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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual Rehabilitation Care | No Intervention | Usual rehab care | |
| Experimental Treatment/Medication Review | Experimental | Treatment for, and prevention of, orthostatic hypotension |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medication review | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Helfand, MD MPH MS | VA Portland Health Care System, Portland, OR | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Portland Health Care System, Portland, OR | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1/ Inpatient Rehabilitation Care (Usual Care) | Usual rehab care |
| FG001 | Arm 2 / Treatment for, and Prevention of, Orthostatic Hypotension. | Orthostatic hypotension interventions |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Excluding one participant that withdrew and did not want data to be included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Usual rehab care |
| BG001 | 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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 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. |
|
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:
Because "not applicable" is not an option, we entered zero values in these fields, indicating they were not relevant and were not measured.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm 1 | Usual rehab care | 13 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | General disorders | Systematic Assessment | This refers to hospitalization in an acute care facility for any reason. Reasons for transfer could include exacerbation of a comorbid condition or an emergent condition. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Other (Not Including Serious) Adverse Events | General disorders | Non-systematic Assessment | Other (Not Including Serious) Adverse Events were not measured or recorded. The threshold for recording was hospitalization or death. |
In 2013 a new PI was appointed. The protocol, practices, and procedures for the study were reviewed, and collection of some data items was discontinued because of measurement problems or a high rate of missing data.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mark Helfand, MD | VAORD | 5032203406 | mark.helfand@va.gov |
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| ID | Term |
|---|---|
| D007024 | Hypotension, Orthostatic |
| ID | Term |
|---|---|
| D054971 | Orthostatic Intolerance |
| D054969 | Primary Dysautonomias |
| D001342 | Autonomic Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| D000090143 | Medication Review |
| D004522 | Educational Status |
| D015444 | Exercise |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D008509 | Medication Systems |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D010346 | Patient Care Management |
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| Nutrition/Salt intake | Other | 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. |
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| Education | Other | 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. |
|
| Exercise | Other | 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. |
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| Drug Recommendations | Other | 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. |
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| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Education | Mean | Standard Deviation | years |
|
| Smoker | Count of Participants | Participants |
|
| Location Admitted From | Count of Participants | Participants |
|
| Falls in past month | Count of Participants | Participants |
|
| Falls in past year | Median | Full Range | Falls |
|
| OG001 | Arm 2 | 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 |
|
|
|
| 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. | Analysis restricted to patients with post-discharge falls data. | Posted | Count of Participants | Participants | 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. |
|
|
|
|
| 177 |
| 22 |
| 177 |
| 0 |
| 0 |
| EG001 | 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 | 14 | 178 | 26 | 178 | 0 | 0 |
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|
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| D007022 | Hypotension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |