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

NCT02938130 | Completed

• 1 other identifier: STUDY19080265
• Study Type: observational
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Spina Bifida; Cerebral Palsy; Spinal Cord Injury; Traumatic Brain Injury

Outcome Measures

Primary Outcomes (9)

• Change in Health Outcomes: function, measured by CHART-SF.

  Change in function as a result of enrollment into community program

  At baseline, and approximately every 3-6 months up to 24 months

• Change in Health Outcomes: mood, measured by PHQ9.

  Change in mood ratings as a result of enrollment into community program

  At baseline, and approximately every 3-6 months up to 24 months

• Change in Health Outcomes: quality of life, measured by WHOQOL-BREF

  Change in quality of life rating as a result of enrollment into community program

  At baseline, and approximately every 3-6 months up to 24 months

• Change in Health Outcomes: self rating of health, measured by a likert-type scale of self rating of health.

  Change in health rating as a result of enrollment into community program

  At baseline, and approximately every 3-6 months up to 24 months

• Change in Health Outcomes: community integration, measured by Social Capital from CQL-POMS.

  Change in community integration as a result of enrollment into community program

  At baseline, and approximately every 3-6 months up to 24 months

• Change in Experience of Care Outcome as measured by PACIC

  Change in experience of care as a result of enrollment into community program

  At baseline, and approximately every 3-6 months up to 24 months

• Cost: Program Cost

  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.

  Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment.

• Cost: Total Medical Cost assessed by the medical and pharmacy costs.

  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.

  Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment.

• Health Care Service Utilization

  Utilization: will be assessed by the frequency of emergency room visits and hospital admissions for unplanned care.

  Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment.

Study Arms (1)

Wellness Programs

Community Partners and Community LIFE programs

Other: Wellness Programs

Interventions

Wellness Programs OTHER

Wellness Programs delivered in the Community Partners and Community LIFE programs

Wellness Programs

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants are those individuals with disabilities who are eligible for Community Partners or Community LIFE programs. Individuals who enrolled in Community Partner program vary in age, as young as 7 years old. We want to be sure to include all age groups in our studies. Community LIFE serves individuals aged 55 and older. Participants in this research study will be restricted those who are 55-64 years old to address the research gap in this age group. Little research has been conducted on younger (i.e. age 55-64) individuals enrolled in PACE models of care. Also the purpose of this study is to investigate the impact of this model of care on this specific subset of the population.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Community Living And Support Services: collaborator
• Community LIFE: collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Spinal Dysraphism; Cerebral Palsy; Spinal Cord Injuries; Brain Injuries, Traumatic

Interventions

Health Promotion

Condition Hierarchy (Ancestors)

Neural Tube Defects; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Spinal Cord Diseases; Trauma, Nervous System; Wounds and Injuries; Brain Injuries; Craniocerebral Trauma

Intervention Hierarchy (Ancestors)

Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Brad Dicianno, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 13, 2016
• First Posted: October 19, 2016
• Study Start: October 1, 2016
• Primary Completion: August 24, 2023
• Study Completion: August 24, 2023
• Last Updated: September 12, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)