Clinical Trial: Orthostatic Hypotension in Rehabilitation Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Orthostatic Hypotension in Rehabilitation Patients
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 Summary:
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.
Sponsor: VA Office of Research and Development
Current Primary Outcome: Orthostatic Hypotension at Discharge [ Time Frame: Last three blood pressures prior to discharge ]
Original Primary Outcome: Decrease the prevalence of OH at the time compared with historical controls
Current Secondary Outcome:
Original Secondary Outcome:
- Decrease in rate of OH blood pressure at end point of study
- Decrease in OH symptoms end of study
- Increase in Functional Independence Measurement (FIM) score at end of study
Information By: VA Office of Research and Development
Dates:
Date Received: June 30, 2005
Date Started: November 2005
Date Completion:
Last Updated: March 18, 2016
Last Verified: March 2016