Spina BifidaNCT02938130
The Impact of Community-based Wellness Programs on The Triple Aim
An observational study of Spina Bifida and Cerebral Palsy, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 7 years and older
- Conditions the study is for
- Spina Bifida, Cerebral Palsy, Spinal Cord Injury
- What is being tested?
- Wellness Programs
- How many people
- 119 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 24 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Individuals who are eligible for the Community Partners program
- Individuals who are eligible for the Community LIFE program between the age of 55-64.
Who cannot join
- Individuals who are eligible for the Community LIFE program under the age of 55 or older than 64 years old.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
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.
Read the 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.
- Being tested
- Wellness Programs
- Medical subject headings
- Spinal Dysraphism, Cerebral Palsy, Spinal Cord Injuries, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wellness ProgramsOther
Wellness Programs delivered in the Community Partners and Community LIFE programs
| Study group | Role | What they receive |
|---|---|---|
| Wellness Programs | Community Partners and Community LIFE programs Receives: Other: Wellness Programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Health Outcomes: function, measured by CHART-SF.
Change in function as a result of enrollment into community program
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Accumulation of costs and Utilization throughout the duration of participation, measured at the end of the study, up to 24 months since enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion24 Aug 2023
- Study completion24 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spina BifidaStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Community Living And Support Services, Community LIFE
- Responsible party
- Principal investigator, Brad Dicianno, University of Pittsburgh
- Investigators
- Brad Dicianno, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02938130
- Sponsor's protocol ID
- STUDY19080265
- Status last verified
- Oct 2026
- First submitted
- 13 Oct 2016
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Community-based Wellness Programs on The Triple Aim
- ClinicalTrials.gov ID
- NCT02938130
- Acronym / sponsor ID
- STUDY19080265
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Community Living And Support Services, Community LIFE
- Study start
- Oct 2016 (actual)
- Primary completion
- 24 Aug 2023 (actual)
- Study completion
- 24 Aug 2023 (actual)
- First posted
- 19 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wellness Programs | – | Other: Wellness ProgramsCommunity Partners and Community LIFE programs |
Who may qualify
- Ages
- 7 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Individuals who are eligible for the Community Partners program
- Individuals who are eligible for the Community LIFE program between the age of 55-64.
Key exclusion criteria (1 listed)
- Individuals who are eligible for the Community LIFE program under the age of 55 or older than 64 years old.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wellness ProgramsWellness Programs delivered in the Community Partners and Community LIFE programs | Other | Wellness Programs |
Primary outcome
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
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
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
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
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
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
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brad Dicianno, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spina Bifida and Cerebral Palsy, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Health Outcomes: function, measured by CHART-SF. (time frame: At baseline, and approximately every 3-6 months up to 24 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.