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BACKGROUND: The legal climate for cannabis use has dramatically changed with an increasing number of states passing legislation legalizing access for medical and recreational use. Among cancer patients, cannabis is often used to ameliorate adverse effects of cancer treatment. Data are limited on the extent and type of use among cancer patients during treatment and the perceived benefits and harms. This multicenter survey was conducted to assess the use of cannabis among cancer patients residing in states with varied legal access to cannabis. METHODS: A total of 12 NCI-Designated Cancer Centers, across states with varied cannabis-access legal status, conducted surveys with a core questionnaire to assess cannabis use among recently diagnosed cancer patients. Data were collected between September 2021 and August 2023 and pooled across 12 cancer centers. Frequencies and 95% confidence intervals for core survey measures were calculated, and weighted estimates are presented for the 10 sites that drew probability samples. RESULTS: Overall reported cannabis use since cancer diagnosis among survey respondents was 32.9% (weighted), which varied slightly by state legalization status. The most common perceived benefits of use were for pain, sleep, stress and anxiety, and treatment side effects. Reported perceived risks were less common and included inability to drive, difficulty concentrating, lung damage, addiction, and impact on employment. A majority reported feeling comfortable speaking to health-care providers though, overall, only 21.5% reported having done so. Among those who used cannabis since diagnosis, the most common modes were eating in food, smoking, and pills or tinctures, and the most common reasons were for sleep disturbance, followed by pain and stress and anxiety with 60%-68% reporting improved symptoms with use. CONCLUSION: This geographically diverse survey demonstrates that patients use cannabis regardless of its legal status. Addressing knowledge gaps concerning benefits and harms of cannabis use during cancer treatment is critical to enhance patient-provider communication.
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Maconha Medicinal , Neoplasias , Humanos , Neoplasias/epidemiologia , Neoplasias/psicologia , Neoplasias/terapia , Feminino , Masculino , Estados Unidos/epidemiologia , Pessoa de Meia-Idade , Prevalência , Adulto , Maconha Medicinal/uso terapêutico , Maconha Medicinal/efeitos adversos , National Cancer Institute (U.S.) , Inquéritos e Questionários , Institutos de Câncer/estatística & dados numéricos , Idoso , PercepçãoRESUMO
BACKGROUND: Digital determinants of health (DDoH), including access to technological tools and digital health literacy, function independently as barriers to health. Assessment for DDoH is not routine within most health care systems, although addressing DDoH could help mitigate differential health outcomes and the digital divide. OBJECTIVE: This study aims to assess the role of individual-level DDoH factors on patient enrollment in and use of the patient portal. METHODS: We developed a multimodal, cross-sectional survey and deployed it to 11,424 individuals based on their preferred mode and language documented within the electronic medical record. Based on the Technology Acceptance Model, enrollment in and intent to use the patient portal were the outcomes of interest. Perceived usefulness and ease of use were assessed to determine construct validity, and exploratory investigations included individual-level DDoH, including internet and device access, availability of technological support, medical complexity, individual relationship with the health care system, and digital health literacy. Counts (n) and proportions (%) were used to describe response categories, and adjusted and unadjusted odds ratios are reported. RESULTS: This study included 1850 respondents (11,424 invited, 16.2% response rate), who were mostly female (1048/1850, 56.6%) and White (1240/1850, 67%), with an average age of 63 years. In the validation of the Technology Acceptance Model, measures of perceived ease of use (ie, using the patient portal will require a lot of mental effort; the patient portal will be very easy to use) and perceived usefulness (ie, the usefulness of the patient portal to send and receive messages with providers, schedule appointments, and refill medications) were positively associated with both enrollment in and intent to use the patient portal. Within adjusted models, perceived ease of use and perceived usefulness constructs, in addition to constructs of digital health literacy, knowing what health resources are available on the internet (adjusted odds ratio [aOR] 3.5, 95% CI 1.8-6.6), portal ease of use (aOR 2.8, 95% CI 1.6-5), and portal usefulness (aOR 2.4, 95% CI 1.4-4.2) were significantly associated with patient portal enrollment. Other factors associated with patient portal enrollment and intent to use included being comfortable reading and speaking English, reported use of the internet to surf the web or to send or receive emails, home internet access, and access to technology devices (computer, tablet, smartphone, etc). CONCLUSIONS: Assessing for and addressing individual-level DDoH, including digital health literacy, access to digital tools and technologies, and support of the relational aspects between patients, social support systems, and health care providers, could help mitigate disparities in health. By focusing efforts to assess for and address individual-level DDoH, an opportunity exists to improve digitally driven health care delivery outcomes like access and structural outcomes like bias built within algorithms created with incomplete representation across communities.
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OBJECTIVE: To evaluate the clinical outcomes of a remote mental health program for managing anxiety and depression, primarily using asynchronous digital communication. METHODS: This retrospective cohort study examined U.S. adults seeking remote care for anxiety and depression from January 2021 to May 2022. The program involves clinician-led assessment, patient education, medication management, and ongoing monitoring, primarily via text. Anxiety and depression were measured using Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder (GAD-7) scores. Outcomes examined were changes in scores, 50% score improvement rate, and remission rate (score <5) at 1, 3, and 6 months. RESULTS: During the period evaluated, 11,844 program participants met the inclusion criteria. Most were female (n = 8328, 70.3%); their age ranged from 18-82 years (median 31 years). At baseline, median PHQ-9 and GAD-7 scores were 13 (IQR 9-17); 67% and 69% met score criteria for depression and anxiety, respectively. Most participants (80%) were prescribed a selective serotonin reuptake inhibitor (SSRI). By one month, average PHQ-9 and GAD-7 scores decreased significantly by 9.2 and 9.1 points (both p < .01). At 1-month follow-up, the 50% score improvement rate was 66% for PHQ-9 and 69% GAD-7 (p < .01). Scores continued to decrease with follow-up. At 3 months, over half achieved remission (percent [95% CI]: 52% [51-54] for anxiety, 53% [52-55] for depression). Similar improvement was observed at 6 months and in sensitivity analyses accounting for loss to follow-up. CONCLUSIONS: Use of a remote mental health program with digital tools was associated with significant clinical improvement in anxiety and depression. Challenges remain in maintaining patient engagement and ensuring appropriate care quality monitoring in digital mental health programs. Additional research comparing remote digital care to traditional in-person models is warranted. Studies should examine long-term outcomes, optimal care protocols, and the challenges to integrating these programs into existing healthcare systems and ensuring equitable access.
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Background: Digital and mobile (mHealth) solutions are online or application-based services intended to support individuals with health needs. Despite evidence supporting the use of mHealth for patients with chronic pain, and the increasing desire of these types of solutions by both patients and providers, adoption of mHealth solutions remains limited. Implementation mapping can serve as a practical method to facilitate implementation and adoption of mHealth solutions within healthcare settings. Methods: Implementation mapping was used to develop implementation strategies based on contextual determinants organized within the Consolidated Framework for Implementation Research (CFIR) for mHealth eLearning solutions across an integrated, multi-site healthcare system. We describe our experience identifying stakeholders, delineating implementation facilitators and barriers, defining implementation outcomes using RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework, outlining initial implementation strategies, and iterating on implementation strategies. Results: A total of 30 implementation strategies were identified and implemented. Over the first year, primary and specialty care providers across all the clinical sites (n = 70) placed 2559 orders for the mHealth solution. Most patients reported receiving the mHealth eLearning module (74%), and most patients felt that the tool improved their knowledge regarding their condition (82%) and their ability to provide self-care related to the condition (73%). Conclusion: Practical applications of implementation science methods can help enable change within healthcare settings. Implementation mapping is an exercise that can engage stakeholders to facilitate the incorporation of new methods of care delivery, including mHealth solutions.
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BACKGROUND: Migraine is a common and major cause of disability, poor quality of life, and high health care use. Access to evidence-based migraine care is limited and projected to worsen. Novel mobile health app-based tools may effectively deliver migraine patient education to support self-management, facilitate remote monitoring and treatment, and improve access to care. The risk that such an intervention may increase the care team workload is a potential implementation barrier. OBJECTIVE: This study aims to describe a novel electronic health record-integrated mobile app-based Migraine Interactive Care Plan (MICP) and evaluate its feasibility, usability, and impact on care teams in a community neurology practice. METHODS: Consecutive enrollees between September 1, 2020, and February 16, 2022, were assessed in a single-arm observational study of usability, defined by 74.3% (127/171) completing ≥1 assigned task. Task response rates, rate and type of care team escalations, and patient-reported outcomes were summarized. Patients were prospectively recruited and randomly assigned to routine care with or without the MICP from September 1, 2020, to September 1, 2021. Feasibility was defined by equal to or fewer downstream face-to-face visits, telephone contacts, and electronic messages in the MICP cohort. The Wilcoxon rank-sum test was used to compare continuous variables, and the chi-square test was used for categorical variables for those with at least 3 months of follow-up. RESULTS: A total of 171 patients were enrolled, and of these, 127 (74.3%) patients completed ≥1 MICP-assigned task. Mean escalations per patient per month was 0.9 (SD 0.37; range 0-1.7). Patient-confirmed understanding of the educational materials ranged from 26.6% (45/169) to 56.2% (95/169). Initial mean headache days per week was 4.54 (SD 2.06) days and declined to 2.86 (SD 1.87) days at week 26. The percentage of patients reporting favorable satisfaction increased from a baseline of 35% (20/57) to 83% (15/18; response rate of 42/136, 30.9% to 28/68, 41%) over the first 6 months. A total of 121 patients with MICP were compared with 62 patients in the control group. No differences were observed in the rate of telephone contacts or electronic messages. Fewer face-to-face visits were observed in the MICP cohort (13/121, 10.7%) compared with controls (26/62, 42%; P<.001). CONCLUSIONS: We describe the successful implementation of an electronic health record-integrated mobile app-based care plan for migraine in a community neurology practice. We observed fewer downstream face-to-face visits without increasing telephone calls, medication refills, or electronic messages. Our findings suggest that the MICP has the potential to improve patient access without increasing care team workload and the need for patient input from diverse populations to improve and sustain patient engagement. Additional studies are needed to assess its impact in primary care.
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The population needing health care services grows faster than the management capabilities of our current health care delivery models. Patients journeying through our current health care systems receive a spectrum of services, often imperfectly matched to medical needs. We describe a framework of the Digital Care Horizon to accelerate digital transformation from the perspective of a health care delivery system. We describe service delivery models across the horizon, discuss potential challenges and partnerships to facilitate the digital extension of health care, and mention concepts beyond the current horizon.
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INTRODUCTION: We sought to determine what type of treatment reengagement after smoking relapse would increase long-term cessation. AIMS AND METHODS: Participants were military personnel, retirees, and family members (TRICARE beneficiaries) recruited across the United States from August 2015 through June 2020. At baseline, consented participants (n = 614) received a validated, four-session, telephonic tobacco-cessation intervention with free nicotine replacement therapy. At the 3-month follow-up, 264 participants who failed to quit or relapsed were offered the opportunity to reengage in cessation. Of these, 134 were randomized into three reengagement conditions: (1) repeat initial intervention ("recycle"), (2) Smoking reduction with eventual cessation goal ("rate reduction"), or (3) Choose #1 or #2 ("choice"). Prolonged abstinence and 7-day point prevalence abstinence were measured at 12 months. RESULTS: Despite being in a clinical trial advertised as having the opportunity for reengagement, only 51% (134 of the 264) of participants who still smoked at 3-month follow-up were willing to reengage. Overall, participants randomized to recycle had higher prolonged cessation rates at 12 months than rate reduction conditions (OR = 16.43, 95% CI: 2.52 to 107.09, Bonferroni adjusted p = .011). When participants who randomly received recycle or rate reduction were pooled, respectively, with participants who chose recycle or rate reduction in the Choice group, recycle had higher prolonged cessation rates at 12 months than rate reduction (OR = 6.50, 95% CI: 1.49 to 28.42, p = .013). CONCLUSIONS: Our findings suggest service members and their family members who fail to quit smoking but are willing to reengage in a cessation program are more likely to benefit from repeating the same treatment. IMPLICATIONS: Finding methods that are both successful and acceptable to reengage people who smoke who want to quit can have a significant impact on improving the health of the public by reducing the portion of the population who smoke. This study suggests that repeating established cessation programs will result in more people ready to quit successfully achieving their goal.
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Militares , Abandono do Hábito de Fumar , Redução do Consumo de Tabaco , Humanos , Abandono do Hábito de Fumar/métodos , Nicotina , Agonistas Nicotínicos/uso terapêutico , Dispositivos para o Abandono do Uso de Tabaco , FamíliaRESUMO
Background and Objectives: Developing high-value care models with limited resources for large populations of individuals with migraine requires advanced understanding of patient preferences for care delivery methods. In this study, we aimed to inform the development of migraine care models by assessing patient preferences for types of care delivery and determining differences based on migraine frequency and disability. Methods: We analyzed unpublished data from a cross-sectional survey of 516 randomly selected individuals with migraine within a community practice associated with Mayo Clinic, Rochester, MN. Results: Individuals with chronic migraine, compared with those with episodic migraine, were more likely to prefer a visit with a neurologist (p = 0.0005), synchronous telephone conference with primary care provider (PCP) and neurologist (p = 0.0102), and a written migraine action plan in the medical record (p = 0.0343). Compared with those with mild/no disability, individuals with moderate-to-severe disability were more likely to prefer a visit with a neurologist (p < 0.0001), synchronous video or telephone conference with PCP and neurologist (p < 0.0001), PCP communication with neurologist (p = 0.0099), electronic message to primary care team with access to neurologist (p = 0.0216), and written action plan in the medical record (p = 0.0011). Collectively, individuals most preferred telephone follow-up and least preferred communications with a nurse or pharmacist or generalized education (all p < 0.001). Discussion: We observed differences in migraine care delivery preferences between migraine frequency and level of migraine disability. Observations support development of care pathways that include a written migraine action plan, primary care-neurology collaboration including nontraditional interactions, and prioritization of traditional neurology consultation for the most disabled patients.
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BACKGROUND/OBJECTIVES: Weight gain is a barrier to smoking cessation. Previous interventions targeting weight gain while quitting smoking have largely been unsuccessful. The current study aimed to assess the efficacy of weight stability and weight loss interventions compared to a low-intensity, self-guided bibliotherapy weight management group. SUBJECTS/METHODS: A randomized controlled trial with 12-month follow-up from 2018 to 2022 was conducted with participants (N = 305) who reported smoking at least five cigarettes per day for the last year and interest in quitting initially recruited from the Memphis, TN, USA area. Recruitment was expanded nationally with the onset of the COVID-19 pandemic. Subsequently, 276 completed 12-month follow-up. INTERVENTIONS/METHODS: The Bibliotherapy group was provided a weight management book. Both the Stability and Loss groups met via telephone for eight weeks to learn strategies for maintaining/losing weight, respectively. All three groups then received the same six-week smoking cessation intervention, with six months of varenicline provided. RESULTS: Individuals in the Loss group lost more weight (-2.01 kg, SE = 1.58) than individuals in the Bibliotherapy group (+1.08 kg, SE = 1.49, p = 0.0004), while the Stability group (-0.30 kg, SE = 1.56) was not significantly different from the Bibliotherapy group (p = 0.17). Those in the Stability group did not gain a significant amount of weight. Participants in the Loss group did not gain back all weight lost after smoking cessation and ended the study approximately 2.01 kg lower than baseline. The Bibliotherapy group did not gain the amount of weight expected after cessation. There were no significant differences between groups related to self-reported smoking cessation at each time point except at eight-month follow-up (p = 0.005). CONCLUSIONS AND RELEVANCE: Results indicated the Stability and the Loss interventions were effective for preventing post-smoking cessation weight gain, with the Loss group having the benefit of sustained weight loss. These interventions may be helpful to implement to combat weight gain and potentially facilitate smoking cessation. TRIAL REGISTRATION: The trial is registered on clinicaltrials.gov (NCT03156660).
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COVID-19 , Abandono do Hábito de Fumar , Humanos , Pandemias/prevenção & controle , COVID-19/prevenção & controle , Aumento de Peso , Redução de PesoRESUMO
INTRODUCTION: While tobacco Quitlines are effective in the promotion of smoking cessation, the majority of callers who wish to quit still fail to do so. The aim of this study was to determine if 12-month tobacco Quitline smoking cessation rates could be improved with re-engagement of callers whose first Quitline treatment failed to establish abstinence. METHODS: In an adaptive trial, 614 adult smokers, who were active duty, retired, and family of military personnel with TRICARE insurance who called a tobacco Quitline, received a previously evaluated and efficacious four-session tobacco cessation intervention with nicotine replacement therapy (NRT). At the scheduled follow-up at 3 months, callers who had not yet achieved abstinence were offered the opportunity to re-engage. This resulted in three caller groups: 1) those who were abstinent, 2) those who were still smoking but willing to re-engage with an additional Quitline treatment; and 3) individuals who were still smoking but declined re-engagement. A propensity score-adjusted logistic regression model was generated to compare past-7-day point prevalence abstinence at 12 months post Quitline consultation. RESULTS: Using a propensity score adjusted logistic regression model, comparison of the three groups resulted in higher odds of past-7-day point prevalence abstinence at follow-up at 12 months for those who were abstinent at 3 months compared to those who re-engaged (OR=9.6; 95% CI: 5.2-17.8; Bonferroni adjusted p<0.0001), and relative to those who declined re-engagement (OR=13.4; 95% CI: 6.8-26.3; Bonferroni adjusted p<0.0001). There was no statistically significant difference in smoking abstinence between smokers at 3 months who re-engaged and those who declined re-engagement (OR=1.39; 95% CI: 0.68-2.85). CONCLUSIONS: Tobacco Quitlines seeking to select a single initiative by which to maximize abstinence at follow-up at 12 months may benefit from diverting additional resources from the re-engagement of callers whose initial quit attempt failed, toward changes which increase callers' probability of success within the first 3 months of treatment. TRIAL REGISTRATION: This study is registered at clinicaltrials.gov (NCT02201810).
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BACKGROUND: Irritable bowel syndrome (IBS) is characterized as a central sensitization syndrome (CSS), a group of conditions including fibromyalgia, chronic fatigue, and restless leg syndrome (RLS) among others with frequent comorbidities of anxiety, depression, and chemical sensitivity. The prevalence of comorbid conditions and their impact on IBS symptom severity and quality of life in rural community populations has not been described. METHODS: We administered a cross-sectional survey to patients with a documented CSS diagnosis in rural primary care practices to evaluate the relationship between CSS diagnoses, quality of life, symptom severity, and interactions with healthcare providers utilizing validated questionnaires. Subgroup analysis was performed on the IBS cohort. Mayo Clinic IRB approved the study. KEY RESULTS: Seven hundred seventy-five individuals out of 5000 completed the survey (15.5% response rate) with 264 (34%) reporting IBS. Only 3% (n = 8) of IBS patients reported IBS alone without comorbid CSS condition. Most respondents reported overlapping migraine (196, 74%), depression (183, 69%), anxiety (171, 64%), and fibromyalgia (139, 52%). IBS patients with more than two comorbid CS condition showed significantly higher symptom severity with linear increase. Quality of life was lower in IBS with comorbid conditions, particularly in patients with IBS and RLS (mean EQ5-D 0.36 vs. 0.8 in IBS only, p < 0.01). Quality of life declined as number of comorbid conditions increased. CONCLUSIONS & INFERENCES: Patients with IBS often have multiple CS disorders which increases symptom severity and lowers quality of life. Understanding the impact of multiple CSS diagnoses and treating these as a global condition may improve patient experience.
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Fibromialgia , Síndrome do Intestino Irritável , Humanos , Síndrome do Intestino Irritável/complicações , Síndrome do Intestino Irritável/epidemiologia , Síndrome do Intestino Irritável/diagnóstico , Fibromialgia/complicações , Fibromialgia/epidemiologia , Sensibilização do Sistema Nervoso Central , Qualidade de Vida , Estudos Transversais , Inquéritos e Questionários , Atenção Primária à SaúdeRESUMO
CONTEXT: Palliative care services are commonly provided to hospitalized patients, but accurately predicting who needs them remains a challenge. OBJECTIVES: To assess the effectiveness on clinical outcomes of an artificial intelligence (AI)/machine learning (ML) decision support tool for predicting patient need for palliative care services in the hospital. METHODS: The study design was a pragmatic, cluster-randomized, stepped-wedge clinical trial in 12 nursing units at two hospitals over a 15-month period between August 19, 2019, and November 17, 2020. Eligible patients were randomly assigned to either a medical service consultation recommendation triggered by an AI/ML tool predicting the need for palliative care services or usual care. The primary outcome was palliative care consultation note. Secondary outcomes included: hospital readmissions, length of stay, transfer to intensive care and palliative care consultation note by unit. RESULTS: A total of 3183 patient hospitalizations were enrolled. Of eligible patients, A total of 2544 patients were randomized to the decision support tool (1212; 48%) and usual care (1332; 52%). Of these, 1717 patients (67%) were retained for analyses. Patients randomized to the intervention had a statistically significant higher incidence rate of palliative care consultation compared to the control group (IRR, 1.44 [95% CI, 1.11-1.92]). Exploratory evidence suggested that the decision support tool group reduced 60-day and 90-day hospital readmissions (OR, 0.75 [95% CI, 0.57, 0.97]) and (OR, 0.72 [95% CI, 0.55-0.93]) respectively. CONCLUSION: A decision support tool integrated into palliative care practice and leveraging AI/ML demonstrated an increased palliative care consultation rate among hospitalized patients and reductions in hospitalizations.
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Inteligência Artificial , Cuidados Paliativos , Humanos , Hospitalização , Readmissão do Paciente , Encaminhamento e ConsultaRESUMO
BACKGROUND: Chronic pain in cancer survivors negatively impacts quality of life. This study sought to investigate the relationship between high-impact chronic pain (HICP) -- defined as chronic pain that limits life or work activities on most days or every day in the past 3 months -- and cannabis in cancer survivors. METHODS: An electronic survey was developed in conjunction with the National Cancer Institute Comprehensive Cancer Centers in the United States. This survey was distributed to cancer survivors within a multi-site, single institution setting. RESULTS: The survey response rate was 23.0% (2304/10,000); 72.7% of these patients (1676/2304) did in fact have a confirmed cancer diagnosis. Among these cancer survivors, 16.5% (unweighted 278/1676) had HICP, and 12.4% (208/1676) reported cannabis use since their cancer diagnosis. The prevalence of past 30-day cannabis use was 12.3% (206/1676). Compared to cancer survivors without pain, those with HICP were more likely to believe in the benefits of cannabis (unweighted 92.1% vs. 74.7%; age-adjusted odds ratio [OR] = 3.1; 95% CI: 1.9-5.1) and less likely to believe in its risks (unweighted 48.2% vs. 58.4%; age-adjusted OR = 0.6; 95% CI: 0.4-0.7). CONCLUSIONS: Cancer survivors with HICP have a higher prevalence of cannabis use compared to those patients without pain. More research is needed to advance pain and symptom management among cancer survivors and to identify clinical scenarios in which benefit is greater than potential harm.
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Sobreviventes de Câncer , Cannabis , Dor Crônica , Neoplasias , Humanos , Estados Unidos/epidemiologia , Dor Crônica/epidemiologia , Dor Crônica/etiologia , Qualidade de Vida , Inquéritos e Questionários , Neoplasias/complicações , Neoplasias/epidemiologiaRESUMO
INTRODUCTION: Telehealth service provision has accelerated during the Coronavirus disease 2019 (COVID-19) pandemic. As the pandemic continues, clinical practices have discovered ways to resume operations. Opportunities exist to understand patient preferences for telehealth clinical services and to tailor offerings to different demographic groups. METHODS: We conducted a survey of patients receiving telehealth services through our outpatient practice to understand the types of healthcare services for which patients report preferences for telehealth. RESULTS: We received 551 survey responses (response rate = 20.8%; 551/2650). More than half of patients indicated being 'very likely' to use telehealth services to refill medication(s) (67.3%), prepare for an upcoming visit (66.1%), review test results (60.3%), or receive education (54.2%). Males had lower odds of preferring telehealth services for reviewing test results (odds ratio (OR) = 0.57; 95% confidence interval (CI): 0.34-0.94) or mental health issues (OR = 0.54; 95% CI: 0.38-0.77). Respondents who received a video visit were significantly more likely than those who received a telephone visit to report preferences for using telehealth for education, care plan discussions, long-term health issues, and mental health. DISCUSSION: Patient preferences for telehealth services vary by services provided and respondent demographics. Experience with telehealth increases the likelihood for future use of these services.
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COVID-19 , Telemedicina , Masculino , Humanos , Preferência do Paciente , COVID-19/epidemiologia , Saúde Mental , Razão de ChancesRESUMO
Objective: To evaluate the safety and effectiveness of combination varenicline with lorcaserin in preventing post-cessation weight gain. Participants and Methods: We conducted a randomized (varenicline for 12 weeks + lorcaserin for 24 weeks vs varenicline for 12 weeks + placebo for 24 weeks) phase II clinical study to obtain preliminary data on the safety and effectiveness of combination varenicline and lorcaserin in preventing post-cessation weight gain in overweight and obese smokers. Eighty-four overweight and obese (body mass index [BMI], 27-40 kg/m2) cigarette smokers were randomized before study termination (lorcaserin: n=40; placebo: n=44). The primary outcomes were weight and waist circumference (WC) changes at 12 and 24 weeks in smokers meeting criteria for prolonged smoking abstinence. Results: Thirty-nine participants met criteria for prolonged smoking abstinence at 12 weeks (46%) and 21 at 24 weeks (25%). No significant treatment effect was observed at 12 weeks with lorcaserin compared with placebo (weight difference, -0.7 kg; 90% CI, -2.6 to 1.1 kg; P=.51; WC difference, -1.9 cm; 90% CI, -4.2 to 0.5 cm; P=.18; or BMI difference, -0.4 kg/m2; 90% CI, -1.1 to 0.3 kg/m2; P=.33). No significant treatment effect was observed between lorcaserin at 24 weeks compared with placebo (weight, 1.4 kg; 90% CI, -3.8 to 6.7 kg; P=.65; WC, -0.9 cm; 90% CI, -5.8 to 4.0 cm; P=.75; or BMI 0.29 kg/m2; 90% CI, -1.5 to 2.12 kg/m2; P=.79). Conclusion: Weight gain and WC increases after prolonged smoking abstinence were not reduced using combination varenicline and lorcaserin. The results do not support further research in the obese and weight-concerned smoking population using lorcaserin or similar drugs. Trial Registration: clinicaltrials.gov Identifier: NCT02412631.
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BACKGROUND: Despite efforts to improve access to Medications for Opioid Use Disorder (MOUD), such as buprenorphine, the number of opioid overdoses in the United States continues to rise. In April 2021, the Department of Health and Human Services removed the mandatory training requirement to obtain a buprenorphine waiver; the goal was to encourage more providers to prescribe buprenorphine, thus improving access. Little is known about the attitudes on buprenorphine prescribing after this policy change. OBJECTIVE: The primary objective was to assess attitudes among primary care providers toward the removal of the buprenorphine waiver training requirement. A secondary objective was to identify other barriers to prescribing buprenorphine. METHODS: We conducted a survey between September 15 and October 13, 2021 to assess the overall beliefs on the effectiveness of MOUD and attitudes toward the removal of the waiver training, current knowledge of buprenorphine, current practice styles related to screening for and treating OUD, and attitudes toward prescribing buprenorphine in the future. This survey was sent to 890 Mayo Clinic primary care providers in 5 US states. RESULTS: One hundred twenty-three respondents (13.8%) completed the survey; 35.8% respondents agreed that the removal of the waiver training was a positive step. These respondents expressed a greater familiarity with the different formulations, pharmacology, and titration of buprenorphine. This group was also more likely to prescribe (or continue to prescribe) buprenorphine in the future. Approximately one-third (34.4%) of respondents reported perceived institutional support in prescribing buprenorphine. This group expressed greater confidence in diagnosing OUD, had greater familiarity with the different formulations, pharmacology, and titration of buprenorphine, and was more likely to prescribe (or continue to prescribe) buprenorphine in the future. Respondents who have been in practice for 11 to 20 years since completion of training were most likely to refer all OUD patients to specialists. CONCLUSIONS: Results of our survey suggests that simply removing the mandatory waiver training requirement is insufficient in positively changing attitudes toward buprenorphine prescribing. A key barrier is the perceived lack of institutional support. Future studies investigating effective ways to provide such support may help improve providers' willingness to prescribe buprenorphine.
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Buprenorfina , Transtornos Relacionados ao Uso de Opioides , Atitude , Buprenorfina/uso terapêutico , Humanos , Transtornos Relacionados ao Uso de Opioides/tratamento farmacológico , Padrões de Prática Médica , Atenção Primária à Saúde , Estados UnidosRESUMO
OBJECTIVE: To design and evaluate, through a human-centered design approach, a multispeciality clinic for patients with central sensitization syndromes that combined virtual previsit consultations, traditional face-to-face appointments, and technology-enabled educational programming. PATIENTS AND METHODS: Patients with suspected fibromyalgia and chronic abdominal pain were seen in a multispecialty practice, and the performance of the clinic was evaluated against a contemporary cohort. Quantitative and qualitative evaluation measures included team estimates of time spent on care-related tasks, physician rank of alignment of patient need with clinic design, major appointment changes, and nonvisit care tasks. Members of the care team also evaluated strengths, weaknesses, opportunities, and threats to the success of the clinic. RESULTS: The pilot clinic was operated from April 1, 2020, to April 30, 2021, and included 34 patients with suspected fibromyalgia/chronic abdominal pain. During the pilot period, physicians ranked the value of the virtual previsit consultations in providing care as 7.5 on a scale of 0 to 10 and reported an average of 50 minutes in preparation for the appointment, execution of the appointment, and postvisit documentation. We did not observe substantial differences in the number of added appointments or messages received within the patient portal when compared with a comparison cohort. Patients who participated in the combination nurse educator-led and digital education program provided positive feedback about their experience. CONCLUSION: Our clinic model provides a framework for the treatment of patients with debilitating centrally sensitized conditions and future expansion of virtual care delivery models to better meet patient care and educational needs.
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AIMS: To compare brief advice (BA), motivational interviewing (MI), rate reduction (RR), and combined MI and RR (MI + RR) to promote smoking cessation in smokers not ready to quit. DESIGN: Randomized controlled trial with four parallel groups of smoking cessation intervention. Participants were randomly assigned 1:2:2:2 to receive one of the following interventions: BA (n = 128), MI (n = 258), RR (n = 257), and MI + RR (n = 260). SETTING: The United States. All participant contact occurred over the telephone to be consistent with the typical quit line format. PARTICIPANTS: A total of 903 adult smokers. Participants had a mean age of 49 (SD = 13.3) years and were 28.9% male and 63.3% Caucasian. INTERVENTIONS: The BA group received advice similar to typical smoking cessation quit lines. The MI group received advice using basic MI principles to elicit language that indicates behavioral change. The RR group received behavioral skills training and nicotine gum. The MI + RR group combined elements of MI and RR conditions. All interventions were six sessions. MEASUREMENTS: The primary outcome measure was self-reported point prevalence at 12 months. The secondary outcome was self-reported prolonged abstinence at 12 months. FINDINGS: Intention to treat (ITT) point prevalence at 12 months indicated that BA (10.9%) had significantly lower point prevalence rates than RR (27.2%, OR = 3.17, 1.69-5.94), and MI + RR (26.9%, OR = 3.16, 1.68-5.93). BA did not have a significantly lower point prevalence rate than MI (15.5%, OR = 1.56, 95% CI = 0.81-3.02). CONCLUSIONS: This randomized controlled trial provided evidence that rate reduction, which offers structured behavioral skills and nicotine gum, either alone or combined with motivational interviewing, is the most effective form of cessation intervention for smokers not ready to quit.