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Orthostatic Hypotension Treatment on Rehab Unit

Information source: Department of Veterans Affairs
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Orthostatic Hypotension; Falls

Intervention: Medication review (Other); Nutrition/Salt intake (Dietary Supplement); Education (Other); Exercise (Other); Drug (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Department of Veterans Affairs

Official(s) and/or principal investigator(s):
Mark Helfand, MD MPH MS, Principal Investigator, Affiliation: VA Portland Health Care System, Portland, OR

Summary

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.

Clinical Details

Official title: Effect of Treatment of Orthostatic Hypotension on a Rehabilitation Unit

Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Orthostatic hypotension at discharge

Secondary outcome: Fall frequency 30 days after discharge

Detailed description: 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, we 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. We expect that 85% will remain in the study until they are discharged from the NH/rehabilitation unit. Following discharge, we will conduct weekly phone calls to monitor incidence of falls for one month. Subsequently, at 12-months post-discharge, we will conduct a chart review, and the study will terminate. We 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. We performed a "pilot" study on up to 10 subjects while waiting for adequate staffing to conduct the study with blinded data collectors. Methods We will evaluate OH blood pressure responses, symptoms during standing, and whether there are any specific adverse outcomes related to treatment. In addition, we 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 our site as well other high-risk patient populations.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- All patients admitted the nursing home, and rehabilitation unit.

Exclusion Criteria: Exclusion criteria are:

- 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, and

- administrative exclusion, such as safety concerns of staff due to violent tendencies

of patient.

Locations and Contacts

VA Portland Health Care System, Portland, OR, Portland, Oregon 97239, United States
Additional Information

Starting date: October 2011
Last updated: August 6, 2015

Page last updated: August 23, 2015

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