NCT03012256: DIVERT-CARE

The DIVERT-CARE (Collaboration Action Research & Evaluation) Trial

Completed NA Last updated 19 August 2020

What this trial tests

NA trial testing Cardio-respiratory management model in Heart Failure in 896 participants. Completed in 15 May 2020.

Timeline

6 February 2018

Primary endpoint
15 May 2020

15 May 2020

Quick facts

Lead sponsor	McMaster University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	896
Start date	6 February 2018
Primary completion	15 May 2020
Estimated completion	15 May 2020
Sites	3 locations across Canada

Drugs / interventions tested

• Cardio-respiratory management model

Conditions studied

• Heart Failure — all drugs for Heart Failure →
• Copd — all drugs for Copd →

Sponsor

McMaster University

Who can join

19 and older, any sex, with Heart Failure or Copd. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Rationale:

In Canada, home care clients are a large and expanding subgroup of medically complex older adults with relatively poor access to effective chronic disease management. They have double the emergency department utilization rate compared to nursing home residents or other older populations. The investigators previously published a case-finding tool (the Detection of Indicators and Vulnerabilities for Emergency Room Trips (DIVERT) Scale) that has been recommended for chronic disease management case-finding in home care. The investigators recently conducted a pilot trial in Niagara, Canada, of a targeted, person-centered model of supportive cardio-respiratory disease management.

Objectives:

The investigators will evaluate a cardio-respiratory disease management model in home care to manage symptoms and avoid emergency department use. A pan-Canadian, pragmatic cluster-randomized trial will be conducted by a collaboration of trial investigators and public home care providers (i.e., health regions).

The main objective is to evaluate the effectiveness and preliminary cost-effectiveness of a targeted, person-centered cardio-respiratory management model.

The main question is:

P: Among home care clients experiencing cardio-respiratory symptoms (objectively targeted using the DIVERT Scale), I: can a guideline-based, feasible, multi-component/complex, cardio-respiratory management model, C: compared to regular care, O: reduce cardio-respiratory symptoms, reduce/postpone unplanned emergency department (ED) visits, reduce unplanned hospital use, improve patient activation, or improve health-related quality of life for clients, T: over a 6-month follow-up period from baseline?

Publications & conference data

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

1. Self-management interventions for people with chronic obstructive pulmonary disease.
   Schrijver J, Lenferink A, Brusse-Keizer M, Zwerink M, et al · · 2022 · cited 105× · PMID 35001366 · DOI 10.1002/14651858.cd002990.pub4
2. Disease management interventions for heart failure.
   Takeda A, Martin N, Taylor RS, Taylor SJ. · · 2019 · cited 91× · PMID 30620776 · DOI 10.1002/14651858.cd002752.pub4
3. DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care.
   Costa AP, Schumacher C, Jones A, Dash D, et al · · 2019 · cited 10× · PMID 31843821 · DOI 10.1136/bmjopen-2019-030301
4. A qualitative study of home care client and caregiver experiences with a complex cardio-respiratory management model.
   Schumacher C, Dash D, Mowbray F, Klea L, et al · · 2021 · cited 4× · PMID 33962577 · DOI 10.1186/s12877-021-02251-5