Orthostatic Hypotension in Rehabilitation Patients

Not Applicable

Completed

• Conditions: Hypotension, Orthostatic
• Interventions: Other: Treatment Phase 1; Drug: Treatment Phase 2; Other: Treatment Phase 3

• Registration Number: NCT00117585
• Lead Sponsor: VA Office of Research and Development

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2005-06-30
• Study First Submitted QC: 2005-07-06
• Study First Posted: 2005-07-07
• Study Start: 2005-11
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2013-11-05
• Results First Submitted QC: 2014-06-04
• Results First Posted: 2014-07-04
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-18
• Last Update Posted: 2016-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 341

Inclusion Criteria

• Admitted to Vancouver VA Nursing Home or Rehabilitation ward

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Exclusion Criteria

• Unable to stand upon admission
• Hospice admission
• Respite admission

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Phase 1	Treatment Phase 1	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)
Treatment Phase 1	Treatment Phase 2	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)
Treatment Phase 1	Treatment Phase 3	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)

Primary Outcome Measures

Name	Time	Method
Orthostatic Hypotension at Discharge	Last three blood pressures prior to 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.

Trial Locations

Locations (1)

VA Portland Health Care System, Portland, OR; 🇺🇸 Portland, Oregon, United States