Study of PhoneCare System to Treat Patients With Chronic Diseases (ComplexPt)
A Randomized Trial of the PhoneCare System to Improve Ambulatory Care for Patients With Chronic Diseases
Visão geral do estudo
Descrição detalhada
TLC-C is a modification of an existing TLC-Multi-Disease system that targets patients with multiple chronic diseases combined with a post-hospital discharge intervention (TLC-RED-Lit). TLC-C uses conversational computer telephony to monitor patients' multiple diseases between their ambulatory care visits. The system works in both routine (patient stable) and exacerbation (patient unstable) modes. The system monitors patients through "virtual visits" and detects and notifies clinicians about important clinical problems to attend to. It also promotes patient self-care (e.g., medication adherence and appointment preparation). In emergent situations the system recommends going to the local Emergency Department (ED). In urgent situations, an alert is sent to the clinician or to his/her coverage provider. Exacerbation mode is used when the patient is discharged from a hospital inpatient service or ED or has worsening symptoms. It concentrates on the exacerbating disease and monitors patient status (improved, stable or deteriorating). Daily contact is maintained until the patient's status improves. Routine mode occurs with the patient at their baseline status and monitors the disease and the patients' self-care behaviors.
The investigators propose to perform a multi-method evaluation study of the patients, the providers, and the practice. This includes a 2-arm randomized clinical trial of TLC-C versus usual care for patients with two or more chronic diseases, at least one previous episode of acute hospital utilization over the last 12 months, and who had been recently discharged from an urban hospital. The randomized clinical trial (RCT) will evaluate the system in 440 patients followed for 6 months.
The primary outcome is acute hospital care utilization (unplanned hospitalizations and ED visits). Secondary outcomes include patient quality of life (EuroQol 5D [EQ-5D]), satisfaction (Clinician and Group Survey [G-CAHPS]), ambulatory appointment show rate and net payer costs. The investigators will explore disease specific metrics (e.g., hemoglobin A1c [HbA1c] or blood pressure). The investigators will perform formative and summative qualitative studies of the implementation of the system, its use and performance over time, and its impact on the patients, providers and the practice as a whole.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02118
- Boston Medical Center
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- age 18 years or more
- on one of Boston Medical Center (BMC)'s general medical services with an unscheduled hospitalization
- has a primary care provider in the BMC General Internal Medicine (GIM) practice or Family Medicine practice or is willing to be assigned a primary care physician (PCP) at BMC GIM or Family Medicine practice upon discharge
- once discharged, patient is planning to continue his/her primary care at BMC for the next 6 months
- communicates in English adequately to participate
Exclusion Criteria:
- patients who are admitted from hospice, nursing home or another institutional setting
- patients who are in police custody or have a suicide sitter
- patients who cannot use a telephone unassisted or who do not have regular access to either a land line or cellular telephone for the next 6 months
- patients unwilling to accept calls to his/her phone for the next 6 months
- patients currently enrolled in this study or in the RED-Lit trial
- patients unable to independently consent to participate
- patients who have sickle cell anemia
- patients responding positively to the question on the Patient Health Questionnaire (PHQ-9) regarding suicidal ideation
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Pesquisa de serviços de saúde
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: PhoneCare system
This arm is evaluating whether utilizing the PhoneCare system aids participants with their complex health care needs.
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The aim of this study is to assess the effectiveness of Telephone-Linked Care for Complex Patients (TLC-C) in the care of patients with complex health care needs.
TLC-C uses conversational computer telephony to monitor patients' multiple diseases between their ambulatory care visits.
The system monitors patients through "virtual visits" and detects and notifies clinicians about important clinical problems to attend to.
It also promotes patient self-care (e.g., medication adherence and appointment preparation).
Outros nomes:
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Sem intervenção: Control Group: without PhoneCare System
Subjects in this arm will receive the usual care.
Usual care is defined as receiving regular care from their physicians and no additional care or intervention from the study.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Acute Hospital Care Utilization
Prazo: 3 months
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3 months
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Acute Hospital Care Utilization
Prazo: 6 months
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6 months
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient Quality of Life
Prazo: 3 months
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3 months
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Ambulatory Appointment Show Rate
Prazo: 3 months
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3 months
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Patient Quality of Life
Prazo: 6 months
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6 months
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Patient Satisfaction
Prazo: 6 months
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A validated, in-house designed questionnaire will be administered to subjects to assess their satisfaction with the TLC system.
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6 months
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Ambulatory Appointment Show Rate
Prazo: 6 months
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6 months
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Brian Jack, MD, Boston Medical Center
Publicações e links úteis
Publicações Gerais
- Wolff JL, Starfield B, Anderson G. Prevalence, expenditures, and complications of multiple chronic conditions in the elderly. Arch Intern Med. 2002 Nov 11;162(20):2269-76. doi: 10.1001/archinte.162.20.2269.
- Forster AJ, Murff HJ, Peterson JF, Gandhi TK, Bates DW. The incidence and severity of adverse events affecting patients after discharge from the hospital. Ann Intern Med. 2003 Feb 4;138(3):161-7. doi: 10.7326/0003-4819-138-3-200302040-00007.
- Friedman RH, Kazis LE, Jette A, Smith MB, Stollerman J, Torgerson J, Carey K. A telecommunications system for monitoring and counseling patients with hypertension. Impact on medication adherence and blood pressure control. Am J Hypertens. 1996 Apr;9(4 Pt 1):285-92. doi: 10.1016/0895-7061(95)00353-3.
- Friedman RH, Stollerman J, Rozenblyum L, Belfer D, Selim A, Mahoney D, Steinbach S. A telecommunications system to manage patients with chronic disease. Stud Health Technol Inform. 1998;52 Pt 2:1330-4.
- Marcantonio ER, McKean S, Goldfinger M, Kleefield S, Yurkofsky M, Brennan TA. Factors associated with unplanned hospital readmission among patients 65 years of age and older in a Medicare managed care plan. Am J Med. 1999 Jul;107(1):13-7. doi: 10.1016/s0002-9343(99)00159-x.
- Dudas V, Bookwalter T, Kerr KM, Pantilat SZ. The impact of follow-up telephone calls to patients after hospitalization. Am J Med. 2001 Dec 21;111(9B):26S-30S. doi: 10.1016/s0002-9343(01)00966-4.
- Friedman RH, Stollerman JE, Mahoney DM, Rozenblyum L. The virtual visit: using telecommunications technology to take care of patients. J Am Med Inform Assoc. 1997 Nov-Dec;4(6):413-25. doi: 10.1136/jamia.1997.0040413.
- Stewart S, Marley JE, Horowitz JD. Effects of a multidisciplinary, home-based intervention on unplanned readmissions and survival among patients with chronic congestive heart failure: a randomised controlled study. Lancet. 1999 Sep 25;354(9184):1077-83. doi: 10.1016/s0140-6736(99)03428-5.
- Friedman RH. Automated telephone conversations to assess health behavior and deliver behavioral interventions. J Med Syst. 1998 Apr;22(2):95-102. doi: 10.1023/a:1022695119046.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- H-27747
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