Trial Outcomes & Findings for Orthostatic Hypotension Treatment on Rehab Unit (NCT NCT01030874)
NCT ID: NCT01030874
Last Updated: 2021-07-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
356 participants
Primary outcome timeframe
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.
Results posted on
2021-07-01
Participant Flow
Participant milestones
| Measure |
Arm 1/ Inpatient Rehabilitation Care (Usual Care)
Usual rehab care
|
Arm 2 / Treatment for, and Prevention of, Orthostatic Hypotension.
Orthostatic hypotension interventions
|
|---|---|---|
|
Overall Study
STARTED
|
178
|
178
|
|
Overall Study
COMPLETED
|
160
|
162
|
|
Overall Study
NOT COMPLETED
|
18
|
16
|
Reasons for withdrawal
| Measure |
Arm 1/ Inpatient Rehabilitation Care (Usual Care)
Usual rehab care
|
Arm 2 / Treatment for, and Prevention of, Orthostatic Hypotension.
Orthostatic hypotension interventions
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Discharged in first 2 weeks
|
17
|
16
|
Baseline Characteristics
Orthostatic Hypotension Treatment on Rehab Unit
Baseline characteristics by cohort
| Measure |
Arm 1
n=177 Participants
Usual rehab care
|
Arm 2
n=178 Participants
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
|
Total
n=355 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.2 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 11.7 • n=7 Participants
|
66.1 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
164 Participants
n=5 Participants
|
168 Participants
n=7 Participants
|
332 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
156 Participants
n=5 Participants
|
163 Participants
n=7 Participants
|
319 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
143 Participants
n=5 Participants
|
151 Participants
n=7 Participants
|
294 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Education
|
13.6 years
STANDARD_DEVIATION 2.3 • n=5 Participants
|
13.6 years
STANDARD_DEVIATION 2.5 • n=7 Participants
|
13.6 years
STANDARD_DEVIATION 2.4 • n=5 Participants
|
|
Smoker
Never
|
32 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Smoker
Current
|
42 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Smoker
Former
|
98 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
182 Participants
n=5 Participants
|
|
Smoker
Missing
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Location Admitted From
VA Hospital
|
114 Participants
n=5 Participants
|
116 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Location Admitted From
Home
|
29 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Location Admitted From
Nursing Home
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Location Admitted From
Homeless
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Location Admitted From
Outside Hospital
|
23 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Location Admitted From
Other
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Falls in past month
Yes
|
55 Participants
n=5 Participants
|
59 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Falls in past month
No
|
113 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Falls in past month
Missing
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Falls in past year
|
1 Falls
n=5 Participants
|
1 Falls
n=7 Participants
|
1 Falls
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1
n=151 Participants
Usual rehab care
|
Arm 2
n=150 Participants
Treatment for, and prevention of, orthostatic hypotension
Medication 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).
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
|
|---|---|---|
|
Orthostatic Hypotension at Discharge
|
39 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Arm 1
n=161 Participants
Usual rehab care
|
Arm 2
n=159 Participants
Treatment for, and prevention of, orthostatic hypotension
Medication 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).
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
|
|---|---|---|
|
Falls 30 Days After Discharge
|
18 Participants
|
20 Participants
|
Adverse Events
Arm 1
Serious events: 22 serious events
Other events: 0 other events
Deaths: 13 deaths
Arm 2
Serious events: 26 serious events
Other events: 0 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Arm 1
n=177 participants at risk
Usual rehab care
|
Arm 2
n=178 participants at risk
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
|
|---|---|---|
|
General disorders
Hospitalization
|
12.4%
22/177 • Inpatient all-cause mortality was collected ("inpatient" means while in inpatient rehabilitation or in an acute care hospital after transfer from inpatient rehabilitation.) Transfers to an acute care hospital from the rehabilitation facility were also measured. Duration in rehabilitation facility varied for participants included in the analyses (range 10-90 days, median 31 days, mean 41.2 days).
"Other (Not Including Serious) Adverse Events" were not measured and the following fields are not applicable: 1. "Frequency Threshold for Reporting Other (Not Including Serious) Adverse Events" 2. "Total Number Affected by Any Other (Not Including Serious) Adverse Event Above the Frequency Threshold" Because "not applicable" is not an option, we entered zero values in these fields, indicating they were not relevant and were not measured.
|
14.6%
26/178 • Inpatient all-cause mortality was collected ("inpatient" means while in inpatient rehabilitation or in an acute care hospital after transfer from inpatient rehabilitation.) Transfers to an acute care hospital from the rehabilitation facility were also measured. Duration in rehabilitation facility varied for participants included in the analyses (range 10-90 days, median 31 days, mean 41.2 days).
"Other (Not Including Serious) Adverse Events" were not measured and the following fields are not applicable: 1. "Frequency Threshold for Reporting Other (Not Including Serious) Adverse Events" 2. "Total Number Affected by Any Other (Not Including Serious) Adverse Event Above the Frequency Threshold" Because "not applicable" is not an option, we entered zero values in these fields, indicating they were not relevant and were not measured.
|
Other adverse events
| Measure |
Arm 1
n=177 participants at risk
Usual rehab care
|
Arm 2
n=178 participants at risk
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
|
|---|---|---|
|
General disorders
Other (Not Including Serious) Adverse Events
|
—
0/0 • Inpatient all-cause mortality was collected ("inpatient" means while in inpatient rehabilitation or in an acute care hospital after transfer from inpatient rehabilitation.) Transfers to an acute care hospital from the rehabilitation facility were also measured. Duration in rehabilitation facility varied for participants included in the analyses (range 10-90 days, median 31 days, mean 41.2 days).
"Other (Not Including Serious) Adverse Events" were not measured and the following fields are not applicable: 1. "Frequency Threshold for Reporting Other (Not Including Serious) Adverse Events" 2. "Total Number Affected by Any Other (Not Including Serious) Adverse Event Above the Frequency Threshold" Because "not applicable" is not an option, we entered zero values in these fields, indicating they were not relevant and were not measured.
|
—
0/0 • Inpatient all-cause mortality was collected ("inpatient" means while in inpatient rehabilitation or in an acute care hospital after transfer from inpatient rehabilitation.) Transfers to an acute care hospital from the rehabilitation facility were also measured. Duration in rehabilitation facility varied for participants included in the analyses (range 10-90 days, median 31 days, mean 41.2 days).
"Other (Not Including Serious) Adverse Events" were not measured and the following fields are not applicable: 1. "Frequency Threshold for Reporting Other (Not Including Serious) Adverse Events" 2. "Total Number Affected by Any Other (Not Including Serious) Adverse Event Above the Frequency Threshold" Because "not applicable" is not an option, we entered zero values in these fields, indicating they were not relevant and were not measured.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place