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

NCT03012256 | Completed

• 1 other identifier: 294080
• Study Type: interventional
• Target: 896
• Locations: 1 country
• Sites: 3

Brief Summary

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?

Conditions

Heart Failure; Copd

Keywords

Cardio-Respiratory Disease Management; Chronic Disease Management; Cluster-randomized Trial; Multi-component Intervention; DIVERT Scale; Frail Elderly; Interprofessional Care; Pragmatic Trial; Targeted Intervention; Home Care

Outcome Measures

Primary Outcomes (4)

• The difference in days to first unplanned emergency department visit (hazard rate)

  As identified from NACRS data set

  Up to six months from baseline

• The difference in total care costs controlling for length of stay

  As identified in administrative (service cost) data sets

  Up to six months from baseline

• Changes in patient activation (patient activation questionnaire)

  As identified from PAM measure

  Baseline, 2 months, 4 months, 6 months

• The difference in the number of symptoms

  As identified from RAI-HC data set

  Baseline, 2 months, 4 months, 6 months

Secondary Outcomes (2)

• The difference in the number of unplanned emergency department visits

  Up to six months from baseline

• Description of health-related quality of life (quality of life questionnaire)

  Baseline, 4 months, 6 months

Study Arms (2)

Cardio-respiratory management model

EXPERIMENTAL

Additional home care management includes medication reconciliation, self-care education, advanced care planning, as well as physician communication and transfer protocols

Other: Cardio-respiratory management model

Control

NO INTERVENTION

Home care (standard of care)

Interventions

Cardio-respiratory management model OTHER

Includes scheduled nurse-led self-management support (based on a training program, and tool-kit), advanced care and goal planning, clinical pharmacist education reconciliation, team case rounds, Situation, Background, Assessment and Recommendation (SBAR) communication protocol with primary care, and a standardized transition package

Cardio-respiratory management model

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Long-stay home care clients living in a noninstitutional setting (i.e. Admitted to home care and receive comprehensive clinical assessment (RAI-HC))
• DIVERT score of 9, 10, 14, or 15 (i.e. at least one cardio-respiratory symptom (chest pain, dyspnea, dizziness, irregular pulse) and at least one cardiac condition (congestive heart failure or coronary artery disease))

You may not qualify if:

• Clients receiving palliative care (i.e. Prognosis of less than six months to live at time of assessment (Q. K8e from RAI-HC))
• Clients receiving dialysis (Q. P2g from RAI-HC)

Sponsors & Collaborators

• McMaster University: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Canadian Frailty Network: collaborator
• Hamilton Niagara Haldimand Brant Local Health Integration Network: collaborator
• Western Health: collaborator
• Vancouver Island Health Authority: collaborator

Study Sites (3)

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

Western Health

Corner Brook, Newfoundland and Labrador, A2H 7E5, Canada

Location

Hamilton Niagara Haldimand Brant Local Health Integration Network

Hamilton, Ontario, L8J 0G5, Canada

Location

Related Publications (3)

• Costa AP, Hirdes JP, Bell CM, Bronskill SE, Heckman GA, Mitchell L, Poss JW, Sinha SK, Stolee P. Derivation and validation of the detection of indicators and vulnerabilities for emergency room trips scale for classifying the risk of emergency department use in frail community-dwelling older adults. J Am Geriatr Soc. 2015 Apr;63(4):763-9. doi: 10.1111/jgs.13336.

  PMID: 25900490 BACKGROUND

• Schumacher, C., Lackey, C., Haughton, D., Peirce, T., Boscart, V. M., Davey, M., Harkness, K., Heckman, G. A., Junek, M., McKelvie, R., Mitchell, L., Sinha, S. K., & Costa, A. P. (2018). A chronic disease management model for home care patients with cardio-respiratory symptoms: the DIVERT-CARE Intervention. Canadian Journal of Cardiovascular Nursing, 28(3), 18-26.

  BACKGROUND

• Costa AP, Schumacher C, Jones A, Dash D, Campbell G, Junek M, Agarwal G, Bell CM, Boscart V, Bronskill SE, Feeny D, Hebert PC, Heckman GA, Hirdes JP, Lee L, McKelvie RS, Mitchell L, Sinha SK, Davis J, Priddle T, Rose J, Gillan R, Mills D, Haughton D. DIVERT-Collaboration Action Research and Evaluation (CARE) Trial Protocol: a multiprovincial pragmatic cluster randomised trial of cardiorespiratory management in home care. BMJ Open. 2019 Dec 15;9(12):e030301. doi: 10.1136/bmjopen-2019-030301.

  PMID: 31843821 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrew Costa, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Schlegel Chair in Clinical Epidemiology & Aging

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: January 6, 2017
• Study Start: February 6, 2018
• Primary Completion: May 15, 2020
• Study Completion: May 15, 2020
• Last Updated: August 19, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)