Orthostatic Hypotension in Rehabilitation Patients

Study Overview
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Brief Summary
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The purpose of this study is to determine the prevalence and clinical course of orthostatic hypotension (OH) on a rehabilitation and nursing home unit during their inpatient stay and to initiate a standardized, interdisciplinary treatment plan for patients with OH and determine the effect of treatment on the clinical course of OH during their inpatient stay.

Detailed Description
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This study is a prospective, quasi-experiment conducted in two consecutive phases. During the observation phase, eligible patients are identified and followed through their usual course of care in the nursing home/rehabilitation unit. During the intervention phase, patients enrolled who have OH will receive the intervention. Patients will be enrolled over two research phases and the investigators expect to evaluate 459 subjects. This research program will occur over a three-year period. Methods: During Phase I, baseline prevalence and natural history of OH will be determined by: enrolling consecutive appropriate subjects (able to stand, not end of life care) from a rehabilitation and nursing home unit and measuring OH 3 times weekly over their inpatient stay. In addition, chart review of diagnoses, medications, functional status, nutrition, and adverse events will be evaluated and correlated with clinical status. During Phase II, the investigators will implement a standardized, interdisciplinary (MD/RN/PT/Dietician) treatment plan for patients with OH. This will include chart review of diagnoses, medications, functional status, nutrition, adverse events, and correlation with clinical status. The goals of the interventions are to identify and treat the underlying causes of OH in rehabilitation patients. Based upon the comprehensive assessment, intervention participants will receive a standardized, interdisciplinary treatment regime.

Official Title
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Orthostatic Hypotension in Rehabilitation Patients

Conditions
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Hypotension, Orthostatic

Intervention / Treatment
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* Other: Treatment Phase 1
* Drug: Treatment Phase 2
* Other: Treatment Phase 3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Admitted to Vancouver VA Nursing Home or Rehabilitation ward Exclusion Criteria: Unable to stand upon admission Hospice admission Respite admission

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment Phase 1<br>Stepped intervention consisting of treatment phase 1, 2 and 3. Subjects whose orthostatic hypotension is resolved after treatment phase 1 will not receive new treatments (phase 2 and 3) | Other: Treatment Phase 1<br>* Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharma<br>Drug: Treatment Phase 2<br>* Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1. Fludrocortisone Salt tablet<br>* Other names: Florinef;Other: Treatment Phase 3<br>* Subjects still experiencing orthostatic hypotension after receiving Treatment Phases 1 and 2 move on to Treatment Phase 3. Individualized treatment is based on subspecialty or orthostatic hypotension consultation at the medical center. Subjects are followed for the duration of their hospital stay, on average 4 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Orthostatic Hypotension at Discharge | Participants are assessed for orthostatic hypotension up to one time per day. The outcome measure is the last three days prior to discharge that blood pressures were assessed for orthostatic hypotension. | Last three blood pressures prior to discharge | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Aging, Blood pressure, Hypotension, Orthostatic, Rehabilitation