Respiratory Disease Management
| Tracking Information | |||||||||
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| First Received Date ICMJE | February 23, 2012 | ||||||||
| Last Updated Date | January 17, 2013 | ||||||||
| Start Date ICMJE | July 2012 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
The combined number of hospital admissions and ED visits for a COPD exacerbation [ Time Frame: 6-month follow-up period ] [ Designated as safety issue: No ] Coordinators will use two strategies, First, they will monitor the automated medical record. All inpatient, outpatient, and ED visits to BJC affiliated institutions. Second coordinators will conduct bi-monthly telephone inquires to patients to determine if they had recent hospital or ED visits. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01543217 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Respiratory Disease Management | ||||||||
| Official Title ICMJE | Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD | ||||||||
| Brief Summary | The aim of this study is to reduce the number of subsequent hospital admissions and/or emergency department (ED) visits for hospitalized patients with chronic obstructive pulmonary disease (COPD) by utilizing a respiratory care practitioner-led disease management (RCP-DM) program compared to standard discharge instructions and planning. |
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| Detailed Description | The investigators propose to carry out a prospective, randomized, trial at Barnes-Jewish Hospital (1250-bed urban academic hospital). Eligible patients will be identified by a senior study coordinator who will also obtain informed consent for study participation. Adults greater than 18 years of age and less than 65 years of age will be eligible for enrollment if the lead investigator and the treating physician agree that the patient meets the enrollment criteria which include the following: patients with spirometrically confirmed COPD at high risk for repeat hospitalization or ED visits as predicted by hospital admission or ED visit in the previous 12 months for a COPD exacerbation, chronic home use of oxygen, or a course of systemic corticosteroid therapy in the preceding 12 months. Exclusion criteria include patients not expected to survive their hospitalization, presence of metastatic cancer, bed-bound individuals, non-English speaking patients, and patients unable to provide informed consent. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
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| Condition ICMJE | Chronic Obstructive Pulmonary Disease | ||||||||
| Intervention ICMJE |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 428 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | July 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years to 64 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01543217 | ||||||||
| Other Study ID Numbers ICMJE | 201201116 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Peggy Watts, Barnes-Jewish Hospital | ||||||||
| Study Sponsor ICMJE | Barnes-Jewish Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Barnes-Jewish Hospital | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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