Respiratory Disease Management

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease
• Interventions: Other: Ususal care; Other: RT management

• Registration Number: NCT01543217
• Lead Sponsor: Barnes-Jewish Hospital

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.

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.

Study Timeline

• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-03-02
• Study Start: 2012-07
• Primary Completion: 2015-10
• Study Completion: 2015-12
• Status Verified: 2016-10
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Ususal care	Ususal care.
Intervention	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.

Primary Outcome Measures

Name	Time	Method
The combined number of hospital admissions and ED visits for a COPD exacerbation	6-month follow-up period	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

Name	Time	Method
Hospitalizations and ED visits for other causes	up to 3 months	Number of times a subject is hospitalized or visit the ED during the study period.
Hospital and intensive care unit (ICU) lengths of stay	6 months	the number of days a subject is in the intensive care unit
Respiratory medication use	6 months	prescribed respiratory medications dose and usage
All causes of mortality	6 months	documentation of all causes of mortality

Trial Locations

Locations (1)

Barnes-Jewish Hospital; 🇺🇸 Saint Louis, Missouri, United States