ClinicalTrials.gg
CompletedNCT02938130Updated Oct 15, 2026

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

An observational study in Spina Bifida, Cerebral Palsy and Spinal Cord Injury, sponsored by University of Pittsburgh. Completed at 1 site in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by University of Pittsburgh · Observational

Updated Oct 15, 2026Enrollment updatedGo to Updates ↓
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
119
Ages
7 Years and older
Sex
All
01

Study 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.

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.

02

Conditions studied

  • Spina Bifida
  • Cerebral Palsy
  • Spinal Cord Injury
  • Traumatic Brain Injury
03

In context

Spinal Dysraphism

142 studies on the registry are indexed under Spinal Dysraphism; 39 are open to participants now.

This study's enrollment of 119 is above the median of 105 across 48 observational studies indexed under Spinal Dysraphism.

Browse Spinal Dysraphism studies →

Lead sponsor

University of Pittsburgh is the lead sponsor of 1,419 studies on the registry; 168 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Individuals who are eligible for the Community LIFE program under the age of 55 or older than 64 years old.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
119 participants (actual)
Patient registry
No

Groups and cohorts

  • Wellness Programs

    Community Partners and Community LIFE programs

    Other: Wellness Programs

Interventions

  • OtherWellness Programs

    Wellness Programs delivered in the Community Partners and Community LIFE programs

06

What researchers measure

Primary outcomes

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

    Change in function as a result of enrollment into community program

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

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

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

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

  3. 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

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

  4. 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

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

  5. 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

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

  6. Change in Experience of Care Outcome as measured by PACIC

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

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

  7. 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.

    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.

  8. 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.

    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.

  9. Health Care Service Utilization

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

    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.

07

Study locations

1 site
  • University of Pittsburgh
    Pittsburgh, Pennsylvania 15260, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Oct 2016 to primary completion in Aug 2023, 82 months.

Of 22 observational studies under Spinal Dysraphism, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 36. This study's 82 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 13, 2016
First posted
Oct 19, 2016
StartActual
Oct 2016
Primary completionActual
Aug 24, 2023
CompletionActual
Aug 24, 2023
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Enrollment
130→119
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Enrollment 130→119
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT02938130
Collaborators
Community Living And Support Services, Community LIFE
Responsible party
Brad Dicianno (Associate Professor, University of Pittsburgh) — Principal investigator
First posted
Oct 19, 2016
Start date
Oct 2016
Primary completion
Aug 24, 2023
Completion
Aug 24, 2023
Last update
Oct 15, 2026

Study contacts

Brad Dicianno, MD
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion