NCT03577002

Brief Summary

This project compares two models of the Serious Illness Care Program (SICP) in primary care: clinician-focused SICP and team-based SICP. Discussion and planning for serious illness care can help patients identify what is most important to them and assure they receive care that best matches their goals and values, such as spending more time at home or not being in pain.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,120

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2019

Longer than P75 for not_applicable

Geographic Reach
2 countries

7 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 31, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
8 months until next milestone

Study Start

First participant enrolled

February 28, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

May 6, 2021

Status Verified

May 1, 2021

Enrollment Period

3.1 years

First QC Date

May 31, 2018

Last Update Submit

May 5, 2021

Conditions

Congestive Heart FailureCancerChronic Obstructive Pulmonary DiseaseCerebrovascular AccidentFrail Elderly SyndromeCardiovascular Diseases

Keywords

Advance care planningPatient-provider communicationsInterdisciplinary teamsPractice-based research networksCluster-randomized controlled trialPrimary care

Outcome Measures

Primary Outcomes (1)

  • Global rating of goal-concordant care, patient-reported

    Comparison between arms of whether care received corresponds to patient goals. This will be assessed at 12 months.

    12 months after enrollment

Secondary Outcomes (11)

  • Cumulative time spent at home, patient-reported questionnaires

    12 months after enrollment

  • Generalized Anxiety Disorder (GAD-7)

    Baseline, 6 months and 12 months after enrollment

  • Patient Health Questionnaire (PHQ-9) - Depression

    Baseline, 6 months and 12 months after enrollment

  • Patient-reported outcomes for individuals living with chronic conditions

    Baseline, 6 months and 12 months after enrollment

  • SICP acceptability

    Baseline, 6 months and 12 months after enrollment

  • +6 more secondary outcomes

Study Arms (2)

Clinician SICP

ACTIVE COMPARATOR

Advance care planning between primary care clinician and the patient/family using the Serious Illness Care Program (SICP)

Other: Serious Illness Care Program (SICP)

Team SICP

ACTIVE COMPARATOR

Advance care planning between team members and the patient/family using the Serious Illness Care Program (SICP)

Other: Serious Illness Care Program (SICP)

Interventions

Serious Illness Care Program (SICP)OTHER

SICP includes the Serious Illness Conversation Guide, which provides patient-tested language for initial and follow-up conversations; training materials, including didactic materials and case studies for structured role playing; and implementation guidance including recommended approaches to identifying appropriate patients and templates for documentation of conversations

Clinician SICPTeam SICP

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Can provide verbal consent
  • Be an adult 18 years of age or older
  • Has a serious illness(es) or condition(s) that is likely to limit the patient's life expectancy to less than 2 years as defined by using clinical intuition or a patient identification algorithm when possible
  • Is community-dwelling or is planned to be discharged to a community-based setting
  • Can speak, read and write in English, French or Spanish
  • Has had an initial advance care planning (ACP) conversation at a primary care practice participating in this project.

You may not qualify if:

  • Patients may not already be enrolled in hospice
  • Patients may not currently be in an intensive care unit or hospital with no expectation of discharge
  • Patient may not be in an institution (e.g., nursing home) or awaiting nursing home placement in the near future

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

State Networks of Colorado Ambulatory Practices and Partners

Aurora, Colorado, 80045, United States

Location

Iowa Research Network

Iowa City, Iowa, 52242, United States

Location

Duke Primary Care Research Consortium

Durham, North Carolina, 27705, United States

Location

Oregon Rural Practice-based Research Network

Portland, Oregon, 97239, United States

Location

Wisconsin Research and Education Network

Madison, Wisconsin, 53175, United States

Location

University of Toronto Practice-based Research Network

Toronto, Ontario, Canada

Location

Quebec Practice-based Research Network

Québec, Quebec, Canada

Location

Related Publications (6)

  • Totten AM, Fagnan LJ, Dorr D, Michaels LC, Izumi SS, Combe A, Legare F. Protocol for a Cluster Randomized Trial Comparing Team-Based to Clinician-Focused Implementation of Advance Care Planning in Primary Care. J Palliat Med. 2019 Sep;22(S1):82-89. doi: 10.1089/jpm.2019.0117.

    PMID: 31486729BACKGROUND

  • Gomes Souza L, Archambault PM, Asmaou Bouba D, Dofara SG, Guay-Belanger S, Cortez Ghio S, Gadio S, Izumi SS, Michaels L, Paquette JS, Totten AM, Legare F; Meta-LARC ACP Cluster Randomized Trial team. Impact of a team-based versus individual clinician-focused training approach on primary healthcare professionals' intention to have serious illness conversations with patients: A theory-informed process evaluation embedded within a cluster randomized trial. PLoS One. 2025 Mar 26;20(3):e0298994. doi: 10.1371/journal.pone.0298994. eCollection 2025.

    PMID: 40138335DERIVED

  • Asmaou Bouba D, Gomes Souza L, Dofara SG, Guay-Belanger S, Gadio S, Mochcovitch D, Paquette JS, Izumi SS, Archambault P, Totten AM, Rivest LP, Legare F. Long-Term Effects of Individual-Focused and Team-Based Training on Health Professionals' Intention to Have Serious Illness Conversations: A Cluster Randomised Trial. J CME. 2024 Nov 3;13(1):2420475. doi: 10.1080/28338073.2024.2420475. eCollection 2024.

    PMID: 39502858DERIVED

  • Ma JE, Lowe J, Berkowitz C, Kim A, Togo I, Musser RC, Fischer J, Shah K, Ibrahim S, Bosworth HB, Totten AM, Dolor R. Provider Interaction With an Electronic Health Record Notification to Identify Eligible Patients for a Cluster Randomized Trial of Advance Care Planning in Primary Care: Secondary Analysis. J Med Internet Res. 2023 May 12;25:e41884. doi: 10.2196/41884.

    PMID: 37171856DERIVED

  • Izumi SS, Caron D, Guay-Belanger S, Archambault P, Michaels L, Heinlein J, Dorr DA, Totten A, Legare F. Development and Evaluation of Serious Illness Conversation Training for Interprofessional Primary Care Teams. J Palliat Med. 2023 Sep;26(9):1198-1206. doi: 10.1089/jpm.2022.0268. Epub 2023 Apr 11.

    PMID: 37040304DERIVED

  • Schmidt ME, Daly JM, Xu Y, Levy BT. Improving Iowa Research Network Patient Recruitment for an Advance Care Planning Study. J Prim Care Community Health. 2021 Jan-Dec;12:21501327211009699. doi: 10.1177/21501327211009699.

    PMID: 33840295DERIVED

Related Links

MeSH Terms

Conditions

Heart FailureNeoplasmsPulmonary Disease, Chronic ObstructiveStrokeCardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular Diseases

Study Officials

  • Annette Totten, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • France Legare, MD, PhD

    Universite Laval

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 31, 2018

First Posted

July 5, 2018

Study Start

February 28, 2019

Primary Completion

April 1, 2022

Study Completion

July 1, 2023

Last Updated

May 6, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will share

The study protocol has been published after ClinicalTrials.gov registration and IRB approval and is now listed in the citations. Data will released in accordance with the funder's policy (PCORI) after the end of the project. Results tables will be submitted to ClinicalTrials.gov

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
Around 12/1/2021 and after the final report acceptance by PCORI or the publication of the primary results which ever comes first in accordance with PCORI policy
Access Criteria
Criteria will be determined to align with PCORI policy at the time the project ends.

Locations

US(5)CA(2)