Clinical trial NCT03063294: Coordination Toolkit and Coaching Project
Official title: Improving PACT Coordination Across Settings and Services (QUE 15-276)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coordination, Administrative
Keywords: Coordination, Administrative
Coaching
Primary Care
Quality Improvement
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2017-02-24
Enrollment: 12
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* VA primary care clinic
* Clinic's facility director must sign a letter of endorsement in support of patients being surveyed about their experience of care
* Identify a clinic champion to serve as point of contact
* Clinic champion has adequate release time to take on a new quality improvement project

Exclusion Criteria:

* Insufficient number of patients to obtain adequate sample size for primary outcome measure.

Primary outcomes:
measure: Health Care System Hassles Scale
timeFrame: Baseline and 12 months' follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: West Los Angeles
country: United States
facility: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
state: California
Study officials:
affiliation: VA Greater Los Angeles Healthcare System, West Los Angeles, CA
name: David Avram Ganz, MD PhD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.