Respiratory Disease Management - Full Text View

Purpose

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.

Condition	Intervention
Chronic Obstructive Pulmonary Disease	Other: RT management Other: Ususal care

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease)

U.S. FDA Resources

Further study details as provided by Barnes-Jewish Hospital:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

Hospitalizations and ED visits for other causes [ Time Frame: up to 3 months ] [ Designated as safety issue: No ]
Number of times a subject is hospitalized or visit the ED during the study period.
Hospital and intensive care unit (ICU) lengths of stay [ Time Frame: 6 months ] [ Designated as safety issue: No ]
the number of days a subject is in the intensive care unit
Respiratory medication use [ Time Frame: 6 months ] [ Designated as safety issue: No ]
prescribed respiratory medications dose and usage
All causes of mortality [ Time Frame: 6 months ] [ Designated as safety issue: No ]
documentation of all causes of mortality

Estimated Enrollment:	428
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control Ususal care.	Other: Ususal care Routine respiratory care.
Active Comparator: Intervention 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.	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.

Arms

Assigned Interventions

Active Comparator: Control

Ususal care.

Other: Ususal care

Routine respiratory care.

Active Comparator: Intervention

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.

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.

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.

Eligibility

Ages Eligible for Study:	18 Years to 64 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543217

Contacts

Contact: Marin Kollef, MD	314 454-8764	MKOLLEF@dom.wustl.edu
Contact: Peggy Watts, MS	314 362-3767	Peggy.Watts@bjc.org

Locations

United States, Missouri
Barnes-Jewish Hospital	Recruiting
St. Louis, Missouri, United States, 63110
Contact: Marin Kollef, MD 314-454-8764
Contact: Peggy Watts, MS 314 362- 3767

Sponsors and Collaborators

Barnes-Jewish Hospital

Investigators

Principal Investigator:

Marin Kollef, MD

Washington University Medical Center

More Information

No publications provided

Responsible Party:	Peggy Watts, Manager Respiratory Care Services, Barnes-Jewish Hospital
ClinicalTrials.gov Identifier:	NCT01543217 History of Changes
Other Study ID Numbers:	201201116
Study First Received:	February 23, 2012
Last Updated:	January 17, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Barnes-Jewish Hospital:

COPD

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013