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

Primary Purpose

Chronic Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PhoneCare system
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Chronic Disease focused on measuring risk factors for complications, precarious medical situations

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PhoneCare system

Control Group: without PhoneCare System

Arm Description

This arm is evaluating whether utilizing the PhoneCare system aids participants with their complex health care needs.

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.

Outcomes

Primary Outcome Measures

Acute Hospital Care Utilization
Acute Hospital Care Utilization

Secondary Outcome Measures

Patient Quality of Life
Ambulatory Appointment Show Rate
Patient Quality of Life
Patient Satisfaction
A validated, in-house designed questionnaire will be administered to subjects to assess their satisfaction with the TLC system.
Ambulatory Appointment Show Rate

Full Information

First Posted
June 29, 2011
Last Updated
April 5, 2013
Sponsor
Boston Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01458184
Brief Title
Study of PhoneCare System to Treat Patients With Chronic Diseases
Acronym
ComplexPt
Official Title
A Randomized Trial of the PhoneCare System to Improve Ambulatory Care for Patients With Chronic Diseases
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Disease
Keywords
risk factors for complications, precarious medical situations

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
264 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PhoneCare system
Arm Type
Experimental
Arm Description
This arm is evaluating whether utilizing the PhoneCare system aids participants with their complex health care needs.
Arm Title
Control Group: without PhoneCare System
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
PhoneCare system
Other Intervention Name(s)
TLC-C
Intervention Description
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).
Primary Outcome Measure Information:
Title
Acute Hospital Care Utilization
Time Frame
3 months
Title
Acute Hospital Care Utilization
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Patient Quality of Life
Time Frame
3 months
Title
Ambulatory Appointment Show Rate
Time Frame
3 months
Title
Patient Quality of Life
Time Frame
6 months
Title
Patient Satisfaction
Description
A validated, in-house designed questionnaire will be administered to subjects to assess their satisfaction with the TLC system.
Time Frame
6 months
Title
Ambulatory Appointment Show Rate
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Jack, MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10403347
Citation
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.
Results Reference
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PubMed Identifier
12418941
Citation
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.
Results Reference
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PubMed Identifier
12558354
Citation
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.
Results Reference
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PubMed Identifier
10509499
Citation
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.
Results Reference
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PubMed Identifier
11790365
Citation
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.
Results Reference
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PubMed Identifier
8722429
Citation
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.
Results Reference
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PubMed Identifier
9391929
Citation
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.
Results Reference
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PubMed Identifier
10384677
Citation
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.
Results Reference
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PubMed Identifier
9571516
Citation
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.
Results Reference
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Study of PhoneCare System to Treat Patients With Chronic Diseases

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