Study of PhoneCare System to Treat Patients With Chronic Diseases

Study Overview
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Brief Summary
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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. These are patients frequently transitioning from inpatient to ambulatory care with multiple chronic diseases that tend to lead to increased health-care utilization and other socio-economic vulnerabilities. The objective is to reduce preventable hospital utilization, improve quality of life, increase satisfaction with ambulatory care, improve disease-specific metrics, and reduce net payer costs.

Detailed Description
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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.

Official Title
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A Randomized Trial of the PhoneCare System to Improve Ambulatory Care for Patients With Chronic Diseases

Conditions
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Chronic Disease

Intervention / Treatment
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* Behavioral: PhoneCare system


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PhoneCare system<br>This arm is evaluating whether utilizing the PhoneCare system aids participants with their complex health care needs. | Behavioral: PhoneCare system<br>* 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).<br>* Other names: TLC-C;|
| No Intervention: Control Group: without PhoneCare System<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute Hospital Care Utilization |  | 3 months | 
| Acute Hospital Care Utilization |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Quality of Life |  | 3 months | 
| Ambulatory Appointment Show Rate |  | 3 months | 
| Patient Quality of Life |  | 6 months | 
| Patient Satisfaction | A validated, in-house designed questionnaire will be administered to subjects to assess their satisfaction with the TLC system. | 6 months | 
| Ambulatory Appointment Show Rate |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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risk factors for complications, precarious medical situations