Clinical trial NCT02938130: The Impact of Community-based Wellness Programs on the Triple Aim
Official title: The Impact of Community-based Wellness Programs on the Triple Aim
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Spina Bifida
Cerebral Palsy
Spinal Cord Injury
Traumatic Brain Injury
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Community Living And Support Services
name: Community LIFE
First posted: 2016-10-19
Enrollment: 130
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

Detailed description: 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.

Living in the community affords many benefits for individuals with disabilities and chronic conditions. Studies have shown that higher integration into the community is associated with better health outcomes, longevity, higher quality of life, and lower cost of care. For example, it is estimated that the social support networks of the elderly saves the U.S. Government over 190 billion dollars annually through positive impacts on health.

The U.S. healthcare system, however, currently lacks a paradigm of care for individuals with disabilities that facilitates their integration into the community. Impactful research studies will be those that investigate delivery models that incorporate community-based services and that are funded through non-traditional means. One example of an innovative model of care is a wellness intervention wherein community-based interventions are delivered by non-profit organizations. For example, a recent study showed that using community-based peer health coaches to conduct telephone interventions for individuals with chronic spinal cord injury (SCI) resulted in greater confidence toward health goals and a greater connection to resources. Another recently published study on the "Living Well" program used health facilitators to conduct weekly health workshops. This program was implemented by 279 community-based independent living centers funded under Title VII of the Rehabilitation Act in 46 states, served approximately 9 million participants, and saved an estimated 30 million dollars. Many other studies have also demonstrated a positive impact of wellness interventions in a wide variety of chronic and disabling conditions.

Community Living and Support Services (CLASS) is a non-profit organization in Pittsburgh, PA, that provides a host of programs that aim to achieve community integration for individuals with disabilities. One such program is Community Partners which began in 1986. Community Partners offer non-traditional case management services which involved physically meeting with consumers in the community and telephonic support. The services provided included assisting clients in managing their personal care needs (e.g. activating attendant care services, or learning how to prepare meals), medical needs (e.g. taking medications on time or ensuring follow up at medical appointments), wellness needs (e.g. eating a balanced diet or engaging in adaptive exercise), and social needs (e.g. connecting with vocational rehabilitation or support groups)

A second example of an innovative model of care is the Program for All Inclusive Care for the Elderly (PACE). A PACE organization is a unique capitated managed care program provided by a non-profit, public entity, and in some cases a for-profit entity. The PACE model is a dually capitated, multidisciplinary approach to delivering both medical services and LTSS in accordance with a participant's needs. The services are delivered in the community whenever possible, usually integrate into a primary care medical home, and offer non-medical services including an adult day health center and in-home support services where appropriate. These organizations are typically responsible for all traditional Medicare-covered services (hospitals, physicians, and post-acute care), as well as supportive care.

The services are delivered in the community whenever possible, usually integrate into a primary care medical home, and offer non-medical services including an adult day health center and in-home support services where appropriate. These organizations are typically responsible for all traditional Medicare-covered services (hospitals, physicians, and post-acute care), as well as supportive care. The services include, but are not limited to, all Medicare and Medicaid services. At a minimum, a PACE organization must provide 16 different types of services including social work, medications, personal care, nutritional counseling, recreational and other therapies, transportation, and meals. The care team is comprised at a minimum of a primary care physician who works a substantial amount of time at the PACE, a nurse, social worker, physical therapist, occupational therapist, recreational therapist or activity coordinator, dietitian, PACE center supervisor, home care liaison, and health workers/aides. These organizations also provide support and respite care for families and other caregivers of participants. Today, 119 PACE programs in 31 states serve over 38,000 participants.

The overall goal of this project is to evaluate the impact of the Community LIFE program (a PACE model) on the Triple Aim for individuals with disabilities (health improvement, satisfaction of care, and cost).

The study findings will provide evidence as to whether these types of community-based delivery system could be scaled to larger populations and adopted by an integrated delivery system through an innovative funding mechanism.

Eligibility 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.

Primary outcomes:
measure: Change in Health Outcomes: function, measured by CHART-SF.
timeFrame: At baseline, and approximately every 3-6 months up to 24 months
measure: Change in Health Outcomes: mood, measured by PHQ9.
timeFrame: At baseline, and approximately every 3-6 months up to 24 months
measure: Change in Health Outcomes: quality of life, measured by WHOQOL-BREF
timeFrame: At baseline, and approximately every 3-6 months up to 24 months
measure: Change in Health Outcomes: self rating of health, measured by a likert-type scale of self rating of health.
timeFrame: At baseline, and approximately every 3-6 months up to 24 months
measure: Change in Health Outcomes: community integration, measured by Social Capital from CQL-POMS.
timeFrame: At baseline, and approximately every 3-6 months up to 24 months
measure: Change in Experience of Care Outcome as measured by PACIC
timeFrame: At baseline, and approximately every 3-6 months up to 24 months
measure: Cost: Program Cost
timeFrame: Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment.
measure: Cost: Total Medical Cost assessed by the medical and pharmacy costs.
timeFrame: Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment.
measure: Health Care Service Utilization
timeFrame: Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment.
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Brad Dicianno, MD
role: PRINCIPAL_INVESTIGATOR
References: