Home-Based Care for Rehabilitation

Recruiting at 1 trial location

Overseen By Study Team

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Long-term care, Hospice, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

650 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new approach to providing rehabilitation and nursing care for individuals needing support after hospital discharge. Some participants will receive Sub-Acute Rehab at Home, while others will receive care in a facility, to determine which method better prevents hospital readmissions and lowers costs. The trial seeks participants living in Greater Worcester or Greater Springfield who need skilled nursing care after a hospital stay and can safely receive care at home. It will measure outcomes such as the length of post-hospital care and changes in quality of life. As an unphased trial, this study offers a unique opportunity to contribute to innovative care solutions that could enhance recovery experiences for future patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this home-based care model is safe for post-acute rehabilitation?

Research has shown that receiving care at home after a hospital stay is generally safe for patients needing rehabilitation. Studies have found that skilled nursing care at home can be as safe as care in a facility. For instance, one study found similar hospital readmission rates for patients receiving care at home and those in nursing facilities.

Other research highlights that home-based care programs meet quality standards and include thorough patient monitoring to ensure safety. Patients receive close supervision to maintain a high standard of care at home.

Overall, evidence suggests that rehabilitation at home is well-tolerated and provides a safe option for those who qualify. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Home-Based Care for Rehabilitation approach because it offers a new way to deliver post-acute care. Unlike the traditional model, which requires patients to stay in skilled nursing facilities, this treatment allows patients to receive rehabilitation services in the comfort of their own homes. This can lead to increased patient comfort and convenience, potentially improving recovery outcomes and reducing healthcare costs. By shifting care to a home setting, it may also help alleviate the burden on healthcare facilities and provide a more personalized care experience.

What evidence suggests that this trial's treatments could be effective?

This trial will compare home-based post-acute care with facility-based care. Research has shown that receiving care at home after a hospital stay can lead to fewer hospital readmissions and lower healthcare costs. Specifically, a trial program found that patients who underwent rehabilitation at home improved significantly and saved money. Another study found that home-based rehab resulted in fewer complications and high patient satisfaction. This method helps people recover while avoiding unnecessary hospital visits. Overall, home-based care offers a promising alternative to traditional facility-based rehab. ^{3 6 7 8 9}

Who Is on the Research Team?

Principal Investigator

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

This trial is for hospitalized patients aged 18 or older in Massachusetts who need post-acute care after discharge. They must require skilled nursing or rehab, pass a home readiness assessment, and live within Greater Worcester or Springfield areas.

Inclusion Criteria

I need skilled nursing care as recommended by my healthcare team.

My home is suitable for medical care.

I live in Greater Worcester or Greater Springfield.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomization and Initial Treatment

Participants are randomly assigned to either home-based or facility-based post-acute care and begin receiving the assigned care

4 weeks

Initial visit for randomization and setup

Post-Acute Care Monitoring

Participants receive ongoing post-acute care and are monitored for hospital readmission and mortality rates

6 months

Regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after the post-acute care period

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sub-Acute Rehab at Home

Trial Overview The study compares two types of post-acute care: receiving it at home versus in a facility. It involves random assignment to either group and measures outcomes like hospital readmission, mortality rates within 30 days, length of stay, quality of life, and healthcare costs.

How Is the Trial Designed?

Group I: Facility-based Active Control 1 Intervention

Facility based post acute care at a skilled nursing facility, as is the standard care model.

Group II: Home-based Active Control 1 Intervention

Home-based Post-Acute Care

Sub-Acute Rehab at Home is already approved in United States for the following indications:

Approved in United States as Sub-Acute Rehab at Home for:

• Post-acute rehabilitation
• Skilled nursing care

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Baystate Health

Collaborator

Trials

9

Recruited

54,500+

UMass Memorial Health

Collaborator

Trials

2

Recruited

750+

Massachusetts Executive Office of Health and Human Services (EOHHS)

Collaborator

Trials

1

Recruited

650+

UMass Memorial Health

Collaborator

Trials

4

Recruited

970+

Published Research Related to This Trial

Adult patients in subacute inpatient rehabilitation are at a high risk for medical complications, which can affect their length of stay and may lead to transfers back to acute care facilities.

The review of 47 studies highlights the need for specialized care from multidisciplinary teams, including experts in both rehabilitation and acute medical management, to address the complexities of these patients' health needs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Frequency and Characteristics of Medical Complications in Rehabilitation Settings: A Scoping Review. Ladbrook, E., Bouchoucha, S., Hutchinson, A.[2023]

The Rehabilitation at Home (RaH) program successfully provided post-acute rehabilitation services to 237 patients, primarily older adults, resulting in significant functional improvements in mobility and daily activities, with 87.3% of participants living independently in the community after 30 days.

Patients with higher baseline ambulation were more likely to achieve substantial functional improvement, while those with a dementia diagnosis faced challenges, indicating that individual patient characteristics can influence rehabilitation outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of Post-Acute Rehabilitation at Home: A Skilled Nursing Facility-Substitutive Model. Augustine, MR., Davenport, C., Ornstein, KA., et al.[2021]

Enhanced Medical Rehabilitation significantly increased therapy intensity and patient engagement among 26 older adults in a skilled nursing facility, leading to improved functional outcomes such as gait speed and distance walked in 6 minutes.

Participants receiving Enhanced Medical Rehabilitation showed greater improvements in gait speed (0.38 m/s vs. 0.22 m/s) and 6-minute walk distance (266 feet vs. 94 feet) compared to those receiving standard care, suggesting that more engaging and intense rehabilitation can enhance recovery in postacute care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhanced medical rehabilitation increases therapy intensity and engagement and improves functional outcomes in postacute rehabilitation of older adults: a randomized-controlled trial. Lenze, EJ., Host, HH., Hildebrand, MW., et al.[2021]

Rehabilitation-at-Home (RaH) services were found to be effective, with 10.1% fewer participants experiencing hospital readmissions and 4.2% fewer deaths within 30 days compared to those receiving Skilled Nursing Facility (SNF) care, based on a study of 173 RaH patients and 5535 SNF patients.

RaH participants had a shorter average post-acute care duration by 2.8 days and a significantly higher rate of 25.8% more individuals discharged to the community, indicating improved outcomes and safety in transitioning patients back home.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Rehabilitation-at-Home Program Compared to Post-acute Skilled Nursing Facility Care on Safety, Readmission, and Community Dwelling Status: A Matched Cohort Analysis. Augustine, MR., Intrator, O., Li, J., et al.[2023]

Among 261,558 Medicare beneficiaries who underwent lumbar spinal fusion from 2012 to 2014, over half (50.8%) were discharged to rehabilitation-based post-acute services, which included older patients with more health issues and longer hospital stays.

Despite the higher needs of patients discharged to rehabilitation services, these individuals had a 36% increased risk of being readmitted to the hospital within 30 days compared to those discharged to other settings, indicating that rehabilitation-based care may not reduce short-term rehospitalization rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of discharge destination with 30-day rehospitalization rates among older adults receiving lumbar spinal fusion surgery. Cook, C., Coronado, RA., Bettger, JP., et al.[2022]

Over 33% of older adults admitted to skilled nursing facilities (SNFs) experience adverse events, such as falls, within the first 35 days of their stay, highlighting a significant safety concern for this population.

Key factors contributing to these adverse events include intrinsic factors like frailty and reduced muscle strength, as well as extrinsic factors such as inappropriate medication use, environmental hazards, and poor communication among staff, indicating areas for potential intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events and Their Contributors Among Older Adults During Skilled Nursing Stays for Rehabilitation: A Scoping Review. Okpalauwaekwe, U., Tzeng, HM.[2022]

A study involving 71 stroke patients showed that home-based rehabilitation during and after hospitalization led to significantly better outcomes in disability (measured by the modified Rankin Scale) and quality of life (measured by EuroQol-5D) compared to standard care.

The home-based rehabilitation approach was not only effective in improving patient outcomes but also more cost-effective than traditional rehabilitation methods, suggesting a beneficial alternative for stroke recovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke rehabilitation at home before and after discharge reduced disability and improved quality of life: a randomised controlled trial. Rasmussen, RS., Østergaard, A., Kjær, P., et al.[2016]

The study compares rehabilitation outcomes for stroke patients receiving care from different postacute providers, including inpatient rehabilitation facilities, skilled nursing facilities, and home health agencies.

It highlights the challenges of conducting observational studies in this area, emphasizing the complexity of evaluating the effectiveness of various rehabilitation services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does postacute care site matter? A longitudinal study assessing functional recovery after a stroke. Deutsch, A.[2018]

In elderly patients recovering from stroke or hip fractures, inpatient rehabilitation facilities (IRFs) lead to better health outcomes for hip fracture patients compared to being discharged home, while skilled nursing facilities (SNFs) reduce mortality for hip fracture patients but increase institutionalization rates for stroke patients.

Both IRFs and SNFs are significantly more expensive than discharging patients home, suggesting that while IRFs may provide better outcomes for certain patients, the higher costs must be weighed against the benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Medicare spending and outcomes after postacute care for stroke and hip fracture. Buntin, MB., Colla, CH., Deb, P., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7387590/

Post-Acute Care as a Key Component in a Healthcare System ... Post-acute care aims to promote the functional recovery of older adults, prevent unnecessary hospital readmission, and avoid premature admission to a long-term ...

2. consultqd.clevelandclinic.org consultqd.clevelandclinic.org/high-intensity-home-based-rehabilitation-offers-alternative-to-skilled-nursing-facility

High-Intensity Home-Based Rehabilitation Offers Alternative to ... A pilot program finds that postacute rehab care at home can lead to functional improvements while nearly halving costs compared with a ...

3. contessahealth.com contessahealth.com/rehabilitation-care-at-home-beyond-home-health/

Rehabilitation Care at Home: Beyond Home Health Our data consistently shows reduced readmissions, low rates of care complications and high patient satisfaction scores with Rehabilitation ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06547645

NCT06547645 | Skilled Nursing Facility at Home Trial The primary outcome of the trial will be the difference in hospital readmission and mortality rates from the time of enrollment to 30 days after enrollment.

5. aspe.hhs.gov aspe.hhs.gov/reports/subacute-care-review-literature-0

Subacute Care: Review of the Literature Subacute care is a comprehensive, cost-effective and outcome oriented approach to care for patients requiring short-term, complex medical and/or ...

6. psnet.ahrq.gov psnet.ahrq.gov/primer/post-acute-transitional-services-safety-home-based-care-programs

Post-Acute Transitional Services: Safety in Home-Based ... Each HHA submits a standardized comprehensive set of patient care data (Outcome and Assessment Information Set or OASIS) to meet quality reporting ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12462527/

Implementation of Post-Acute Rehabilitation at Home This program aims to serve as a substitute for PAC at an SNF, delivering SNF-level care at home to selected patients with a broader range of ...

8. researchgate.net researchgate.net/publication/374101852_Effects_of_a_Rehabilitation-at-Home_Program_Compared_to_Post-acute_Skilled_Nursing_Facility_Care_on_Safety_Readmission_and_Community_Dwelling_Status_A_Matched_Cohort_Analysis

Effects of a Rehabilitation-at-Home Program Compared to ... Objectives To evaluate the effectiveness and safety of Rehabilitation-at-Home (RaH), which provides high-frequency, multidisciplinary post-acute ...

9. aspe.hhs.gov aspe.hhs.gov/sites/default/files/private/pdf/138576/scltrves.pdf

SUBACUTE CARE: Subacute care is referred to as a less costly alternative to hospital care for those patients who require intense medical supervision and therapy, but are not.