Surveying The Outcomes Of Lubiprostone (The STOOL Study) in Nursing Home Residents

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Constipation

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients must meet all of the following criteria to be eligible for the study: Adult men and women nursing home residents; Confirmed diagnosis of CIC using Rome criteria; Prescribed two or more laxatives, at recruitment; Taking 9 or more oral medicines (including prescription, OTC and prn) Free from conditions likely to be fatal within six months; Able to read or understand English; and Able and willing to provide informed consent or has a guardian/agent who can provide consent. Exclusion Criteria: Currently pregnant; Presence of megacolon; Presence of rectal sigmoid cancer; Presence of colon cancer; Presence of anal incompetence; Conditions likely to be fatal within six months; Taking 8 or fewer medicines; Enrolled in hospice; Non-English speaking patients; and Unwilling or unable to provide informed consent and has no guardian/agent. Expected to be discharged within 3 months.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lubiprostone<br>Subjects switching from current bowel medicines to lubiprostone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the overall reduction in the number of oral medicines taken by each NH resident at enrollment and at 60 days. |  | 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) |  | 60 days | 
| 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) |  | 60 days | 
| To compare the occurrence of fecal incontinence during a 60-day period prior to initiating Lubiprostone with a 60 day period after initiating Lubiprostone. |  | 60 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Constipation, Nursing Home, Quality Indicator