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The Coordination Toolkit and Coaching (CTAC) project aims to disseminate strategies for coordination of care for high-risk Veterans via an online toolkit, while evaluating the benefits of adding a distance-coaching strategy to assist sites with deploying the toolkit's tools. The project's focus is on care coordination across outpatient settings.
This multi-site project provides: 1) An online toolkit to support better care coordination for vulnerable patients visiting primary care, 2) Random assignment of participating clinics to either a toolkit or a combined toolkit/distance coaching strategy, and 3) A quality improvement approach with "plan-do-study-act" cycles of improvement, designed to support clinics in a locally initiated effort.
The project is recruiting clinics with the goal of improving Veteran experience of care (as measured by a survey called the Hassles Scale).
Background: High-risk Veterans are defined as individuals who are at increased risk for poor clinical outcomes and higher use of unplanned health services relative to their non-high-risk counterparts. These Veterans typically have multiple chronic health problems and are vulnerable to gaps in care due to impaired physical, psychological, and/or social functioning. Despite efforts to integrate care through VA's Patient Aligned Care Teams (PACT) in primary care, deficits in care coordination persist. In VA, most high-risk Veterans are managed in primary care rather than a specialty service. PACT was expected to improve care coordination by creating the care manager role for the PACT teamlet nurse. However, there have been significant challenges in implementing the care manager role as intended. Many of the care coordination challenges involve the "medical neighborhood" outside of PACT.
To improve the quality of care coordination in outpatient care and also develop better methods for spreading innovations, the Coordination Toolkit and Coaching project was funded by VA's Quality Enhancement Research Initiative (QUERI). This project develops and pilots an online toolkit and distance-based coaching process, and then compares the effectiveness of the toolkit alone to the combination of the toolkit plus distance coaching for improving VA patients' experience of care. Both toolkit and combined toolkit/coaching strategies have been used individually in VA quality improvement initiatives, and each strategy has been compared individually to other alternatives. However, to the investigators' knowledge, these strategies have not formally been compared head-to-head.
Additional Outcome Information: The project's primary outcome is a measure of patient experience, the Health System Hassles Scale. This 16-item scale asks patients questions such as whether their medications are being refilled on time, whether they were given information about why they were referred to a specialist, whether there has been poor communication between different doctors or clinics, or whether there have been disagreements between doctors about the patient's diagnosis or the best treatment for the patient.
Sample Size Calculations: The sample size calculation for this study is based on a simple presumption of a difference-in-differences analysis (across the two time points) for the comparison of the two implementation strategies. The primary outcome is the Health System Hassles Scale. The investigators assume 12 clinics in the study (6 per study group), which will be viewed as clusters in order to evaluate the sample size. Since the number of patients per cluster may vary, the investigators assume a coefficient of variation of cluster sizes of about 0.9. With an effect size of 0.3 standard deviations (which is considered to be a small to medium effect size in Cohen's terminology) for the difference-in-difference analysis and an intra-cluster correlation of 0.023 (based on preliminary evaluation of prior data), then with 80% power and two-sided 5% significance level, 149 patients per clinic are needed for a total of 1788 patients (evenly divided between the two groups).
Statistical Analysis Plan: The primary endpoint of the Health System Hassles Scale will be compared between the two implementation groups (toolkit and combined toolkit/coaching) using a difference-in-differences (between the two time points: baseline and 12 months) analysis adjusted for the clustering by clinic. This analysis will be performed initially with a general linear model using the between time point difference as the dependent variable and study group as the independent variable, with clinic as the clustering variable (and, thus, using an appropriately chosen variance-covariance matrix). A further adjustment model may incorporate appropriate covariates including patient-level factors, such as gender, age, and use of non-VA care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toolkit only | Active Comparator | Clinics in this arm are given access to an online care coordination toolkit. |
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| Toolkit plus coaching | Experimental | Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Toolkit | Other | The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. |
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| Measure | Description | Time Frame |
|---|---|---|
| Health Care System Hassles Scale | The primary outcome was the 16-item Health Care System Hassles Scale. Recognized as a measure of care coordination, the Hassles questionnaire lists problems that patients may encounter with their general healthcare, as opposed to their care experience with one specific visit or provider. The questionnaire prompts patients to indicate how much situations such as "lack of information about why you've been referred to a specialist" have been a problem, using a 5-point scale ranging from 0 -4. Ratings were dichotomized (0 = "Not a problem at all" vs. 1 = any level of problem indicated) and summed to yield a hassles count ranging from 0 to 16, with higher scores indicating more hassles. | Baseline and 12 months' follow-up |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Avram Ganz, MD PhD MPH | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073-1003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34479654 | Derived | Olmos-Ochoa TT, Fenwick KM, Ganz DA, Chawla N, Penney LS, Barnard JM, Miake-Lye IM, Hamilton AB, Finley EP. Reflective writing: a tool to support continuous learning and improved effectiveness in implementation facilitators. Implement Sci Commun. 2021 Sep 3;2(1):98. doi: 10.1186/s43058-021-00203-z. | |
| 34391443 | Derived |
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Patient survey data were collected cross-sectionally at baseline and 12-months' follow-up to measure clinic outcomes. For the primary outcome (Health Care System Hassles Scale), both baseline and follow-up data are presented in the "outcomes" section; the primary measure of effectiveness depends on the change in outcome from baseline to follow-up.
We recruited and enrolled VA primary care clinics from October 2016 to June 2018 using a multi-pronged approach, including teleconference presentations and direct outreach to regional and national leadership. Enrolled clinics participated in a 12-month quality improvement project.
| ID | Title | Description |
|---|---|---|
| FG000 | Toolkit Only | Clinics in this arm are given access to an online care coordination toolkit. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. |
| FG001 | Toolkit Plus Coaching | Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline participant data attributed to analyzed units (i.e., the 12 primary care clinics) come from 2484 clinic participants who responded to a cross-sectional baseline survey at the 12 clinics. Of these individuals, 40 reported receiving no VA care (the clinics being analyzed are part of the VA) in the past 12 months, so they were excluded from further analysis. Data on the remaining 2444 respondents are presented here.
| ID | Title | Description |
|---|---|---|
| BG000 | Toolkit Only | Clinics in this arm are given access to an online care coordination toolkit. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. |
| BG001 | Toolkit Plus Coaching |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Health Care System Hassles Scale | The primary outcome was the 16-item Health Care System Hassles Scale. Recognized as a measure of care coordination, the Hassles questionnaire lists problems that patients may encounter with their general healthcare, as opposed to their care experience with one specific visit or provider. The questionnaire prompts patients to indicate how much situations such as "lack of information about why you've been referred to a specialist" have been a problem, using a 5-point scale ranging from 0 -4. Ratings were dichotomized (0 = "Not a problem at all" vs. 1 = any level of problem indicated) and summed to yield a hassles count ranging from 0 to 16, with higher scores indicating more hassles. | These data derive from two cross-sectional participant surveys at separate (i.e., baseline and follow-up) timepoints. The numbers of participants shown here exceed the numbers presented in the Baseline module because respondents from the surveys are two separate (i.e., independent) samples of participants. Sample sizes for each arm are smaller than reported in the participant flow module because not all survey responses received had valid primary outcome data for analysis. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline and 12 months' follow-up | Primary care clinics | Primary care clinics |
Not applicable (no adverse event data were collected because the unit of randomization and analysis was the primary care clinic).
Although data were collected for this project from patients served by the clinics using a serial cross-sectional design (in order to determine outcomes for each of the clinics at baseline and follow-up), the patients from whom survey data were collected were not human subjects (this project was determined to be non-research by the VA Greater Los Angeles Healthcare System's Institutional Review Board). Thus, patients were not followed longitudinally and no adverse event data were collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Toolkit Only | Clinics in this arm are given access to an online care coordination toolkit. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Avram Ganz, MD, PhD | Veterans Affairs Greater Los Angeles Healthcare System | 310-478-3711 | David.Ganz@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 26, 2015 | Oct 22, 2020 | Prot_SAP_000.pdf |
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| Distance-based coaching | Other | The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic. |
|
| Penney LS, Bharath PS, Miake-Lye I, Leng M, Olmos-Ochoa TT, Finley EP, Chawla N, Barnard JM, Ganz DA. Toolkit and distance coaching strategies: a mixed methods evaluation of a trial to implement care coordination quality improvement projects in primary care. BMC Health Serv Res. 2021 Aug 14;21(1):817. doi: 10.1186/s12913-021-06850-1. |
| 34154670 | Derived | Olmos-Ochoa TT, Ganz DA, Barnard JM, Penney L, Finley EP, Hamilton AB, Chawla N. Sustaining implementation facilitation: a model for facilitator resilience. Implement Sci Commun. 2021 Jun 21;2(1):65. doi: 10.1186/s43058-021-00171-4. |
| 34109545 | Derived | Noel PH, Barnard JM, Leng M, Penney LS, Bharath PS, Olmos-Ochoa TT, Chawla N, Rose DE, Stockdale SE, Simon A, Lee ML, Finley EP, Rubenstein LV, Ganz DA. The Coordination Toolkit and Coaching Project: Cluster-Randomized Quality Improvement Initiative to Improve Patient Experience of Care Coordination. J Gen Intern Med. 2022 Jan;37(1):95-103. doi: 10.1007/s11606-021-06926-y. Epub 2021 Jun 9. |
Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic. |
| BG002 | Total | Total of all reporting groups |
| Primary care clinics |
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| Participants |
| Participants |
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| Sex/Gender, Customized | Count of Participants | Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants | Participants |
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| ID | Title | Description |
|---|---|---|
| OG000 | Toolkit Only | Clinics in this arm are given access to an online care coordination toolkit. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. |
| OG001 | Toolkit Plus Coaching | Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic. |
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| EG001 | Toolkit Plus Coaching | Clinics in this arm are given access to an online care coordination toolkit plus quality improvement support from a distance-based coach. Online Toolkit: The online toolkit provides a set of tools that clinics can use to improve their care coordination processes. Distance-based coaching: The distance-based coach supports included clinics in carrying out a quality improvement project focused on care coordination, either using the online toolkit or other resources determined by the clinic. | 0 | 0 | 0 | 0 | 0 | 0 |
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