Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents
The purpose is to assess the efficacy, clinical outcomes, and potential Quality Indicator benefits associated with the use of Lubiprostone in nursing home residents with a confirmed diagnosis of chronic idiopathic constipation.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Surveying The Outcomes Of Lubiprostone (The STOOL Study): The Effect of Lubiprostone on Reducing the Number of Medications Prescribed to Nursing Home Residents and Its Impact on Selected Quality Indicators|
- To determine the overall reduction in the number of oral medicines taken by each NH resident at enrollment and at 60 days. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- Reduce the number of oral medicines being taken by any nursing home resident from 9 or more to fewer than 9. (Quality Indicator Number 6) [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- To compare the occurrence of fecal impaction during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone. (Quality Indicator Number 11) [ Time Frame: 60 days ] [ Designated as safety issue: No ]
- To compare the occurrence of fecal incontinence during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
|Study Start Date:||November 2009|
|Estimated Study Completion Date:||November 2010|
|Estimated Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
Subjects switching from current bowel medicines to lubiprostone
The study is a prospective, observational, open-label, non-placebo, controlled study to measure the effects of Lubiprostone on CIC in nursing home residents. All clinical sites will follow a common protocol using standardizes definitions in which eligible patients will be asked to participate in the proposed study. During the course of the study, various selected parameters will be measured and compared to establish the clinical efficacy of Lubiprostone in the treatment of CIC.
The study sample (N=105) will be comprised of nursing home residents with a confirmed diagnosis of CIC. A power analysis generated a sample size of 97 residents. To protect the validity of the test, 8 residents were added to the final study sample to allow for losses to followup. Therefore, a final sample size of 105 residents was identified for the study.
Patients meeting the inclusion criteria will be recruited for participation in the study. 3 sites in Central Florida with multiple Nursing Homes per site will be recruited to participate in the proposed study.
|United States, Florida|
|Geriatric Medical Associates|
|Brooksville, Florida, United States|
|Cassellberry Family Practice|
|Casselberry, Florida, United States|
|Melbourne, Florida, United States|
|Principal Investigator:||Malcolm R Fraser, MD||Synergy Health Solutions|