Study of PhoneCare System to Treat Patients With Chronic Diseases (ComplexPt)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Boston Medical Center
ClinicalTrials.gov Identifier:
NCT01458184
First received: June 29, 2011
Last updated: April 5, 2013
Last verified: April 2013

June 29, 2011
April 5, 2013
September 2008
April 2013   (final data collection date for primary outcome measure)
  • Acute Hospital Care Utilization [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Acute Hospital Care Utilization [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01458184 on ClinicalTrials.gov Archive Site
  • Patient Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Ambulatory Appointment Show Rate [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Patient Quality of Life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Patient Satisfaction [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Chronic Disease
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
  • Experimental: PhoneCare system
    This arm is evaluating whether utilizing the PhoneCare system aids participants with their complex health care needs.
    Intervention: Behavioral: PhoneCare system
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
264
April 2013
April 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01458184
H-27747
No
Boston Medical Center
Boston Medical Center
Not Provided
Principal Investigator: Brian Jack, MD Boston Medical Center
Boston Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP