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Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial.

ABSTRACT: Importance:Traditionally, group medical visits (GMVs) for persons with diabetes improved glycemia by intensifying medications, which infrequently led to weight loss. Incorporating GMVs with intensive dietary change could enable weight loss and improve glycemia while decreasing medication intensity. Objective:To examine whether a program of GMVs combined with intensive weight management (WM) is noninferior to GMVs alone for change in glycated hemoglobin (HbA1c) level at 48 weeks (prespecified margin of 0.5%) and superior to GMVs alone for hypoglycemic events, diabetes medication intensity, and weight loss. Design, Setting, and Participants:This randomized clinical trial identified via the electronic medical record 2814 outpatients with type 2 diabetes, uncontrolled HbA1c, and body mass index (BMI; calculated as weight in kilograms divided by height in meters squared) of 27 or higher from Veterans Affairs Medical Center clinics in Durham and Greenville, North Carolina. Between January 12, 2015, and May 30, 2017, 263 outpatients started the intervention. Interventions:Participants randomized to the GMV group (n?=?136) received counseling about diabetes-related topics with medication optimization every 4 weeks for 16 weeks, then every 8 weeks (9 visits). Participants randomized to the WM/GMV group (n?=?127) received low-carbohydrate diet counseling with baseline medication reduction and subsequent medication optimization every 2 weeks for 16 weeks followed by an abbreviated GMV intervention every 8 weeks (13 visits). Main Outcomes and Measures:Outcomes included HbA1c level, hypoglycemic events, diabetes medication effect score, and weight at 48 weeks analyzed using hierarchical generalized mixed models to account for clustering within group sessions. Results:Among 263 participants (mean [SD] age, 60.7 [8.2] years; 235 [89.4%] men; 143 [54.4%] black), baseline HbA1c level was 9.1% (1.3%) and BMI was 35.3 (5.1). At 48 weeks, HbA1c level was improved in both study arms (8.2% in the WM/GMV arm and 8.3% in the GMV arm; mean difference, -0.1%; 95% CI, -0.5% to 0.2%; upper 95% CI, <0.5% threshold; P?=?.44). The WM/GMV arm had lower diabetes medication use (mean difference in medication effect score, -0.5; 95% CI, -0.6 to -0.3; P?

SUBMITTER: Yancy WS

PROVIDER: S-EPMC6830502 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial.

Yancy William S WS Crowley Matthew J MJ Dar Moahad S MS Coffman Cynthia J CJ Jeffreys Amy S AS Maciejewski Matthew L ML Voils Corrine I CI Bradley Anna Barton AB Edelman David D

JAMA internal medicine 20200101 1

<h4>Importance</h4>Traditionally, group medical visits (GMVs) for persons with diabetes improved glycemia by intensifying medications, which infrequently led to weight loss. Incorporating GMVs with intensive dietary change could enable weight loss and improve glycemia while decreasing medication intensity.<h4>Objective</h4>To examine whether a program of GMVs combined with intensive weight management (WM) is noninferior to GMVs alone for change in glycated hemoglobin (HbA1c) level at 48 weeks (p ...[more]

PMID: 31682682

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Project description:ImportanceRural populations have a higher prevalence of obesity and poor access to weight loss programs. Effective models for treating obesity in rural clinical practice are needed.ObjectiveTo compare the Medicare Intensive Behavioral Therapy for Obesity fee-for-service model with 2 alternatives: in-clinic group visits based on a patient-centered medical home model and telephone-based group visits based on a disease management model.Design, setting, and participantsCluster randomized trial conducted in 36 primary care practices in the rural Midwestern US. Inclusion criteria included age 20 to 75 years and body mass index of 30 to 45. Participants were enrolled from February 2016 to October 2017. Final follow-up occurred in December 2019.InterventionsAll participants received a lifestyle intervention focused on diet, physical activity, and behavior change strategies. In the fee-for-service intervention (n = 473), practice-employed clinicians provided 15-minute in-clinic individual visits at a frequency similar to that reimbursed by Medicare (weekly for 1 month, biweekly for 5 months, and monthly thereafter). In the in-clinic group intervention (n = 468), practice-employed clinicians delivered group visits that were weekly for 3 months, biweekly for 3 months, and monthly thereafter. In the telephone group intervention (n = 466), patients received the same intervention as the in-clinic group intervention, but sessions were delivered remotely via conference calls by centralized staff.Main outcomes and measuresThe primary outcome was weight change at 24 months. A minimum clinically important difference was defined as 2.75 kg.ResultsAmong 1407 participants (mean age, 54.7 [SD, 11.8] years; baseline body mass index, 36.7 [SD, 4.0]; 1081 [77%] women), 1220 (87%) completed the trial. Mean weight loss at 24 months was -4.4 kg (95% CI, -5.5 to -3.4 kg) in the in-clinic group intervention, -3.9 kg (95% CI, -5.0 to -2.9 kg) in the telephone group intervention, and -2.6 kg (95% CI, -3.6 to -1.5 kg) in the in-clinic individual intervention. Compared with the in-clinic individual intervention, the mean difference in weight change was -1.9 kg (97.5% CI, -3.5 to -0.2 kg; P = .01) for the in-clinic group intervention and -1.4 kg (97.5% CI, -3.0 to 0.3 kg; P = .06) for the telephone group intervention.Conclusions and relevanceAmong patients with obesity in rural primary care clinics, in-clinic group visits but not telephone-based group visits, compared with in-clinic individual visits, resulted in statistically significantly greater weight loss at 24 months. However, the differences were small in magnitude and of uncertain clinical importance.Trial registrationClinicalTrials.gov Identifier: NCT02456636.

Project description:PurposeWomen with breast cancer have complex and unique gynecologic needs that are challenging to effectively and comprehensively meet in a traditional gynecology visit format. Group medical visits are an effective and well-received model of care in other disease settings and can provide comprehensive health education as an adjunct to one-on-one evaluation and treatment. There are limited data regarding the use of this type of health care delivery in providing gynecology-focused care to women affected by breast cancer.MethodsA group medical visit model was created for gynecology providers to see new breast cancer patient consults. From May 2012 to February 2014, 148 patients (3-6 per group) participated in a 1-hour informational session followed by a 15- to 30-minute individual visit with a physician that included history, physical examination and evaluation. We surveyed 101 women who attended these visits to evaluate a group model for providing gynecologic care and educational support to women with breast cancer.ResultsOf those who responded to the survey question, 100% agreed or somewhat agreed that their expectations for an initial intake visit were met during the group visit; 81% agreed or somewhat agreed that they felt a group visit was preferable to an individual introductory visit. More than 95% agreed or somewhat agreed that the information was understandable and their questions were answered during the visit. Only 5 respondents expressed dissatisfaction with the additional time commitment for this type of visit.ConclusionsThe majority of women surveyed expressed satisfaction with their experience with a group visit format. The women who participated preferred this format compared to an individual intake appointment when establishing gynecology care after breast cancer diagnosis/treatment, regardless of age, menopausal status, cancer stage or hormone receptor status. While further studies are warranted to directly compare and further assess satisfaction and efficacy, gynecologists may consider using a group model to provide comprehensive education and care to this patient population.

Project description:ImportanceSingle-agent immune checkpoint inhibition has not shown activities in advanced refractory colorectal cancer (CRC), other than in those patients who are microsatellite-instability high (MSI-H).ObjectiveTo evaluate whether combining programmed death-ligand 1 (PD-L1) and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibition improved patient survival in metastatic refractory CRC.Design, setting, and participantsA randomized phase 2 study was conducted in 27 cancer centers across Canada between August 2016 and June 2017, and data were analyzed on October 18, 2018. Eligible patients had histologically confirmed adenocarcinoma of the colon or rectum; received all available standard systemic therapies (fluoropyrimidines, oxaliplatin, irinotecan, and bevacizumab if appropriate; cetuximab or panitumumab if RAS wild-type tumors; regorafenib if available); were aged 18 years or older; had adequate organ function; had Eastern Cooperative Oncology Group performance status of 0 or 1, and measurable disease.InterventionsWe randomly assigned patients to receive either 75 mg of tremelimumab every 28 days for the first 4 cycles plus 1500 mg durvalumab every 28 days, or best supportive care alone (BSC) in a 2:1 ratio.Main outcomes and measuresThe primary end point was overall survival (OS) and a 2-sided P<.10 was considered statistically significant. Circulating cell-free DNA from baseline plasma was used to determine microsatellite instability (MSI) and tumor mutation burden (TMB).ResultsOf 180 patients enrolled (121 men [67.2%] and 59 women [32.8%]; median [range] age, 65 [36-87] years), 179 were treated. With a median follow-up of 15.2 months, the median OS was 6.6 months for durvalumab and tremelimumab and 4.1 months for BSC (hazard ratio [HR], 0.72; 90% CI, 0.54-0.97; P = .07). Progression-free survival was 1.8 months and 1.9 months respectively (HR, 1.01; 90% CI, 0.76-1.34). Grade 3 or 4 adverse events were significantly more frequent with immunotherapy (75 [64%] patients in the treatment group had at least 1 grade 3 or higher adverse event vs 12 [20%] in the BSC group). Circulating cell-free DNA analysis was successful in 168 of 169 patients with available samples. In patients who were microsatellite stable (MSS), OS was significantly improved with durvalumab and tremelimumab (HR, 0.66; 90% CI, 0.49-0.89; P = .02). Patients who were MSS with plasma TMB of 28 variants per megabase or more (21% of MSS patients) had the greatest OS benefit (HR, 0.34; 90% CI, 0.18-0.63; P = .004).Conclusions and relevanceThis phase 2 study suggests that combined immune checkpoint inhibition with durvalumab plus tremelimumab may be associated with prolonged OS in patients with advanced refractory CRC. Elevated plasma TMB may select patients most likely to benefit from durvalumab and tremelimumab. Further confirmation studies are warranted.Trial registrationClinicalTrials.gov Identifier: NCT02870920.

Project description:BackgroundMedically underserved people with type 2 diabetes mellitus face limited access to group-based diabetes care, placing them at risk for poor disease control and complications. Immersive technology and telemedicine solutions could bridge this gap.ObjectiveThe purpose of this study was to compare the effectiveness of diabetes medical group visits (DMGVs) delivered in an immersive telemedicine platform versus an in-person (IP) setting and establish the noninferiority of the technology-enabled approach for changes in hemoglobin A1c (HbA1c) and physical activity (measured in metabolic equivalent of task [MET]) at 6 months.MethodsThis study is a noninferiority randomized controlled trial conducted from February 2017 to December 2019 at an urban safety net health system and community health center. We enrolled adult women (aged ≥18 years) who self-reported African American or Black race or Hispanic or Latina ethnicity and had type 2 diabetes mellitus and HbA1c ≥8%. Participants attended 8 weekly DMGVs, which included diabetes self-management education, peer support, and clinician counseling using a culturally adapted curriculum in English or Spanish. In-person participants convened in clinical settings, while virtual world (VW) participants met remotely via an avatar-driven, 3D VW linked to video teleconferencing. Follow-up occurred 6 months post enrollment. Primary outcomes were mean changes in HbA1c and physical activity at 6 months, with noninferiority margins of 0.7% and 12 MET-hours, respectively. Secondary outcomes included changes in diabetes distress and depressive symptoms.ResultsOf 309 female participants (mean age 55, SD 10.6 years; n=195, 63% African American or Black; n=105, 34% Hispanic or Latina; n=151 IP; and n=158 in VW), 207 (67%) met per-protocol criteria. In the intention-to-treat analysis, we confirmed noninferiority for primary outcomes. We found similar improvements in mean HbA1c by group at 6 months (IP: -0.8%, SD 1.9%; VW: -0.5%, SD 1.8%; mean difference 0.3, 97.5% CI -∞ to 0.3; P<.001). However, there were no detectable improvements in physical activity (IP: -6.5, SD 43.6; VW: -9.6, SD 44.8 MET-hours; mean difference -3.1, 97.5% CI -6.9 to ∞; P=.02). The proportion of participants with significant diabetes distress and depressive symptoms at 6 months decreased in both groups.ConclusionsIn this noninferiority randomized controlled trial, immersive telemedicine was a noninferior platform for delivering diabetes care, eliciting comparable glycemic control improvement, and enhancing patient engagement, compared to IP DMGVs.Trial registrationClinicalTrials.gov NCT02726425; https://clinicaltrials.gov/ct2/show/NCT02726425.

Project description:ImportancePostdischarge video-based virtual visits are a growing aspect of surgical care and have dramatically increased in the setting of the coronavirus disease 2019 (COVID-19) pandemic.ObjectiveTo evaluate the outcomes of all-cause 30-day hospital encounter proportion among patients who have a postdischarge video-based virtual visit follow-up compared with in-person follow-up.Design, setting, and participantsRandomized, active, controlled noninferiority trial in an urban setting, including patients from a small community hospital and a large, tertiary care hospital. Patients who underwent minimally invasive appendectomy or cholecystectomy by a group of surgeons who cover emergency general surgery at these 2 hospitals were included. Patients undergoing elective and nonelective procedures were included.InterventionsPatients were randomized in a 2:1 fashion to video-based virtual visit or in-person visit.Main outcomes and measuresThe primary outcome is the percentage of patients with 30-day hospital encounter, and we hypothesized that there would not be a significant increase in the 30-day hospital encounter proportion for patients who receive video-based virtual postdischarge care compared with patients who receive standard (in-person) care. Hospital encounter includes emergency department visit, observation, or inpatient admission.ResultsA total of 1645 patients were screened; 289 patients were randomized to the virtual group and 143 to the in-person group. Fifty-three patients crossed over to the in-person follow-up group. The percentage of patients who had a hospital encounter was noninferior for virtual visits (12.8% vs 13.3% for in-person, Δ 0.5% with 1-sided 95% CI, -∞ to 5.2%). The amount of time patients spent with the clinician (mean of 8.4 minutes virtual vs 7.8 minutes in-person; P = .30) was not different, but the median overall postoperative visit time was 27.5 minutes shorter (95% CI, -33.5 to -24.0).Conclusions and relevancePostdischarge video-based virtual visits did not increase hospital encounter proportions and provided shorter overall time commitment but equal time with the surgical team member. This information will help surgeons and patients feel more confident in using video-based virtual visits.Trial registrationClinicalTrials.gov Identifier: NCT03258177.

Project description:Coronavirus disease 2019 (COVID-19) is currently the major public health problem worldwide. Neutral electrolyzed saline solution that contains reactive chlorine and oxygen species may be an effective therapeutic. In the present study, the treatment efficacy of intravenous and/or nebulized neutral electrolyzed saline combined with usual medical care vs. usual medical care alone was evaluated in ambulatory patients with COVID-19. A prospective, 2-arm, parallel-group, randomized, open-label, multi-center, phase I-II clinical trial including 214 patients was performed. The following two outcomes were evaluated during the 20-day follow-up: i) The number of patients with disease progression; and ii) the patient acceptable symptom state. Serial severe acute respiratory syndrome coronavirus 2 naso/oro-pharyngeal detection by reverse transcription-quantitative (RT-q) PCR was performed in certain patients of the experimental group. Biochemical and hematologic parameters, as well as adverse effects, were also evaluated in the experimental group. The experimental treatment decreased the risk of hospitalization by 89% [adjusted relative risk (RR)=0.11, 95% confidence interval (CI): 0.03-0.37, P<0.001] and the risk of death by 96% (adjusted RR=0.04, 95% CI: 0.01-0.42, P=0.007) and also resulted in an 18-fold higher probability of achieving an acceptable symptom state on day 5 (adjusted RR=18.14, 95% CI: 7.29-45.09, P<0.001), compared with usual medical care alone. Overall, neutral electrolyzed saline solution was better than usual medical care alone. Of the patients analyzed, >50% were negative for the virus as detected by RT-qPCR in naso/oro-pharyngeal samples on day 4, with only a small number of positive patients on day 6. Clinical improvement correlated with a decrease in C-reactive protein, aberrant monocytes and increased lymphocytes and platelets. Cortisol and testosterone levels were also evaluated and a decrease in cortisol levels and an increase in the testosterone-cortisol ratio were observed on days 2 and 4. The experimental treatment produced no serious adverse effects. In conclusion, neutral electrolyzed saline solution markedly reduced the symptomatology and risk of progression in ambulatory patients with COVID-19. The present clinical trial was registered in the Cuban public registry of clinical trials (RPCEC) database (May 5, 2020; no. TX-COVID19: RPCEC00000309).

Dataset Information

Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial.

Publications

Comparison of Group Medical Visits Combined With Intensive Weight Management vs Group Medical Visits Alone for Glycemia in Patients With Type 2 Diabetes: A Noninferiority Randomized Clinical Trial.

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