Orthostatic Hypotension Treatment on Rehab Unit

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01030874
First received: December 10, 2009
Last updated: October 1, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention
Orthostatic Hypotension
Falls
Other: Medication review
Dietary Supplement: Nutrition/Salt intake
Other: Education
Other: Exercise
Drug: Drug

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Treatment of Orthostatic Hypotension on a Rehabilitation Unit

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Orthostatic hypotension at discharge [ Time Frame: Discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Fall frequency 30 days after discharge [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 350
Study Start Date: October 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Arm 1
Usual rehab care
Experimental: Arm 2
Treatment for, and prevention of, orthostatic hypotension
Other: 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).
Dietary Supplement: 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 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.
Other: Education
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.
Other: Exercise
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.
Drug: Drug
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.

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, we 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. We expect that 85% will remain in the study until they are discharged from the NH/rehabilitation unit. Following discharge, we will conduct weekly phone calls to monitor incidence of falls for one month. Subsequently, at 12-months post-discharge, we will conduct a chart review, and the study will terminate. We 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. We performed a "pilot" study on up to 10 subjects while waiting for adequate staffing to conduct the study with blinded data collectors.

Methods We will evaluate OH blood pressure responses, symptoms during standing, and whether there are any specific adverse outcomes related to treatment. In addition, we 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 our site as well other high-risk patient populations.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Exclusion criteria are:

  • 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, and
  • administrative exclusion, such as safety concerns of staff due to violent tendencies of patient.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01030874

Locations
United States, Oregon
VA Medical Center, Portland
Portland, Oregon, United States, 97201
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Helfand, MD MPH MS Portland VA Medical Center, Portland, OR
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01030874     History of Changes
Other Study ID Numbers: E7278-R
Study First Received: December 10, 2009
Last Updated: October 1, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
hypotension, orthostatic
falls
rehabilitation
blood pressure
aging

Additional relevant MeSH terms:
Hypotension
Hypotension, Orthostatic
Autonomic Nervous System Diseases
Cardiovascular Diseases
Nervous System Diseases
Orthostatic Intolerance
Primary Dysautonomias
Vascular Diseases

ClinicalTrials.gov processed this record on October 30, 2014