Orthostatic Hypotension Treatment on Rehab Unit
| Status: | Completed |
|---|---|
| Conditions: | Cardiology, Orthopedic |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 99 |
| Updated: | 8/4/2018 |
| Start Date: | October 2011 |
| End Date: | May 2016 |
Effect of Treatment of Orthostatic Hypotension on a Rehabilitation Unit
For patients recovering from acute illness, the ability to stand, walk, climb stairs, and
participate in therapy are critical to their recovery and eventual discharge to the least
restrictive environment. Orthostatic hypotension is a common finding in medically ill adult
and elderly patients and is a potentially reversible contributor to functional impairment.
This 4-year project will be a randomized controlled trial of a
multidisciplinary-multicomponent intervention to determine whether routine identification and
treatment of OH improves functional outcomes such as: balance, fall rates, therapy
participation, length of stay, transfer to acute care hospital, and discharge location.
Routine screening and management of OH may improve outcomes for rehabilitation and long term
care patients, as well other high-risk patient populations.
participate in therapy are critical to their recovery and eventual discharge to the least
restrictive environment. Orthostatic hypotension is a common finding in medically ill adult
and elderly patients and is a potentially reversible contributor to functional impairment.
This 4-year project will be a randomized controlled trial of a
multidisciplinary-multicomponent intervention to determine whether routine identification and
treatment of OH improves functional outcomes such as: balance, fall rates, therapy
participation, length of stay, transfer to acute care hospital, and discharge location.
Routine screening and management of OH may improve outcomes for rehabilitation and long term
care patients, as well other high-risk patient populations.
Objectives Orthostatic hypotension (OH) is a condition that contributes to falls, dizziness,
syncope, transient ischemic attack, and impaired functional status. OH is defined
specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic BP within 3 min
of standing. The objectives of this study are to: (1) Examine the effect of OH treatment on
functional outcomes, and OH prevalence during a subject's inpatient stay, and (2) Evaluate
whether OH treatment during a subject's inpatient stay affects fall prevalence, and
functional outcomes by 12 months after discharge.
Plan This 4-year project will be a randomized controlled trial of a
multidisciplinary-multicomponent intervention to improve OH in patients admitted to Nursing
Home (NH) and rehabilitation settings. During the 37-month enrollment period, the
investigators expect to consent 350 subjects who will be randomized into intervention and
control groups (175 subjects each). During their stay, subjects in the intervention group
will receive a standardized treatment for their OH, or to prevent OH, while those in the
control group will receive usual care. The investigators expect that 85% will remain in the
study until they are discharged from the NH/rehabilitation unit. Following discharge, the
investigators will conduct weekly phone calls to monitor incidence of falls for one month.
Subsequently, at 12-months post-discharge, the investigators will conduct a chart review, and
the study will terminate. The investigators expect 85% of the subjects discharged from the
NH/rehabilitation unit that were enrolled in the study will remain in the study at 12-months
post discharge. The investigators performed a "pilot" study on up to 10 subjects while
waiting for adequate staffing to conduct the study with blinded data collectors.
Methods The investigators will evaluate OH blood pressure responses, symptoms during
standing, and whether there are any specific adverse outcomes related to treatment. In
addition, the investigators will evaluate whether treatment of OH improves: motor functional
independence measure (mFIM) scores, therapy participation, length of stay, transfer to the
acute care hospital, discharge location, and mortality.
Clinical Relevance OH is a very common finding in many medically ill adult and elderly
patients, and is associated with falls, syncope, and hip fractures. More aggressive screening
(possibly the 6th vital sign) and management of this condition may improve outcomes for
rehabilitation and long term care patients at the investigators' site as well other high-risk
patient populations.
syncope, transient ischemic attack, and impaired functional status. OH is defined
specifically as a 20mmHg drop in systolic, and/or a 10mmHg drop in diastolic BP within 3 min
of standing. The objectives of this study are to: (1) Examine the effect of OH treatment on
functional outcomes, and OH prevalence during a subject's inpatient stay, and (2) Evaluate
whether OH treatment during a subject's inpatient stay affects fall prevalence, and
functional outcomes by 12 months after discharge.
Plan This 4-year project will be a randomized controlled trial of a
multidisciplinary-multicomponent intervention to improve OH in patients admitted to Nursing
Home (NH) and rehabilitation settings. During the 37-month enrollment period, the
investigators expect to consent 350 subjects who will be randomized into intervention and
control groups (175 subjects each). During their stay, subjects in the intervention group
will receive a standardized treatment for their OH, or to prevent OH, while those in the
control group will receive usual care. The investigators expect that 85% will remain in the
study until they are discharged from the NH/rehabilitation unit. Following discharge, the
investigators will conduct weekly phone calls to monitor incidence of falls for one month.
Subsequently, at 12-months post-discharge, the investigators will conduct a chart review, and
the study will terminate. The investigators expect 85% of the subjects discharged from the
NH/rehabilitation unit that were enrolled in the study will remain in the study at 12-months
post discharge. The investigators performed a "pilot" study on up to 10 subjects while
waiting for adequate staffing to conduct the study with blinded data collectors.
Methods The investigators will evaluate OH blood pressure responses, symptoms during
standing, and whether there are any specific adverse outcomes related to treatment. In
addition, the investigators will evaluate whether treatment of OH improves: motor functional
independence measure (mFIM) scores, therapy participation, length of stay, transfer to the
acute care hospital, discharge location, and mortality.
Clinical Relevance OH is a very common finding in many medically ill adult and elderly
patients, and is associated with falls, syncope, and hip fractures. More aggressive screening
(possibly the 6th vital sign) and management of this condition may improve outcomes for
rehabilitation and long term care patients at the investigators' site as well other high-risk
patient populations.
Inclusion Criteria:
- All patients admitted to the nursing home, and rehabilitation unit
Exclusion Criteria:
- hospice admission
- respite admission
- long-stay admission
- transplant admission
- inability to stand
- expected length of stay less than 14 days
- patients specifically admitted for treatment of OH
- cognitive dysfunction of such a severity that the admitting provider does not feel the
patient could understand the study and safely participate in the data collection
- administrative exclusion, such as safety concerns of staff due to violent tendencies
of patient
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