Respiratory Disease Management

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543217
• Other study ID #: 201201116
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Barnes-Jewish Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: December 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Adults greater than 18 years of age and less than 64 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 emergency department (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:

• 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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Other:
• RT management
Patients assigned to the RT management arm will receive a 1-hour educational in-service conducted by a respiratory therapist case manager. The patient education session will include general information about COPD, direct observation of inhaler techniques, a review and adjustment of outpatient COPD medications, smoking cessation counseling, recommendations concerning influenza and pneumococcal vaccinations, encouragement of regular exercise, and instruction in hand hygiene.
• Ususal care
Routine respiratory care.

Locations

Country	Name	City	State
United States	Barnes-Jewish Hospital	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Barnes-Jewish Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The combined number of hospital admissions and ED visits for a COPD exacerbation	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.	6-month follow-up period
Secondary	Hospitalizations and ED visits for other causes	Number of times a subject is hospitalized or visit the ED during the study period.	up to 3 months
Secondary	Hospital and intensive care unit (ICU) lengths of stay	the number of days a subject is in the intensive care unit	6 months
Secondary	Respiratory medication use	prescribed respiratory medications dose and usage	6 months
Secondary	All causes of mortality	documentation of all causes of mortality	6 months