scholarly journals Developing, Implementing, and Evaluating a Multimedia Patient Decision Aid Program to Reform the Informed Consent Process of a Peripherally Inserted Central Venous Catheter Procedure: Protocol for Quality Improvement  (Preprint)

2018 ◽  
Author(s):  
Azizeh Khaled Sowan ◽  
Arlienita R Beraya ◽  
Adrian Carrola ◽  
Charles C Reed ◽  
Sherrie V Matthews ◽  
...  

BACKGROUND Informed consent has considerable clinical, ethical, and legal implications for patient safety and liability. Little information is available about the use of multimedia patient decision aids (PtDA) in the consent process for therapeutic invasive procedures such as the peripherally inserted central venous catheter (PICC). In addition, none of the available studies have designed their multimedia PtDAs based on the Agency for Healthcare Research and Quality’s (AHRQ) comprehensive guide for informed consent. OBJECTIVE This paper describes a patient-centered, systematic, multidisciplinary approach to develop, implement, and alpha test a multimedia PtDA to reform the informed consent process of a PICC for patients in 10 acute and intensive care units. METHODS The development, implementation, and evaluation processes of the PtDA followed the phases in the Multimedia Production Framework: preproduction, production, and postproduction. Within this framework, we applied the criteria for judging the quality of PtDAs, the AHRQ’s Health Literacy Universal Precautions Toolkit, and the AHRQ’s Patient Education Materials Assessment Tool Guide. The methodology was guided by the Interprofessional Shared Decision-Making Model and the AHRQ’s Making Informed Consent an Informed Choice guide. In the preproduction phase, we (1) reviewed the current consent form; (2) observed 18 consent processes; (3) surveyed the vascular access team (N=6 nurses) about their perception of the current process; (4) surveyed 30 patients for knowledge recall and retention, overall satisfaction, and attitude toward using a multimedia PtDA; and (5) wrote and reviewed the script for the multimedia program. The production phase focused on filming the PtDA in English and Spanish languages. The postproduction phase included integrating the multimedia programs into the care processes, developing a modified workflow for the consent process, and alpha testing of the English and Spanish PtDAs by (1) a group of 5 patients for clarity and understandability of the information; (2) nurses using the AHRQ’s Patient Education Materials Assessment Tool Audio and Video; and (3) by the multidisciplinary change team. RESULTS Based on the alpha testing, patients indicated that the content was easy to follow and read; nurses provided positive feedback, and their comments were mainly related to the changes in the workflow in the consent process of the PICC after using the PtDA; and the multidisciplinary change team suggested edits related to changing a few scenes. The final multimedia program consisted of 7 min and 37 s demonstrating detailed information about the PICC. CONCLUSIONS A systematic development of PtDAs for nonurgent invasive procedures may eliminate many limitations of the conventional consent process by ensuring comprehensive, standardized, and easy-to-comprehend information and providing sufficient time for the patients to reflect on the information. To be effective, PtDAs should follow a systematic, patient-centered, evidence-based, and rigorous approach in the development, implementation, and evaluation processes. INTERNATIONAL REGISTERED REPOR RR1-10.2196/10709

2018 ◽  
Author(s):  
Azizeh K Sowan ◽  
Arlienita R Beraya ◽  
Adrian Carrola ◽  
Charles Reed

BACKGROUND Informed consent is a complex process to help patients engage in care processes and reach the best treatment decisions. There are many limitations to the conventional consent process that is based on oral discussion of information related to treatment procedures by the health care provider. A conclusive body of research supports the effectiveness of multimedia patient decision aids (PtDAs) in the consent process in terms of patient satisfaction, increased knowledge about the procedure, reduced anxiety level, and higher engagement in the decision making. Little information is available about the effectiveness of multimedia PtDAs in the consent process of invasive therapeutic procedures such as the peripherally inserted central venous catheter (PICC). OBJECTIVE The objective of this study was to examine the effectiveness of a multimedia PtDA in supplementing the consent process of the PICC for patients in 10 acute and intensive care units in terms of knowledge recall, knowledge retention, satisfaction with the consent process, and satisfaction with the PICC multimedia PtDA. METHODS This pre-post quasi-experimental study included 130 patients for whom a PICC was ordered. Patients in the control group (n=65) received the conventional consent process for the PICC, while those in the intervention group (n=65) received the multimedia PtDA to support the consent process of a PICC. All patients were surveyed for knowledge recall and retention about the procedure and satisfaction with the consent process. Patients in the intervention group were also surveyed for their satisfaction with the multimedia PtDA. RESULTS Compared with the control group, patients in the intervention group scored around 2 points higher on knowledge recall (t125=4.9, P<.001) and knowledge retention (t126=4.8, P<.001). All patients in the intervention group were highly satisfied with the multimedia PtDA, with a mean score of >4.5 out of 5 on all items. Items with the highest mean scores were related to the effect of the multimedia PtDA on knowledge retention (mean 4.9 [SD 0.2]), patient readiness to learn (mean 4.8 [SD 0.5]), complete understanding of the procedure-related complications (mean 4.8 [SD 0.4]), and patient role in maintaining the safety of the PICC (mean 4.8 [SD 0.5]). Patients in the two groups were highly satisfied with the consent process. However, 15% (10/65) patients in the control group reported that the following information was omitted from the discussion: patient and provider roles in the safety of the PICC, other treatment options, and common side effects. Furthermore, 2 patients commented that they were not ready to engage in the discussion. CONCLUSIONS The multimedia PtDA is an effective standardized, structured, self-paced learning tool to supplement the consent process of the PICC and improve patient satisfaction with the process, knowledge recall, and knowledge retention.


2019 ◽  
Vol 11 (4) ◽  
pp. 422-429
Author(s):  
Jason A. Lord ◽  
Danny J. Zuege ◽  
Maria Palacios Mackay ◽  
Amanda Roze des Ordons ◽  
Jocelyn Lockyer

ABSTRACT Background Determining procedural competence requires psychometrically sound assessment tools. A variety of instruments are available to determine procedural performance for central venous catheter (CVC) insertion, but it is not clear which ones should be used in the context of competency-based medical education. Objective We compared several commonly used instruments to determine which should be preferentially used to assess competence in CVC insertion. Methods Junior residents completing their first intensive care unit rotation between July 31, 2006, and March 9, 2007, were video-recorded performing CVC insertion on task trainer mannequins. Between June 1, 2016, and September 30, 2016, 3 experienced raters judged procedural competence on the historical video recordings of resident performance using 4 separate tools, including an itemized checklist, Objective Structured Assessment of Technical Skills (OSATS), a critical error assessment tool, and the Ottawa Surgical Competency Operating Room Evaluation (O-SCORE). Generalizability theory (G-theory) was used to compare the performance characteristics among the tools. A decision study predicted the optimal testing environment using the tools. Results At the time of the original recording, 127 residents rotated through intensive care units at the University of Calgary, Alberta, Canada. Seventy-seven of them (61%) met inclusion criteria, and 55 of those residents (71%) agreed to participate. Results from the generalizability study (G-study) demonstrated that scores from O-SCORE and OSATS were the most dependable. Dependability could be maintained for O-SCORE and OSATS with 2 raters. Conclusions Our results suggest that global rating scales, such as the OSATS or the O-SCORE tools, should be preferentially utilized for assessment of competence in CVC insertion.


2020 ◽  
Vol 46 (03) ◽  
pp. 245-255
Author(s):  
Lise J. Estcourt

AbstractThis is a review of the evidence for the use of different platelet count thresholds prior to invasive procedures and surgery. This review will focus on three procedures that are common in patients with thrombocytopenia—central venous catheter insertion, liver biopsy, and lumbar punctures and epidural catheters—as well as highlighting the lack of evidence for more major surgery. Tunneled or untunneled central venous catheters are low-risk procedures and can be safely performed without any intervention when the platelet count is 20 × 109/L or above. Evidence for their safety is more limited below this threshold, but as bleeding is easily treated, interventions should focus on treating any bleeding that occurs rather than preventative strategies. The available evidence for neuraxial anesthesia is based on very low-quality evidence from observational studies. Based on this evidence, the risk of an epidural hematoma is less than 0.19% (upper limit of 95% confidence interval) for pregnant women undergoing an epidural anesthetic when the platelet count is between 70 and 99 × 109/L. No randomized trials have been performed in children, nor have any randomized trials been performed in major or emergency surgeries.


Author(s):  
Amir Aaron Hakimi ◽  
Lauren Standiford ◽  
Edward Chang ◽  
Brian Jet-Fei Wong

AbstractThere has been a growing interest in improving the informed consent process to ensure patients truly understand the benefits, risks, and alternatives of their procedures. Herein, we sought to describe the production of an educational video to supplement the traditional rhinoplasty informed consent process. Additionally, we evaluate satisfaction and risk recall among prospective rhinoplasty patients who participated in the video-assisted informed consent process. One author attended 30 rhinoplasty consultations where informed consent was performed and generated 65 questions related to the benefits, risks, alternatives, and general knowledge of rhinoplasty operations. A video of the senior author answering these questions was filmed and edited to 25 minutes. Prospective rhinoplasty patients watched the video before their initial consultation and were asked to complete two surveys assessing their satisfaction with the video-assisted process as well as their ability to recall risks discussed in the video. Understandability and actionability of the video was assessed by three independent reviewers using the Patient Education Materials Assessment Tool. Postvideo surveys were completed by 40 patients. Patients strongly agreed that the video informed them about rhinoplasty risks and benefits (4.90/5.00), effectively answered their questions and/or concerns (4.78/5.00), and provided adequate information before surgery (4.85/5.00). Participants strongly recommended that all prospective patients watch the video prior to surgery (4.97/5.00). Participants on average correctly answered 4.00 ± 0.877 out of five risk recall questions. There was no statistically significant difference in risk recall performance between college graduates (4.19 ± 0.602) and those who did not graduate college (3.79 ± 1.08), p = 0.076. No significant correlation was found between patient age and recall performance (r = –0.011), p = 0.943. The overall mean understandability and actionability scores for the video were 100%. Video-assisted informed consent for rhinoplasty may enhance and overcome limitations to the traditional verbal consent process by ensuring comprehensive, standardized, and readily understandable information.


Author(s):  
Theresa Cox ◽  
Thomas Parish ◽  
Robert Reasoner

Physician Assistants (PAs) are frequently delegated the task of performing invasive procedures. While there is a nearly 40 year record of PAs performing procedures of various types, limited published information is available that verifies the safety of delegating these medical responsibilities. As the scope of practice expands for the PA profession, research data will be necessary to document the safety and effectiveness of PAs performing invasive procedures. This prospectivestudy followed 9 PAs inserting central venous catheter (CVC) lines in pulmonary critical care and cardiothoracic surgery settings in a large urban hospital from June 1, 2002 through December 1, 2002. Each PA required general supervision for the procedures. The most common complication of CVC placement is pneumothorax. None of these occurred during the study period in 233 CVC lines inserted by PAs. Additionally, during the study period, this group of PAs inserted 75 Swan-Ganz catheters, performed 25 thoracenteses, 30 endotracheal intubations, and 10 chest tube placements. Complications were noted and recorded via the on site researcher. The only complication noted during the study period was a single pneumothorax while performing a thoracentesis. This research study demonstrates that with the proper training and supervision from a physician, PAs can perform invasive medical procedures with a complication rate comparable to that of physicians in a similar setting.


Medicinus ◽  
2021 ◽  
Vol 8 (3) ◽  
pp. 111
Author(s):  
Margaret Merlyn Tjiang ◽  
Dimas Arsana Prayoga

<p><strong>Background: </strong>Central venous catheters (CVCs) are frequently used in patients for several indications such as cancer treatment, diagnostic monitoring, parenteral nutrition, hemodialysis, and administration of fluids, blood products or medication. Double lumen catheter induced CVCs thrombosis has not been paid into proper attention in developing countries such as Indonesia.</p><p><strong>Aims:</strong> The aim of this study is to identify the incidence and characteristic of double lumen catheter induced CVCs thrombosis in patients undergoing hemodialysis.</p><p><strong>Methods: </strong>This systematic review has been registered in PROSPERO (CRD42020181584). A systematic search of literature for observational and randomized controlled trial was conducted in PubMed, PubMed central, and Google Scholar through April 16, 2020. Two reviewers independently searched and selected. The risk of bias was evaluated using the Newcastle-Ottawa Quality assessment tool.<strong> </strong></p><p><strong>Results: </strong>A total of 408 patients were included in our study. There were 192 (47.1%) male patients. The double lumen catheter was mostly placed in the jugular vein (60%), followed by subclavian vein (25%) and femoral vein (15%). Four (1.1%) patients had deep vein thrombosis after about one month of double lumen catheter placement. All these four patients, the double lumen catheter was inserted in the femoral vein. Any other significant risk factors for thrombosis other than double lumen catheter insertion not found. Out of these four patients, one of them passed away. All patients were treated using heparin.</p><p><strong>Conclusion: </strong>The incidence of double lumen catheter induced thrombosis is low (1.1%) in patients undergoing hemodialysis. However, further larger study is needed to confirm and find the associating factors.</p>


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