NCT01458184

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
264

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 29, 2011

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 24, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2013

Completed
Last Updated

April 8, 2013

Status Verified

April 1, 2013

Enrollment Period

4.6 years

First QC Date

June 29, 2011

Last Update Submit

April 5, 2013

Conditions

Chronic Disease

Keywords

risk factors for complicationsprecarious medical situations

Outcome Measures

Primary Outcomes (2)

  • Acute Hospital Care Utilization

    3 months

  • Acute Hospital Care Utilization

    6 months

Secondary Outcomes (5)

  • Patient Quality of Life

    3 months

  • Ambulatory Appointment Show Rate

    3 months

  • Patient Quality of Life

    6 months

  • Patient Satisfaction

    6 months

  • Ambulatory Appointment Show Rate

    6 months

Study Arms (2)

PhoneCare system

EXPERIMENTAL

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

Behavioral: PhoneCare system

Control Group: without PhoneCare System

NO INTERVENTION

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.

Interventions

PhoneCare systemBEHAVIORAL

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).

Also known as: TLC-C
PhoneCare system

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (9)

  • 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.

    PMID: 10403347BACKGROUND

  • 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.

    PMID: 12418941BACKGROUND

  • 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.

    PMID: 12558354BACKGROUND

  • 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.

    PMID: 10509499BACKGROUND

  • 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.

    PMID: 11790365BACKGROUND

  • 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.

    PMID: 8722429BACKGROUND

  • 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.

    PMID: 9391929BACKGROUND

  • 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.

    PMID: 10384677BACKGROUND

  • 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.

    PMID: 9571516BACKGROUND

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Brian Jack, MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2011

First Posted

October 24, 2011

Study Start

September 1, 2008

Primary Completion

April 1, 2013

Study Completion

April 1, 2013

Last Updated

April 8, 2013

Record last verified: 2013-04

Locations

US(1)