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The CONFIDENT study protocol: a randomized controlled trial comparing two methods to increase long-term care worker confidence in the COVID-19 vaccines

Stevens, Gabrielle; Johnson, Lisa C; Saunders, Catherine H; Schmidt, Peter; Sierpe, Ailyn; Thomeer, Rachael P; Little, N Ruth; Cantrell, Matthew; Yen, Renata W; Pogue, Jacqueline A; Holahan, Timothy; Schubbe, Danielle C; Forcino, Rachel C; Fillbrook, Branden; Sheppard, Rowena; Wooten, Celeste; Goldmann, Don; O'Malley, A James; Dubé, Eve; Durand, Marie-Anne; Elwyn, Glyn
BACKGROUND:Clinical and real-world effectiveness data for the COVID-19 vaccines have shown that they are the best defense in preventing severe illness and death throughout the pandemic. However, in the US, some groups remain more hesitant than others about receiving COVID-19 vaccines. One important group is long-term care workers (LTCWs), especially because they risk infecting the vulnerable and clinically complex populations they serve. There is a lack of research about how best to increase vaccine confidence, especially in frontline LTCWs and healthcare staff. Our aims are to: (1) compare the impact of two interventions delivered online to enhanced usual practice on LTCW COVID-19 vaccine confidence and other pre-specified secondary outcomes, (2) determine if LTCWs' characteristics and other factors mediate and moderate the interventions' effect on study outcomes, and (3) explore the implementation characteristics, contexts, and processes needed to sustain a wider use of the interventions. METHODS:We will conduct a three-arm randomized controlled effectiveness-implementation hybrid (type 2) trial, with randomization at the participant level. Arm 1 is a dialogue-based webinar intervention facilitated by a LTCW and a medical expert and guided by an evidence-based COVID-19 vaccine decision tool. Arm 2 is a curated social media web application intervention featuring interactive, dynamic content about COVID-19 and relevant vaccines. Arm 3 is enhanced usual practice, which directs participants to online public health information about COVID-19 vaccines. Participants will be recruited via online posts and advertisements, email invitations, and in-person visits to care settings. Trial data will be collected at four time points using online surveys. The primary outcome is COVID-19 vaccine confidence. Secondary outcomes include vaccine uptake, vaccine and booster intent for those unvaccinated, likelihood of recommending vaccination (both initial series and booster), feeling informed about the vaccines, identification of vaccine information and misinformation, and trust in COVID-19 vaccine information provided by different people and organizations. Exploration of intervention implementation will involve interviews with study participants and other stakeholders, an in-depth process evaluation, and testing during a subsequent sustainability phase. DISCUSSION:Study findings will contribute new knowledge about how to increase COVID-19 vaccine confidence and effective informational modalities for LTCWs. TRIAL REGISTRATION:NCT05168800 at ClinicalTrials.gov, registered December 23, 2021.
PMCID:9948785
PMID: 36823559
ISSN: 1471-2458
CID: 5448292

"Something for us": Co-development of the COVID-19 Social Site, a web app for long-term care workers

Saunders, Catherine; Sierpe, Ailyn; Stevens, Gabrielle; Elwyn, Glyn; Cantrell, Matthew; Engel, Jaclyn; Gonzalez, Melissa; Hayward, Martha; Huebner, Joellen; Johnson, Lisa; Jimenez, Alejandro; Little, Ruth; McKenna, Corinne; Onteeru, Manu; Oo Khine, May; Pogue, Jacqueline; Salinas Vargas, José Luis; Schmidt, Peter; Thomeer, Rachael; Durand, Marie-Anne
BACKGROUND:Improving confidence in and uptake of the COVID-19 vaccines and boosters among long-term care workers (LTCWs) is a crucial public health goal, given their role in the care of the elderly and people at risk. While difficult to reach with workplace communication interventions, most LTCWs regularly use social media and smartphones. Various social media interventions have improved attitudes and uptake for other vaccines and hold promise for the LTCW population. OBJECTIVE:e aimed to develop a curated social web app (interactive website) to increase COVID-19 vaccine confidence (three-arm randomized trial underway). METHODS:Following user-centric design and participatory research approaches, we undertook three steps: 1) content identification, 2) platform development, and 3) community building. A LTCW and stakeholder advisory group provided iterative input. For content identification, we identified topics of concern about COVID-19 vaccines via desktop research (published literature, public opinion polls and social media monitoring), refined by interviewing and polling LTCWs. We also conducted a national online panel survey. We curated and fact-checked posts from popular social media platforms that addressed the identified concerns. During platform development, we solicited preferences for design and functionality via interviews and user experience (UX) testing with LTCWs. We also identified best practices for online community building, like comment moderation. RESULTS:In the interviews (n=9), we found three themes: LTCWs 1) are proud of their work but feel undervalued; 2) have varying levels of trust in COVID-19 related information, and 3) would welcome a curated COVID-19 resource that is easy to understand and use. Desktop research, LTCW interviews and our national online panel survey (n=592) found participants are interested in information about COVID-19 in general, vaccine benefits, vaccine risks, and vaccine development. Content identification resulted in 434 posts addressing these topic areas, with 209 uploaded to the final web app. Our LTCW poll (n=8) revealed preferences for personal stories and video content. The platform we developed is an accessible WordPress-based social media web app, refined through formal (n=3) and informal UX testing. Users can sort posts by topic or subtopic and react to or comment on them. To build an online community, we recruited three LTCW 'community ambassadors' and instructed them to encourage discussion, acknowledge concerns and offer factual information on COVID-19 vaccines. We also set 'community standards' for the web app. CONCLUSIONS:An iterative, user-centric, participatory approach led to the launch of an accessible social media web app with curated content for COVID-19 vaccines targeting LTCWs in the U.S. Through our trial, we will determine if this approach successfully improves vaccine confidence. If so, a similar social media resource could be used to develop curated social media interventions in other populations and with other public health goals. CLINICALTRIAL/BACKGROUND:This effort is part of a broader clinical trial; ClinicalTrials.gov NCT05168800.
PMID: 35926074
ISSN: 1438-8871
CID: 5288232

COVID-19 Infection Enhances Susceptibility to Oxidative Stress-Induced Parkinsonism

Smeyne, Richard J; Eells, Jeffrey B; Chatterjee, Debotri; Byrne, Matthew; Akula, Shaw M; Sriramula, Srinivas; O'Rourke, Dorcas P; Schmidt, Peter
BACKGROUND:Viral induction of neurological syndromes has been a concern since parkinsonian-like features were observed in patients diagnosed with encephalitis lethargica subsequent to the 1918 influenza pandemic. Given the similarities in the systemic responses after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection with those observed after pandemic influenza, there is a question whether a similar syndrome of postencephalic parkinsonism could follow coronavirus disease 2019 infection. OBJECTIVE:The goal of this study was to determine whether prior infection with SARS-CoV-2 increased sensitivity to a mitochondrial toxin known to induce parkinsonism. METHODS:K18-hACE2 mice were infected with SARS-CoV-2 to induce mild-to-moderate disease. After 38 days of recovery, mice were administered a non-lesion-inducing dose of the parkinsonian toxin 1-methyl-4-phenyl-1,2,3,6-tetrahydropyridine (MPTP) and euthanized 7 days later. Subsequent neuroinflammation and substantia nigra pars compacta (SNpc) dopaminergic (DA) neuron loss were determined and compared with SARS-CoV-2 or MPTP alone. RESULTS:K18-hACE2 mice infected with SARS-CoV-2 or MPTP showed no SNpc DA neuron loss after MPTP. In mice infected and recovered from SARS-CoV-2 infection, MPTP induced a 23% or 19% greater loss of SNpc DA neurons than SARS-CoV-2 or MPTP, respectively (P < 0.05). Examination of microglial activation showed a significant increase in the number of activated microglia in both the SNpc and striatum of the SARS-CoV-2 + MPTP group compared with SARS-CoV-2 or MPTP alone. CONCLUSIONS:Our observations have important implications for long-term public health, given the number of people who have survived SARS-CoV-2 infection, as well as for future public policy regarding infection mitigation. However, it will be critical to determine whether other agents known to increase risk for PD also have synergistic effects with SARS-CoV-2 and are abrogated by vaccination. © 2022 The Authors. Movement Disorders published by Wiley Periodicals LLC on behalf of International Parkinson and Movement Disorder Society.
PMID: 35579496
ISSN: 1531-8257
CID: 5277442

Long term safety, tolerability, and efficacy of intracutaneous zolmitriptan (M207) in the acute treatment of migraine

Nahas, Stephanie J; Hindiyeh, Nada; Friedman, Deborah I; Elbuluk, Nada; Kellerman, Donald J; Foreman, Pamela K; Schmidt, Peter
OBJECTIVE:To determine the long-term safety and tolerability profile of M207 in the acute treatment of migraine. BACKGROUND:M207 is an investigational microneedle-based system for intracutaneous delivery of zolmitriptan for the treatment of migraine attacks. Following on the positive results of a Phase 2/3 placebo-controlled efficacy study (ZOTRIP), this study was designed to evaluate the safety of this novel product during repeated use for the treatment of migraine attacks. METHODS:In this 6-12 month open-label, multicenter observational study, participants used an eDiary to record headache symptoms and adverse events at specified intervals up to 48 h following treatment of a qualifying attack with M207 3.8 mg (intracutaneous zolmitriptan). Participants underwent clinical evaluations at specified intervals up to 12 months. RESULTS:Among 335 participants who treated ≥1 migraine attack, 257 completed 6 months and 127 completed 1 year of treatment. The most common reason for withdrawal from the study was a low frequency of reported attacks post randomization. Overall, 5963 migraine attacks were treated. Most participants (96%) experienced at least 1 adverse event, the vast majority of which concerned the application site, and > 95% of which were mild. Fifteen participants (4%) withdrew due to adverse events; 4 withdrew due to 7 application site reactions, 6 of which were mild. Participants achieved pain freedom in 2477/5617 (44%) of attacks, most bothersome symptom freedom in 3315/5330 (62%) of attacks, and pain relief 2 h post-dose in 4552/5617 (81%) of attacks. Sustained pain freedom 2-24 h was seen in 1761/4698 (38%) of attacks, and 2-48 h in 1534/4429 (35%) of attacks. CONCLUSIONS:The majority of participants experienced cutaneous adverse reactions such as application site erythema, swelling, and bleeding, and most reactions were scored as mild. These results are consistent with what was observed in the single migraine attack treatment ZOTRIP trial indicating that M207 is well tolerated in the setting of longer-term repeated use. Efficacy findings were also similar to those in the ZOTRIP trial. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov on September 13, 2017 ( NCT03282227 ).
PMCID:8127195
PMID: 34001002
ISSN: 1129-2377
CID: 4876802

COVID-19: A Vaccine Priority Index Mapping Tool for Rapidly Assessing Priority Populations in North Carolina

Kearney, Gregory D; Jones, Katherine; Park, Yoo Min; Howard, Rob; Hylock, Ray; Wall, Bennett; Clay, Maria; Schmidt, Peter; Silvernail, John
BACKGROUND:The initial limited supply of COVID-19 vaccine in the U.S. presented significant allocation, distribution, and delivery challenges. Information that can assist health officials, hospital administrators and other decision makers with readily identifying who and where to target vaccine resources and efforts can improve public health response. OBJECTIVE:The objective of this project was to develop a publicly available geographical information system (GIS) web mapping tool that would assist North Carolina health officials readily identify high-risk, high priority population groups and facilities in the immunization decision making process. METHODS:Publicly available data were used to identify 14 key health and socio-demographic variables and 5 differing themes (social and economic status; minority status and language; housing situation; at risk population; and health status). Vaccine priority population index (VPI) scores were created by calculating a percentile rank for each variable over each N.C. Census tract. All Census tracts (N = 2,195) values were ranked from lowest to highest (0.0 to 1.0) with a non-zero population and mapped using ArcGIS. RESULTS:The VPI tool was made publicly available (https://enchealth.org/) during the pandemic to readily assist with identifying high risk population priority areas in N.C. for the planning, distribution, and delivery of COVID-19 vaccine. DISCUSSION/CONCLUSIONS:While health officials may have benefitted by using the VPI tool during the pandemic, a more formal evaluation process is needed to fully assess its usefulness, functionality, and limitations. CONCLUSION/CONCLUSIONS:When considering COVID-19 immunization efforts, the VPI tool can serve as an added component in the decision-making process.
PMCID:8765798
PMID: 35082975
ISSN: 1947-2579
CID: 5154612

Do level iii support measures differ between chinese and caucasian women? [Meeting Abstract]

Cheng, W; Xie, B; Gordon, M T; Schmidt, P; Burns, L P; Sun, X; Wang, J; Swenson, C W; DeLancey, J O L; Chen, L
Objective: Test the null hypothesis that Level III support measures do not differ between Chinese and Caucasian nulliparous women with normal support.
Method(s): Pelvic floor 3D MRIs at rest were analyzed (Image J, 3D slicer v. 4.10.1) from Chinese and Caucasian nulliparous women with no prolapse at/below the hymen. Urogenital hiatus (UGH), levator hiatus (LH), and levator bowl volume (LBV) were measured and levator plate (LP) was traced (Figure 1A-D). Perineal body (PB) location was measured relative to Pelvic Inclination Correction System (PICS) line, 34degree below the SCIPP line. Muscle fiber directions were traced for the pubococcygeus (PCM), puborectalis (PR), and external anal sphincter muscles (EAS) in parasagittal slides (Figure1E-F). LP shape was analyzed using principal component analysis (PCA) (Figure 2C-D). Student's t-test was used to compare measurements between groups.
Result(s): Eleven Chinese and 10 Caucasian women were included with average ages of 28+/-3 and 23+/-2 years, respectively (P<.001). BMI was lower in Chinese women (21.5+/-2.5kg/m2 vs 25.6+/-5.6kg/m2, P=.04) and height was similar (1.63 +/-0.06m vs 1.65+/-0.12m, P=.56). Chinese women had 18% smaller UGH, 10% smaller LH and 33% smaller LBV compared to Caucasian women at rest (Figure 2A). PB position was higher in Chinese versus Caucasian women (-2mm vs-12mm, P<.001). PCM fiber direction was more horizontal in Chinese women compared to Caucasian women (16+/-12degree vs 25+/-5degree, P=.047), while the direction of PR (-21+/-5degree vs-20+/-5degree, P=.91) and EAS (-49+/-9degree vs-51 +/-10degree, P=.80) are similar (Figure 2B). PCA showed the LP is significantly more horizontal in Chinese than Caucasian women (PC1 score for Chinese-6.5 vs Caucasian 7.1, P=.020).
Conclusion(s): We reject our null hypothesis. In nulliparas with normal support, Chinese women have a smaller hiatus size and LBV than Caucasian women and their PCM fiber direction and LP shape are oriented more horizontally. Comment: This analysis is consistent with the hypothesis that PCM fiber direction varies with LP shape and bowl volume. These baseline differences in anatomy may influence birth injury, mechanism of prolapse, and treatment outcomes
EMBASE:633958391
ISSN: 2154-4212
CID: 4792082

Telemedicine for Parkinson's Disease: Limited Engagement Between Local Clinicians and Remote Specialists

Elson, Molly J; Stevenson, E Anna; Feldman, Blake A; Lim, Jihoon; Beck, Christopher A; Beran, Denise B; Schmidt, Peter N; Biglan, Kevin M; Simone, Richard; Willis, Allison W; Dorsey, E Ray; Boyd, Cynthia M
INTRODUCTION/BACKGROUND:The integration of remote specialists into local care teams has not been widely evaluated. METHODS:Therefore, we surveyed clinicians whose patients with Parkinson's disease had participated in a national randomized controlled trial of video visits to determine (1) whether clinicians received recommendations from remote specialists; (2) whether those recommendations were implemented; (3) what barriers to specialty care local clinicians perceived; and (4) whether they would recommend video visits. RESULTS:Of 183 clinicians surveyed, 89 (49%) responded. Less than half received the recommendations of remote specialists, but they implemented most of the recommendations they received and found them to be beneficial. CONCLUSION/CONCLUSIONS:The greatest perceived barrier among respondents was distance from patient to specialist, and 40% of local clinicians would recommend video visits. As telemedicine grows, improved communication between remote specialists and local clinicians is likely needed.
PMID: 29297769
ISSN: 1556-3669
CID: 3123782

Patient and Physician Perceptions of Virtual Visits for Parkinson's Disease: A Qualitative Study

Mammen, Jennifer R; Elson, Molly J; Java, James J; Beck, Christopher A; Beran, Denise B; Biglan, Kevin M; Boyd, Cynthia M; Schmidt, Peter N; Simone, Richard; Willis, Allison W; Dorsey, E Ray
Background and Introduction: Delivering care through telemedicine directly into the patient's home is increasingly feasible, valuable, and beneficial. However, qualitative data on how patients' and physicians' perceive these virtual house calls are lacking. We conducted a qualitative analysis of perceptions of these visits for Parkinson's disease to (1) determine how patients and physicians perceive virtual visits and (2) identify components contributing to positive and negative perceptions.
PMID: 28787250
ISSN: 1556-3669
CID: 3123762

National randomized controlled trial of virtual house calls for Parkinson disease

Beck, Christopher A; Beran, Denise B; Biglan, Kevin M; Boyd, Cynthia M; Dorsey, E Ray; Schmidt, Peter N; Simone, Richard; Willis, Allison W; Galifianakis, Nicholas B; Katz, Maya; Tanner, Caroline M; Dodenhoff, Kristen; Aldred, Jason; Carter, Julie; Fraser, Andrew; Jimenez-Shahed, Joohi; Hunter, Christine; Spindler, Meredith; Reichwein, Suzanne; Mari, Zoltan; Dunlop, Becky; Morgan, John C; McLane, Dedi; Hickey, Patrick; Gauger, Lisa; Richard, Irene Hegeman; Mejia, Nicte I; Bwala, Grace; Nance, Martha; Shih, Ludy C; Singer, Carlos; Vargas-Parra, Silvia; Zadikoff, Cindy; Okon, Natalia; Feigin, Andrew; Ayan, Jean; Vaughan, Christina; Pahwa, Rajesh; Dhall, Rohit; Hassan, Anhar; DeMello, Steven; Riggare, Sara S; Wicks, Paul; Achey, Meredith A; Elson, Molly J; Goldenthal, Steven; Keenan, H Tait; Korn, Ryan; Schwarz, Heidi; Sharma, Saloni; Stevenson, E Anna; Zhu, William
OBJECTIVE:To determine whether providing remote neurologic care into the homes of people with Parkinson disease (PD) is feasible, beneficial, and valuable. METHODS:In a 1-year randomized controlled trial, we compared usual care to usual care supplemented by 4 virtual visits via video conferencing from a remote specialist into patients' homes. Primary outcome measures were feasibility, as measured by the proportion who completed at least one virtual visit and the proportion of virtual visits completed on time; and efficacy, as measured by the change in the Parkinson's Disease Questionnaire-39, a quality of life scale. Secondary outcomes included quality of care, caregiver burden, and time and travel savings. RESULTS:< 0.0001). CONCLUSIONS:Providing remote neurologic care directly into the homes of people with PD was feasible and was neither more nor less efficacious than usual in-person care. Virtual house calls generated great interest and provided substantial convenience. CLINICALTRIALSGOV IDENTIFIER/UNASSIGNED:NCT02038959. CLASSIFICATION OF EVIDENCE/METHODS:This study provides Class III evidence that for patients with PD, virtual house calls from a neurologist are feasible and do not significantly change quality of life compared to in-person visits. The study is rated Class III because it was not possible to mask patients to visit type.
PMCID:5595275
PMID: 28814455
ISSN: 1526-632x
CID: 3123772

Regular Exercise, Quality of Life, and Mobility in Parkinson's Disease: A Longitudinal Analysis of National Parkinson Foundation Quality Improvement Initiative Data

Rafferty, Miriam R; Schmidt, Peter N; Luo, Sheng T; Li, Kan; Marras, Connie; Davis, Thomas L; Guttman, Mark; Cubillos, Fernando; Simuni, Tanya
BACKGROUND:Research-based exercise interventions improve health-related quality of life (HRQL) and mobility in people with Parkinson's disease (PD). OBJECTIVE:To examine whether exercise habits were associated with changes in HRQL and mobility over two years. METHODS:We identified a cohort of National Parkinson Foundation Quality Improvement Initiative (NPF-QII) participants with three visits. HRQL and mobility were measured with the Parkinson's Disease Questionnaire (PDQ-39) and Timed Up and Go (TUG). We compared self-reported regular exercisers (≥2.5 hours/week) with people who did not exercise 2.5 hours/week. Then we quantified changes in HRQL and mobility associated with 30-minute increases in exercise, across PD severity, using mixed effects regression models. RESULTS:Participants with three observational study visits (n = 3408) were younger, with milder PD, than participants with fewer visits. After 2 years, consistent exercisers and people who started to exercise regularly after their baseline visit had smaller declines in HRQL and mobility than non-exercisers (p < 0.05). Non-exercisers worsened by 1.37 points on the PDQ-39 and a 0.47 seconds on the TUG per year. Increasing exercise by 30 minutes/week was associated with slower declines in HRQL (-0.16 points) and mobility (-0.04 sec). The benefit of exercise on HRQL was greater in advanced PD (-0.41 points) than mild PD (-0.14 points; p < 0.02). CONCLUSIONS:Consistently exercising and starting regular exercise after baseline were associated with small but significant positive effects on HRQL and mobility changes over two years. The greater association of exercise with HRQL in advanced PD supports improving encouragement and facilitation of exercise in advanced PD.
PMCID:5482526
PMID: 27858719
ISSN: 1877-718x
CID: 3123742