Progressing Home Health Rehabilitation for Older Adults

University of Colorado Denver (CU Denver)

Status: Completed

Conditions: Older Adults; Physical Deconditioning

Treatments: Behavioral: Progressive Multi-Component (PMC); Behavioral: Enhanced Usual Care (EUC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02905370

R01NR016209 (U.S. NIH Grant/Contract)

15-2125

Details and patient eligibility

About

This research study explores the effects of a progressive, multi-component intervention following a stay in the hospital or rehabilitation facility. The purpose of this research study is to compare a multi-component intervention (higher intensity exercise, nutritional supplementation, and greater emphasis on functionally enhanced care transitions) with usual care physical therapy.

Full description

Declines in physical function as a result of acute illness are strongly and independently associated with a number of adverse health events for older adults. Home Health (HH) physical therapy may be the ideal venue for addressing these declines in physical function because around 3 million older adults receive HH services following discharge from acute or post-acute facilities. However, as currently structured, HH care does not appear to adequately restore function, as evidenced by poor long-term outcomes and high rates of hospital readmission. Diminished physical function has been particularly implicated as a risk factor for re-hospitalization --older adults with lower levels of ambulatory activity are 6 times more likely to be re-hospitalized than those with greater ambulatory activity. A more intensive approach to HH physical therapy for older adults has great potential to maximize physical function and reduce hospital readmissions. Therefore, the investigators have developed a high intensity home-based, progressive, interdisciplinary, multi-component (PMC) intervention that directly addresses the functional deficits seen after hospitalization. This intervention will include intensive rehabilitation, a care transitions program, and daily protein supplementation. The investigators will conduct a two-arm, randomized clinical trial (RCT) of 200 participants admitted to HH from an acute or post-acute facility. Participants will receive either 1) an intensive, PMC intervention using resistance exercise and evidenced-based motor control training to improve physical function, along with nutritional supplementation and emphasis on functionally enhanced care transitions or 2) usual care (UC) physical therapy. The primary goal of this investigation is to determine if PMC intervention, initiated upon admission to HH, improves physical function, as measured by performance and self-report assessments, more than UC physical therapy. The investigators will also examine the effects on fatigue, balance confidence, and activities of daily living. In an exploratory analysis, the effects of the PMC intervention on re-hospitalization rates, nursing home placement, emergency room visits, and falls after discharge from the acute care hospital will also be examined. All outcomes will be examined at baseline, 30, 60 (primary endpoint), 90 and 180 days. If successful in improving patient function and decreasing re-hospitalization rates, PMC intervention holds potential for future health care cost savings.

Enrollment: 353 patients

Sex: All

Ages: 65 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. 65 years of age and older

2. Referred to home care physical therapy following acute medical deconditioning

3. Have at least 3 comorbid conditions including those listed below:

   • Chronic Obstructive Pulmonary Disease
   • Gastrointestinal Bleed
   • Urinary Tract Infection
   • Pneumonia
   • Chronic ulcerative wounds
   • Diabetes
   • Hypertension
   • Depression/mental health
   • Irritable Bowel Syndrome
   • Hernia
   • Post-op pancreatic surgery
   • Osteoporosis/OA/RA/Gout
   • Heart Disease
   • Hypercholesterolemia
   • Peripheral Arterial Disease
   • Spinal Stenosis
   • Dehydration
   • Syncope
   • Atrial fibrillation
   • Hypo/Hyperthyroid
   • Renal Failure (no dialysis)
   • Post-op bowel surgery
   • Congestive Heart Failure

4. Be ambulatory without human assistance prior to hospitalization

5. Be English-speaking

Exclusion Criteria: (one or more):

1. Acute lower extremity fracture with weight-bearing restriction
2. "Elective" joint replacement surgery
3. Lower extremity amputation
4. Acute cardiac surgery
5. Terminal illness
6. Active cancer treatment in which exercise is contraindicated
7. Deep vein thrombosis/pulmonary embolus (DVT/PE)
8. Recent stroke (within 1 yr)
9. Score of <20 on SLUMS (as of 08.16.2018, revised to exclusion #14)
10. Inability to ambulate 10 feet without human assistance at time of hospital discharge
11. Gait Speed <0.3m/s or >1.0 m/s
12. Progressive neurodegenerative diagnosis (e.g. Parkinson's, MS, ALS)
13. Use of illegal substances
14. Clinical discretion of study physician to exclude patients who are determined to be unsafe and/or inappropriate to participate in high intensity rehabilitation as defined by the inclusion/exclusion criteria
15. Active involvement of Adult Protection Services
16. Current dialysis treatment
17. Prisoners or those on probation or other alternative sentencing

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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353 participants in 3 patient groups

Progressive Multi-Component (PMC)

Experimental group

Description:

High intensity strength training protocol, daily protein supplementation, functionally enhanced transitions of care

Treatment:

Behavioral: Progressive Multi-Component (PMC)

Enhanced Usual Care (EUC)

Active Comparator group

Description:

Low intensity rehabilitation protocol, standard education for nutrition, standard transitions of care Name of Participant Arm updated to "Enhanced Usual Care" from "Usual Care" effective 8/16/18 to distinguish from Passive Comparator "True Usual Care" group.

Treatment:

Behavioral: Enhanced Usual Care (EUC)

True Usual Care (TUC)

No Intervention group

Description:

Real-world home health rehabilitation, real-world education for nutrition, real-world transitions of care, non-randomized observation Participants in the "True Usual Care" group will receive physical therapy following discharge from acute hospitalization. Activities and number of visits are not protocolized and are provided by real world home health care providers per physician orders. Participant Arm added effective 8/16/18.