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Most patients diagnosed with and dying from cancer in Canada are older adults, with aging contributing to the large projected growth in cancer incidence. Older adults with cancer have unique needs, and on a global scale increasing efforts have been made to address recognized gaps in their cancer care. However, in Canada, geriatric oncology remains a new and developing field. There is increasing recognition of the value of geriatric oncology and there is a growing number of healthcare providers interested in developing the field. While there is an increasing number of dedicated programs in geriatric oncology, they remain limited overall. Developing novel methods to delivery geriatric care in the oncology setting and improving visibility is important. Formal incorporation of a geriatric oncology curriculum into training is critical to both improve knowledge and demonstrate its value to healthcare providers. Although a robust group of dedicated researchers exist, increased collaboration is needed to capitalize on existing expertise. Dedicated funding is critical to promoting clinical programs, research, and training new clinicians and leaders in the field. By addressing challenges and capitalizing on opportunities for improvement, Canada can better meet the unique needs of its aging population with cancer and ultimately improve their outcomes.
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Neoplasias , Humanos , Canadá , Neoplasias/terapia , Idoso , Oncologia/métodos , Geriatria/métodos , Idoso de 80 Anos ou mais , Melhoria de QualidadeRESUMO
INTRODUCTION: Geriatric assessment and management (GAM) is recommended by professional organizations and recently several randomized controlled trials (RCTs) demonstrated benefits in multiple health outcomes. GAM typically leads to one or more recommendations for the older adult on how to optimize their health. However, little is known about how well recommendations are adhered to. Understanding these issues is vital to designing GAM trials and clinical programs. Therefore, the aim of this study was to examine the number of GAM recommendations made and adherence to and satisfaction with the intervention in a multicentre RCT of GAM for older adults with cancer. MATERIALS AND METHODS: The 5C study was a two-group parallel RCT conducted in eight hospitals across Canada. Each centre kept a detailed recruitment and retention log. The intervention teams documented adherence to their recommendations. Medical records were also reviewed to assess which recommendations were adhered to. Twenty-three semi-structured interviews were conducted with 12 members of the intervention teams and 11 oncology team members to assess implementation of the study and the intervention. RESULTS: Of the 350 participants who were enrolled, 173 were randomized to the intervention arm. Median number of recommendations was seven. Mean adherence to recommendations based on the GAM was 69%, but it varied by type of recommendation, ranging from 98% for laboratory tests to 28% for psychosocial/psychiatry oncology referrals. There was no difference in the number of recommendations or non-adherence to recommendations by sex, level of frailty, or functional status. Oncologists and intervention team members were satisfied with the study implementation and intervention delivery. DISCUSSION: Adherence to recommendations was variable. Adherence to laboratory investigations and further imaging were generally high but much lower for recommendations regarding psychosocial support. Further collaborative work with older adults with cancer is needed to understand how to optimize the intervention to be consistent with patient goals, priorities, and values to ensure maximal impact on health outcomes.
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Fragilidade , Neoplasias , Humanos , Idoso , Avaliação Geriátrica , Canadá , Neoplasias/terapia , Satisfação Pessoal , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
PURPOSE: American Society of Clinical Oncology recommends that older adults with cancer being considered for chemotherapy receive geriatric assessment (GA) and management (GAM), but few randomized controlled trials have examined its impact on quality of life (QOL). PATIENTS AND METHODS: The 5C study was a two-group parallel 1:1 single-blind multicenter randomized controlled trial of GAM for 6 months versus usual oncologic care. Eligible patients were age 70+ years, diagnosed with a solid tumor, lymphoma, or myeloma, referred for first-/second-line chemotherapy or immunotherapy or targeted therapy, and had an Eastern Cooperative Oncology Group performance status of 0-2. The primary outcome QOL was measured with the global health scale of the European Organisation for the Research and Treatment of Cancer QOL questionnaire and analyzed with a pattern mixture model using an intent-to-treat approach (at 6 and 12 months). Secondary outcomes included functional status, grade 3-5 treatment toxicity; health care use; satisfaction; cancer treatment plan modification; and overall survival. RESULTS: From March 2018 to March 2020, 350 participants were enrolled. Mean age was 76 years and 40.3% were female. Fifty-four percent started treatment with palliative intent. Eighty-one (23.1%) patients died. GAM did not improve QOL (global QOL of 4.4 points [95% CI, 0.9 to 8.0] favoring the control arm). There was also no difference in survival, change in treatment plan, unplanned hospitalization/emergency department visits, and treatment toxicity between groups. CONCLUSION: GAM did not improve QOL. Most intervention group participants received GA on or after treatment initiation per patient request. Considering recent completed trials, GA may have benefit if completed before treatment selection. The COVID-19 pandemic may have affected our QOL outcome and intervention delivery for some participants.
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COVID-19 , Neoplasias , Humanos , Feminino , Idoso , Masculino , Qualidade de Vida , Avaliação Geriátrica , Método Simples-Cego , Pandemias , Neoplasias/tratamento farmacológico , Hospitalização , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
INTRODUCTION: Geriatric assessment (GA) provides information on key health domains of older adults and is recommended to help inform cancer treatment decisions and cancer care. However, GA is not feasible in many health institutions due to lack of geriatric staff and/or resources. To increase accessibility to GA and improve treatment decision making for older adults with cancer (≥65 years), we developed a self-reported, electronic geriatric assessment tool: Comprehensive Assessment for My Plan (CHAMP). MATERIALS AND METHODS: Older adults with cancer were invited to join user-centered design sessions to develop the layout and content of the tool. Subsequently, they participated in usability testing to test the usability of the tool (ease of use, acceptability, etc.). Design sessions were also conducted with oncology clinicians (oncologists and nurses) to develop the tool's clinician interface. GA assessment questions and GA recommendations were guided by a systematic review and Delphi expert panel. RESULTS: A total of seventeen older adults participated in the study. Participants were mainly males (82.4%) and 75% were aged 75 years and older. Nine oncology clinicians participated in design sessions. Older adults and clinicians agreed that the tool was user-friendly. Domains in the final CHAMP tool (with questions and recommendations) included functional status, falls risk, cognitive impairment, nutrition, medication review, social supports, depression, substance use disorder, and miscellaneous items. DISCUSSION: CHAMP was designed for use by older adults and oncologists and may enhance access to GA for older adults with cancer. The next phase of the CHAMP study will involve field validation in oncology clinics.
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Avaliação Geriátrica , Neoplasias , Idoso , Masculino , Humanos , Feminino , Neoplasias/terapia , Oncologia , AutorrelatoRESUMO
PURPOSE: Vulnerable Elder Survey (VES-13) is a screening tool used in assessing older vulnerable patients at risk of functional decline. We sought to evaluate how VES-13 tool would impact oncologist referral pattern to geriatricians as our primary outcome. We also sought to better understand how VES-13 scores impacted referral to additional services (allied healthcare), and modification to oncological treatment. METHODS: A retrospective review of VES-13 questionnaires completed by older women (age 70 or older) with breast cancer referred to the Senior Women's Breast Cancer Clinic (SWBCC) was undertaken. Patients with a VES-13 score of three or greater, who were at significantly higher risk of functional decline, had further retrospective chart review for risk factors that would contribute to functional decline such as Eastern Cooperative Oncology Group (ECOG) score, social supports, and current living situation. The primary and secondary endpoints described above were analyzed through bivariate comparisons and multivariable logistical regression to determine if there was any statistical significance (p < 0.05). RESULTS: 701 patients completed VES-13 form, of which 235 (33.5%) had a VES-13 score of three or greater. Less than 5% of oncologists documented VES-13 scores in their notes, with less than 5% of patients being referred for geriatric services. Neither VES-13 (p= 0.900) nor ECOG (p= 0.424) were associated with referral for geriatrics assessment. Referral to allied healthcare services was significantly associated with (ECOG) score (OR 2.24 [1.49-3.37], p < 0.0001), while not significantly associated with VES-13 score (OR 0.89 [0.78-1.02], p= 0.102). VES-13 (OR 1.23 [1.04-1.45], p=0.014) and ECOG (OR 2.37 [1.29-4.37), p=0.005) were both associated with modification in oncology treatment (chemotherapy or radiation). CONCLUSION: Approximately one third of our population was at risk of functional decline. VES-13 scores were infrequently mentioned in oncologists notes from their clinical assessments, with very few patients being referred for geriatric assessment. By not collecting and analyzing VES-13 scores, and relying on performance status alone, there is a missed opportunity in assessing for functional decline and reducing potential complications from treatment for our patients.
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Neoplasias da Mama , Idoso , Neoplasias da Mama/terapia , Feminino , Avaliação Geriátrica , Humanos , Ontário , Estudos Retrospectivos , Inquéritos e QuestionáriosAssuntos
Neoplasias da Mama , Médicos , Neoplasias da Mama/terapia , Comunicação , Feminino , Humanos , Ontário/epidemiologia , PesquisadoresRESUMO
Background Whole breast irradiation therapy (WBRT), accelerated partial breast irradiation (APBI), and omission of radiotherapy (ORT) are options for women aged 65 years and older with low-risk breast cancer post lumpectomy. Aim The aim of the study was to develop and pilot a decision aid pamphlet (DA), among women aged 65 years and older with low-risk breast cancer and who were undergoing or had undergone WBRT, to ensure they were fully informed about the different options for radiation treatment following lumpectomy. Methods We piloted the decision aid with 40 participants, women aged 65-86 years with low-risk breast cancer and who had undergone or were undergoing WBRT. The women completed a pre-DA Decisional Conflict Scale (DCS) and post-DA DCS, Knowledge, Preparation for Decision-Making and Acceptability questionnaires. We then used descriptive statistics to compare the DCS scores before and after distributing the decision aid. Results The median age of the 40 participants was 72 years (range, 65-86 years), 38% less than 70, 48% between 70 and 80 and 15% over 80. Ethnicity included 53% Caucasians and the remaining 48% African-Americans, Asians, Europeans, and others. Thirty-three percent completed high school, 25% college/university, and 7.5% elementary education. Seventy-eight percent had T1 and 23% T2 breast cancer. Thirty-three percent completed RT less than one year prior to the study, 30% between one to two years, and 38% greater than two years. The median pre-DA DCS score was 31.2 (31.2-90.6), and the median post-DA DCS score was 23.4 (0-75.0). Six (6/40) patients scored 0 on the DCS post intervention, while 13 (13/40) scored less than 15.6. The median knowledge score was 70%. Preparation for decision-making median score was 90%. Ninety-nine percent stated that the DA was useful for future patients. Conclusion We piloted a DA that aimed to provide the necessary information for women aged 65 years and older with low-risk breast cancer, to understand radiation treatment options post lumpectomy. The results obtained from the study highlighted the utility of the DA in increasing patient comprehension about the different treatment options, reducing decisional conflict in terms of perceptions of uncertainty and preparing patients to engage with their radiation oncologist during the treatment decision-making process. Ultimately, this study promoted the importance of patient-centered care in geriatric oncology by piloting this DA to see its effectiveness while also being responsive to patient's thoughts regarding the tool, so as to have their values guide its further development.
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BACKGROUND/OBJECTIVES: Patients aged 70 years and older may be suboptimally treated with cancer therapy because of the lack of clinical trial data in this population. The Comprehensive Geriatric Assessment can be time consuming, and access to geriatricians is limited. This study aims to determine whether gait speed (GS) analysis is equivalent to the widely accepted Vulnerable Elders Survey 13 (VES-13) in identifying vulnerable or frail patients in need of a Comprehensive Geriatric Assessment. METHODS: A pilot prospective cohort study was carried out at a tertiary cancer centre in Toronto, Canada, in a radiation oncology breast follow-up clinic. GS analysis and VES-13 were completed by each patient at the same clinic visit. GS of <1 meter/second (m/s) and VES-13 score ≥3 were considered abnormal. Sensitivity, specificity, positive and negative predictive values, and Kappa characteristic were calculated for GS compared with VES-13. RESULTS AND DISCUSSION: Twenty-nine participants aged 70 years and older with any stage of breast cancer were included. The GS was 67% sensitive and 95% specific for abnormal VES-13 scores. The GS had an 86% positive predictive value and 86% negative predictive value for abnormal scores on VES-13. Overall, the GS showed a substantial strength of agreement with the VES-13 (kappa 0.66, P < .0001). CONCLUSION: The GS analysis compared very well with VES-13 scores, and this may be a reasonable alternative to VES-13 screening. This pilot data warrant further study in a larger group of patients.
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Atividades Cotidianas , Neoplasias da Mama/diagnóstico , Detecção Precoce de Câncer/métodos , Idoso Fragilizado/estatística & dados numéricos , Marcha/fisiologia , Avaliação Geriátrica/métodos , Velocidade de Caminhada/fisiologia , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/fisiopatologia , Feminino , Humanos , Projetos Piloto , Estudos Prospectivos , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: Geriatric assessment and management is recommended for older adults with cancer referred for chemotherapy but no randomised controlled trial has been completed of this intervention in the oncology setting. TRIAL DESIGN: A two-group parallel single blind multi-centre randomised trial with a companion trial-based economic evaluation from both payer and societal perspectives with process evaluation. PARTICIPANTS: A total of 350 participants aged 70+, diagnosed with a solid tumour, lymphoma or myeloma, referred for first/second line chemotherapy, who speak English/French, have an Eastern Collaborative Oncology Group Performance Status 0-2 will be recruited. All participants will be followed for 12 months. INTERVENTION: Geriatric assessment and management for 6 months. The control group will receive usual oncologic care. All participants will receive a monthly healthy ageing booklet for 6 months. OBJECTIVE: To study the clinical and cost-effectiveness of geriatric assessment and management in optimising outcomes compared with usual oncology care. RANDOMISATION: Participants will be allocated to one of the two arms in a 1:1 ratio. The randomisation will be stratified by centre and treatment intent (palliative vs other). OUTCOME: Quality of life. SECONDARY OUTCOMES: (1) Cost-effectiveness, (2) functional status, (3) number of geriatric issues successfully addressed, (4) grades3-5 treatment toxicity, (5) healthcare use, (6) satisfaction, (7) cancer treatment plan modification and (8) overall survival. PLANNED ANALYSIS: For the primary outcome we will use a pattern mixture model using an intent-to-treat approach (at 3, 6 and12 months). We will conduct a cost-utility analysis alongside this clinical trial. For secondary outcomes 2-4, we will use a variety of methods. ETHICS AND DISSEMINATION: Our study has been approved by all required REBs. We will disseminate our findings to stakeholders locally, nationally and internationally and by publishing the findings. TRIAL REGISTRATION NUMBER: NCT03154671.
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Avaliação Geriátrica , Neoplasias/terapia , Idoso , Antineoplásicos/efeitos adversos , Antineoplásicos/uso terapêutico , Canadá , Análise Custo-Benefício , Avaliação Geriátrica/métodos , Humanos , Neoplasias/tratamento farmacológico , Neoplasias/economia , Método Simples-Cego , Resultado do TratamentoRESUMO
Currently, there is no formal curriculum addressing geriatric oncology within Canadian radiation oncology (RO) residency programs. Knowledge related to geriatric medicine may help radiation oncologists modify RT based on frailty status and geriatric considerations. Understanding specific learning needs allow program coordinators to align the current curriculum with residents' geriatric oncology learning needs. The purpose of this study is to determine the geriatric oncology educational needs of the Canadian RO residents and to inform Canadian RO residency training. A cross-sectional survey, with Likert, multiple choice, and open-ended questions, was pretested and distributed electronically by program directors to Canadian RO residents over 6 weeks. Responses were analyzed with descriptive statistics and common themes. One-hundred and thirty-five Canadian RO residents were contacted and 63 responded (47%). Half (49%) lacked confidence managing the elderly with multiple comorbidities, polypharmacy, functional and cognitive impairment, and challenging social circumstances;73% agreed additional training would be helpful. Forty-four percent lacked confidence regarding psychogeriatric referrals, fall prevention, palliative and hospice care, and community resources preventing re-hospitalization; 63% agreed additional training would be helpful. Seventy-six percent believed discussion groups, continuing education, geriatric oncology electives, and journal clubs would provide learning opportunities. Seventy-one percent agreed integrating geriatric assessment into RO curricula would improve care. Seventy-nine percent believed geriatric oncology principles have not been adequately integrated into radiation oncology curricula. There are significant gaps specific to geriatric assessment and management of older cancer patients in the current Canadian RO curricula. Most residents agreed that it is important to integrate geriatric oncology training to improve and personalize the care of older cancer patients.
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Currículo/normas , Geriatria/educação , Internato e Residência/organização & administração , Avaliação das Necessidades/estatística & dados numéricos , Neoplasias/radioterapia , Radioterapia (Especialidade)/educação , Inquéritos e Questionários , Idoso , Canadá , Competência Clínica , Estudos Transversais , Avaliação Geriátrica , Geriatria/estatística & dados numéricos , Conhecimentos, Atitudes e Prática em Saúde , HumanosRESUMO
This study explored older women's perceptions and expectations of the prospective Senior Women's Breast Cancer Clinic (SWBCC) at Sunnybrook Odette Cancer Centre (SOCC) in Toronto, Ontario, Canada. In our previous studies, older breast cancer patients had expressed a greater need for informational, decisional, and post-treatment support. This study also assessed women's perspectives on the involvement of geriatricians and incorporation of geriatric assessment in their cancer care. Twelve breast cancer patients aged 68 years or older who were treated at the SOCC participated in the study. We recorded and transcribed 11 interviews and analyzed them using qualitative thematic analysis methods to identify major themes; one interview was excluded due to recording defect. Eight major themes were identified: transportation issues, service, communication between patient and healthcare professionals, communication between healthcare professionals, support during treatment, support after treatment, informational resources, and patient suggestions. Important issues were raised by participants, such as difficulties in arranging transportation to the clinic, barriers in accessing family physician service, and communication breakdown that result in treatment delay and unaddressed complications. In conclusion, there were important gaps in the cancer care of older women with breast cancer that could be detected earlier and better addressed in the new multidisciplinary SWBCC. The participating women were highly supportive of the initiative and made several suggestions on how the clinic could better accommodate their specific needs during and after breast cancer treatment.
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Instituições de Assistência Ambulatorial , Neoplasias da Mama/psicologia , Avaliação Geriátrica , Avaliação das Necessidades , Percepção , Idoso , Comunicação , Feminino , Humanos , Ontário , Estudos Prospectivos , Pesquisa QualitativaRESUMO
BACKGROUND: Retrospective record review using trigger tools remains the most widely used method for measuring adverse events (AEs) to identify targets for improvement and measure temporal trends. However, medical records often contain limited information about factors contributing to AEs. We implemented an augmented trigger tool that supplemented record review with debriefing front-line staff to obtain details not included in the medical record. We hypothesised that this would foster the identification of factors contributing to AEs that could inform improvement initiatives. METHOD: A trained observer prospectively identified events in consecutive patients admitted to a general medical ward in a tertiary care academic medical centre (November 2010 to February 2011 inclusive), gathering information from record review and debriefing front-line staff in near real time. An interprofessional team reviewed events to identify preventable and potential AEs and characterised contributing factors using a previously published taxonomy. RESULTS: Among 141 patients, 14 (10%; 95% CI 5% to 15%) experienced at least one preventable AE; 32 patients (23%; 95% CI 16% to 30%) experienced at least one potential AE. The most common contributing factors included policy and procedural problems (eg, routine protocol violations, conflicting policies; 37%), communication and teamwork problems (34%), and medication process problems (23%). However, these broad categories each included distinct subcategories that seemed to require different interventions. For instance, the 32 identified communication and teamwork problems comprised 7 distinct subcategories (eg, ineffective intraprofessional handovers, poor interprofessional communication, lacking a shared patient care, paging problems). Thus, even the major categories of contributing factors consisted of subcategories that individually related to a much smaller subset of AEs. CONCLUSIONS: Prospective application of an augmented trigger tool identified a wide range of factors contributing to AEs. However, the majority of contributing factors accounted for a small number of AEs, and more general categories were too heterogeneous to inform specific interventions. Successfully using trigger tools to stimulate quality improvement activities may require development of a framework that better classifies events that share contributing factors amenable to the same intervention.
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Near Miss/estatística & dados numéricos , Segurança do Paciente , Melhoria de Qualidade , Gestão da Segurança/métodos , Centros Médicos Acadêmicos , Idoso , Idoso de 80 Anos ou mais , Feminino , Hospitais , Humanos , Masculino , Prontuários Médicos , Pessoa de Meia-Idade , Ontário , Quartos de Pacientes , Estudos ProspectivosRESUMO
The treatment of breast cancer presents specifc concerns that are unique to the needs of older female patients. While treatment of early breast cancer does not vary greatly with age, the optimal management of older women with breast cancer often requires complex interdisciplinary supportive care due to multiple comorbidities. This article reviews optimal approaches to breast cancer in women 65 years and older from an interdisciplinary perspective. A literature review was conducted using MEDLINE and EMBASE, choosing articles concentrated on the management of older breast cancer patients from the point of view of several disciplines, including geriatrics, radiation oncology, medical oncology, surgical oncology, psychooncology, palliative care, nursing, and social work. This patient population requires interprofessional collaboration from the time of diagnosis, throughout treatment and into the recovery period. Thus, we recommend an interdisciplinary program dedicated to the treat ment of older women with breast cancer to optimize their cancer care.
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Antineoplásicos/uso terapêutico , Neoplasias da Mama/terapia , Enfermagem Geriátrica/métodos , Oncologia/métodos , Enfermagem Oncológica/métodos , Equipe de Assistência ao Paciente/organização & administração , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Neoplasias da Mama/epidemiologia , Comportamento Cooperativo , Feminino , Humanos , Comunicação InterdisciplinarRESUMO
IMPORTANCE: Hospital readmissions are common and costly, and no single intervention or bundle of interventions has reliably reduced readmissions. Virtual wards, which use elements of hospital care in the community, have the potential to reduce readmissions, but have not yet been rigorously evaluated. OBJECTIVE: To determine whether a virtual ward-a model of care that uses some of the systems of a hospital ward to provide interprofessional care for community-dwelling patients-can reduce the risk of readmission in patients at high risk of readmission or death when being discharged from hospital. DESIGN, SETTING, AND PATIENTS: High-risk adult hospital discharge patients in Toronto were randomly assigned to either the virtual ward or usual care. A total of 1923 patients were randomized during the course of the study: 960 to the usual care group and 963 to the virtual ward group. The first patient was enrolled on June 29, 2010, and follow-up was completed on June 2, 2014. INTERVENTIONS: Patients assigned to the virtual ward received care coordination plus direct care provision (via a combination of telephone, home visits, or clinic visits) from an interprofessional team for several weeks after hospital discharge. The interprofessional team met daily at a central site to design and implement individualized management plans. Patients assigned to usual care typically received a typed, structured discharge summary, prescription for new medications if indicated, counseling from the resident physician, arrangements for home care as needed, and recommendations, appointments, or both for follow-up care with physicians as indicated. MAIN OUTCOMES AND MEASURES: The primary outcome was a composite of hospital readmission or death within 30 days of discharge. Secondary outcomes included nursing home admission and emergency department visits, each of the components of the primary outcome at 30 days, as well as each of the outcomes (including the composite primary outcome) at 90 days, 6 months, and 1 year. RESULTS: There were no statistically significant between-group differences in the primary or secondary outcomes at 30 or 90 days, 6 months, or 1 year. The primary outcome occurred in 203 of 959 (21.2%) of the virtual ward patients and 235 of 956 (24.6%) of the usual care patients (absolute difference, 3.4%; 95% CI, -0.3% to 7.2%; P = .09). There were no statistically significant interactions to indicate that the virtual ward model of care was more or less effective in any of the prespecified subgroups. CONCLUSIONS AND RELEVANCE: In a diverse group of high-risk patients being discharged from the hospital, we found no statistically significant effect of a virtual ward model of care on readmissions or death at either 30 days or 90 days, 6 months, or 1 year after hospital discharge. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01108172.
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Assistência Ambulatorial/métodos , Serviços de Saúde Comunitária , Continuidade da Assistência ao Paciente , Readmissão do Paciente/estatística & dados numéricos , Adulto , Idoso , Feminino , Visita Domiciliar , Humanos , Análise de Intenção de Tratamento , Masculino , Pessoa de Meia-Idade , Mortalidade , TelemedicinaRESUMO
BACKGROUND: For patients with critical laboratory abnormalities, timely clinical alerts with decision support could improve management and reduce adverse events. METHODS: The authors developed a real-time clinical alerting system for critical laboratory abnormalities. The system sent alerts to physicians as text messages to a smartphone or alphanumeric pager. Decision support was available via smartphone or hospital intranet. The authors evaluated the system in a prospective controlled stepped-wedge study with blinded outcome assessment in general internal medicine units at two academic hospitals. The outcomes were the proportion of potential clinical actions that were actually completed in response to the alert, and adverse events (worsening of condition or complications related to treatment of the condition). RESULTS: The authors evaluated 498 laboratory conditions on 271 patients. Overall, only 50% of potential clinical actions were carried out, and there were adverse clinical events within 48 h for 36% of the laboratory conditions. The median (IQR) proportion of potential clinical actions that were actually completed was 50% (33-75%) with alerting system on and 50% (33-100%) with alerting system off (p=0.94, Wilcoxon rank sum test). When the alerting system was on (n=164 alerts) there were 67 adverse events within 48 h of the alerts (42%). When the alerting system was off (n=334 alerts), there were 112 adverse events within 48 h (33%; difference: 9% higher with alerting system on, p=0.06). CONCLUSIONS: The provision of real-time clinical alerts and decision support for critical laboratory abnormalities did not improve clinical management or decrease adverse events.