NCT02021955: InCasE

Integrating Care After Exacerbation of COPD

Completed NA Results posted Last updated 27 July 2023

What this trial tests

NA trial testing guideline treatment recommendations in Chronic Obstructive Pulmonary Disease in 717 participants. Completed in 31 January 2019.

Timeline

11 February 2015

Primary endpoint
29 November 2018

31 January 2019

Quick facts

Lead sponsor	VA Office of Research and Development
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	health services research
Enrollment	717
Start date	11 February 2015
Primary completion	29 November 2018
Estimated completion	31 January 2019
Sites	2 locations across United States

Drugs / interventions tested

• guideline treatment recommendations

Conditions studied

• Chronic Obstructive Pulmonary Disease — all drugs for Chronic Obstructive Pulmonary Disease →

Sponsor

VA Office of Research and Development — full company profile →

Who can join

Eligibility, any sex, with Chronic Obstructive Pulmonary Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Patients With Hospital Re-admission and Mortality Primary · 180 days post-discharge

Composite measure of hospital readmission for any cause at 180 days and all-cause mortality.

Group	Value	95% CI
Usual Care	84
Guideline Treatment Recommendations	61

COPD-related Patient Quality-of-life (Clinical COPD Questionnaire) Primary · 6 weeks post-discharge

self-report survey of patients' quality-of-life with scores ranging from 0-6 with lower scores representing better health; not all participants completed surveys.

Group	Value	95% CI
Usual Care	3.50	± 1.22
Guideline Treatment Recommendations	2.97	± 1.20

Patients Participants' General Health Status (Veterans RAND 12 Item Health Survey ) Physical Component Score (VR-12 PCS) Secondary · 6 weeks post-discharge

self-report survey of patients' general physical health quality-of-life scored from 0-100 with higher scores indicating better health.

Group	Value	95% CI
Usual Care	29.92	± 12.22
Guideline Treatment Recommendations	33.25	± 11.94

Adverse events — posted to ClinicalTrials.gov

Time frame: 180 days after index hospital discharge. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Usual Care

Serious: 84/191 (44%)

Deaths: 21/191

Guideline Treatment Recommendations

Serious: 68/161 (42%)

Deaths: 15/161

Serious adverse events (1 terms)

Reaction	System	Usual Care	Guideline Treatment Recomm…
Overall number	General disorders	—	—

Other adverse events (1 terms — click to expand)

Reaction	System	Usual Care	Guideline Treatment Recomm…
Non-serious Adverse events	General disorders	—	—

Most-reported serious reactions: Overall number.

Data from ClinicalTrials.gov NCT02021955 adverse events section.

Sponsor's own description

This clinical trial is designed to determine whether an intervention that provides information to primary care providers about gaps in care for their patients recently discharged from hospital for COPD can reduce hospital re-admissions and mortality and improve their patients' quality-of-life.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. Health System Approach to Improve Chronic Obstructive Pulmonary Disease Care after Hospital Discharge: Stepped-Wedge Clinical Trial.
   Au DH, Collins MP, Berger DB, Carvalho PG, et al · · 2022 · cited 15× · PMID 35333140 · DOI 10.1164/rccm.202107-1707oc
2. Primary Care Provider Experience With Proactive E-Consults to Improve COPD Outcomes and Access to Specialty Care.
   Spece LJ, Weppner WG, Weiner BJ, Collins M, et al · · 2023 · cited 2× · PMID 36472622 · DOI 10.15326/jcopdf.2022.0357
3. Abstracts from the 2024 Annual Meeting of the Society of General Internal Medicine
   · 2024