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Coordination Toolkit and Coaching Project

Improving PACT Coordination Across Settings and Services (QUE 15-276)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03063294
Acronym
CTAC
Enrollment
12
Registered
2017-02-24
Start date
2017-03-01
Completion date
2020-04-27
Last updated
2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coordination, Administrative

Keywords

Coordination, Administrative, Coaching, Primary Care, Quality Improvement

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.

Interventions

OTHEROnline Toolkit

The online toolkit provides a set of tools that clinics can use to improve their care coordination processes.

OTHERDistance-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.

Sponsors

VA Office of Research and Development
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Health Care System Hassles ScaleBaseline and 12 months' follow-upThe 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.

Countries

United States

Participant flow

Recruitment details

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.

Pre-assignment details

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.

Participants by arm

ArmCount
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.
1,223
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.
6
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.
1,221
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.
6
Total2,456

Baseline characteristics

CharacteristicToolkit OnlyToolkit Plus CoachingTotal
Age, Customized
Age
65 or older
712 Participants751 Participants1463 Participants
Age, Customized
Age
Less than 65
508 Participants463 Participants971 Participants
Age, Customized
Age
Unknown
3 Participants7 Participants10 Participants
Race/Ethnicity, Customized
Race/ethnicity
Asian or Asian-American
74 Participants43 Participants117 Participants
Race/Ethnicity, Customized
Race/ethnicity
Black or African-American
137 Participants142 Participants279 Participants
Race/Ethnicity, Customized
Race/ethnicity
Hispanic
142 Participants182 Participants324 Participants
Race/Ethnicity, Customized
Race/ethnicity
Multi-race/ethnicity
66 Participants74 Participants140 Participants
Race/Ethnicity, Customized
Race/ethnicity
Non-Hispanic White
704 Participants684 Participants1388 Participants
Race/Ethnicity, Customized
Race/ethnicity
Other minority
27 Participants13 Participants40 Participants
Race/Ethnicity, Customized
Race/ethnicity
Unknown race/ethnicity
73 Participants83 Participants156 Participants
Sex/Gender, Customized
Gender
Female
180 Participants181 Participants361 Participants
Sex/Gender, Customized
Gender
Male
1036 Participants1030 Participants2066 Participants
Sex/Gender, Customized
Gender
Other
1 Participants2 Participants3 Participants
Sex/Gender, Customized
Gender
Unknown
6 Participants8 Participants14 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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.

Time frame: Baseline and 12 months' follow-up

Population: 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.

ArmMeasureGroupValue (MEAN)
Toolkit OnlyHealth Care System Hassles ScaleBaseline5.20 units on a scale
Toolkit OnlyHealth Care System Hassles Scale12-month Follow-up4.78 units on a scale
Toolkit Plus CoachingHealth Care System Hassles ScaleBaseline4.71 units on a scale
Toolkit Plus CoachingHealth Care System Hassles Scale12-month Follow-up4.30 units on a scale
Comparison: Zero-inflated negative binomial regression was used to obtain predicted mean Hassles scale scores for the toolkit only clinics and toolkit plus coaching clinics at baseline and follow-up, adjusting for study design and characteristics of survey respondents. The difference-in-difference was then computed as described below, under method of estimation. Bootstrap resampling was used to calculate the 95% confidence intervals around the predicted means and the difference-in-difference.95% CI: [-0.47, 0.5]

Source: ClinicalTrials.gov · Data processed: Feb 22, 2026