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The Impact of Community-based Wellness Programs on The Triple Aim

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ClinicalTrials.gov Identifier: NCT02938130
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : November 6, 2018
Sponsor:
Collaborators:
Community Living And Support Services
Community LIFE
Information provided by (Responsible Party):
Brad Dicianno, University of Pittsburgh

Brief Summary:
People with disabilities experience a staggering incidence of secondary conditions that can result in death or negatively impact their health, participation in the community, and quality of life. Many of these chronic secondary conditions are preventable. The Institute for Healthcare Improvement has advocated for optimizing care through programs that simultaneously improve health and the patient experience of care, while reducing cost, called the "Triple Aim." Studies have shown that the Triple Aim can be achieved through programs that facilitate community integration; however the U.S. healthcare system lacks a paradigm of care for individuals with disabilities that promotes community integration. In order to identify potential models of healthcare delivery for individuals with disabilities that are effective in achieving the Triple Aim, we will conduct a rigorous research project to evaluate the impact of two different models of care on the Triple Aim: 1) a community-based care management program delivered by a non-profit organization through waiver funds, and 2) the Program for All-inclusive Care for the Elderly (PACE) applied to younger individuals with disabilities between ages 55-64.

Condition or disease Intervention/treatment Phase
Spina Bifida Cerebral Palsy Spinal Cord Injury Traumatic Brain Injury Other: Wellness Programs Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Community-based Wellness Programs on The Triple Aim
Study Start Date : October 2016
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Wellness Programs
Community Partners and Community LIFE programs
Other: Wellness Programs
Wellness Programs delivered in the Community Partners and Community LIFE programs




Primary Outcome Measures :
  1. Change in Health Outcomes: function, measured by CHART-SF. [ Time Frame: At baseline, and approximately every 3-6 months up to 24 months ]
    Change in function as a result of enrollment into community program

  2. Change in Health Outcomes: mood, measured by PHQ9. [ Time Frame: At baseline, and approximately every 3-6 months up to 24 months ]
    Change in mood ratings as a result of enrollment into community program

  3. Change in Health Outcomes: quality of life, measured by WHOQOL-BREF [ Time Frame: At baseline, and approximately every 3-6 months up to 24 months ]
    Change in quality of life rating as a result of enrollment into community program

  4. Change in Health Outcomes: self rating of health, measured by a likert-type scale of self rating of health. [ Time Frame: At baseline, and approximately every 3-6 months up to 24 months ]
    Change in health rating as a result of enrollment into community program

  5. Change in Health Outcomes: community integration, measured by Social Capital from CQL-POMS. [ Time Frame: At baseline, and approximately every 3-6 months up to 24 months ]
    Change in community integration as a result of enrollment into community program

  6. Change in Experience of Care Outcome as measured by PACIC [ Time Frame: At baseline, and approximately every 3-6 months up to 24 months ]
    Change in experience of care as a result of enrollment into community program

  7. Cost: Program Cost [ Time Frame: Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment. ]
    Program Cost: will be assessed by the salary and benefit cost of the clinical staff needed to support enrollees, educational material provided to the enrollees, and other program costs per participant over the period of enrollment, which is up to 24 months.

  8. Cost: Total Medical Cost assessed by the medical and pharmacy costs. [ Time Frame: Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment. ]
    Total Medical Cost: will be assessed by the medical and pharmacy costs which will be calculated by using claims data for each participant enrolled in UPMC Health Plan by summing cost over a period of 1 year prior to enrollment (baseline), then over each year of enrollment. Total medical cost will be defined as the amount that the insurance company paid to the provider for all services provided, including medications and emergent, urgent, inpatient and outpatient care.

  9. Health Care Service Utilization [ Time Frame: Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment. ]
    Utilization: will be assessed by the frequency of emergency room visits and hospital admissions for unplanned care.



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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals who are eligible for the Community Partners program
  • Individuals who are eligible for the Community LIFE program between the age of 55-64.

Exclusion Criteria:

  • Individuals who are eligible for the Community LIFE program under the age of 55 or older than 64 years old.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02938130


Contacts
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Contact: Zara Ambadar, PhD 4126086118 ambadarz@upmc.edu

Locations
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United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15260
Contact: Zara Ambadar, Ph.D    412-608-6118    ambadarz@upmc.edu   
Sponsors and Collaborators
University of Pittsburgh
Community Living And Support Services
Community LIFE
Investigators
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Principal Investigator: Brad Dicianno, MD University of Pittsburgh

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Responsible Party: Brad Dicianno, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT02938130     History of Changes
Other Study ID Numbers: IDEAS-R2&R3
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Brain Injuries
Spinal Cord Injuries
Brain Injuries, Traumatic
Cerebral Palsy
Spinal Dysraphism
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Spinal Cord Diseases
Brain Damage, Chronic
Neural Tube Defects
Nervous System Malformations
Congenital Abnormalities