Orthostatic Hypotension Treatment on Rehab Unit

NCT01030874 | Completed Results DMC

• 1 other identifier: E7278-R
• Study Type: interventional
• Target: 356
• Locations: 1 country
• Sites: 1

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.

Conditions

Orthostatic Hypotension; Falls

Keywords

hypotension, orthostatic; falls; rehabilitation; blood pressure; aging

Outcome Measures

Primary Outcomes (1)

• 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.

Secondary Outcomes (1)

• 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.

Study Arms (2)

Usual Rehabilitation Care

NO INTERVENTION

Usual rehab care

Experimental Treatment/Medication Review

EXPERIMENTAL

Treatment for, and prevention of, orthostatic hypotension

Other: Medication review; Other: Nutrition/Salt intake; Other: Education; Other: Exercise; Other: Drug Recommendations

Interventions

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).

Also known as: Chart review

Experimental Treatment/Medication Review

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.

Also known as: Review orders, Change nutrition/Salt intake orders

Experimental Treatment/Medication Review

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.

Experimental Treatment/Medication Review

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.

Also known as: Physical therapy

Experimental Treatment/Medication Review

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.

Also known as: Consultant recommendation

Experimental Treatment/Medication Review

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients admitted to the nursing home, and rehabilitation unit

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Hypotension, Orthostatic

Interventions

Medication Review; Educational Status; Exercise; Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Medication Systems; Organization and Administration; Health Services Administration; Patient Care Management; Socioeconomic Factors; Population Characteristics; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Therapeutics; Rehabilitation

Limitations and Caveats

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.

Results Point of Contact

• Title: Mark Helfand, MD
• Organization: VAORD

mark.helfand@va.gov

5032203406

Study Officials

• Mark Helfand, MD MPH MS

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 2009
• First Posted: December 14, 2009
• Study Start: October 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: July 1, 2021
• Results First Posted: July 1, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)