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

Trial Summary

What is the purpose of this trial?

Skilled Nursing Facility at Home is a multicenter randomized control trial that aims to evaluate a home-based model of providing post-acute care (PAC). We will enroll 650 hospitalized patients who require rehabilitation and/or skilled-nursing support upon discharge and randomly assign them to an intervention (home-based PAC) or control arm (facility-based PAC). Our design includes two different health systems in Massachusetts: Baystate Health and UMass Memorial Health. We will perform 1:1 randomization between the intervention and control arm using a permuted block design, with stratification by clinical site and payor group. 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. Secondary clinical, functional, and cost outcomes include length of stay in PAC, difference in health-related quality of life (HRQoL), and healthcare cost and utilization.

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 data supports the effectiveness of the treatment Sub-Acute Rehab at Home?

Research shows that home-based rehabilitation can reduce disability and improve quality of life for stroke patients. Additionally, providing post-acute rehabilitation at home as an alternative to skilled nursing facilities can offer effective therapy services, potentially improving functional outcomes. ^{1 2 3 4 5}

Is home-based rehabilitation generally safe for humans?

Research suggests that home-based rehabilitation, like the Rehabilitation-at-Home program, is generally safe for humans. It provides high-frequency, multidisciplinary care in patients' homes and has been evaluated for safety compared to traditional skilled nursing facilities. ^{2 5 6 7 8}

How is the Home-Based Care for Rehabilitation treatment different from other treatments for post-acute rehabilitation?

Home-Based Care for Rehabilitation is unique because it provides intensive therapy services directly in patients' homes, unlike traditional treatments that require patients to stay in skilled nursing facilities. This approach can improve outcomes by allowing patients to recover in a familiar environment, potentially reducing rehospitalization rates and improving quality of life. ^{1 2 5 6 9}

Research Team

Principal Investigator

Principal Investigator

University of Massachusetts, Worcester

Eligibility Criteria

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 am 18 years old or older.

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

My home is suitable for medical care.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Stroke rehabilitation at home before and after discharge reduced disability and improved quality of life: a randomised controlled trial. [2016]

2. United States pubmed.ncbi.nlm.nih.gov

Implementation of Post-Acute Rehabilitation at Home: A Skilled Nursing Facility-Substitutive Model. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Medicare spending and outcomes after postacute care for stroke and hip fracture. [2022]

4. United States 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. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The association of discharge destination with 30-day rehospitalization rates among older adults receiving lumbar spinal fusion surgery. [2022]

6. United States 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. [2023]

7. Sweden pubmed.ncbi.nlm.nih.gov

Frequency and Characteristics of Medical Complications in Rehabilitation Settings: A Scoping Review. [2023]

8. New Zealand pubmed.ncbi.nlm.nih.gov

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

9. United States pubmed.ncbi.nlm.nih.gov

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