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Developing a Home Telehealth Program to Manage Pressure Ulcers in SCI/D - NCT00624806-44106(Clinical Trial 205004)



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City:  Cleveland
State:  
OH
Zip Code: 44106
Conditions: Spinal Cord Injury
Purpose: The practical impact of this research will be to develop, evaluate and validate the home telehealth disease management protocol items to help patients with spinal cord injury manage/prevent skin breakdown.
Study summary: Spinal cord injury and disorders (SCI/D) is the most costly medical condition in VA and pressure ulcers (PrUs) are a major source of morbidity and mortality and decreased quality of life in the SCI/D population, accounting for about 1/3 of all VA SCI admissions. PrUs are a serious, costly, and life-long complication of SCI/D due to lack of sensation and immobility. Promoting prevention and early detection/reporting of PrUs in the community-dwelling SCI/D population are important goals for VA. VHA has promoted monitoring patients' self-care and non-institutional care needs using in-home messaging devices with disease management protocols (DMPs) to reduce unnecessary duplication in healthcare costs and/or to improve quality of life for individuals with chronic disease conditions by preventing/minimizing the effects of a disease through care coordination. No such DMPs exist for the SCI/D population. Our study objective is to develop the tools for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing PrUs. Specific objectives of the study include: 1) Using an expert panel to validate PrU DMP items, recommending item frequency, prioritizing items (high/medium/low), specifying clinical responses to items; 2) Developing a draft of a standardized protocol relevant to the participating hub and spoke sites for the nurse Care Coordinator to manage patients who develop open skin wounds; 3) Assessing individual telehealth DMP items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) Using information from the provider interviews to develop an instrument to assess staff satisfaction with this method of patient management. A convenience sample of veterans discharged from the Cleveland SCI/D inpatient unit (including patients from the Cleveland SCI Center spoke sites) will be asked to participate in a validation study of the PrU DMP items. Subjects will be randomly assigned to receive either daily (M-F) or weekly calls and asked to respond to the dialogue questions for 2 months. Patients will be stratified according to their risk of developing PrUs, using the Braden Risk Assessment tool. Up to 50 patients will be enrolled over a 2 month period. Interviews will be conducted with patients on a daily or weekly basis, at baseline and the end of study. Patient knowledge, use of self-management strategies and behaviors and satisfaction with the program will be assessed at baseline and 2 months post-discharge. Clinical information, including Braden PrU risk data, nutritional assessment, etc., will be obtained from the electronic medical record. We will also obtain the following information from patients if they experience skin breakdown: wound photos, follow-up with primary care provider at spokes site about further treatment, size, color, dressings/treatment details. The practical impact of this research will be to develop, evaluate and validate the home telehealth DMP items to help patients manage/prevent skin breakdown. VHA has been a leader in the use of distance technology to monitor patients' self-care and non-institutional care needs using an in-home messaging device with disease management protocols (DMPs). This strategy has been used extensively in VA as a method of reducing unnecessary duplication in healthcare costs and/or to improve quality of life for individuals with chronic disease conditions by preventing or minimizing the effects of a disease through care coordination. No such DMPs exist for the SCI/D population. Thus our overall objective for this study is to develop the tools necessary for implementing a new home telehealth program to manage community-dwelling veterans with SCI/D at high risk of developing PrUs. Specific objectives of the study include: 1) Convening an expert panel to validate PrU DMP items, to recommend the frequency for asking specific items, to classify items into high/medium/low priority, and to specify nurse responses to items (based on item priority classification); 2) Developing a draft of a standardized protocol relevant to the participating hub and spoke sites for the nurse Care Coordinator to manage patients who develop open skin wounds; 3) Assessing individual telehealth DMP items by calling a sample of patients on a daily or weekly basis for up to 2 months to determine their validity and 4) Using information from the provider interviews to develop an instrument to assess staff satisfaction with this method of patient management. A convenience sample of veterans discharged from the Cleveland SCI/D inpatient unit (including patients from the Cleveland SCI Center spoke sites) will be asked to participate in a validation study of the PrU DPM items. Subjects will be randomly assigned to receive either daily (M-F) or weekly calls and asked to respond to the dialogue questions for 2 months. Patients will be stratified according to their risk of developing PrUs, using the Braden Risk Assessment tool. UP to 50 patients will be enrolled over a 2 month period. Interviews will be conducted with patients on a daily or weekly basis, at baseline and the end of study. Patient knowledge, use of self-management strategies and behaviors and satisfaction with the program will be assessed at baseline and 2 months post-discharge. Clinical information, including Braden PrU risk data, nutritional assessment, etc., will be obtained from the electronic medical record. We will also obtain the following information from patients if they experience skin breakdown: wound photos, follow-up with primary care provider at spokes site about further treatment, size, color, dressings/treatment details. The practical impact of this research will be to develop, evaluate and validate the home telehealth DMP items to help patients manage/prevent skin breakdown.
Criteria: Inclusion Criteria: - Veterans admitted to Cleveland VA SCI unit or treated in the outpatient clinic (pending) Exclusion Criteria: - No phone - Cognitive impairment
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Data Source: ClinicalTrials.gov
Date Processed: January 19, 2010
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