At-Home Skilled Nursing Care for Rehabilitation

Recruiting at 4 trial locations

Overseen By David M Levine, MD, MPH, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Brigham and Women's Hospital

Must not be taking: Methadone, Intravenous controlled substances

Disqualifiers: Undomiciled, Psychiatric diagnosis, Hemodialysis, others

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

Compensation: Varies

Number of Visits: Unknown

300 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are on methadone or require certain specialty medications or intravenous controlled substances, you may need to discuss this with the trial team.

What data supports the effectiveness of the treatment Skilled Nursing Facility Care at Home?

Research shows that home-based rehabilitation can reduce disability and improve quality of life for stroke patients, suggesting that similar at-home skilled nursing care might also be effective in enhancing recovery and independence. ^{1 2 3 4 5}

Is at-home skilled nursing care generally safe for humans?

Research shows that adverse events (unintended harm) can occur in both skilled nursing facilities and home healthcare settings, with about one-third of patients experiencing such events. However, many of these events are preventable, and nursing care plays a crucial role in reducing risks. ^{4 6 7 8 9}

How is the treatment 'Skilled Nursing Facility Care at Home' different from other treatments for rehabilitation?

This treatment is unique because it provides skilled nursing care and rehabilitation services directly in the patient's home, rather than in a traditional facility. This approach can offer more personalized care and convenience, potentially improving recovery outcomes by allowing patients to remain in a familiar environment. ^{5 10 11 12 13}

What is the purpose of this trial?

We will perform a parallel-group multicenter patient-level randomized controlled evaluation of skilled nursing facility care at home. Patients typically referred to a skilled nursing facility following hospitalization will be eligible for enrollment. Instead of admission to a skilled nursing facility, participants will receive care from a technology-enabled team in their own homes or will be allocated to receive care in a traditional skilled nursing facility setting.

Eligibility Criteria

This trial is for adults over 18 who need skilled nursing facility care after hospitalization. It's for stroke patients not covered by insurance, those recommended for rehabilitative therapy, and surgical trauma patients able to bear weight and transfer with minimal help. Participants must have lived at home before hospitalization and be likely to return home after short-term rehab.

Inclusion Criteria

I can move with minimal help after surgery.

I had a stroke and need rehab not covered by insurance, not qualifying for long-term care.

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

Exclusion Criteria

My home lacks the space needed for sleep, eating, and therapy.

Clinical: Acute delirium noted by RAH liaison requiring more than one caregiver

Clinical: Requires durable medical equipment not already in place at home and excluded below

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Rehabilitation

Participants receive rehabilitation care either at home or in a skilled nursing facility

Up to 6 months

Follow-up

Participants are monitored for 30-day readmission or mortality after discharge from rehab

30 days

Treatment Details

Interventions

• Skilled Nursing Facility Care at Home

Trial Overview The study compares receiving skilled nursing facility care at home versus traditional in-facility care post-hospitalization. Patients are randomly placed into two groups: one receives tech-supported home care, while the other gets standard in-facility services.

Participant Groups

Group I: Usual skilled nursing facility care Active Control 1 Intervention

Control subjects will receive care at a skilled nursing facility as per usual.

Group II: Rehab at home Active Control 1 Intervention

Intervention subjects will receive care in their home from a specialized care team.

Who Is Running the Clinical Trial?

Brigham and Women's Hospital

Lead Sponsor

Trials

1,694

Recruited

14,790,000+

Boston Medical Center

Collaborator

Trials

410

Recruited

890,000+

Cambridge Health Alliance

Collaborator

Trials

65

Recruited

22,400+

Findings from Research

Patients transitioning from a skilled nursing facility (SNF) back to home face significant challenges, including unmet information needs regarding medication management and therapy, which can impact their recovery and independence.

The study highlights the importance of providing individualized in-home support immediately after discharge from the SNF to enhance patient outcomes and prevent adverse effects, emphasizing that maintaining independence at home is a key goal for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Complex Transitions from Skilled Nursing Facility to Home: Patient and Caregiver Perspectives. Carnahan, JL., Inger, L., Rawl, SM., et al.[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]

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]

In a study of 140 patients in a skilled nursing facility (SNF), the Patient Health Questionnaire (PHQ-9) for depression was identified as the only significant predictor of improvement in gait speed during their stay.

Despite 87% of patients showing a meaningful improvement in overall physical function, a significant portion (69%) still had low SPPB scores at discharge, indicating a high risk for future disability and adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predictors of Functional Change in a Skilled Nursing Facility Population. Gustavson, AM., Falvey, JR., Forster, JE., et al.[2020]

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]

Patients from post-acute and long-term care (PA/LTC) settings, while only 4.4% of the emergency department (ED) population, accounted for 21% of all adverse events (AEs), indicating they experience a higher rate of harm compared to non-PA/LTC patients.

Most AEs in PA/LTC patients were present upon arrival at the ED, primarily related to patient care (39%), medication (34%), and infections (16%), suggesting that these patients may have more severe underlying health issues that need to be addressed for quality improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-Acute and Long-Term Care Patients Account for a Disproportionately High Number of Adverse Events in the Emergency Department. Griffey, RT., Schneider, RM., Adler, L., et al.[2021]

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 consensus workshop with 31 healthcare professionals identified and ranked common adverse events in community care, highlighting the need for better understanding of how these events affect care quality.

The workshop emphasized the importance of further research to establish standardized definitions of adverse events and to prioritize research questions that can improve patient safety in community care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. Masotti, P., Green, M., Shortt, S., et al.[2022]

In a study of 600 home healthcare records in Sweden, 74% of identified adverse events were classified as nursing-sensitive, indicating that registered nurses play a crucial role in preventing these incidents.

Most of the nursing-sensitive events, such as falls and pressure ulcers, were deemed preventable, highlighting the need for improved nursing care and risk assessment in home healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring nursing-sensitive events in home healthcare: A national multicenter cohort study using a trigger tool. Nilsson, L., Lindblad, M., Johansson, N., et al.[2023]

Stroke patients in Medicare skilled nursing facilities experience varying levels of rehabilitation effectiveness based on the facility's focus and resources.

Facilities that prioritize rehabilitation and community discharge, and offer more intensive therapy from a diverse range of skilled professionals, achieve better patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Rehabilitation in Nursing Homes. Kramer, AM., Schlenker, RE., Eilertsen, TB., et al.[2015]

Approximately 69% of rural Medicare beneficiaries who received acute care in urban hospitals returned for skilled nursing care (SNC) near their homes, indicating a strong preference for local care.

Factors influencing the likelihood of receiving SNC near home included race, gender, age, distance from the SNC facility, and the ownership status of the hospital providing acute care, suggesting that policy changes should consider these variables to improve access to local care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Characteristics Influence Whether Rural Beneficiaries Receiving Care From Urban Hospitals Return Home for Skilled Nursing Care? Hoffman, AF., Pink, GH., Kirk, DA., et al.[2021]

Patients who underwent rehabilitation in inpatient rehabilitation facilities (IRFs) showed better post-stroke health outcomes, such as higher rates of community discharge and lower all-cause mortality, compared to those in skilled nursing facilities (SNFs).

However, rehabilitation in IRFs was associated with higher costs than in SNFs, indicating a trade-off between improved outcomes and increased expenses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Postacute Care Setting, Facility Characteristics, and Poststroke Outcomes: A Systematic Review. Alcusky, M., Ulbricht, CM., Lapane, KL.[2019]

A new home care rehabilitation nursing team was developed at a large agency in northern Virginia, focusing on providing specialized care for patients after hospital discharge.

This innovative team offers in-service programs, consultations, and case management for various medical conditions, highlighting the growing importance of rehabilitation nursing in home care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The rehabilitation nursing team in the home healthcare setting. Neal, LJ.[2019]

References

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

Complex Transitions from Skilled Nursing Facility to Home: Patient and Caregiver Perspectives. [2022]

2. 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]

3. 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]

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

Predictors of Functional Change in a Skilled Nursing Facility Population. [2020]

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

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

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

Post-Acute and Long-Term Care Patients Account for a Disproportionately High Number of Adverse Events in the Emergency Department. [2021]

7. 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]

8. Canada pubmed.ncbi.nlm.nih.gov

Adverse events in community care: developing a research agenda. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Exploring nursing-sensitive events in home healthcare: A national multicenter cohort study using a trigger tool. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Stroke Rehabilitation in Nursing Homes. [2015]

11. England pubmed.ncbi.nlm.nih.gov

What Characteristics Influence Whether Rural Beneficiaries Receiving Care From Urban Hospitals Return Home for Skilled Nursing Care? [2021]

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

Postacute Care Setting, Facility Characteristics, and Poststroke Outcomes: A Systematic Review. [2019]

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

The rehabilitation nursing team in the home healthcare setting. [2019]