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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03577002
Other study ID # PLC-1609-36277
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date December 14, 2022

Study information

Verified date June 2018
Source Oregon Health and Science University
Contact LeAnn Michaels
Phone 503-494-1583
Email michaell@ohsu.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Background and Significance:

Many people die after living with chronic conditions that have a broadly predictable course. This should give patients and families the opportunity to consider what is most important to them and plan for the care they wish to receive in their final months and at the end of life. However, in many cases health care defaults to more testing and treatments, creating a potential mismatch between healthcare services and what patients and families want.

Serious illness care planning occurs once a patient with advanced illness reaches a life expectancy of one to two years. Patients face a wide range of choices that can profoundly affect their quality of life. Planning for the last months and days may improve quality of life, by assuring health care supports patient goals and that preferences for life-sustaining interventions honored. For many patients, this planning should occur in the primary care setting, but primary care practices are over-extended, clinicians and staff are often uncomfortable discussing prognosis, and patients and families often do not ask.

The Serious Illness Care Program (SICP) provides a comprehensive implementation strategy, training modules, and a structured conversation guide to promote realistic and compassionate discussions with seriously ill patients in any health care setting. SICP is widely used, having trained hundreds of clinicians and used with thousands of patients. It contributes to the quadruple aims of optimizing healthcare performance through improving patient experience and appropriate utilization of resources, increasing population health, and improving the work life of clinicians. The challenge is that it is unclear whether whether targeting clinicians or entire teams is more efficient and effective when implementing SICP in primary care.

Study Aims:

The study will fill this critical gap by comparing two models of SICP in primary care: clinician-focused SICP and team-based SICP. In the clinician-focused model, a patient's primary care clinician is responsible for serious illness care planning, while in the team-based model, tasks are purposefully shared across roles. This cluster-randomized trial has the following aims:

- AIM 1. Assess the comparative effectiveness in primary care of team-based vs. primary clinician-focused SICP to achieve the long-term outcomes of concordance of care with patient goals and more time at home for patients with prognoses of two years of life or less.

- AIM 2. Assess the comparative effectiveness in primary care of a team-based SICP vs. clinician-focused SICP on place of death and family bereavement in cases where the patient dies during the study period, as well as additional secondary short term and intermediate outcomes including patient, family and clinician satisfaction with communication and decisions and quality of life.

- AIM 3. Identify determinants of successful implementation of the two different models of SICP across varying settings, with a focus on the comparison of practices in the U.S. and Canada and on practice-level characteristics.

Overall study design A cluster-randomized controlled trial (cRCT) conducted in primary care practices recruited from seven practice-based research networks (PBRNs) in the U.S. and Canada. The practices will be randomly assigned to implement either the primary care clinician-focused model or the team-based model. A cRCT is proposed because the two models cannot be implemented simultaneously in the same practice. SICP requires changes in work flow and different training is required for the clinician-focused and team-based models.

Main components of the intervention and comparators The clinician-focused model provides training and standard infrastructure support within the practice, similar to what would be provided for any primary care clinician activity. The team-based model splits the serious illness care conversation and planning into its components and these are shared across team members and may be spread over time. The composition of the teams and how they divide their tasks will be allowed to vary across practices and patients; this is necessary and realistic as staffing patterns and resources vary across practices and ACP should be customized to patient needs.

Study population The target population is adults living in the community with serious illnesses and their families. The study will be conducted in a minimum of 36 primary care practices in seven primary care PBRNs (five in the U.S., two in Canada). Each PBRN will recruit a minimum of six practices to enroll 130 patients for a total of 1260 enrolled, so that with attrition, over 750 will be available for analysis.

Primary and secondary outcomes The primary outcomes are patient-centered. These are: a) care that corresponds to patient goals and b) time spent at home. Assuring goal-concordant care is the overarching purpose of the SICP. Patient outcomes will be measured at enrollment, six months, and one year of follow-up. If the patient dies during the study period, place of death will be recorded and a family member contacted to complete a bereavement survey.

Secondary outcomes will also include intermediate and proximal or short-term outcomes for patients and families including patient and caregiver quality of life, depression and anxiety, satisfaction with communication, decision quality, engagement and acceptability of the SICP program and model to patients.

Analytic methods Analytic models will be refined with the input of the Research Project Partnership (Steering Committee), including patient and clinician stakeholder representatives as well as experts in biostatistics. Analysis will be conducted under an intention to treat assumption with multiple imputation procedures and selection models for missing data. Multilevel modeling will be used to account for clustering at the practice (cluster) and individual level, and interaction terms will be included in the analysis to identify potential heterogeneity of treatment effects.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 1260
Est. completion date December 14, 2022
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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

Study Design


Intervention

Other:
Serious Illness Care Program (SICP)
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

Locations

Country Name City State
n/a

Sponsors (7)

Lead Sponsor Collaborator
Oregon Health and Science University Duke University, Laval University, University of Colorado, Denver, University of Iowa, University of Toronto, University of Wisconsin, Madison

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Cumulative time spent at home, patient-reported questionnaires Days at home will be reported over a 6-month range and will be compared between arms. Patients will report number of days spent in a hospital, nursing home or post-acute care home and number of trips to the emergency department during the last 6-month period. The number of days and ED trips reported will be combined then subtracted from the number of days in the 6-month reporting period to arrive a final number of days at home. This measure will be compared between both study arms. 12 months after enrollment
Secondary Generalized Anxiety Disorder (GAD-7) Participant assessment of anxiety using the Generalized Anxiety Disorder 7-item scale (GAD7) using 4-point scale for seven anxiety questions where low scores indicate less anxiety and high scores are higher levels of anxiety symptoms and a single composite score is calculated. Baseline, 6 months and 12 months after enrollment
Secondary Patient Health Questionnaire (PHQ-9) - Depression Participant assessment of depression using the Patient Health Questionnaire depression test questionnaire (PHQ-9) scale using 4-point scale for nine depression questions where low scores indicate less depressive and high scores are higher levels of depressive symptoms and a single composite score is calculated. Baseline, 6 months and 12 months after enrollment
Secondary Patient-reported outcomes for individuals living with chronic conditions Participant assessment of health, quality of life, mental health, satisfaction with social activities and roles, daily activities of living, anxiety/depression, sleep and pain using the PROMIS Global Health 10 short form Baseline, 6 months and 12 months after enrollment
Secondary SICP acceptability Participant assessment of the SICP conversation and program using and adapted SICP-developed Patient Acceptability Survey Baseline, 6 months and 12 months after enrollment
Secondary SICP experience Participant assessment of the SICP conversation and program using and adapted SICP-developed Patient Experience Survey Baseline, 6 months and 12 months after enrollment
Secondary Quality of communication Participant rating of the communication with the clinician or care team using a subset of questions from the Quality of Community questionnaire which uses an 11-point scale on 13 questions to rate care from the worst I could imagine (low score) to the very best I could imagine (high score), with a summed total score Baseline, 6 months and 12 months after enrollment
Secondary Shared decision making for healthcare decisions Measurement of shared decision-making using questionnaires to measure different aspects of making healthcare decisions, such as engagement, sureness, difficulty making a decision, and level of distress or remorse after making a decision. Each of these shared decision-making subscales will be scored Baseline, 6 months and 12 months after enrollment
Secondary Hospice use Participant report of use of hospice or palliative care services Baseline, 6 months and 12 months after enrollment
Secondary Detailed items on goal-concordant care Patient reports on confidence in future care, trust in providers and family, and advance care planning processes responding to 10-point scale or yes/no questions. 6 months and 12 months after enrollment
Secondary Global rating of goal-concordant care, patient-reported Comparison between arms of whether care received corresponds to patient goals. This will be assessed at 6 months. 6 months after enrollment
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