Hypotension, Orthostatic
Conditions
Keywords
Aging, Blood pressure, Hypotension, Orthostatic, Rehabilitation
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.
Interventions
OTHERTreatment Phase 1
* Patient Education * Physical Therapy Exercises * Increased Salt Intake * Elevation of head of bed with 2-4 inch wedge * Medication Review by MD, Pharma
DRUGTreatment Phase 2
Subjects receive Treatment Phase 2 if they are still orthostatic after receiving Treatment Phase 1. * Fludrocortisone * Salt tablet
OTHERTreatment Phase 3
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Admitted to Vancouver VA Nursing Home or Rehabilitation ward
Exclusion criteria
* Unable to stand upon admission * Hospice admission * Respite admission
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Recruitment details
341 subjects were recruited. These subjects were recruited from all admits to the rehabilitation unit.
Pre-assignment details
Exclusion criteria included subjects who: couldn't stand, were admitted for respite, and were anticipated to only be on station for less than 7 days.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Stepped intervention consisting of three treatment phases
Treatment 1 :
Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist
Treatment 2 : Fludrocortisone Salt tablets
Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center | 341 |
| Total | 341 |
Baseline characteristics
| Characteristic | Arm 1 |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 341 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 75 years STANDARD_DEVIATION 8 |
| Region of Enrollment United States | 341 participants |
| Sex: Female, Male Female | 41 Participants |
| Sex: Female, Male Male | 300 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 341 |
| serious Total, serious adverse events | 6 / 341 |
Outcome results
Primary
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.
Time frame: Last three blood pressures prior to discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm 1 | Orthostatic Hypotension at Discharge | 96 participants |