Trial Of Telemedicine Research Articles

Integrating Fitness Training in Oncologic Care: Lessons Learned from a Large Telemedicine Trial

ObjectiveTo provide insights from patients and clinicians regarding the benefits and barriers of the introduction of a telerehabilitation fitness program into the oncologic care of people with late-stage cancer. DesignThis study is a qualitative assessment of the COllaborative Care to Preserve PErformance in Cancer trial, which involved the insertion of a telerehabilitation fitness program into the oncologic care of patients with late-stage cancer. SettingA large midwestern medical center. ParticipantsThirty-one patients who matched the overall demographics of the study participants as well as 3 oncologists, 2 physical therapist fitness care managers (FCMs), nurse pain care manager, and 2 supervisory physicians involved in the study. InterventionsFive hundred sixteen patients with late-stage (IIIC or IV) cancer were randomly assigned to 1 of 3 arms: a control group that received usual oncologic care and 2 intervention groups. The members of the latter continued with their usual care but also received either 6 months of a fitness program, with or without the addition of pain management assistance. All components were delivered via telemedicine with the fitness program consisting of progressive resistance and walking components. Main Outcome MeasuresPerceived benefits and shortcomings of the intervention were obtained via written narratives from the patients and as well as through interviews with the oncologists, FCMs, nurse pain care manager, and supervisory physicians involved in the study. ResultsThematic analysis revealed 87% (27/31) of the participants found the program helpful. Regular contact with someone who understood their situation, helped improve their function, and encouraged active engagement in their care was perceived as particularly beneficial. The FCMs who worked remotely with participants to coordinate their exercise programs agreed that regular interactions with the patient facilitated engagement, education, and meaningful goal setting. The oncologists were supportive of the intervention but had concerns about patient suitability. The supervisory physicians noted a number of institutional barriers such as oncology workflows and the need for better sharing of information across disciplines. ConclusionsA fitness program delivered via telemedicine was perceived as beneficial by the patients, the FCMs, and the supervising physicians. Success hinged on the quality of the interaction between patients and the FCMs. Institutional barriers to implementation seem similar to those encountered by many new programs that need to be inserted into the workflows of busy clinics and practices.

A phase II telemedicine study of pemigatinib in adult patients with unresectable or metastatic pancreas cancer with FGFR2 gene fusions or other FGFR genetic alterations.

TPS717 Background: Advanced pancreas cancer has a poor prognosis with few effective targeted therapies. Given this current state, novel therapies for pancreas cancer are an unmet need. Genomic alterations in FGFR, including fusions and point mutations are known driver mutations in cancer. FGFR kinase inhibitors have been FDA approved in cholangiocarcinoma and urothelial carcinoma, however, have not been well studied in other cancers. Our team previously identified and treated four patients with advanced pancreas cancer and FGFR2 fusions with FGFR kinase inhibitors resulting in durable responses and prolonged survival. Additionally, through a review of Foundation Medicine’s clinical genomic database, consisting of 30,229 pancreas cancer tumors, we determined that FGFR1-3 fusions have a prevalence of approximately 1% in pancreas cancer, most commonly in FGFR2 (0.8%). Our observations provide preliminary evidence that FGFR targeted therapy results in excellent clinical outcomes. We hypothesize that FGFR altered pancreas cancer treated with a FGFR kinase inhibitor will result in durable responses. We developed a phase 2, telemedicine trial of pemigatinib, an FDA approved FGFR kinase inhibitor, in FGFR altered pancreas cancer. Since the COVID-19 pandemic, telemedicine is used in routine oncology care and clinical trials and is associated with cost savings for patients. The growing adoption of this technology provides an opportunity to enhance the study of ultra-rare cancers. Methods: The trial consists of unresectable or metastatic pancreas cancer of any histology in two cohorts: 1) Primary cohort of FGFR2 fusions (n=30) and 2) exploratory cohort of other known activating mutations in FGFR (n=10). Patients are identified from across the United States through Foundation Medicine, Caris Life Sciences, and the Pancreatic Cancer Action Network. Eligible patients will be treated with oral pemigatinib through telemedicine by investigators at The Ohio State University in collaboration with local oncologists for supportive care. This trial uses single-stage phase 2 design with sample size calculations based on an expected overall response rate of ≥ 33% and <10% as unfavorable response, at one‐sided Type I error of 0.05, 90% power and up to 13% attrition rate. Results: The primary objective is overall response rate. Secondary objectives are overall survival, progression free survival, and duration of response. Exploratory objectives are analysis of correlation of circulating tumor DNA with response to treatment and development of resistance. Conclusions: FGFR kinase inhibitorshave the potential to be an effective targeted therapy in pancreas cancer. Additionally, telemedicine is a novel tool that can aid in the study of ultra-rare cancers and reduce barriers to patient participation in clinical trials.

Self-Measured Blood Pressure-Guided Pharmacotherapy: A Systematic Review and Meta-Analysis of United States-Based Telemedicine Trials.

The optimal approach to implementing telemedicine hypertension management in the United States is unknown. We examined telemedicine hypertension management versus the effect of usual clinic-based care on blood pressure (BP) and patient/clinician-related heterogeneity in a systematic review/meta-analysis. We searched United States-based randomized trials from Medline, Embase, CENTRAL, CINAHL, PsycINFO, Compendex, Web of Science Core Collection, Scopus, and 2 trial registries. We used trial-level differences in BP and its control rate at ≥6 months using random-effects models. We examined heterogeneity in univariable metaregression and in prespecified subgroups (clinicians leading pharmacotherapy [physician/nonphysician], self-management support [pharmacist/nurse], White versus non-White patient predominant trials [>50% patients/trial], diabetes predominant trials [≥25% patients/trial], and White patient predominant but not diabetes predominant trials versus both non-White and diabetes patient predominant trials]. Thirteen, 11, and 7 trials were eligible for systolic and diastolic BP difference and BP control, respectively. Differences in systolic and diastolic BP and BP control rate were -7.3 mm Hg (95% CI, -9.4 to -5.2), -2.7 mm Hg (-4.0 to -1.5), and 10.1% (0.4%-19.9%), respectively, favoring telemedicine. Greater BP reduction occurred in trials where nonphysicians led pharmacotherapy, pharmacists provided self-management support, White patient predominant trials, and White patient predominant but not diabetes predominant trials, with no difference by diabetes predominant trials. Telemedicine hypertension management is more effective than clinic-based care in the United States, particularly when nonphysicians lead pharmacotherapy and pharmacists provide self-management support. Non-White patient predominant trials achieved less BP reduction. Equity-conscious, locally informed adaptation of telemedicine interventions is needed before wider implementation.

Discussion to: Results of a postoperative telemedicine trial after cardiac surgery and incorporation into practice

Discussion to: Results of a postoperative telemedicine trial after cardiac surgery and incorporation into practice

Results of a postoperative telemedicine trial after cardiac surgery and incorporation into practice

ObjectiveThe study objective was to describe the implementation and results of a postoperative telemedicine program for adult cardiac surgery, including a clinical study and an organic postoperative telemedicine program aimed at reducing readmission rates and barriers to care. MethodsPatients undergoing coronary artery bypass grafting consented to enrollment in our Perfect Care study funded by The Duke Endowment including advanced practice provider–led postdischarge telemedicine services with data collection. There were 2 telemedicine visits at days 3 and 10 postdischarge using a live face-to-face video platform. Patients were provided with home wearables for heart rate monitoring, blood pressure cuffs, and scales. The success of the Perfect Care study led to the formation of our organic program, the Tele Heart Care, which was adapted to include a larger patient population while remaining structurally similar. ResultsFifty patients were enrolled prospectively between January and October 2021 in Perfect Care. The 30-day readmission rates for those enrolled was 4% compared with a 16% readmission rate for nonenrolled patients during this period. Furthermore, 36% of enrolled patients received medication modifications to optimize blood pressure, heart rate and rhythm, and fluid-volume status, or to treat infectious symptoms. Tele Heart Care enrolled 203 patients and was associated with a decrease in 30-day readmission rates in all cardiac surgery patients at our institution from 24% to 4% over a 6-month period. ConclusionsAn advanced practice provider–led postdischarge telemedicine program after cardiac surgery can reduce hospital readmission and barriers to care, and improve patient satisfaction. With involvement of multiple stakeholders, a successful program can be launched despite the present state of national health system finances with limited human capital and constrained access to monitoring equipment.

Digital Health Technologies for Post-Discharge Care after Heart Failure Hospitalisation to Relieve Symptoms and Improve Clinical Outcomes.

The prevention of recurrent heart failure (HF) hospitalisations is of particular importance, as each such successive event may increase the risk of death. Effective care planning during the vulnerable phase after discharge is crucial for symptom control and improving patient prognosis. Many clinical trials have focused on telemedicine interventions in HF, with varying effects on the primary endpoints. However, the evidence of the effectiveness of telemedicine solutions in cardiology is growing. The scope of this review is to present complementary telemedicine modalities that can support outpatient care of patients recently hospitalised due to worsening HF. Remote disease management models, such as video (tele) consultations, structured telephone support, and remote monitoring of vital signs, were presented as core components of telecare. Invasive and non-invasive monitoring of volume status was described as an important step forward to prevent congestion-the main cause of clinical decompensation. The idea of virtual wards, combining these facilities with in-person visits, strengthens the opportunity for education and enhancement to promote more intensive self-care. Electronic platforms provide coordination of tasks within multidisciplinary teams and structured data that can be effectively used to develop predictive algorithms based on advanced digital science, such as artificial intelligence. The rapid progress in informatics, telematics, and device technologies provides a wide range of possibilities for further development in this area. However, there are still existing gaps regarding the use of telemedicine solutions in HF patients, and future randomised telemedicine trials and real-life registries are still definitely needed.

Mindfulness-based therapy for insomnia alleviates insomnia, depression, and cognitive arousal in treatment-resistant insomnia: A single-arm telemedicine trial

ObjectivesCognitive-behavioral therapy and pharmacotherapy are effective insomnia treatments, yet half of patients do not remit. Emerging evidence indicates refractory cognitive arousal is associated with poor insomnia treatment outcomes, giving rise to the concept that therapeutic approaches directly aimed at reducing cognitive arousal may benefit patients with a history of inadequate response to intervention. This proof-of-concept study examined the effects of mindfulness-based therapy for insomnia (MBTI) delivered individually via telemedicine on insomnia, depression, and cognitive arousal in patients with treatment-resistant insomnia.MethodsA single-arm trial wherein 19 patients whose insomnia did not remit with prior psychotherapy and/or pharmacotherapy received a course of MBTI as second-stage therapy, which included eight weekly 1-h sessions in an individual format via telemedicine video. Study outcomes included the 15-item version of the five-facet mindfulness questionnaire (FFMQ-15), insomnia severity index (ISI), Patient Health Questionnaire-9 to assess depression (PHQ-9), and three cognitive arousal indices: pre-sleep arousal scale's cognitive factor, perseverative thinking questionnaire, and the daytime insomnia symptom response scale.ResultsPatients reported increased mindfulness from pretreatment to posttreatment (FFMQ-15: 52.95 ± 8.30 to 57.47 ± 9.82, p = 0.008). Patients also reported large reductions in ISI (16.42 ± 3.95 to 8.37 ± 4.19, p < 0.001, Cohen's dz = 1.73; 57.9% remission), PHQ-9 (6.42 ± 3.47 to 3.32 ± 2.93, p = 0.001, Cohen's dz = 0.93), and all cognitive arousal indices (Cohen's dzs = 0.82–1.30) at posttreatment. Six months later, ISI scores and cognitive arousal levels remained significantly lower than pretreatment, although effect sizes decreased for ISI (Cohen's dz = 1.11) and cognitive arousal (Cohen's dzs = 0.63–0.68). Antidepressant effects were no longer significant at follow-up.ConclusionTreatment-resistant insomnia patients are engaged in MBTI, which produces large acute reductions in insomnia, depression, and cognitive arousal. MBTI effects on insomnia and cognitive arousal were moderate to large 6 months after treatment. These findings support the concept and feasibility of MBTI for treatment-resistant patients along with indication that longer-term strategies are needed to help maintain acute treatment gains.Clinical trial registrationClinicalTrials.gov, identifier NCT03724305.

Videoconferencing in Pressure Injury: Randomized Controlled Telemedicine Trial in Patients With Spinal Cord Injury

BackgroundGeographical, financial and travel-related barriers may impact access to necessary health care for people in need of long-term follow-up.ObjectiveThe goal of the research was to perform a nonblinded, randomized, controlled trial on health-related quality of life (HRQoL), healing, interaction, and satisfaction of patients with spinal cord injury (SCI) and PI receiving multidisciplinary videoconference consultations from a wound clinic to the participant’s home versus regular outpatient care. The multidisciplinary team consisted of a medical doctor, a wound nurse, and an occupational therapist. In both groups, district nurses attended the consultations at the participant’s home.MethodsA total of 56 participants, 28 in each group, were randomized to a videoconference group (VCG) or a regular care group (RCG). Validated questionnaires were used to measure and compare the follow-up effect on HRQoL. Percentage reduction of wound volume was measured at end of the follow-up. A Likert scale was used to measure the satisfaction of the patients and district nurses regarding the interaction between different modalities of care in the 2 groups.ResultsThe HRQoL did not show significant differences between the 2 groups (P values ranging from .09 to .88) or the rate of PI healing, experienced interaction, and satisfaction in the groups. A total of 67% (37/55) of all PIs healed, 64% (18/28) in the VCG and 70% (19/27) in the RCG. Mean reduction in ulcer volume was 79% in the VCG and 85% in the RCG (P=.32). A Kaplan-Meier plot with a logrank test regarding time to healing did not show any significant difference between the 2 groups.ConclusionsVideoconference-based care seems to be a safe and efficient way to manage PIs in terms of HRQoL, healing, interaction, and satisfaction compared to conventional care for people with SCI. This should be considered when planning for future care. SCI has a huge impact on the individual, the family, and the health care system. There is an urgent need to improve systems of care so that individuals who live far from specialists and require long-term follow-up for conditions such as PI can get optimal treatment.Trial RegistrationClinicalTrials.gov NCT02800915; https://clinicaltrials.gov/ct2/show/NCT02800915 and Current Research Information System in Norway (CRISTIN) 545284; https://app.cristin.no/projects/show.jsf?id=545284

Accuracy of Simulated Research Tasks by Community Hospitals Participating in a Multicenter Telemedicine Trial.

Background/Aims: Clinical trials evaluating facility-to-facility telemedicine may include sites that have limited research experience. For the trial to be successful, these sites must correctly perform research-related tasks. This study aimed to determine whether health care professionals at community hospitals could accurately identify simulated study eligible patients and submit data to a research coordinating center. Methods: Twenty-seven community hospitals in the United States and Canada participated in this study. An electronic survey was sent to one designated health care professional at each site. The survey included a description of trial eligibility criteria and five written neonatal resuscitation scenarios. For each scenario, the participant determined whether the neonate was study eligible. One scenario required participants to submit 14 data elements to the coordinating center. Accuracy of study eligibility and data submission was summarized using standard descriptive statistics. Results: The survey response rate was 100% (27/27). Overall accuracy in determining study eligibility was 89% (120/135), and accuracy varied across the five scenarios (range 82-93%). Overall accuracy of data submission was 92% (310/336). Data were >95% accurate for 9 of the 14 data elements, with 100% accuracy achieved for 6 data elements. These results were used to clarify eligibility criteria, inform database design, and improve training materials for the subsequent clinical trial. Conclusions: Health care professionals at community hospitals accurately determined trial eligibility and submitted study data based on written clinical scenarios. Research teams conducting telemedicine trials with community hospitals should consider completing pre-trial simulation activities to identify opportunities for improving trial processes and materials.

Patient-centered HCV care via telemedicine for individuals on medication for opioid use disorder: Telemedicine for Evaluation, Adherence and Medication for Hepatitis C (TEAM-C)

BackgroundTelemedicine has the potential to increase healthcare access especially for vulnerable populations. Telemedicine for Evaluation, Adherence, and Medication for Hepatitis C (TEAM-C) is comparing telemedicine access to specialty medical care to usual care for management of hepatitis C virus (HCV) infection among persons with opioid use disorder (PWOUD). PWOUD have the highest hepatitis C virus (HCV) prevalence and incidence, yet they infrequently receive HCV care. The study objectives are to compare access to specialty care via telemedicine to offsite specialty referral (usual care) on 1) treatment initiation, completion, and sustained virological response, 2) patient satisfaction with health care delivery, and 3) HCV reinfection after successful HCV cure. MethodsTEAM-C is a multi-site, non-blinded, randomized pragmatic clinical trial conducted at 12 opioid treatment programs (OTP) throughout New York State that utilizes the stepped-wedge design. The unit of randomization is the OTP with a total sample size of 624 participants. HCV-infected PWOUD were treated via telemedicine or referral. Telemedicine encounters are conducted onsite in the OTP with co-administration of direct acting antivirals for HCV with medications for opioid use disorder. The primary outcome is undetectable HCV RNA obtained 12 weeks post-treatment cessation. We also follow participants for two years to assess for reinfection. ConclusionsThe study utilizes a rigorous study design to evaluate the effectiveness and implementation of virtual treatment for HCV integrated into behavioral treatment. We demonstrate the feasibility, engagement principles and lessons learned from the initial prospective randomized trial of telemedicine targeted to a vulnerable population.

Pilot trial of telemedicine in urology: Video vs. telephone consultations.

In the past year, due to the COVID-19 pandemic, in-person clinical activities have been drastically restricted, driving the already growing interest in the use of telemedicine in the urban setting to reduce unnecessary commute. Therefore, there has been a rapid shift to telephone and video consultations in outpatient practice. We sought to conduct a pilot trial to establish feasibility and acceptability of video consultations as an alternative to telephone consultations in urology patients to inform the design of a future randomized controlled trial. We conducted a single-center, prospective, non-randomized pilot trial comparing telephone consultations (TC) vs. video consultations (VC) for urology outpatient visits. Two patient questionnaires were used to collect demographic information, as well as data about acceptability, feasibility, satisfaction, cost, and issues with telemedicine. Questions were identical for both VC and TC except for certain questions inquiring about issues specific to each technology. Forty-eight TC and 66 VC urology patients were included in this study. Patients believed that telemedicine visits did not significantly hinder their ability to communicate with their urologists and that these visits would be associated with cost savings. There was 1/48 (2.1%) failed TC and 16/66 (24.2%) failed VC. VC failures were concentrated at the beginning of the trial prior to giving feedback to the VC platform creators, with only one failure occurring thereafter. When comparing TC to VC, differences between the two patient groups were small but tended to be in favor of VC. Patients' satisfaction was greater with VC compared to TC. Both modalities were associated with many cost benefits for patients. Despite more technical issues with VC, this modality is feasible and acceptable to patients, likely due to improved shared decision-making with VC. Future considerations for trials comparing VC and TC should include adequate Wi-Fi infrastructure and choice of platform. For the VC, continuous knowledge transfer between investigators and platform engineers plays an important role in limiting failed encounters.

A Blueprint for the Conduct of Large, Multisite Trials in Telemedicine.

Recent literature supports the efficacy and efficiency of telemedicine in improving various health outcomes despite the wide variability in results. Understanding site-specific issues in the implementation of telemedicine trials for broader replication and generalizability of results is needed. Lessons can be learned from existing trials, and a blueprint can guide researchers to conduct these challenging studies using telemedicine more efficiently and effectively. This viewpoint presents relevant challenges and solutions for conducting multisite telemedicine trials using 7 ongoing and completed studies funded by the Patient-Centered Outcomes Research Institute portfolio of large multisite trials to highlight the challenges in implementing telemedicine trials. Critical issues of ensuring leadership and buy-in, appropriate funding, and diverse and representative trials are identified and described, as well as challenges related to clinical, informatics, regulatory, legal, quality, and billing. The lessons learned from these studies were used to create a blueprint of key aspects to consider for the design and implementation of multisite telemedicine trials.

Telemedicine in addictions feasibility RCT – staff and patient qualitative satisfaction

AimsOpioid dependence has high risks. Opioid substitution treatment (OST) improves outcomes. Addiction specialist prescribers prescribe OST and monitor safety, but nonattendance may lead to worse outcomes. Telemedicine can reduce travel and improve attendance at appointments. Before COVID-19, we started a telemedicine in addictions trial to see if this helped in addictions. We present the qualitative patient and staff experience results.MethodHealth Research Authority approval for randomized controlled feasibility trial of Telemedicine versus Face-to-Face (control) consultations at community addictions semirural service (2500km2) using a modified Hub-and-Spoke (outreach) model. Adult opioid dependent patients prescribed OST and attending outreach were recruited. Participants received two appointments in randomized group. Telemedicine was delivered using Skype-for-business videoconferencing. Patients attended outreach, saw keyworker for drug testing first, and telemedicine conducted via keyworker's laptop. Addiction prescribers located remotely at Hub. Post-trial research interview conducted assessing patient and staff experience of Telemedicine versus Face-to-Face consultations. Data transcribed, inputted to RedCap Cloud and free-text analysed using qualitative thematic analysis.ResultOf fifty-nine patient participants, 58 completed a research interview. Patient participants reported similar levels of satisfaction between the Telemedicine and Face to Face groups. The themes generated in relation to Face-to-Face were no difference, easy, kind staff and liking being part of research. For Telemedicine, themes were less travel, good experience, easier to access, good communication, saves time and saves money. For instance, one patient stated ‘Clear, easy to access less travel’ and another patient stated ‘I struggle with travel. I found it easier’. Of 19 staff participant research interviews completed, Staff reported Good or Very Good experience with telemedicine which was equivalent for Face-to-Face consultations. Eleven staff had experience of telemedicine consultations during the trial. They reported similar themes to patients with telemedicine leading to less travel, beneficial to patient care, improves attendance and was innovative technology. One staff member reported satisfaction with telemedicine due to ‘Time, travel and money reduction’. When questioned on the downsides to telemedicine, technological issues were mainly related to connection issues and sound issues.ConclusionIn the first known RCT of Telemedicine versus Face-to-Face consultations for patients with opioid dependence attending prescriber review, we found that both patients and staff were satisfied with telemedicine as compared to face-to-face consultations. Overall themes were reduced travel, saving time and more convenience. This will be very important given the impact of COVID-19 on access to addictions services.Financial SponsorshipEast Riding CCGAcademic Health Science Network

Patient experience of telemedicine in addictions

AimsOpioid dependence has high risks and opioid substitution treatment (OST) improves outcomes and reduces deaths. Attendance at addiction specialist prescribers may be limited, particularly in rural areas. Telemedicine, such as videoconferencing, can reduce travel and improve access and attendance. Pre-COVID-19, we started a telemedicine service for patients with opioid dependence, prescribed opioid substitution treatment, requiring addiction specialist prescriber consultations. We present patient experience and assess whether patients recommend telemedicine.MethodHealth Research Authority approval for Randomized Controlled Trial of Telemedicine versus Face-to-Face (control) appointments in large semi-rural community addictions service (2500km2) using a modified Hub-and-Spoke (outreach). Adult opioid dependent patients prescribed OST and attending outreach clinics recruited. Participants received two consultations in group. Telemedicine delivered using Skype-for-business videoconferencing. Patients attended outreach clinic, where an outreach worker undertook drug testing and telemedicine conducted via the outreach workers laptop. Specialist addiction prescribers located remotely, at the Hub. Patients self-completed NHS Friends and Family Test (FFT) immediately after appointment, separate from the wider research study. Data collected Sept 2019– March 2020 (pre-COVID-19 lockdown), Microsoft Excel analysis, with qualitative thematic free-text analysis.ResultThirty completed FFTs were received, of which all participants were ‘extremely likely’ (n = 19;67%) or ‘likely’ (n = 11;37%) to recommend the Telemedicine service to friends or family, if they needed similar care. Two themes for reasons for recommending the service were; 1. Convenience (reduced travel, reduced travel time and reduced travel costs) and 2. Supportive Staff (including listening, caring and good support). One patient mentioned ‘it is a convenient way to communicate with medical staff, saving time and effort’. Regarding Telemedicine appointments, most participants responded that the timing of telemedicine appointments was good (n = 26;87%), given enough information (n = 30;100%), enough privacy (n = 28;93%), enough time to talk (n = 30;100%), involved as much as they wanted (n = 25;83%), given advice on keeping well (n = 28;93%), and NHS staff were friendly and helpful (n = 29;97%). No participants thought they were treated unfairly. When asked what went well, patient themes were: 1. Everything and 2. Communication (including listening and explaining). One patient stated ‘Everything better, telemedicing good, heard it well, everything improved this year’. In terms of what the service could do better, there were no issues identified.ConclusionThe Telemedicine in Addictions service was overwhelmingly highly recommended by patients. Patients recommended the service because of convenience and supportive staff. The use of telemedicine is acceptable to patients and could be considered more widely. Due to COVID-19, this technology may be beneficial access to addiction services.

Detection of new-onset atrial fibrillation in heart failure patients using daily non-invasive ECG monitoring in the TIM-HF2 telemedicine trial

Abstract Background Heart failure (HF) and atrial fibrillation (AF) impair the prognosis when they occur concomitantly. Recent telemedical studies suggest that HF patients with AF may derive a greater benefit from telemedicine care but the results are inconsistent. The rate of newly detected AF in HF patients by daily non-invasive electrocardiogram (ECG) monitoring is unknown and a possible influence on the outcome of remote patient management (RPM) remains unclear. Purpose We aimed to investigate the detection of new atrial fibrillation in patients assigned to RPM in comparison to patients assigned to usual care (UC) in the TIM-HF2 trial. Methods The prospective, multicentre and controlled TIM-HF2 trial randomised 1538 patients (765 RPM, 773 UC). All patients had a 12-channel ECG at baseline and after one year at the final study visit. Patients who were assigned to RPM additionally transmitted a daily ECG to the telemedical centre (TMC). We excluded all patients with pacemaker including implantable cardioverter defibrillator (ICD) or cardiac resynchronisation therapy (CRT) in the baseline ECG, leaving 879 patients for analysis (RPM: 442 and UC: 437). The patients were stratified into patients with SR and patients with AF according to the rhythm documented at baseline. The primary endpoint of this analysis was newly documented AF within one year after randomisation. We analysed the daily to the telemedical centre transmitted ECGs of patients assigned to RPM with the documented rhythm status of the ECGs performed at the final study visit of patients assigned to UC. Results 569 patients had SR and 310 patients had AF at baseline. The proportion of patients with AF was nearly the same in the RPM (159, 36.0%) and the UC (151, 34.6%) group. 68 patients (24.0%) were detected with new atrial fibrillation in the RPM group compared to 22 patients (7.8%) in the UC trial arm during the one-year follow-up (p<0.001, number needed to screen 6). Conclusion In patients with heart failure and daily ECG transmission, atrial fibrillation was detected three times more frequently in comparison to usual care within one year. Funding Acknowledgement Type of funding source: Public grant(s) – National budget only. Main funding source(s): The TIM-HF2 study was supported by a research grant of the German Federal Ministry of Education and Research (grant numbers 13KQ0904A, 13KQ0904B, 13KQ1104A). The TIM-HF2 study was a part of the research and development project “Gesundheitsregion der Zukunft Nordbrandenburg – Fontane” (Fontane). The Fontane system was developed in private–public partnership (PPP) supported by research and development grants from the German Federal Ministry of Education and Research, the European Regional Development, and the Federal State Brandenburg.

A Randomized Controlled Trial of Telemedicine for Long-Term Sleep Apnea Continuous Positive Airway Pressure Management.

Rationale: The effects of telemedicine on adherence in patients with obstructive sleep apnea with long-term continuous positive airway pressure (CPAP) use have never been investigated.Objectives: To examine effects of a telemedicine intervention on adherence in long-term CPAP users.Methods: In a prospective, randomized, multicenter noninferiority trial conducted in 17 sleep centers across Japan, patients who had used CPAP for >3 months and were receiving face-to-face follow-up by physicians every 1 or 2 months were randomized by a coordinating center in a blind manner to the following three groups: 1) follow-up every 3 months accompanied by a monthly telemedicine intervention (telemedicine group: TM-group), 2) follow-up every 3 months (3-month group: 3M-group), or 3) monthly follow-up (1-month group: 1M-group). Each group was followed up for 6 months. The change in percentage of days with ≥4 h/night of CPAP use from baseline to the end of the study period was evaluated. A decline of ≥5% from baseline was considered deterioration of adherence. Noninferiority of TM- and 3M-groups compared with the 1M-group according to the number of patients with deterioration of adherence was evaluated with the Farrington and Manning test (noninferiority margin 15%).Results: A total of 483 patients were analyzed (median duration of CPAP use, 29 [interquartile range, 12-71] mo), and deterioration of adherence was found in 41 of 161 (25.5%), 55 of 166 (33.1%), and 35 of 156 (22.4%) patients in the TM-, 3M-, and 1M-groups, respectively. The noninferiority of the TM-group compared with the 1M-group was verified (difference in percentage of patients with adherence deterioration, 3.0%; 95% confidence interval [CI], -4.8% to 10.9%; P < 0.01). Conversely, the 3M-group did not show noninferiority to the 1M-group (percentage difference, 10.7%; 95% CI, 2.6% to 18.8%; P = 0.19). In the stratified analysis, adherence in TM- and 1M-group patients with poor adherence at baseline improved (TM: 45.8% ± 18.2% to 57.3% ± 24.4%; P < 0.01; 1M: 43.1% ± 18.5% to 53.6% ± 24.3%; P < 0.01), whereas that of the 3M-group did not (39.3% ± 20.8% to 39.8% ± 24.8%; P = 0.84).Conclusions: Intensive telemedicine support could help to optimize CPAP adherence even after long-term CPAP use.Clinical trial registered with www.umin.ac.jp/ctr/index.htm (trial number: UMIN000023118).

Research Implications for future telemedicine studies and innovations

Abstract Despite the increasing application of information and communication technologies (ICT) in health care, robust data on the effectiveness and implementation of digital health solutions is lacking. Therefore, the objective of this analysis is to identify and categorise implications for future research in order to inform policy and practice decisions. Systematic reviews and meta-analyses of RCTs evaluating the effectiveness of telemedicine in chronic diseases, all identified via a recent umbrella review, were used as primary sources of information. Qualitative content analysis following Mayring (2000) was used to categorize future research topics mentioned in the discussion sections and conclusions of included research published after 2015. Parallel, independent data extraction and coding using inductive category development was performed by two researchers with previous coding experience. Any disagreements were solved by discussion. Of the 25 included systematic reviews and meta analyses, 23 reported on future research implications. They were categorised as follows: (1) Need for high quality studies including specific outcome measures; (2) Need for comprehensive technology assessment; (3) Need for in-depth considerations of patients’ characteristics &amp; more diverse study populations; (4) Ethics &amp; Safety; and (5) Translation &amp; implementation strategies. A codebook comprising descriptions and examples of those categories and sub-categories was developed. Results show a need for larger and more rigorous studies with longer intervention durations, mid- to long-term follow-ups as well as more heterogeneous study populations. More pragmatic study designs to evaluate multimodal and tailored interventions like telemedicine solutions are needed to develop an improved understanding on mechanisms and target-group specific effectiveness. Key messages We need a stronger focus on relevant and well-designed studies to improve the impact of telemedicine trials. Identified needs have the potential to inform future guidelines for the use of telemedicine.

A randomized trial of telemedicine for migraine management

To determine whether synchronous video-based telemedicine visits with specialists are feasible and to evaluate clinical effectiveness, patient perceptions, and other benefits of telemedicine visits for follow-up migraine care in a tertiary headache center. A one-year, randomized clinical trial. Fifty patients were screened and 45 entered the study (43 women, two men). Out of 96 scheduled visits, 89 were successfully conducted using telemedicine. Eighteen patients (out of 22) in the telemedicine cohort and 12 patients (out of 23) in the in-office cohort completed the study. In this small study, clinical outcomes, namely improvement in MIDAS, number of headache days, and average severity at 12 months for participants in the telemedicine group, were not different from those in the in-office group. Convenience was rated higher and visit times were shorter in the telemedicine group. In this cohort of patients with severe migraine-related disability, telemedicine was a feasible mode of treatment and an effective alternative to in-office visits for follow-up migraine care. Physician productivity could be higher with telemedicine, and patients may get better access because of its convenience. This study is listed on ClinicalTrials.gov (NCT01706003).

Identifying pathways to quitting smoking via telemedicine-delivered care.

A randomized controlled trial of quitline-like phone counseling (QL) versus telemedicine integrated into primary care (ITM) compared the effectiveness of these modalities for smoking cessation. Study design and components were based on self-determination theory (SDT). The purpose of this study was to test our SDT-based model in which perceived health care provider autonomy support, working alliance, autonomous motivation, and perceived competence were hypothesized to mediate the effects of ITM on smoking cessation. Rural smokers (n = 560) were randomized to receive 4 sessions over a 3-month period of either QL or ITM. Follow-up assessments were conducted at Months 3, 6, and 12. The primary outcome was biochemically verified 7-day point prevalence at 12 -months. Structural equation modeling with latent change scores was used for the analysis. Participants in the ITM condition reported greater increases in perceived health care provider autonomy support (PAS) at end of treatment, which in turn was associated with enhanced perceived competence to quit smoking (PC). Increased PC was associated with a higher likelihood of cessation at 12-months. Mediation analysis demonstrated significant indirect effects, including a path from ITM to increases in PAS to increases in PC to cessation at 12-months (indirect effect = 0.0183, 95% confidence interval [.003, .0434]). When integrated into primary care, ITM may influence smoking cessation by enhancing the extent to which smokers feel supported by their providers and thereby increase their perceived ability to quit. Findings suggest that locating tobacco treatment services in health care provider offices imparts a motivational benefit for cessation. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

A Randomized Controlled Trial of TELEmedicine for Patients with Inflammatory Bowel Disease (TELE-IBD).

Telemedicine has shown promise in inflammatory bowel disease (IBD). The objective of this study was to compare disease activity and quality of life (QoL) in a 1-year randomized trial of IBD patients receiving telemedicine vs. standard care. Patients with worsening symptoms in the prior 2 years were eligible for randomization to telemedicine (monitoring via texts EOW or weekly) or standard care. The primary outcomes were the differences in change in disease activity and QoL between the groups; change in healthcare utilization among groups was a secondary aim. 348 participants were enrolled (117 control group, 115 TELE-IBD EOW, and 116 TELE-IBD weekly). 259 (74.4%) completed the study. Age was 38.9 ± 12.3 years, 56.6% were women, 91.9% were Caucasian, 67.9% had Crohn's disease (CD) and 42.5% had active disease at baseline. In CD, all groups experienced a decrease in disease activity (control -5.2 ± 5.0 to 3.7 ± 3.6, TELE-IBD EOW 4.7 ± 4.1 to 4.2 ± 3.9, and TELE-IBD weekly 4.2 ± 4.2 to 3.2 ± 3.4, p < 0.0001 for each of the groups) In UC, only controls had a significant decrease in disease activity (control 2.9 ± 3.1 to 1.4 ± 1.4, p = 0.01, TELE-IBD EOW 2.7 ± 3.1 to 1.7 ± 1.9, p = 0.35, and TELE-IBD Weekly 2.5 ± 2.5 to 2.0 ± 1.8, p = 0.31). QoL increased in all groups; the increase was significant only in TELE-IBD EOW (control 168.1 ± 34.0 to 179.3 ± 28.2, p = 0.06, TELE-IBD EOW 172.3 ± 33.1 to 181.5 ± 28.2, p = 0.03, and TELE-IBD Weekly 172.3 ± 34.5 to 179.2 ± 32.8, p = 0.10). Unadjusted and adjusted changes in disease activity and QoL were not significantly different among groups. Healthcare utilization increased in all groups. TELE-IBD weekly were less likely to have IBD-related hospitalizations and more likely to have non-invasive diagnostic tests and electronic encounters compared to controls; both TELE-IBD groups had decreased non-IBD related hospitalizations and increased telephone calls compared to controls. Disease activity and QoL, although improved in all participants, were not improved further through use of the TELE-IBD system. TELE-IBD participants experienced a decrease in hospitalizations with an associated increase in non-invasive diagnostic tests, telephone calls and electronic encounters. Research is needed to determine if TELE-IBD can be improved through patient engagement and whether it can decrease healthcare utilization by replacing standard care.