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: March 31, 2014
Last verified: March 2014

December 10, 2009
March 31, 2014
October 2011
June 2015   (final data collection date for primary outcome measure)
Orthostatic hypotension at discharge [ Time Frame: Discharge ] [ Designated as safety issue: No ]
Orthostatic hypotension at discharge, fall frequency 6 months after discharge [ Time Frame: 6 months after discharge ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01030874 on ClinicalTrials.gov Archive Site
Fall frequency 30 days after discharge [ Time Frame: 30 days after discharge ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Orthostatic Hypotension Treatment on Rehab Unit
Effect of Treatment of Orthostatic Hypotension on a Rehabilitation Unit

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 39-month enrollment period, we expect to consent 530 subjects that will be randomized into intervention and control groups (265 subjects each). During their stay, subjects in the intervention group will receive a standardized treatment for their OH, while those in the control group will receive usual care. We expect that 85% (n=212/group) 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% (n=180/group) 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 will conduct 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, adherence to treatment recommendations, and whether there are any specific adverse outcomes related to treatment. In addition, we will evaluate whether treatment of OH improves: balance as assessed by posturography, 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
  • Orthostatic Hypotension
  • Falls
  • 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. All intervention subjects will be walked at least one additional time daily (weekdays) by our research/intervention physical therapist, if approved by their Provider and Physical Therapist/Kinesiotherapist/Occupational Therapist.
  • Other: Elevation of head of bed
    For the intervention subjects, the bed will be placed in reverse trendelenberg 3 degrees head up tilt by using a 4" bed wedge. (Ten Harkel, Van Lieshout et al. 1992). If tolerated and if the subject is still orthostatic, then an additional 2 inch wedge will be added to increase the angle to 4 degrees. Subjects will be encouraged to take the bed wedge home at the time of discharge. These wedges were used in our recently completed study, are placed between the frame and the mattress, and are not apparent to the members of the care team. Occasionally they are not used in subjects with severe edema and/or poorly healing extremity wounds.
  • 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 will 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 will 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 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.
  • No Intervention: Arm 1
    Usual rehab care
  • Experimental: Arm 2
    Treatment for, and prevention of, orthostatic hypotension
    Interventions:
    • Other: Medication review
    • Dietary Supplement: Nutrition/Salt intake
    • Other: Education
    • Other: Elevation of head of bed
    • Other: Exercise
    • Drug: Drug
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
530
September 2015
June 2015   (final data collection date for primary outcome measure)

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.
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01030874
E7278-R
Yes
Department of Veterans Affairs
Department of Veterans Affairs
Not Provided
Principal Investigator: Mark Helfand, MD MPH MS Portland VA Medical Center, Portland, OR
Department of Veterans Affairs
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP