patients randomly assigned to the intervention group received pictogram-enhanced medication information on all of their antiretrovirals plus standard counseling provided by a study pharmacist. Pictogram-enhanced medication information included a pictogram sticker placed on the vial representing the targeted information for that medication and verbal explanation of the meaning of the pictogram as it related to that drug. Each vial also contained the standard label usually dispensed by the ambulatory pharmacy. The verbal explanation was provided by study pharmacists using a predetermined script specific to each pictogram and was consistent with the standard information provided to patients. Standard counseling included a verbal description of each medication’s indication, dosage instructions, adverse effects, monitoring procedures, and the targeted information communicated verbally. Patients also received a medication information sheet that summarized the information given verbally, but the label was the only place the pictogram appeared. All participants were given an opportunity to ask questions about their medications. Those randomly assigned to the control group received only standard counseling (including verbal targeted information and the same written information sheet) by a study pharmacist.

addressed to the patient for each medication. Patients who reported the targeted information were scored as giving a correct response, and those who did not report the targeted information were scored as giving an incorrect response. Because outcomes were evaluated using participants’ actual antiretrovirals, the number of medications and the required pieces of targeted information differed among participants. Thus, each of these values was recorded by the study pharmacist for each participant. Secondary Outcome

To measure whether patients could interpret the intended meaning of pictograms that they had not previously seen without assistance and thereby limit respondent burden, patients were asked to interpret 10 randomly selected pictograms from among the complete set (n = 116). Pharmacists showed patients the pictograms printed on a sheet of plain paper and asked patients to write their interpretation beside each pictogram. Patients who interpreted the intended meaning of the pictogram were scored as giving a correct response, while those who interpreted anything but the intended meaning of the pictogram were scored as giving an incorrect response. In the event that patients were shown pictograms that they had seen previously in the intervention, their interpretations of those pictograms were excluded from the analysis. Thus, the outcome was the proportion of correctly identified never-seen-before pictograms. STATISTICAL ANALYSES

OUTCOMES

To limit the burden on participants and avoid unnecessary visits to the pharmacy, outcomes were evaluated for all study participants at their next routine follow-up appointment at the ambulatory pharmacy. As the time between routine appointments varies, time to follow-up was recorded for each participant. All outcome assessments were performed by 2 of the 5 study pharmacists to increase the likelihood of consistency of the evaluation. One investigator (KW) then independently analyzed the responses received in the exit interview and tabulated the results. Primary Outcome

To measure patients’ recall of targeted information relevant to their medication regimen, pharmacists reviewed each of the current HIV medications, one by one, with each patient. Patients in the intervention group were shown all of their drugs with pictogram stickers, and those in the control group were shown all of their drugs without pictogram stickers. For each medication, pharmacists asked the patient, “What can you tell me about this medication?” and documented their response. This was the only question 1380

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Mean (SD) was calculated for age, number of current HIV medications, number of pictograms viewed, number of targeted information, and number of days to follow-up; the proportion was calculated for the sex variable. Given the small number of correctly identified pictograms in the control group, the Fisher exact test was used to compare the total number of correctly identified pieces of targeted information between the intervention and control groups. Logistic regression was used to determine the relationship between the proportion of the correctly identified never-seen-before pictograms and treatment group, adjusting for age and sex. The mean time to follow-up was calculated for the intervention and control groups and compared for differences. All p values