key: cord-0869556-jdo81a51 authors: Babapour Mofrad, Rosha; Fruijtier, Agnetha D.; Visser, Leonie N. C.; Hoogland, Nina; van Dijk, Maisa; van Rossum, Frederique; Bouwman, Femke H.; Smets, Ellen M. A.; Teunissen, Charlotte E.; van der Flier, Wiesje M. title: Lumbar puncture patient video increases knowledge and reduces uncertainty: An RCT date: 2021-02-14 journal: Alzheimers Dement (N Y) DOI: 10.1002/trc2.12127 sha: d6beafaa88216acc9aaab01f01be0de79f34469b doc_id: 869556 cord_uid: jdo81a51 BACKGROUND: Patients often perceive a lumbar puncture (LP) as an invasive procedure. We aimed to evaluate the impact of a 3‐minute educational animation‐video explaining the LP procedure, on patients’ knowledge, uncertainty, anxiety, and post‐LP complications. METHODS: We included 203 newly referred memory clinic patients, who were randomly assigned to one of three conditions: (1) home viewing of the video, (2) clinic viewing of the video, or (3) control condition (care as usual). Participants completed questionnaires measuring knowledge as information recall, uncertainty, anxiety, and post‐LP complications, the latter when patients underwent an LP procedure (n = 145). RESULTS: Viewing the video increased information recall for both home (P < .001), and clinic viewers (P < .001) compared to controls. Levels of uncertainty decreased after viewing (P(for interaction )= .044), particularly for clinic viewers. Viewing the video or not did not affect anxiety and post‐LP complications. DISCUSSION: Preparing individuals for an LP by means of an educational video can help to increase knowledge about the procedure and reduce feelings of uncertainty. sufficiently aware of what the procedure entails, or the reasons to perform an LP. 4, 5 In reality, severe complications associated with LPs are rare (ie, requiring hospitalization = 0.9%). 6, 7 We previously found that feelings of anxiety concerning the LP increase the actual risk for complications, such as atypical post-LP headache and local back pain. 6 A lack of (accurate) information prior to the LP may negatively affect patients' anxiety and expectations regarding the LP procedure, which in turn increase the risk of complications. 7 Results obtained in different settings, such as prior to a colonoscopy, or during genetic counseling, showed that information about a medical procedure or health risk can reduce uncertainty and anxiety. [8] [9] [10] [11] [12] [13] Audiovisual materials, like educational patient videos, are an effective method to inform patients. 14, 15 Informing patients through audiovisual materials has been found to be more effective than by verbal or written methods as videos can better satisfy a patient's needs, and aid in information uptake and recall. 16, 17 In co-creation with stakeholders, we recently developed an animation-video to inform and prepare patients and caregivers for the LP procedure in the context of AD diagnosis 18 This study entails an RCT for which we consecutively invited all newly referred patients visiting the memory clinic of the Alzheimer Center Amsterdam for standardized dementia screening 19 between April 2019 and March 2020. Participants were recruited by telephone by the researchers prior to their visit to the outpatient clinic. Participants were excluded when they had audiovisual impairments, did not master the Dutch language, or if an e-mail address was unavailable. Of the 203 consenting participants, 145 received a lumbar puncture and were available for follow-up on post-LP complications ( Figure 1 ). All participants gave informed consent prior to participation. The study was reviewed and the need for formal approval was waived by the local medical ethical committee. The RCT was registered prior to the start at trialregister.nl, the Dutch Trial Registry (Trial NL7725). Questionnaires were issued at four timepoints ( Figure 2 ). Upon consent, participants received the baseline questionnaire (timepoint 1; T1), approximately 1 week prior to their visit. After completion of the T1 questionnaire, participants were randomly assigned to one of three conditions, by means of simple randomization: (1) home viewing, (2) clinic viewing, and (3) control condition. The study was embedded in the extensive routine work-up in the outpatient clinic, and all participants received care as usual (ie, verbal information and an informational folder on the LP procedure) regardless of the study condition. The information provided in the video closely resembled the standard verbal and written information, which included information regarding • We used a randomized controlled trial to improve information for patients about the lumbar puncture (LP) procedure. • Viewing our informative video improves knowledge and reduces uncertainty. • Viewing the animation or not did increase anxiety levels. • Providing the video can help prepare patients for an LP. • Both home viewing and integrating the video in the diagnostic visit is beneficial. We assessed four main outcomes: patients' recall of information, feelings of uncertainty and anxiety, and post-LP complications. Additional outcomes of interest included patients' satisfaction with the information and with the LP procedure. Based on the information provided through standard care, we developed a questionnaire measuring knowledge as information recall. This questionnaire was pilot tested among six individuals to test clarity of questions and variation in responses. Participants were provided with eight multiple-choice questions and were instructed to select the correct answer out of four. Sum scores for information recall were calculated after assigning one point for each correct answer. Information recall was assessed at T2 and T3. State anxiety levels were assessed using a Dutch six-item version of the State-Trait Anxiety Inventory (S-STAI-S) at T1 and T2. 21 The items could be answered on a four-point Likert scale ranging from 1 = not at all to 4 = very much so. 21, 22 Higher scores indicated greater uncertainty and anxiety. Primary outcome measures were change over time as indicated by a comparison of uncertainty and anxiety levels reported at T1 and T2. Approximately 2 weeks after their visit (T4), participants were asked by telephone in a structured interview about the occurrence of post-LP complications, previously described in Duits et al. 6 In brief, participants reported: (1) headache (yes/no), which in case of a positive answer was next specified as typical post-LP headache or atypical headache, (2) local back pain (yes/no), or (3) severe complications (yes/no). Typical post-LP headache was defined according to the International Classification of Headache Disorders (ICHD). 23 Severe complications were defined as complications serious enough to require hospitalization or an epidural blood patch. At baseline (T1), questions addressed patient demographics (eg, age, level of education). Additionally, baseline medical knowledge and knowledge about an LP procedure were both measured using a Visual Analog Scale (VAS; eg, "How much knowledge do you think you have about an LP procedure?") ranging from zero (no knowledge at all) to ten (a lot of knowledge). Further, all participants were asked whether they had already seen an educational LP video prior to their visit to the outpatient clinic. At T2, home viewers were asked how often they had watched the video, and both home and clinic viewers were asked with whom they had watched the video. Moreover, at T3, all participants could indicate their satisfaction with the provision of information about the LP, and the LP procedure itself on VAS scales ranging from 1 = not at all to 10 = very much so. and prior LP knowledge) and outcome variables. A P < 0.05 was considered significant. We included 203 participants, with an average age of 63 There was a trend toward more females in condition 1 (home viewing; We found differences in information recall between conditions at T2 ANOVA for repeated measures showed an effect of the intervention on the decrease in uncertainty (F[2, 183] = 5.02, P for interaction = .008). Here, clinic viewing showed the strongest decline in uncertainty over time, compared to both home viewing, and the control condition ( Figure 3 ), though post hoc analyses did not yield significant differences between conditions. Results were largely comparable for uncorrected analyses (Table A. 3), and after restricting analyses to participants who underwent an LP (ie, per-protocol analyses; Table A (Table A. 2), as did uncorrected analyses (Table A. 3). All reported post-LP complications for participants who underwent an LP are listed in Table 2 . Of all participants who underwent an LP, none reported a severe complication. Minor complications were quite common, as 67 (46%) reported one or two. We did not find any differences between conditions in the reported occurrence of non-specific headache, typical post-LP headache, or back pain. In addition, we found an association between age and change in uncertainty over time (ρ = -0.28, P < .001), as younger patients level of uncertainty decreased more over time (Figure 4) . Further, we found that patients with higher MMSE had better information recall scores (ρ = 0.29, P < .001; Figure 4) , and a larger decrease in uncertainty over time (ρ = 0.31, P < .001; Figure 4 ). In addition, patients with more years of education experienced a greater reduction in uncertainty over time (ρ = 0.21, P = .004; Figure 4) . Additionally, patients who reported to have more knowledge regarding the LP procedure at baseline experienced a greater decrease in uncertainty over time (ρ = 0.32, P < .001; Figure 4 ). The main finding of this randomized controlled trial on the effectiveness of an educational video as an adjunct to standard information was an improvement in knowledge and a reduction in level of uncertainty. Hence, our study suggests that a simple video is an effective tool for preparing individuals for a lumbar puncture in the context of AD diagnostics. Importantly, such a video is equally effective when offered at home or in the clinic. As expected, the video increased patients' knowledge about the LP procedure, compared to care as usual. This increase in patients' procedural knowledge may be a result of repeating the information. Nevertheless, previous literature showed that the use of audiovisual information was associated with increased procedural knowledge, compared to solely verbal and written information. 11, 14, 16, [24] [25] [26] [27] Therefore, our finding may also be explained by having provided the information in an audiovisual format. Accurate knowledge about the diagnostic procedure may benefit patients and clinicians in several ways. First, in a former study, we found that memory clinic patients highly value procedural information about diagnostic tests. 28 Second, information fosters realistic patient expectations regarding the procedure and post-LP complications. Third, procedural information allows patients to consider the relevance for their personal situation and preferences, and thus, empowers them to address such issues during patientclinician interactions. Finally, using a video as a vehicle for patient education has the advantage of providing the same information to each patient, thus reducing unwarranted practice variation. This standardized information provision might also result in a reduction of consultation time. 26 Future work could assess potential benefits of the video regarding patient expectations and participation in patient-clinician interactions. Watching the video also contributed to a reduction in uncertainty in patients who viewed the video at the day of the LP procedure (condition 2: clinic viewing). These findings are in line with two former studies, which reported reduced procedural uncertainty after audiovisual information provision on bariatric surgery and cardiac catheterization. 12, 13 In addition, our explorative association analyses showed that the video appeared to reduce uncertainty most in younger participants, those with a higher MMSE, more years of education, or more prior self-reported LP knowledge. It should be noted that self- This study has some limitations. First, the baseline questionnaire had to be filled in online, which may be more difficult for individuals with cognitive impairment. However, partners were allowed to assist the patient with filling in patients' answers to the questionnaire. In addition, this was a single-center study in a tertiary memory clinic, resulting in a relatively highly educated and young population. Of note, particularly the young and highly educated patients were most likely to benefit from the intervention. Second, inclusion was terminated prematurely due to SARS-CoV-2, the coronavirus that caused the COVID-19 pandemic. 35 This resulted in a somewhat smaller sample size than envisioned, and may have led to loss of power, particularly with respect to the post-LP complications analysis. Nevertheless, for this type of study, we were able to achieve a relatively large sample size. A major strength of this study is the RCT design, which allowed us to establish the effectiveness of the video compared to standard information provision. In addition, this study was embedded into daily clinical routine, and therefore, it was designed to mimic the use of the video in a real clinical setting. Thus, our results translate directly to clinical practice, and show that it is feasible to implement the video in daily routine. In conclusion, this RCT shows that a brief educational video increased patients' knowledge, and decreased uncertainty in a large memory clinic cohort. This suggests that the video is of value for individuals undergoing an LP procedure, by helping them to prepare for the procedure in daily clinical practice. These results support the development of similar videos for other diagnostic modalities, such as a positron emission tomography or magnetic resonance imaging scan. This type of empirical research can also be applied to optimize information provision for individuals with low health literacy or other underrepresented populations. The authors would like to thank all participants and the following people for their contribution to this study: Dr. Mathilde Verdam and Astrid analysis, and interpretation of data; in writing of the manuscript; and the decision to submit the article for publication. The authors have declared no conflicts of interest for this article. CSF markers for incipient Alzheimer's disease. 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