Usual Care Arm Research Articles

Use of artificial intelligence‐guided echocardiography to detect cardiac dysfunction and heart valve disease in rural and remote areas: Rationale and design of the AGILE‐echo trial

Transthoracic echocardiography (TTE) is essential in the diagnosis of cardiovascular diseases (CVD), including but not limited to heart failure (HF) and heart valve disease (HVD). However, its dependence on expert acquisition means that its accessibility in rural areas may be limited, leading to delayed management decisions and potential missed diagnoses. Artificial intelligence-guided (AI)-TTE offers a solution by permitting non-expert image acquisition. The impact of AI-TTE on the timing of diagnosis and early initiation of cardioprotection is undefined. AGILE-Echo (use of Artificial intelligence-Guided echocardiography to assIst cardiovascuLar patient managEment) is a randomized-controlled trial conducted in 5 rural and remote areas around Australia. Adults with CV risk factors and exercise intolerance, or concerns regarding HVD are randomized into AI-TTE or usual care (UC). AI-TTE participants may have a cardiovascular problem excluded, identified (leading to AI-guided interventions) or unresolved (leading to conventional TTE). UC participants undergo usual management, including referral for standard TTE. The primary endpoint is a composite of HVD or HF diagnosis at 12-months. Subgroup analysis, stratified based on age range and sex, will be conducted. All statistical analyses will be conducted using R. Of the first 157 participants, 78 have been randomized into AI-TTE (median age 68 [IQR 17]) and 79 to UC (median age 65 [IQR 17], P = .034). HVD was the primary concern in 37 participants (23.6%) while 84.7% (n = 133) experienced exercise intolerance. The overall 10-year HF incidence risk was 13.4% and 20.0% (P = .089) for UC and AI-TTE arm respectively. Atrial remodeling, left ventricular remodeling and valvular regurgitation were the most common findings. Thirty-three patients (42.3%) showed no abnormalities. This randomized-controlled trial of AI-TTE will provide proof-of-concept for the role of AI-TTE in identifying pre-symptomatic HF or HVD when access to TTE is limited. Additionally, this could promote the usage of AI-TTE in rural or remote areas, ultimately improving health and quality of life of community dwelling adults with risks, signs or symptoms of cardiac dysfunction.

Effect of a Cardiovascular Polypill on Poststroke Cognition Among Ghanaians: Secondary Analysis of a Randomized Clinical Trial.

Poststroke cognitive impairment is prevalent worldwide, with no satisfactory preventative therapeutic strategies. We report on the effect of a cardiovascular polypill on cognitive performance among recent stroke survivors. The SMAART (Stroke Minimization through Additive Anti-atherosclerotic Agents in Routine Treatment) trial was a phase II randomized trial primarily assessing the polypill versus usual care for secondary prevention after a recent ischemic stroke. Participants allocated to the experimental arm were provided 2 Polycaps taken orally once a day for 12 months. A capsule of Polycap contained aspirin 100 mg, simvastatin 20 mg, hydrochlorothiazide 12.5 mg, ramipril 5 mg, and atenolol 50 mg. Participants in the usual care arm received standard secondary prevention therapy. We compared slopes of the trajectory of raw scores in the executive, language, memory, and visuospatial cognitive domains and aggregated cognitive scores over 12 months via a linear mixed-effects model. We enrolled 148 eligible participants (n=74 in each arm) and 59 versus 64 participants in the polypill and usual care arms, respectively, at month 12. Compared with the usual care arm, the slopes of cognitive performance over 12 months in the polypill arm were steeper by 2.02 units (95% CI, 0.52-3.53), P=0.009 in executive domain, 1.88 units (95% CI, 0.42-3.34), P=0.012 in language domain, 2.60 (0.03-5.17), P=0.049 in memory domain, 0.55 (-0.80 to 1.91), P=0.42 in the visuospatial domain, and global cognitive performance 6.87 units (95% CI, 1.44-12.30), P=0.013. The cardiovascular polypill is associated with a signal of better cognitive performance over 12 months among stroke survivors. Further definitive trials are warranted. URL: https://www.clinicaltrials.gov; Unique Identifier: NCT03329599.

A Novel Model of Integrated Care of Older Patients With Atrial Fibrillation in Rural China

BackgroundAn integrated management approach is essential to improving outcomes for patients with atrial fibrillation (AF). China's rural health care system, primarily reliant on village doctors, falls short of providing optimal management of AF in rural populations with limited resources and access to health care. To support village doctors in providing integrated care for AF, we have developed a digital health support platform. ObjectivesThis study aims to evaluate the effectiveness of this telemedicine-based, village doctor–led, multifaceted care model. MethodsThe MIRACLE-AF (a novel Model of IntegRAted Care of oLdEr patients with Atrial Fibrillation in rural China) trial is a prospective cluster-randomized clinical trial. Thirty village clinics in Jiangdu County, Jiangsu Province, were randomly assigned to village doctor-led telemedicine integrated care or enhanced usual care in a 1:1 ratio. All the patients diagnosed with AF who resided in this rural area and were aged ≥65 years were eligible for enrollment. The primary outcome in stage 1 was the proportion of patients who met all 3 criteria for the atrial fibrillation better care pathway at 12 months, and in stage 2, a composite of cardiovascular death, all strokes including ischemic stroke and hemorrhagic stroke, worsening of heart failure or acute coronary syndrome, and emergency visits due to AF over 36 months. ResultsIn total, 1,039 participants were recruited from December 1, 2020, to May 9, 2022, with 524 in the telemedicine care arm and 515 in the enhanced usual care arm. All the enrolled patients are under scheduled follow-up. ConclusionsThe MIRACLE-AF trial will provide evidence for this novel integrated care model for treating rural older patients with AF. (New Model of Integrated Care of Older Patients with Atrial Fibrillation in Rural China; NCT04622514)

Rationale, Design and Baseline Characteristics of a Randomized Controlled Trial of a Cardiovascular Quality Improvement Strategy in India: The C-QIP Trial

BackgroundQuality of chronic care for cardiovascular disease (CVD) remains suboptimal worldwide. The Collaborative Quality ImProvement (C-QIP) trial aims to develop and test the feasibility and clinical effect of a multicomponent strategy among patients with prevalent CVD in India. MethodsThe C-QIP is a clinic-based, open randomized trial of a multicomponent intervention versus usual care that was locally developed and adapted for use in Indian settings through rigorous formative research guided by Consolidated Framework for Implementation Research (CFIR). The C-QIP intervention consisted of 5 components: 1) electronic health records and decision support system for clinicians, 2) trained non-physician health workers (NPHW), 3) text-message based lifestyle reminders, 4) patient education materials, 5) quarterly audit and feedback reports. Patients with CVD (ischemic heart disease, ischemic stroke, or heart failure) attending outpatient CVD clinics were recruited from September 2022 to September 2023 and were randomized to the intervention or usual care arm for at least 12 months follow-up. The co-primary outcomes are implementation feasibility, fidelity (i.e., dose delivered and dose received), acceptability, adoption and appropriateness, measured at multiple levels: patient, provider and clinic site-level, The secondary outcomes include prescription of guideline directed medical therapy (GDMT) (provider-level), and adherence to prescribed therapy, change in mean blood pressure (BP) and LDL-cholesterol between the intervention and control groups (patient-level). In addition, a trial-based process and economic evaluations will be performed using standard guidelines. ResultsWe recruited 410 socio-demographically diverse patients with CVD from four hospitals in India. Mean (SD) age was 57.5 (11.7) years, and 73.0% were males. Self-reported history of hypertension (48.5%) and diabetes (41.5%) was common. At baseline, mean (SD) BP was 127.9 (18.2) /76.2 (11.6) mm Hg, mean (SD) LDLc: 80.3 (37.3) mg/dl and mean (SD) HbA1c: 6.8% (1.6%). At baseline, the GDMT varied from 62.4% for patients with ischemic heart disease, 48.6% for ischemic stroke and 36.1% for heart failure. ConclusionThis study will establish the feasibility of delivering contextually relevant, and evidence-based C-QIP strategy and assess whether it is acceptable to the target populations. The study results will inform a larger scale confirmatory trial of a comprehensive CVD care model in low-resource settings. Trial registrationClinical Trials Registry India: CTRI/2022/04/041847; Clinicaltrials.gov number: NCT05196659

When Usual Care Is Not So Usual: Protocol Violations and Generalizability in a Treat-to-Target Strategy Trial in Patients With Axial Spondyloarthritis.

The objective of this study was to evaluate the impact of protocol violations in the treat-to-target group in the Tight Control in Spondyloarthritis (TICOSPA) trial and to compare the proportion of patients optimally treated according to the Assessment of Spondyloarthritis International Society (ASAS)/EULAR 2016 recommendations for patients with axial spondyloarthritis (axSpA) between the treat-to-target versus usual care (UC) arms. This study was a cluster-randomized, controlled 48-week trial including patients with axSpA who fulfilled the ASAS criteria, had an Axial Spondyloarthritis Disease Activity Score >2.1, and were biologic disease-modifying antirheumatic drug naive. Eighteen axSpA expert centers were randomly allocated to one treatment arm: (a) treat-to-target prespecified management strategy (four-week visits), and (b) UC treatment decisions at the rheumatologist's discretion (12-week visits). Protocol violations in the treat-to-target arm and the fulfillment of the 2016 ASAS/EULAR recommendations in both arms were evaluated at every visit. ASAS Health Index (ASAS-HI) and disease activity outcomes at 48 weeks were compared between treat-to-target violators versus nonviolators. Patients treated according to the ASAS/EULAR recommendations were compared between both arms. A total of 160 patients initiated the trial (80 patients with treat to target; 80 patients with UC). In the treat-to-target arm, 51.2% patients violated the protocol at least once (62.2% of violations resulting in maintenance/reduction of treatment against protocol). After 48 weeks, treat-to-target violators versus nonviolators showed similar ratios of ASAS-HI improvement. The proportion of patients managed according to the ASAS/EULAR recommendations after the first 12 weeks were 63.9% versus 61.8% for the treat-to-target and UC arms, respectively. Protocol violations in the treat-to-target arm in the TICOSPA trial were frequent, although they did not have an impact on the rate of the primary outcome. The groups with UC was optimally treated, partly explaining the nonachievement of the primary objective in the TICOSPA trial.

Intensive therapeutic education strategy for patients with acute heart failure (EduStra-HF): Design of a randomized controlled trial

BackgroundHeart failure is associated with reduced quality of life, hospitalizations, death and high healthcare costs. Despite care improvements, the rehospitalization rate after an acute heart failure episode, especially for acute heart failure, remains high. MethodsThe Education Strategy for patients with acute Heart Failure (EduStra-HF; ClinicalTrials.gov Identifier NCT03035123) study will randomize patients admitted for acute heart failure in six French hospitals to usual care (control) or therapeutic education (intervention). All patients will be evaluated at baseline and will meet with a therapeutic education nurse before discharge. Those in the usual care arm will have standard appointments with their cardiologist and general practitioner. Those in the intervention arm will have an intensive follow-up schedule of phone calls, home visits and text messages from the therapeutic education nurses, plus cardiologist visits. Patients will be stratified by discharge location (home or cardiac rehabilitation centre) before randomization, and will be followed up for 1 year. The primary outcome will be the readmission rates for acute heart failure during 1 year in the two groups. Secondary outcomes will include: quality of life; time from inclusion to first readmission for acute heart failure; non-heart failure cardiovascular rehospitalization rates; length of stay for heart failure; cardiovascular and all-cause death; rates of patients receiving optimal medical therapies; evolution of knowledge about heart failure; and cost-effectiveness. ConclusionsThis study will assess the efficacy and feasibility of a standardized management strategy for the care and follow-up of patients discharged after hospitalization for acute heart failure. The EduStra-HF strategy will combine various nurse care methods to help prevent rehospitalization.

Effectiveness of direct patient outreach with a narrative naloxone and overdose prevention video to patients prescribed long-term opioid therapy in the USA: the Naloxone Navigator randomised clinical trial

IntroductionPublic health efforts to reduce opioid overdose fatalities include educating people at risk and expanding access to naloxone, a medication that reverses opioid-induced respiratory depression. People receiving long-term opioid therapy...

Impact of mobile health technologies on human papillomavirus vaccination uptake among mothers of unvaccinated girls aged 9-14 years in Lagos, Nigeria (mHealth-HPVac): Study protocol of a randomised controlled trial.

Despite the availability of effective vaccines, human papillomavirus (HPV) vaccine uptake remains low in most resource-limited settings including Nigeria. Mobile health technology (mHealth) may empower patients to control their health, reduce inequalities, and improve the uptake of HPV vaccination. The "mHealth-HPVac" study will assess the effects of mHealth using short text messages on the uptake of HPV vaccination among mothers of unvaccinated girls aged 9-14 years and also determine the factors influencing the uptake of HPV vaccination among these mothers. This protocol highlights a randomised controlled trial involving women aged 25-65 years who will be enrolled on attendance for routine care at the General Outpatient clinics of Lagos University Teaching Hospital, Lagos, Nigeria between July and December 2024. At baseline, n=224 women will be randomised to either a short text message or usual care (control) arm. The primary outcome is vaccination of the participant's school-age girl(s) at any time during the 6 months of follow-up. The associations between any two groups of continuous variables will be tested using the independent sample t-test (normal distribution) or the Mann-Whitney U test (skewed data) and that of two groups of categorical variables with Chi-square (X2) or Fisher's exact test where appropriate. Using the multivariable binary logistic regression model, we will examine the effects of all relevant sociodemographic and clinical variables on HPV vaccination uptake among mothers of unvaccinated but vaccine-eligible school-age girls. Statistical significance will be defined as A P<0.05. The mHealth-Cervix study will evaluate the impact of mobile technologies on HPV vaccination uptake among mothers of unvaccinated but vaccine-eligible school-age girls in Lagos, Nigeria as a way of contributing to the reduction in the wide disparities in cervical cancer incidence through primary prevention facilitated using health promotion to improve HPV vaccination uptake. PACTR202406727470443 (6th June 2024).

Impact of mobile health technologies on human papillomavirus vaccination uptake among mothers of unvaccinated girls aged 9–14 years in Lagos, Nigeria (mHealth-HPVac): study protocol of a randomised controlled trial

BackgroundDespite the availability of effective vaccines, human papillomavirus (HPV) vaccine uptake remains low in most resource-limited settings including Nigeria. Mobile health technology (mHealth) has the potential to empower patients to manage their health, reduce health disparities, and enhance the uptake of HPV vaccination.AimThe “mHealth-HPVac” study will assess the effects of mHealth using short text messages on the uptake of HPV vaccination among mothers of unvaccinated girls aged 9–14 years and also determine the factors influencing the uptake of HPV vaccination among these mothers.MethodsThis protocol highlights a randomised controlled trial involving women aged 25–65 years who will be enrolled on attendance for routine care at the General Outpatient clinics of Lagos University Teaching Hospital, Lagos, Nigeria between July and December 2024. At baseline, n = 123 women will be randomised to either a short text message or usual care (control) arm. The primary outcome is vaccination of the participant’s school-age girl(s) at any time during the 6 months of follow-up. The associations between any two groups of continuous variables will be assessed using the independent sample t-test for normally distributed data, or the Mann-Whitney U test for skewed data. For two groups of categorical variables, the Chi-square (X2) test or Fisher’s exact test will be used, as appropriate. Using the multivariable binary logistic regression model, we will examine the effects of all relevant sociodemographic and clinical variables on HPV vaccination uptake among mothers of unvaccinated but vaccine-eligible school-age girls. Statistical significance will be reported as P < 0.05.DiscussionThe mHealth-Cervix study will evaluate the impact of mobile technologies on HPV vaccination uptake among mothers of unvaccinated but vaccine-eligible school-age girls in Lagos, Nigeria as a way of contributing to the reduction in the wide disparities in cervical cancer incidence through primary prevention facilitated using health promotion to improve HPV vaccination uptake.RegistrationPACTR202406727470443 (6th June 2024).

Remote Blood Pressure Monitoring With Social Support for Patients With Hypertension

Hypertension management has traditionally been based on office visits. Integrating remote monitoring into routine clinical practices and leveraging social support might improve blood pressure (BP) control. To evaluate the effectiveness of a bidirectional text monitoring program focused on BP control and medication adherence with and without social support in adults with hypertension. This randomized clinical trial included adults aged 18 to 75 treated at an academic family medicine practice in Philadelphia in 2018 and 2019. Patients had been seen at least twice in the prior 24 months and had at least 2 elevated BP measurements (>150/90 mm Hg or >140/90 mm Hg for patients aged 18-59 years or with diabetes or chronic kidney disease) during visits. All participants had a cell phone with text messaging, offered at least 1 support partner, and were taking maintenance medications to treat hypertension. Patients were randomized 2:2:1 to remote monitoring of BP and medication adherence (RM), remote monitoring of BP and medication adherence with feedback provided to a social support partner (SS), or usual care (UC). Data were analyzed on an intention-to-treat basis between October 14, 2019, and May 30, 2020, and were revisited from May 23 through June 2, 2023. The RM and SS groups received an automatic home BP monitor, 3 weekly texts requesting BP measurements, 1 weekly text inquiring about medication adherence, and a weekly text with feedback. In the SS arm, support partners received a weekly progress report. The UC group received UC through their primary care practice. Clinicians caring for the patients in the intervention groups received nudges via electronic health records to adjust medications when 3 of 10 reported BP measurements were elevated. Patients were followed up for 4 months. The primary outcome was systolic BP at 4 months measured during the final follow-up visit. Secondary outcomes included achievement of normotension and diastolic BP. In all, 246 patients (mean [SD] age, 50.9 [11.4] years; 175 females [71.1%]; 223 Black individuals [90.7%] and 13 White individuals [5.3%]) were included in the intention-to-treat analysis: 100 patients in the RM arm, 97 in the SS arm, and 49 in the UC arm. Compared with the UC arm, there was no significant difference in systolic or diastolic BP at the 4-month follow-up visit in the RM arm (systolic BP adjusted mean difference, -5.25 [95% CI, -10.65 to 0.15] mm Hg; diastolic BP adjusted mean difference, -1.94 [95% CI, -5.14 to 1.27] mm Hg) or the SS arm (systolic BP adjusted mean difference, -0.91 [95% CI, -6.37 to 4.55] mm Hg; diastolic BP adjusted mean difference, -0.63 [95% CI, -3.77 to 2.51] mm Hg). Of the 206 patients with a final BP measurement at 4 months, BP was controlled in 49% (41 of 84) of patients in the RM arm, 31% (27 of 87) of patients in the SS arm, and 40% (14 of 35) of patients in the UC arm; these rates did not differ significantly between the intervention arms and the UC group. In this randomized clinical trial, neither remote BP monitoring nor remote BP monitoring with social support improved BP control compared with UC in adults with hypertension. Additional efforts are needed to examine whether interventions directed at helping patients remember to take their BP medications can lead to improved BP control. ClinicalTrials.gov Identifier: NCT03416283.

Timeframe for lymphedema therapy for head and neck cancer survivors.

e13535 Background: More than 90% of head and neck cancer (HNC) survivors experience secondary head and neck lymphedema. Prompt identification and treatment are essential given the progressive nature of lymphedema and potential complications. Usual care includes complete decongestive therapy performed by a lymphedema therapist followed by lifelong home self-care. The ability to participate in lymphedema therapy (LT) is deleteriously impacted by numerous barriers. We are conducting a phase 3 multisite randomized trial involving HNC survivors with treatment-naïve lymphedema which compares usual lymphedema care to the use of an advanced pneumatic compression device (APCD). For patients treated on the usual care arm, data pertaining to LT delivery was collected prospectively. Herein we report the preliminary analysis from this dataset. Methods: Eligible patients were age ≥18 years, had pathologically confirmed HNC, completed curative intent cancer therapy with no evidence of active cancer, were diagnosed with internal or external head and neck lymphedema with at least one core lymphedema associated symptom and had not previously received treatment for lymphedema. Participants were randomized to either usual care with complete decongestive therapy directed by a lymphedema therapist followed by home self-care or daily self-directed use of APCD. Anatomic measurements and patient reported outcome measures were obtained at 2-, 4- and 6-month endpoints. The intervention phase lasted 6 months and therapy records were received for analysis. Key outcome measures included the time from referral to LT evaluation consultation, time from LT evaluation to treatment session and time from referral to treatment session. Results: At the time of this analysis, 87 participants randomized to usual care arm were eligible for inclusion in this assessment. Of the 87 patients, we were unable to document completion of LT consultation or therapy for 39 patients. Among the 48 participants who were referred for LT and received therapy, 72% were male and 28% were female, with 91% identifying as white, 7% as black, and 2% as other. The average age was 62. The mean time from referral by a health care provider to initial lymphedema consultation was 19.6 (σ 18.1) days. Of note, there was a wide-ranging timeframe from referral to LT treatment, varying from 0 to 93 days. The mean time from consultation to treatment was 1.7 days (σ 5.1) and referral to treatment was 21.3 (σ 17.8). Conclusions: A key finding of this study is the high rate (45%) of those referred for LT were not documented to complete a therapy consultation or to receive therapy. Of those patients who receive therapy, consultation and treatment were delay significantly in a high percentage of patients. These finding highlight the need for additional investigation into barriers to timely implementation of LT for head and neck cancer survivors. Guidelines and standards of care should be developed to guide practitioners. Clinical trial information: NCT04797390 .

Uptake of germline cancer genetic services in a randomized trial of remote telehealth services as compared to usual care: A report from the Childhood Cancer Survivor Study (CCSS).

10009 Background: Limited access to genetic services in community practices, leaves many childhood cancer survivors who are genetic carriers unidentified and at risk for subsequent malignant neoplasms (SMNs) due to therapy or an inherited cancer predisposition. The ENGaging and Activating cancer survivors in Genetic services (ENGAGE) study evaluated the effectiveness of an in-home, collaborative PCP (primary care provider) model of remote centralized telehealth services to increase uptake of cancer genetic services in survivors compared to usual care. Methods: 414 survivors were randomized to remote services by phone or videoconference (n = 281) or usual care (n = 133). The primary outcome was uptake of genetic counseling or testing at 6 months. In secondary analyses we evaluated baseline characteristics and patient reported outcomes associated with uptake of services. We used Fisher’s Exact tests, Chi-squared tests, and T-tests for analyses. Results: Participants were identified through the NCI-funded Childhood Cancer Survivor Study and included 189 (45.7%) male, 88 (21.1%) nonwhite participants with mean age 52 years (SD 0.65), recruited from over 40 states with a history of CNS tumors (n = 190, 46%), sarcoma (n = 116, 28%), or SMN or a family history of cancer (n = 108, 26%). At 6 months, 40% (n = 113) of survivors in the remote telehealth services arms utilized genetic services as compared to 16% (n = 21) in the usual care arm (p &lt; 0.001). Factors associated with uptake of services included lower baseline genetic knowledge score (31.0, SD 5.8 without uptake versus 29.7, SD 5.1 with uptake, p = 0.025), having more relatives with cancer (1.6, SD 1.5, without uptake versus 2.0, SD 1.8 with uptake, p = 0.019), having a higher perceived risk of cancer on a Likert scale (3.6, SD 1.0 without uptake versus 3.9, SD 0.8 with uptake, p = 0.011), having a history of internet use (35% uptake with use versus 0% without use, p = 0.040), and not having a high deductible plan (30% uptake with high plan versus 42% without, p = 0.025). Having a higher positive attitude toward genetic testing score (e.g. higher perceived value, lower perception of high cost and lower anticipated distress) was associated with uptake of services (29.5, SD 4.3 without uptake versus 31.2, SD 4.4 with uptake, p &lt; 0.001). Conclusions: These data suggest that offering remote centralized telehealth genetic services increases the uptake of genetic services in survivors of childhood cancer across the US using a collaborative PCP model. Although uptake was higher than usual care, barriers to uptake of genetic services remain, including concerns about cost and negative perceptions about genetic testing. Strategies to address multi-level barriers to genetic services are needed to realize the potential of genetic testing in childhood cancer survivors and patients in community practices. Clinical trial information: NCT04455698 .

A randomized phase III clinical trial of yoga for chemotherapy-induced peripheral neuropathy treatment (YCT).

TPS12152 Background: Chemotherapy-induced peripheral neuropathy (CIPN) is common and debilitating among cancer survivors receiving neurotoxic chemotherapy, which can cause functional disabilities and significantly increase the risk of falls. There are limited approaches to managing CIPN symptoms and related functional limitations. Our pilot study demonstrated yoga therapy's feasibility and preliminary efficacy in improving CIPN pain and functional outcomes. We developed the YCT trial to assess the effect of yoga therapy on improving pain and balance symptoms among cancer survivors with CIPN pain. Methods: YCT is a prospective phase III multicenter, parallel three-arm randomized clinical trial at Dana-Farber Cancer Institute (DFCI) and Memorial Sloan Kettering Cancer Center (MSK) (ClinicalTrials.gov Identifier: NCT05121558). YCT aims to determine the efficacy of an eight-week yoga treatment vs. education control (EC) vs. usual care (UC) in improving CIPN pain and balance in cancer survivors. We plan to enroll and randomize 268 participants (2:1:1) to yoga, EC, and UC groups to detect an effect size of at least 0.48 for the primary pain outcome at eight weeks post-randomization between yoga vs. EC, with 80% power and a 2.5% Type I error rate, assuming 12% attrition by week 8 and 20% attrition by week 24. Major eligibility criteria include 1) adults who have no evidence of disease or stable diseases, 2) who have completed neurotoxic chemotherapy such as platinum agents, taxanes, vinca alkaloids, and bortezomib at least three months before enrollment, 3) who have a clinical diagnosis of CIPN with moderate to severe pain, defined as a score of at least four on the Brief Pain Inventory (BPI) average pain item, and 4) who experience self-identified CIPN balance difficulty. Eligible subjects in the yoga arm will receive hourly gentle therapeutic yoga classes taught by protocol-trained oncology yoga instructors, twice weekly for eight weeks, and practice home-based yoga. Subjects in the EC arm will receive hourly education classes taught by protocol-trained healthcare instructors twice weekly for eight weeks. Subjects in the UC arm will continue usual care for eight weeks. We offer free yoga sessions for participants in control groups after study completion. Aside from patient-reported outcome measures (i.e., BPI, FACT/GOG-Ntx, QLQ-CIPN 20), we measured functional improvements by functional reach, timed up-and-go, and chair-to-stand tests. We also conducted quantitative sensory testing to assess changes in sensory function. Progress: 1) We are transitioning this trial to a multicenter trial, with DFCI being the coordinating center and MSK a subsite; 2) As of January 18, 2024, 104 of the planned 268 participants have been enrolled. We anticipate initiating participant enrollment at DFCI in February 2024. Anticipated accrual completion: March 2025. Clinical trial information: NCT05121558 .

Early diagnosis of melanoma: a randomized trial assessing the impact of the transmission of photographs taken with a smartphone from the general practitioner to the dermatologist on the time to dermatological consultation

BackgroundDifficulty obtaining a dermatological consultation is an obstacle to the early diagnosis of melanoma. On the one hand, patients survival depends on the lesion thickness at the time of diagnosis. On the other hand, dermatologists treat many patients with benign lesions. Optimizing patient care pathways is a major concern. The aim of the present study was to assess whether the e-mail transmission of photographs of suspected melanoma lesions between general practitioners (GPs) and dermatologists reduces the time to dermatological consultation for patients whose suspicious skin lesions ultimately require resection.MethodsWe conducted a cluster-randomized controlled study in primary care involving 51 French GPs between April 2017 and August 2019. A total of 250 patients referred to a dermatologist for a suspected melanoma lesion were included GPs were randomized to either the smartphone arm or the usual care arm. In the smartphone arm, the GPs referred patients to the dermatologist by sending 2 photographs of the suspicious lesion using their smartphone. The dermatologist then had to set up an appointment at an appropriate time. In the usual care arm, GPs referred patients to a dermatologist according to their usual practice. The primary outcome was the time to dermatological consultation for patients whose lesion ultimately required resection.Results57 GPs volunteered were randomized (27 to the smartphone arm, and 30 to the usual care arm). A total of 125 patients were included in each arm (mean age: 49.8 years; 53% women) and followed 8 months. Twenty-three dermatologists participated in the study. The time to dermatological consultation for patients whose suspicious skin lesion required resection was 56.5 days in the smartphone arm and 63.7 days in the usual care arm (mean adjusted time reduction: -18.5 days, 95% CI [-74.1;23.5], p = .53).ConclusionsThe e-mail transmission of photographs from GPs to dermatologists did not improve the dermatological management of patients whose suspicious skin lesions ultimately required resection. Further research is needed to validate quality criteria that might be useful for tele-expertise in dermatology.Trial RegistrationRegistered on ClinicalTrials.gov under reference number NCT03137511 (May 2, 2017).

Overcoming challenges in real-world evidence generation: An example from an Adult Medical Care Coordination program.

The Adult Medical Care Coordination program ("the program") was implemented at Mayo Clinic to promote patient self-management and improve 30-day unplanned readmission for patients with high risk for readmission after hospital discharge. This study aimed to evaluate the impact of the program compared to usual care using a pragmatic, stepped wedge cluster randomized trial ("stepped wedge trial"). However, several challenges arose including large differences between the study arms. Our goal is to describe the challenges and present lessons learned on how to overcome such challenges and generate evidence to support practice decisions. We describe the challenges encountered during the trial, the approach to addressing these challenges, and lessons learned for other learning health system researchers facing similar challenges. The trial experienced several challenges in implementation including several clinics dropping from the study and care disruptions due to COVID-19. Additionally, there were large differences in the patient population between the program and usual care arms. For example, the mean age was 76.8 for the program and 68.1 for usual care. Due to these differences, we adapted the methods using the propensity score matching approach that is traditionally applied to observational designs and adjusted for differences in observable characteristics. When conducting pragmatic research, researchers will encounter factors beyond their control that may introduce bias. The lessons learned include the need to weigh the tradeoffs of pragmatic design elements and the potential value of adaptive designs for pragmatic trials. Applying these lessons would promote the successful generation of evidence that informs practice decisions.

Enhanced tuberculosis diagnosis with computer-aided chest X-ray and urine LAM in adults with HIV admitted to hospital (CASTLE study): A cluster randomised trial.

People with HIV (PHIV) admitted to hospital have high mortality, with tuberculosis (TB) being the major cause of death. Systematic use of new TB diagnostics could improve TB diagnosis and might improve outcomes. We conducted a cluster randomised trial among adult PHIV admitted to Zomba Central Hospital, Malawi. Admission-days were randomly assigned to: enhanced TB diagnostics using urine lipoarabinomannan (LAM) antigen tests (SILVAMP-LAM, Fujifilm, Japan and Determine-LAM, Alere/Abbot, USA), digital chest X-ray with computer aided diagnosis (dCXR-CAD, CAD4TBv6, Delft, Netherlands), plus usual care ("enhanced TB diagnostics"); or usual care alone ("usual care"). The primary outcome was TB treatment initiation during admission. Secondary outcomes were 56-day mortality, TB diagnosis within 24-hours, and undiagnosed TB at discharge, ascertained by culture of one admission sputum sample. Between 2 September 2020 and 15 February 2022, we recruited 419 people. Four people were excluded post-recruitment, leaving 415 adults recruited during 207 randomly assigned admission-days in modified intention-to-treat analysis. At admission, 90.8% (377/415) were taking antiretroviral therapy (ART) with median (IQR) CD4 cell count 240 cells/mm3. In the enhanced diagnostic arm, median CAD4TBv6 score was 60 (IQR: 51-71), 4.4% (9/207) had SILVAMP-LAM-positive and 14.4% (29/201) had Determine-LAM positive urine with three samples positive by both urine tests. TB treatment was initiated in 46/208 (22%) in enhanced TB diagnostics arm and 24/207 (12%) in usual care arm (risk ratio [RR] 1.92, 95% CI 1.20-3.08). There was no difference in mortality by 56 days (enhanced TB diagnosis: 54/208, 26%; usual care: 52/207, 25%; hazard ratio 1.05, 95% CI 0.72-1.53); TB treatment initiation within 24 hours (enhanced TB diagnosis: 8/207, 3.9%; usual care: 5/208, 2.4%; RR 1.61, 95% CI 0.53-4.71); or undiagnosed microbiological-confirmed TB at discharge (enhanced TB diagnosis, 0/207 (0.0%), usual care arm 2/208 (1.0%) (p = 0.50). Urine SILVAMP-LAM/Determine-LAM plus dCXR-CAD diagnostics identified more hospitalised PHIV with TB than usual care. The increase in TB treatment appeared mainly due to greater use of Determine-LAM, rather than SILVAMP-LAM or dCXR-CAD. Poor concordance between Determine-LAM and SILVAMP-LAM urine tests requires further investigation. Inpatient mortality for adults with HIV remains unacceptability high.

Leveraging home health aides to improve outcomes in heart failure: A pilot study protocol

Heart failure (HF) affects six million people in the U.S., is associated with high morbidity, mortality, and healthcare utilization.(1, 2) Despite a decade of innovation, the majority of interventions aimed at reducing hospitalization and readmissions in HF have not been successful.(3–7) One reason may be that most have overlooked the role of home health aides and attendants (HHAs), who are often highly involved in HF care.(8–13) Despite their contributions, studies have found that HHAs lack specific HF training and have difficulty reaching their nursing supervisors when they need urgent help with their patients. Here we describe the protocol for a pilot randomized control trial (pRCT) assessing a novel stakeholder-engaged intervention that provides HHAs with a) HF training (enhanced usual care arm) and b) HF training plus a mobile health application that allows them to chat with a nurse in real-time (intervention arm). In collaboration with the VNS Health of New York, NY, we will conduct a single-site parallel arm pRCT with 104 participants (HHAs) to evaluate the feasibility, acceptability, and effectiveness (primary outcomes: HF knowledge; HF caregiving self-efficacy) of the intervention among HHAs caring for HF patients. We hypothesize that educating and better integrating HHAs into the care team can improve their ability to provide support for patients and outcomes for HF patients as well (exploratory outcomes include hospitalization, emergency department visits, and readmission). This study offers a novel and potentially scalable way to leverage the HHA workforce and improve the outcomes of the patients for whom they care.Clinical trial.gov registration: NCT04239911

Appropriateness and acceptability of continuous glucose monitoring in people with type 1 diabetes at rural first-level hospitals in Malawi: a qualitative study

ObjectivesThe purpose of this qualitative study is to describe the acceptability and appropriateness of continuous glucose monitoring (CGM) in people living with type 1 diabetes (PLWT1D) at first-level (district) hospitals...

Feasibility of continuous glucose monitoring in patients with type 1 diabetes at two district hospitals in Neno, Malawi: a randomised controlled trial

ObjectivesTo assess the feasibility and change in clinical outcomes associated with continuous glucose monitoring (CGM) use among a rural population in Malawi living with type 1 diabetes.DesignA 2:1 open randomised...

VASCULAR AGE AS A KEY FOR A TEAM-BASED APPROACH TO MANAGE BLOOD PRESSURE AND CARDIOVASCULAR RISK BETWEEN COMMUNITY PHARMACISTS AND PRIMARY HEALTH CARE CENTERS (TOGETHER)

Objective: Hypertension (HTN) is the main cause of premature death worldide. Previous studies in Portugal, Austria and Spain have shown that estimating arterial stiffness in Community Farmacies (CPh) improves its management. The main objective is to evaluate whether empowering hypertensive subjects by determining arterial stiffness in CPh increases the rate of HTN control. Secondary objective is to establish paths of lasting cooperation between Primary Care (PC) doctors and CPh. Design and method: TOGETHER is a randomized study in Portugal, Austria and Spain. All consecutive expected 1260 subjects entering CPh will be offered blood pressure measurement and ambulatory blood pressure monitoring (ABPM) for those cases with high values. 140 CPh will be randomly grouped into a usual care arm (health education associated with HTN and communication of the results to PC). In the experimental care group, early vascular aging (EVA) will additionally be assessed estimating oscillometric pulse wave velocity. The concept and therapeutic options of EVA will be explained to patients and PC. HTN will be treated by PC according to usual clinical practice. After 6 months a second evaluation with ABPM will be performed and HTN control will be compared between the two arms. The degree of patient-doctor interaction and economic implications will be determined through validated surveys. Results: TOGETHER will address five fundamental unmet needs: 1) lack of HTN screening programs; 2) the concept of cardiovascular risk is difficult to understand. The EVA concept (“Your arteries are 10 years older than you”) is simple and more informative; 3) understanding CV risk on an individual basis (individual EVA) should improve patient adherence and reduce physician inertia; 4) TOGETHER will implement health educational programs, combined with the concept of EVA; 5) there is an objective need to improve collaboration and develop a team-based approach to HTN care between CPh and PC. Conclusions: The complementary strengths and organizational settings of CPh and PC will allow TOGETHER to create new strategies for early identification and intervention in HTN, ranging from lifestyle to medical treatment, taking social, economic, and behavioral aspects into account.