NCT01912430

Brief Summary

New payment methods such as Accountable Care Organization (ACO's) and medical homes facilitate are new models for providers to deliver cost effective, quality patient outcomes. Integrated Care Coaching (ICC) is a healthcare delivery model combining telephonic interventions with an intelligent information technology platform that offered validated protocols and patient outcomes tracking. Health Integrated, Inc. has developed a validated program of Integrated Care Coaching (ICC), which was branded as "VitalCare", and implemented with over 7,000 members of the Scott and White Health Plan in Texas, would reduce healthcare costs/achieve a return on investment (ROI), improve clinical outcomes, and be satisfying for participants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17,559

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2012

Shorter than P25 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

July 1, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
Last Updated

August 1, 2013

Status Verified

July 1, 2013

Enrollment Period

5 months

First QC Date

July 18, 2013

Last Update Submit

July 30, 2013

Conditions

Keywords

Integrated Care CoachingChronic Care CoachingCare Coaching

Outcome Measures

Primary Outcomes (1)

  • Return of Investment and Cost of Medical Care

    Primary outcomes were ROI and cost of medical care (including inpatient, outpatient, emergency room, office and other (ie, physical therapy). ICC participants and control group members had a minimum of 6 months to a maximum of 12 months measurement period.

    6 to 12 months

Secondary Outcomes (1)

  • Level of Depressive Symptoms per Interactive Patient Health Questionnaire (PHQ-9) scores

    6 to 12 months

Other Outcomes (1)

  • Patient Satisfaction

    6 to 12 months

Study Arms (2)

ICC (Integrated Care Coaching)

EXPERIMENTAL

Received evidence-based, protocol-driven integrated care coaching intervention to improve chronic illness health outcomes (clinical, financial).

Behavioral: ICC (Integrated Care Coaching) Intervention Group

Control Group

EXPERIMENTAL

Matched cohort by age and chronic illness diagnoses - no intervention

Behavioral: ICC (Integrated Care Coaching) Intervention Group

Interventions

Also known as: Health Integrated Inc. Integrated Care Coaching (ICC)
Control GroupICC (Integrated Care Coaching)

Eligibility Criteria

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

You may qualify if:

  • years or older
  • Having one or more of 21 chronic conditions, including those with depression and multiple chronic comorbidities.

You may not qualify if:

  • Presence of Major Cancer, HIV, or ESRD in either the baseline or measurement periods
  • Claims in excess of $100,000 in either baseline or intervention period.
  • Claims for long term care or hospice in either baseline or intervention period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Scott & White Health Plan

Temple, Texas, 76502, United States

Location

MeSH Terms

Conditions

Chronic Disease

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Marylou Buyse, M.D., M.S.

    Scott and White Health Plan

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 18, 2013

First Posted

July 31, 2013

Study Start

July 1, 2012

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

August 1, 2013

Record last verified: 2013-07

Locations