Study of PhoneCare System to Treat Patients With Chronic Diseases (ComplexPt)
|ClinicalTrials.gov Identifier: NCT01458184|
Recruitment Status : Completed
First Posted : October 24, 2011
Last Update Posted : April 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Chronic Disease||Behavioral: PhoneCare system||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||264 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||A Randomized Trial of the PhoneCare System to Improve Ambulatory Care for Patients With Chronic Diseases|
|Study Start Date :||September 2008|
|Actual Primary Completion Date :||April 2013|
|Actual Study Completion Date :||April 2013|
Experimental: PhoneCare system
This arm is evaluating whether utilizing the PhoneCare system aids participants with their complex health care needs.
Behavioral: PhoneCare system
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).
Other Name: TLC-C
No Intervention: 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.
- Acute Hospital Care Utilization [ Time Frame: 3 months ]
- Acute Hospital Care Utilization [ Time Frame: 6 months ]
- Patient Quality of Life [ Time Frame: 3 months ]
- Ambulatory Appointment Show Rate [ Time Frame: 3 months ]
- Patient Quality of Life [ Time Frame: 6 months ]
- Patient Satisfaction [ Time Frame: 6 months ]A validated, in-house designed questionnaire will be administered to subjects to assess their satisfaction with the TLC system.
- Ambulatory Appointment Show Rate [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458184
|United States, Massachusetts|
|Boston Medical Center|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Brian Jack, MD||Boston Medical Center|