Complete an article analysis and ethics evaluation of the research attached using the "Article Analysis and Evaluation of Research Ethics" template. See Chapter 5 of your textbook as needed, for assis

256 P&T ® April 2017 Vol. 42 No. 4 Can a Short Video Improve Apixaban Knowled\fe in an Inpatient Settin\f? Christopher Giuliano, PharmD; Thomas Nofar, PharmD Candidate; and Stephanie B. Edwin, PharmD, BCPS-AQ Cardiology ABSTRACT Purpose: To increase patient knowledge about apixaban (Eliquis, Bristol-Myers Squibb) using an educational video delivered in an urban inpatient setting.

Methods: This prospective, quasi-experimental study evalu - ated knowledge gain and retention in patients receiving apixa - ban after viewing a short educational video. Knowledge was assessed with a questionnaire immediately before, immediately after, and one month following the educational video.

Results: After 33 patients watched the video, scores increased by 19.7% from the pre-test to the immediate post-test time point (95% con dence interval [CI], 14.5–24.9; P <0.001).

Patients previously receiving apixaban or another anticoagulant were less likely to improve scores compared with new patients (P <0.05). Twenty-two of the 33 patients (66.7%) completed the one-month follow-up. No difference in scores from pre-test to one month post-test were noted (6.4%; 95% CI, 1.6–14.5; P = 0.11).

Conclusion: The apixaban educational video led to improve - ments in short-term knowledge; however, patients did not retain this knowledge at one month. Future studies should seek ways to improve long-term knowledge retention.

Keywords: apixaban, anticoagulants, patient education, knowledge retention INTRODUCTION The development of direct oral anticoagulants (DOACs) has made anticoagulation more manageable for patients. In contrast to warfarin, these agents have more predictable pharmacological properties, require less frequent monitor - ing, and are less dependent on factors such as diet and con- comitant medications. 1 Because of the reduced complexity of DOACs compared with warfarin, the perceived need for patient education may be diminished. 2 The Institute for Safe Medication Practices classi es anti- coagulation therapy as high risk, as misuse is associated with a signi cant risk of serious injury or death. 3 Furthermore, the Joint Commission’s National Patient Safety Goal 03.05.01 focuses on reducing the likelihood of patient harm associated with anticoagulation therapy. 4 This goal speci cally mentions the importance of comprehensive patient counseling. Dr. Giuliano is an Associate Professor at the Eugene Apple - baum College of Pharmacy and Health Science at Wayne State University and a Clinical Pharmacy Specialist in Internal Medi - cine at St. John Hospital and Medical Center in Detroit, Michigan.

Mr. Nofar is a Doctor of Pharmacy Candidate at the Eugene Apple- baum College of Pharmacy and Health Science at Wayne State University. Dr. Edwin is a Clinical Pharmacy Specialist in Cardiac Intensive Care at St. John Hospital and Medical Center. Effective patient education is essential in helping patients opti- mize their medications. 5 In patients taking apixaban (Eliquis, Bristol-Myers Squibb), a lack of understanding regarding appro - priate use could lead to an increased risk of thromboembolism or bleeding. Patients taking apixaban should understand the purpose of anticoagulation therapy and how to properly take the medication, including how to handle missed doses and reduce the medication dose after a week of therapy if being treated for acute venous thromboembolism. 6 Patients should also be familiar with adverse effects of the medication, including how to recognize situations that require emergency medical care. One way of providing education is through the use of educational videos. Previous studies have demonstrated that educational videos have many bene ts, including increasing patient knowledge, decreasing health professional time for patient counseling, improving disease control, and increas - ing patient satisfaction. 7–10 Currently, there is no literature evaluating apixaban video education. The purpose of our study was to validate an apixaban educational video by measuring knowledge before and after the video.

\bETHODS Research Desi\fn A quasi-experimental study was conducted at St. John Hospital and Medical Center, a 772-bed community teaching hospital in Detroit, Michigan, from July 2015 to March 2016.

Patients were identi ed via a clinical decision support system (Sentri7, Wolters Kluwer). Patients 18 to 90 years of age who were prescribed apixaban for treatment of deep vein throm- bosis (DVT) or pulmonary embolism (PE), reduction of risk of recurrent DVT/PE, and prevention of stroke in nonvalvular atrial brillation (AFIB) were included in the study. Patients were excluded if they were diagnosed with Alzheimer’s disease, were pregnant, or were unable to execute study procedures.

Only the rst patient admission during the study period was included for analysis. Informed consent was obtained from all patients, and the study was approved through the hospital’s institutional review board.

The primary outcome of this study was the change in short- term knowledge as measured by the difference in overall scores between a pre-test and immediate post-test. Secondary outcomes of this study included evaluation of long-term knowl - edge retention as measured by changes in test scores after one month and evaluating if learning was dependent upon previous treatment with apixaban, previous treatment with any anticoagulant, or level of education. Level of education was evaluated by comparing those with less than high school education, those with high school education, and those with more than high school education.

Disclosures: The authors report no commercial or nancial interests in regard to this article\f PT_1704_Giuliano_Apixaban_3kr.indd 256 3/10/17 10:07 AM Vol. 42 No. 4 April 2017 P&T ® 257 Video Development Prior to study commencement, two apixaban educational videos (each approximately ve minutes in length) were devel - oped by the investigators using Camtasia (Techsmith). Separate videos were created for the treatment and prevention of DVT/PE and prevention of stroke in AFIB due to differences in dosing between indications. Two corresponding ques- tionnaires were created to assess knowledge (Table 1). The videos and questionnaires were written to address six main constructs: purpose of medication, how to take the medication, management of missed doses, identifying adverse events, when to seek emergency treatment, and what patients should inform their physicians or pharmacists about while taking apixaban.

Videos were purposefully kept short, as previous research has shown that the more information that is presented, the less the patient remembers. 11 An additional construct was added for acute DVT/PE treatment that assessed whether patients understood the difference in dosing during the rst week of treatment. Content validation of the questionnaires and videos was performed by three specialists with expertise Can a Short Video Improve Apixaban Knowled\fe in an Inpatient Settin\f? Table 1 Apixaban Knowled\fe Questionnaire ConstructQuestion 1 Question 2 Medication purpose Which disease is Eliquis \fapixaban) used to treat or pre\bent?

a. High cholesterol b. Blood clots c. Diabetes d. High blood pressure What type of medication is Eliquis \fapixaban)?

Blood thinner b. Decreases blood pressure c. Diabetes medication d. Decreases cholesterol Identify ad\berse efects What is a major side efect of Eliquis \fapixaban)?

a. Bleeding b. Changes in eye sight c. Coughing d. Decreased blood pressure Which of the following is a sign of bleeding?

Dry skin b. Cofee-looking \bomit c. Green stool d. Sneezing and watery eyes How to take the medication How should you take Eliquis \fapixaban)? a. With food b. Without food c. It doesn’t matter \fwith or without food) d. Without water When can Eliquis \fapixaban) be stopped safely?

Once you run out of prescription re lls b. If you start eating healthy c. Only when the doctor tells you to stop d. When you feel better Missed doses If you miss one dose of Eliquis \fapixaban), what should you do?

a. Skip it if you forgot for more than two hours.

b. Stop taking it.

c. Take it as soon as you remember. Do not take two tablets at one time.

d. Take four tablets to make up for the missed pill. Why is it important to not miss doses?

Increased risk of bleeding b. Increased risk of blood clots or stroke c. Decreased risk of bleeding d. Decreased risk of blood clots or stroke When to seek emergency attention When should you seek emergency attention while taking Eliquis \fapixaban)?

a. When skin is dry b. If you ha\be blood in your stool and/or urine c. If you ha\be mild pain d. If you ha\be small bruises from bumping something Which of the following situations is not a bleeding emergency?

a. Blood in urine b. A small amount of blood from brushing your teeth c. A cut that doesn’t stop bleeding d. Red or dark “tar” stools O\ber-the-counter medications Which of the following should you tell your doctors and pharmacists about before taking Eliquis \fapixaban)?

a. Broccoli and lettuce b. Herbal or o\ber-the-counter medications c. Water or sports drinks d. Cofee Which of the following increases bleeding risk while taking Eliquis \fapixaban)?

a. Ibuprofen b. Benadryl c. Fiber supplement d. Sunscreen Dosing diferences \fdeep \bein thrombosis only) What is the dose of Eliquis \fapixaban) for the rst se\ben days?

a. 10 mg \ftwo 5-mg tablets) twice a day b. 20 mg \ffour 5-mg tablets) twice a day c. 5 mg \fone 5-mg tablet) twice a day d. 15 mg \fthree 5-mg tablets) twice a day How will you take Eliquis \fapixaban) after the rst se\ben days?

a. 10 mg \ftwo 5-mg tablets) twice a day b. 20 mg \ffour 5-mg tablets) twice a day c. 5 mg \fone 5-mg tablet) twice a day d. 15 mg \fthree 5-mg tablets) twice a day PT_1704_Giuliano_Apixaban_3kr.indd 257 3/10/17 10:07 AM 258 P&T ® April 2017 Vol. 42 No. 4 Can a Short Video Improve Apixaban Knowled\fe in an Inpatient Settin\f? RESULTS Seventy patients were screened for entry into the study, and 33 patients were included (24 patients refused consent, and 13 patients were unable to complete study procedures).

Reasons for being unable to complete study procedures included poor mental status (n = 5), dementia (n = 3), discharged prior to study completion (n = 2), blindness (n = 2), and medication discontinuation (n = 2). Baseline characteristics are described in Table 2. All 33 patients were analyzed for the primary endpoint. Twenty-two patients (66.6%) completed the one-month follow-up phone call. No signi cant differences were noted in patients who were lost to follow-up with regard to age (73 ± 11.2 years versus 68 ± 12.4 years; P =0.26) or previous treatment with apixaban (81.8% versus 63.6%; P = 0.43). Patient scores increased from pre-test to immediate post- test by 19.7% (95% con dence interval [CI], 14.5–24.9). This improvement was not signi cantly different for those with an indication of AFIB versus DVT/PE (19.1% versus 22.2%; P =0.646). Improvement in scores depended on previous apixaban or anticoagulant use (P <0.05), but not level of education (Figure 1). Patients previously on anticoagulants improved their scores on average from 72.3% to 87.9% (an increase of 15.6 percentage points); those patients who were starting anticoagulant therapy for the rst time improved their scores from 57% to 82.9% (a 25.9-percentage-point increase).

Patients previously on apixaban improved their scores from an average of 72.0% to 83.3% (an 11.3-percentage-point increase); those patients who were newly started on apixaban improved their scores from 63.8% to 87.1% (a 23.3%-percentage-point increase). Individual question responses and changes from pre-test to immediate post-test are listed in Table 3. Patients had signi cant improvements in understanding the purpose of the medication, identifying adverse effects, knowing how to take the medication, understanding when to seek emergency attention, and management of over-the-counter medications.

Scores from pre-test to one-month post-test were not signi - cantly different (6.4% increase; 95% CI, 1.6–14.5). Four of the 22 patients said they watched the video after discharge and before the one-month follow-up. Seven of the 22 patients had in anticoagulation therapy, and the videos were pilot tested in ve associates with no prior medical training. The videos are available at the following links: http://tinyurl.

com/ApixabanAFIB and http://tinyurl.com/DVT-PEapixaban.

Videos during the study period were accessible only through a provided link. Questionnaires had a seventh-grade reading level according to Flesch-Kincaid analysis.

Study Procedure Patients were approached for potential enrollment during their hospital stay. Once consent was obtained, the pre-test was administered by the study investigators. Patients then watched the apixaban video that corresponded with their prescribed indication (AFIB or DVT/PE). Patients viewed the video on a tablet computer provided by the study investigator. After the video, patients completed a post-test and a satisfaction survey.

The satisfaction survey consisted of three questions that asked how much patients learned from the video, how helpful the video was, and if they would recommend watching the video to a family member. Study investigators answered any addi- tional questions related to apixaban and provided education on knowledge de cits present after completion of the immediate post-test. The patient was given a card with a YouTube link for the video and a copy of the video on a DVD so that he or she could access it at home. After one month, patients were contacted via telephone, and the questionnaire was adminis- tered again. If patients were not reached after three attempts, they were recorded as “lost to follow-up.” Demographic data collected from patients included age, gender, education level, previous anticoagulants taken, and indication. Deidenti ed data were obtained from YouTube to evaluate view duration, average percent viewed, and unique views. Unique views allow views to be counted once per device so that multiple views are not counted.

Statistical Analysi\Hs The sample size was calculated using a minimal clinical dif - ference between the pre- and immediate post-test of 17.5% with a standard deviation of 12.5%. These estimates were taken from an unpublished study evaluating a rivaroxaban video at our institution. Using a power of 90% and a two-tailed alpha of 0.05, we calculated a required sample size of eight pairs. However, to meet assumptions of the paired t-test, we planned to enroll 30 patients, and after accounting for a 10% estimated drop-out rate, our goal was a total of 33 patients. Descriptive statistics were used to characterize the study population with respect to demographic and clinical factors, as well as to describe video views. The primary outcome—score improvement on imme - diate post-test compared with the pre-test—was tested by the paired t-test. The change in correctness on individual questions from the pre-test to immediate post-test was analyzed using McNemar’s test. Score changes at one month were evaluated by paired t -test. Additionally, we evaluated whether the primary outcome differed for patients previously on apixaban, previously on any anticoagulants, or by level of education. This was ana - lyzed using a mixed analysis of variance, and interactions were evaluated. All data were analyzed using SPSS VS 22.0, and a P value of 0.05 or less was used to indicate statistical signi cance. Table 2 Baseline Characteristics Variable n (%) or mean (SD) Age in years 69.6 \f12.1) Male gender 15 \f45.5) Pre\bious oral anticoagulant use 20 \f60.6) Pre\bious apixaban use 10 \f30.3) Indication Atrial brillation 27 \f81.8) DVT/PE 6 \f18.2) Education le\bel < High school 2 \f6.1) High school 11 \f33.3) Post-high school 20 \f60.6) Internet access 26 \f78.8) DVT = deep \bein thrombosis; PE = pulmonary embolism; SD = standard de\biation. PT_1704_Giuliano_Apixaban_3kr.indd 258 3/10/17 10:07 AM Vol. 42 No. 4 April 2017 P&T ® 259 Table 3 Number and Percent Correct on Pre-test and Immediate Post-test for Individual Questions Construct Q1 Pre-test n (%) Q1 Post-test n (%) P Value Q2 Pre-testn (%) Q2 Post-test n (%) P Value Medication purpose 26 \f78.8) 32 \f97)0.03130 \f90.9) 32 \f97) 0.625 Identify ad\berse efects 24 \f72.7) 30 \f90.9)0.03111 \f33.3) 20 \f60.6) 0.016 How to take the medication 13 \f39.4) 24 \f72.7)0.00332 \f97) 32 \f97) 1.00 Missed doses 17 \f51.5) 23 \f69.7) 0.146 20 \f60.6) 26 \f78.8) 0.07 When to seek emergency attention 12 \f36.4) 22 \f66.7) 0.00223 \f69.7) 27 \f81.8) 0.219 O\ber-the-counter medications 18 \f54.5) 29 \f87.9) 0.0120 \f60.6) 24 \f72.7) 0.219 Dosing diferences \fDVT only) 6 \f100) 6 \f100) 1.00 4 \f66.6) 6 \f100) 0.50 DVT = deep \bein thrombosis. Can a Short Video Improve Apixaban Knowled\fe in an Inpatient Settin\f? been provided with additional apixaban education by a health care provider between the rst visit and one-month post-test.

This included education from ve physicians, one pharmacist, and one nurse. During the course of the study there were 57 unique video views for the AFIB video. The average video view percentage was 69.5%, and the average duration was 3:22. There were 18 unique views for the DVT video. The average view per - centage was 62.4%, and the average duration was 3:08. On the satisfaction survey, 81.9% of patients said they learned quite a bit or a huge amount, and 97% said they found the video helpful or very helpful. Lastly, 97% of patients would recommend that another patient on apixaban watch the video.

DISCUSSION This is the rst study that has evaluated an apixaban educa - tional video in any setting. Our study found an improvement in short-term knowledge for important clinical concepts related to apixaban use; however, this increase in knowledge was not retained at one month. Patients newly started on apixaban had a larger change in knowledge and achieved similar scores after education compared to patients with prior apixaban use.

Most patients were satis ed with the video, with almost all patients indicating they would recommend this video to a family member.

Our study agrees with previous studies that have evalu- ated short-term changes in knowledge in patients receiving anticoagulation therapy. One study with similar methodology evaluating a 12-minute warfarin video saw an improvement in the rate of patients passing a knowledge test after the video (43% versus 90%; P <0.001). 12 While the percentage of patients who passed improved, absolute changes in scores were not reported, and there was no follow-up evaluation to measure retention of material. Another study evaluating a ve-minute video on venous thromboembolism prophylaxis found improved knowledge scores after watching the video (62% versus 83%; P < 0.001). 13 No follow-up evaluation of knowledge retention was completed. We could not nd any previous studies that have evaluated long-term knowledge retention when evaluat- ing videos as an intervention. However, previous research has shown that information should be repeated to patients for effective learning. 14 In our study, we were disappointed that only four patients (18%) said they watched the video after discharge at our one- month follow-up. If a higher proportion of patients had revisited the videos, this may have improved longer-term knowledge Fi\fure 1 De\free of \HKnowled\fe Chan\fe Dep\Hends on Previous An\Hticoa\fulant or Apix\Haban Use 100 9080 70 60 50 Pre Post PrePost PrePost No Ye s No Ye s No Ye s Previous anticoagul\dants On api\baban previous\dly *p < \f05 *p < \f05 Any college % Correct PT_1704_Giuliano_Apixaban_3kr.indd 259 3/10/17 10:07 AM 260 P&T ® April 2017 Vol. 42 No. 4 Can a Short Video Improve Apixaban Knowled\fe in an Inpatient Settin\f? retention. Although we had unique YouTube views, this data is not identi able and may have occurred at any point during the study period, including after we contacted patients for the one-month follow-up. We attempted to increase video viewing by providing a card to patients with the YouTube link and giving patients a DVD with the video. However, this does not seem to be an effective strategy. One meta-analysis found a larger effect size for diabetes education when the intervention involved Internet and text versus text alone. 15 Texting a video link could serve as a reminder to the patient to watch the video and would prevent information from being lost upon discharge.

While our study provided a tool for inpatient apixaban education, we believe that these videos would also be excel- lent outpatient education tools. Following study completion, we have been asked to share our video with several outpatient clinics. Additionally, we opened the videos for public viewing on YouTube. Prior studies of patient education materials available on YouTube have shown variable quality of video content. 16 We believe it is important to provide patients with validated, evidenced-based videos that are publically available.

Furthermore, the videos we produced are indication-speci c, whereas previous anticoagulant videos have provided only an overview for all indications. Proving indication-speci c videos is particularly important for apixaban, as different indications have different dosing. 17 This study had limitations. First, knowledge changes were not compared to a control group; therefore, we cannot compare our results with traditional counseling from a health care provider.

However, video education does not need to be a substitute for provider counseling. In fact, a meta-analysis evaluating multi - media education showed larger effects when the multimedia intervention was used as a supplement to health care provider counseling as opposed to a substitute for provider counseling. 18 Second, we were able to contact only 22 of the 33 patients for the one-month knowledge assessment. While these patients were similar in age and prior apixaban use, numerically there were more patients who were new to apixaban. This may have decreased the bene t seen at the one-month follow-up because these patients demonstrated the largest improvement in immedi - ate knowledge gain. Also, our patients may have different levels of education compared to other populations, and therefore, the results may vary at other institutions. However, changes in knowledge scores did not depend on education level, and the video was developed to teach patients at less than a high school level of education. Future studies should investigate whether additional strategies aimed at increasing video views are associated with improved long-term knowledge.

CONCLUSION The apixaban educational video led to improvements in short-term knowledge. Patients did not retain this knowledge at one month; however, few patients reviewed the video after discharge. Future studies should seek ways to encourage patients to revisit video education or evaluate other strategies to improve long-term knowledge retention.

REFERENCES 1. Hanley CM, Kowey PR. Are the novel anticoagulants better than warfarin for patients with atrial brillation? J Thorac Dis 2015;7(2):165–171. 2.

Heidbuchel H, Berti D, Campos M, et al. Implementation of non- vitamin K antagonist oral anticoagulants in daily practice: the need for comprehensive education for professionals and patients. Thromb J 2015;13:22.

3. Institute for Safe Medication Practices. Medication self-assessment for hospitals. 2011. Available at: www.ismp.org/selfassessments/Hospital/2011. Accessed July 13, 2016.

4. The Joint Commission. National patient safety goals 2016. Available at: www.jointcommission.org/assets/1/6/2016_NPSG_HAP.pdf. Accessed July 13, 2016.

5. Grime J, Blenkinsopp A, Raynor DK, et al. The role and value of written information for patients about individual medicines: a systematic review. Health Expect 2007;10(3):286–298.

6. Eliquis (apixaban) prescribing information. New York, New York: Bristol-Myers Squibb; 2016.

7. Superior CK, Broyles JE, Oliphant CS, et al. Development and evaluation of a medication education videotape for hospitalized patients. Am J Health Syst Pharm 2002;59(9):859–861.

8. Baldwin DM. Viewing an educational video can improve phosphorus control in patients on hemodialysis: a pilot study. Nephrol Nurs J 2013;40(5):437–442; quiz 443.

9. Katz SJ, Leung S. Teaching methotrexate self-injection with a Web-based video maintains patient care while reducing health care resources: a pilot study. Rheumatol Int 2015;35(1):93–96.

10. Moore SJ, Blair EA, Steeb DR, et al. Impact of video technology on ef ciency of pharmacist-provided anticoagulation counseling and patient comprehension. Ann Pharmacother 2015;49(6):631–638.

11. McGuire LC. Remembering what the doctor said: organization and adults’ memory for medical information. Exp Aging Res 1996;22(4):403–428.

12. Kim JJ, Mohammad RA, Coley KC, Donihi AC. Use of an iPad to provide warfarin video education to hospitalized patients. J Patient Saf 2015;11(3):160–165.

13. Marini BL, Funk K, Kraft MD, et al. The effects of an informational video on patient knowledge, satisfaction, and compliance with venous thromboembolism prophylaxis: a pilot study. Patient Educ Couns 2014;96(2):264–267.

14. Ley P. Satisfaction, compliance, and communication. Br J Clin Psychol 1982;21(pt 4):241–254.

15. Saffari M, Ghanizadeh G, Koenig HG. Health education via mobile text messaging for glycemic control in adults with type-2 diabetes: a systematic review and meta-analysis. Prim Care Diabetes 2014;8(4):275–285.

16. Mukewar S, Mani P, Wu X, et al. YouTube and in ammatory bowel disease. J Crohns Colitis 2013;7(5):392–402.

17. Roca B, Roca M. The new oral anticoagulants: reasonable alterna -tives to warfarin. Cleve Clin J Med 2015;82(12):847–854.

18. Ciciriello S, Johnston RV, Osborne RH, et al. Multimedia educational interventions for consumers about prescribed and over-the-counter medications. Cochrane Database Syst Rev 2013;(4):CD008416. n Search for “P&T [Pharmacy and Therapeutics]” @PTJournal780 Search for “P&T” in Groups Atte\btio\b Rea\fers: P&T® is on Facebook, Twitter, and LinkedIn\f PT_1704_Giuliano_Apixaban_3kr.indd 260 3/10/17 10:07 AM Copyright ofP&T: APeer- Reviewed JournalforManaged Care&Formulary Management is the property ofMediMedia ManagedMarkets,anICON Company anditscontent maynotbe copied oremailed tomultiple sitesorposted toalistserv without thecopyright holder's express writtenpermission. However,usersmayprint, download, oremail articles for individual use.