Clinical trial NCT01543217: Respiratory Disease Management
Official title: Use of a Respiratory Care Practitioner Disease Management (RCP-DM) Program for Patients Hospitalized With COPD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
Lead sponsor: Barnes-Jewish Hospital
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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.

Primary outcomes:
measure: The combined number of hospital admissions and ED visits for a COPD exacerbation
timeFrame: 6-month follow-up period
Secondary outcomes:
measure: Hospitalizations and ED visits for other causes
timeFrame: up to 3 months
measure: Hospital and intensive care unit (ICU) lengths of stay
timeFrame: 6 months
measure: Respiratory medication use
timeFrame: 6 months
measure: All causes of mortality
timeFrame: 6 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Marin Kollef, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Poot CC, Meijer E, Kruis AL, Smidt N, Chavannes NH, Honkoop PJ. Integrated disease management interventions for patients with chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2021 Sep 8;9(9):CD009437. doi: 10.1002/14651858.CD009437.pub3.
citation: Silver PC, Kollef MH, Clinkscale D, Watts P, Kidder R, Eads B, Bennett D, Lora C, Quartaro M. A Respiratory Therapist Disease Management Program for Subjects Hospitalized With COPD. Respir Care. 2017 Jan;62(1):1-9. doi: 10.4187/respcare.05030. Epub 2016 Nov 29.