Falls, Orthostatic Hypotension
Conditions
Keywords
hypotension, orthostatic, falls, rehabilitation, blood pressure, aging
Brief 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.
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, the investigators 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. The investigators expect that 85% will remain in the study until they are discharged from the NH/rehabilitation unit. Following discharge, the investigators will conduct weekly phone calls to monitor incidence of falls for one month. Subsequently, at 12-months post-discharge, the investigators will conduct a chart review, and the study will terminate. The investigators 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. The investigators performed a pilot study on up to 10 subjects while waiting for adequate staffing to conduct the study with blinded data collectors. Methods The investigators will evaluate OH blood pressure responses, symptoms during standing, and whether there are any specific adverse outcomes related to treatment. In addition, the investigators 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 the investigators' site as well other high-risk patient populations.
Interventions
OTHERMedication review
Current scheduled and as needed medications will be reviewed. Those medications with potentially hypotensive actions will be identified. There will be a joint review by Provider, Pharmacist, and Research staff of those medications and the patient's current clinical status. Plan to continue, decrease, discontinue, or substitute will be made. Examples include substitution of tamsulosin for prazosin in treating benign prostatic hypertrophy, reduction of furosemide dose for patient with stable congestive heart failure, change of sleeping medication from trazodone to lorazepam or zolpidem; change of antidepressant therapy or neuroleptic therapy to one with less hypotensive effects.(Mader 1989); (Poon and Braun 2005);(Mader 2006); (2008).
OTHERNutrition/Salt intake
Current diet orders and meal consumption will be reviewed for sodium and fluid intake. Liberalization of calories, fluid, addition of salt packets to tray, or addition of salty foods/beverages (V8) will be considered as appropriate. Subjects receiving tube feedings will have water flushes replaced with saline flushes. Subjects with a history of congestive heart failure will be liberalized slowly and monitored closely by both the research and treatment team.
OTHEREducation
The research intervention staff will review symptoms of OH with patient/family and explain pathophysiology using a standardized pt information handout (NINDS 2007), subjects will be encouraged to spend maximal time out of bed, and to ambulate on ward as much as possible.
OTHERExercise
The patient's PT and/or Provider will review patient function for the ability to perform appropriate exercises and train patients (Ten Harkel, van Lieshout et al. 1994); (Bouvette, McPhee et al. 1996). Research staff will reinforce using these exercises while standing.
OTHERDrug Recommendations
The protocol permits the study physician to recommend medications for orthostatic hypotension. The patient's clinical team can implement, ignore, or modify these recommendations and only the clinical team can write orders for them. Fludrocortisone may be given 0.05mg at bedtime up to 0.2mg twice a day (Ten Harkel, Van Lieshout et al. 1992). Subjects with a history of congestive heart failure or peripheral edema will be carefully monitored. Sodium chloride tablets may be given starting at 1gm daily and increased to 2 gms twice daily \[Mukai 2002; Grubb 2003\]. Subjects with a history of congestive heart failure or peripheral edema will be carefully reviewed and monitored closely by the research staff and the treatment team. Midodrine may be given 2.5-5mg daily to three times daily \[Low, 1997\]. The dose will be started at 2.5mg every morning and then increased to 5mg every morning, then 5mg every morning and afternoon, then 5mg three times a day.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* All patients admitted to the nursing home, and rehabilitation unit
Exclusion criteria
* 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 * administrative exclusion, such as safety concerns of staff due to violent tendencies of patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Orthostatic Hypotension at Discharge | Duration in rehabilitation facility (time to discharge or transfer) varied for participants. For patients included in the analysis, mean length of stay was 41.2 days (median 31 days), with a range of 10 to 90 days. | Patients were categorized as having orthostatic hypotension at discharge if they had a decrease in systolic BP \> 30 or diastolic pressure \>15 mm Hg at 1 or 3 minutes after standing compared with the mean of the supine values, on two or more readings in the last week of admission. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Falls 30 Days After Discharge | Time to discharge varied for participants. For patients included in the analysis, mean length of stay was 41.2 days (median 31 days), with a range of 10 to 90 days, so 30 days after discharge ranged from 40 days to 120 days. | Falls 30 days after discharge was dichotomized to indicate whether a patient had at least one fall during the 30 days after discharge versus no falls. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Arm 1 Usual rehab care | 177 |
| Arm 2 Treatment for, and prevention of, orthostatic hypotension
Medications will be reviewed to identify those with potentially hypotensive actions. After joint review by Provider, Pharmacist, and Research staff, a plan to continue, decrease, discontinue, or substitute will be made. Examples include substitution of tamsulosin for prazosin in treating benign prostatic hypertrophy, reduction of furosemide dose for patient with stable congestive heart failure, change of sleeping medication from trazodone to lorazepam or zolpidem; change of antidepressant therapy or neuroleptic therapy to one with less hypotensive effects.(Mader 1989); (Poon and Braun 2005);(Mader 2006); (2008).
Nutrition/Salt intake: Current diet orders and meal consumption will be reviewed for sodium and fluid intake. Liberalization of calories, fluid, addition of salt packets to t | 178 |
| Total | 355 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharged in first 2 weeks | 17 | 16 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Arm 1 | Arm 2 | Total |
|---|---|---|---|
| Age, Continuous | 67.2 years STANDARD_DEVIATION 10.5 | 65.0 years STANDARD_DEVIATION 11.7 | 66.1 years STANDARD_DEVIATION 11.1 |
| Education | 13.6 years STANDARD_DEVIATION 2.3 | 13.6 years STANDARD_DEVIATION 2.5 | 13.6 years STANDARD_DEVIATION 2.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 156 Participants | 163 Participants | 319 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 18 Participants | 11 Participants | 29 Participants |
| Falls in past month Missing | 9 Participants | 7 Participants | 16 Participants |
| Falls in past month No | 113 Participants | 112 Participants | 225 Participants |
| Falls in past month Yes | 55 Participants | 59 Participants | 114 Participants |
| Falls in past year | 1 Falls | 1 Falls | 1 Falls |
| Location Admitted From Home | 29 Participants | 32 Participants | 61 Participants |
| Location Admitted From Homeless | 1 Participants | 0 Participants | 1 Participants |
| Location Admitted From Nursing Home | 8 Participants | 5 Participants | 13 Participants |
| Location Admitted From Other | 2 Participants | 3 Participants | 5 Participants |
| Location Admitted From Outside Hospital | 23 Participants | 22 Participants | 45 Participants |
| Location Admitted From VA Hospital | 114 Participants | 116 Participants | 230 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 13 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants | 18 Participants | 36 Participants |
| Race (NIH/OMB) White | 143 Participants | 151 Participants | 294 Participants |
| Sex: Female, Male Female | 13 Participants | 10 Participants | 23 Participants |
| Sex: Female, Male Male | 164 Participants | 168 Participants | 332 Participants |
| Smoker Current | 42 Participants | 54 Participants | 96 Participants |
| Smoker Former | 98 Participants | 84 Participants | 182 Participants |
| Smoker Missing | 5 Participants | 6 Participants | 11 Participants |
| Smoker Never | 32 Participants | 34 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 13 / 177 | 14 / 178 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 22 / 177 | 26 / 178 |
Outcome results
Primary
Orthostatic Hypotension at Discharge
Patients were categorized as having orthostatic hypotension at discharge if they had a decrease in systolic BP \> 30 or diastolic pressure \>15 mm Hg at 1 or 3 minutes after standing compared with the mean of the supine values, on two or more readings in the last week of admission.
Time frame: Duration in rehabilitation facility (time to discharge or transfer) varied for participants. For patients included in the analysis, mean length of stay was 41.2 days (median 31 days), with a range of 10 to 90 days.
Population: Analyses were restricted to patients for which OH status could be determined at both baseline and discharge. This required at least four blood pressure assessments, with at least two assessments each in separate weeks.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Orthostatic Hypotension at Discharge | 39 Participants |
| Arm 2 | Orthostatic Hypotension at Discharge | 44 Participants |
p-value: 0.695% CI: [0.67, 1.99]Regression, Logistic
Secondary
Falls 30 Days After Discharge
Falls 30 days after discharge was dichotomized to indicate whether a patient had at least one fall during the 30 days after discharge versus no falls.
Time frame: Time to discharge varied for participants. For patients included in the analysis, mean length of stay was 41.2 days (median 31 days), with a range of 10 to 90 days, so 30 days after discharge ranged from 40 days to 120 days.
Population: Analysis restricted to patients with post-discharge falls data.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Arm 1 | Falls 30 Days After Discharge | 18 Participants |
| Arm 2 | Falls 30 Days After Discharge | 20 Participants |
p-value: 0.395% CI: [0.74, 3.24]Regression, Logistic