Clinical Trials Directory

Trials / Completed

CompletedNCT01458184

Study of PhoneCare System to Treat Patients With Chronic Diseases

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
264 (actual)
Sponsor
Boston Medical Center · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

Summary

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

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPhoneCare systemThe 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).

Timeline

Start date
2008-09-01
Primary completion
2013-04-01
Completion
2013-04-01
First posted
2011-10-24
Last updated
2013-04-08

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01458184. Inclusion in this directory is not an endorsement.