Joan Russo Archives - Implementation Science at UW

✪ Association of organizational culture and climate with variation in the clinical outcomes of collaborative care for maternal depression in community health centers

Abstract:

Background

Organizational factors may help explain variation in the effectiveness of evidence-based clinical innovations through implementation and sustainment. This study tested the relationship between organizational culture and climate and variation in clinical outcomes of the Collaborative Care Model (CoCM) for treatment of maternal depression implemented in community health centers.

Method

Organizational cultures and climates of 10 community health centers providing CoCM for depression among low-income women pregnant or parenting were assessed using the organizational social context (OSC) measure. Three-level hierarchical linear models tested whether variation in culture and climate predicted variation in improvement in depression symptoms from baseline to 6.5-month post-baseline for N = 468 women with care ±1 year of OSC assessment. Depression symptomology was measured using the Patient Health Questionnaire (PHQ-9).

Results

After controlling for patient characteristics, case mix, center size, and implementation support, patients served by centers with more proficient cultures improved significantly more from baseline to 6.5-month post-baseline than patients in centers with less proficient cultures (mean improvement = 5.08 vs. 0.14, respectively, p = .020), resulting in a large adjusted effect size of dadj = 0.78. A similar effect was observed for patients served by centers with more functional climates (mean improvement = 5.25 vs. 1.12, p < .044, dadj = 0.65). Growth models indicated that patients from all centers recovered on average after 4 months of care. However, those with more proficient cultures remained stabilized whereas patients served by centers with less proficient cultures deteriorated by 6.5-month post-baseline. A similar pattern was observed for functional climate.

Conclusions

Variation in clinical outcomes for women from historically underserved populations receiving Collaborative Care for maternal depression was associated with the organizational cultures and climates of community health centers. Implementation strategies targeting culture and climate may improve the implementation and effectiveness of integrated behavioral health care for depression.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

✪ Integrating pragmatic and implementation science randomized clinical trial approaches: a PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) analysis

Abstract:

Background

Over the past two decades, pragmatic and implementation science clinical trial research methods have advanced substantially. Pragmatic and implementation studies have natural areas of overlap, particularly relating to the goal of using clinical trial data to leverage health care system policy changes. Few investigations have addressed pragmatic and implementation science randomized trial methods development while also considering policy impact.

Methods

The investigation used the PRagmatic Explanatory Continuum Indicator Summary-2 (PRECIS-2) and PRECIS-2-Provider Strategies (PRECIS-2-PS) tools to evaluate the design of two multisite randomized clinical trials that targeted patient-level effectiveness outcomes, provider-level practice changes and health care system policy. Seven raters received PRECIS-2 training and applied the tools in the coding of the two trials. Descriptive statistics were produced for both trials, and PRECIS-2 wheel diagrams were constructed. Interrater agreement was assessed with the Intraclass Correlation (ICC) and Kappa statistics. The Rapid Assessment Procedure Informed Clinical Ethnography (RAPICE) qualitative approach was applied to understanding integrative themes derived from the PRECIS-2 ratings and an end-of-study policy summit.

Results

The ICCs for the composite ratings across the patient and provider-focused PRECIS-2 domains ranged from 0.77 to 0.87, and the Kappa values ranged from 0.25 to 0.37, reflecting overall fair-to-good interrater agreement for both trials. All four PRECIS-2 wheels were rated more pragmatic than explanatory, with composite mean and median scores ≥ 4. Across trials, the primary intent-to-treat analysis domain was consistently rated most pragmatic (mean = 5.0, SD = 0), while the follow-up/data collection domain was rated most explanatory (mean range = 3.14–3.43, SD range = 0.49–0.69). RAPICE field notes identified themes related to potential PRECIS-2 training improvements, as well as policy themes related to using trial data to inform US trauma care system practice change; the policy themes were not captured by the PRECIS-2 ratings.

Conclusions

The investigation documents that the PRECIS-2 and PRECIS-2-PS can be simultaneously used to feasibly and reliably characterize clinical trials with patient and provider-level targets. The integration of pragmatic and implementation science clinical trial research methods can be furthered by using common metrics such as the PRECIS-2 and PRECIS-2-PS. Future study could focus on clinical trial policy research methods development.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

✪ Population-based implementation of behavioral health detection and treatment into primary care: early data from New York state

Abstract:

Background

The Collaborative Care Model is a well-established, evidence-based approach to treating depression and other common behavioral health conditions in primary care settings. Despite a robust evidence base, real world implementation of Collaborative Care has been limited and very slow. The goal of this analysis is to better describe and understand the progression of implementation in the largest state-led Collaborative Care program in the nation—the New York State Collaborative Care Medicaid Program.

Data are presented using the RE-AIM model, examining the proportion of clinics in each of the model’s five steps from 2014 to 2019.

Methods

We used the RE-AIM model to shape our data presentation, focusing on the proportion of clinics moving into each of the five steps of this model over the years of implementation. Data sources included: a New York State Office of Mental Health clinic tracking database, billing applications, quarterly reports, and Medicaid claims.

Results

A total of 84% of clinics with which OMH had an initial contact [n = 611clinics (377 FQHCs and 234 non-FQHCs)] received some form of training and technical assistance. Of those, 51% went on to complete a billing application, 41% reported quarterly data at least once, and 20% were able to successfully bill Medicaid. Of clinics that reported data prior to the first quarter of 2019, 79% (n = 130) maintained Collaborative Care for 1 year or more. The receipt of any training and technical assistance was significantly associated with our implementation indices: (completed billing application, data reporting, billing Medicaid, and maintaining Collaborative Care). The average percent of patient improvement for depression and anxiety across 155 clinics that had at least one quarter of data was 44.81%. Training and technical assistance source (Office of Mental Health, another source, or both) and intensity (high/low) were significantly related to implementation indices and were observed in FQHC versus non-FQHC samples.

Conclusions

Offering Collaborative Care training and technical assistance, particularly high intensity training and technical assistance, increases the likelihood of implementation. Other state-wide organizations might consider the provision of training and technical assistance when assisting clinics to implement Collaborative Care.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

An effectiveness-implementation hybrid trial study protocol targeting post-traumatic stress disorder and comorbidity

Abstract:

Background

Each year in the USA, 1.5–2.5 million Americans are so severely injured that they require inpatient hospitalization. Multiple conditions including posttraumatic stress disorder (PTSD), alcohol and drug use problems, depression, and chronic medical conditions are endemic among physical trauma survivors with and without traumatic brain injuries.

Methods/Design

The trauma survivors outcomes and support (TSOS) effectiveness-implementation hybrid trial is designed to test the delivery of high-quality screening and intervention for PTSD and comorbidities across 24 US level I trauma center sites. The pragmatic trial aims to recruit 960 patients. The TSOS investigation employs a stepped wedge cluster randomized design in which sites are randomized sequentially to initiate the intervention. Patients identified by a 10-domain electronic health record screen as high risk for PTSD are formally assessed with the PTSD Checklist for study entry. Patients randomized to the intervention condition will receive stepped collaborative care, while patients randomized to the control condition will receive enhanced usual care. The intervention training begins with a 1-day on-site workshop in the collaborative care intervention core elements that include care management, medication, cognitive behavioral therapy, and motivational-interviewing elements targeting PTSD and comorbidity. The training is followed by site supervision from the study team. The investigation aims to determine if intervention patients demonstrate significant reductions in PTSD and depressive symptoms, suicidal ideation, alcohol consumption, and improvements in physical function when compared to control patients. The study uses implementation science conceptual frameworks to evaluate the uptake of the intervention model. At the completion of the pragmatic trial, results will be presented at an American College of Surgeons’ policy summit. Twenty-four representative US level I trauma centers have been selected for the study, and the protocol is being rolled out nationally.

Discussion

The TSOS pragmatic trial simultaneously aims to establish the effectiveness of the collaborative care intervention targeting PTSD and comorbidity while also addressing sustainable implementation through American College of Surgeons’ regulatory policy. The TSOS effectiveness-implementation hybrid design highlights the importance of partnerships with professional societies that can provide regulatory mandates targeting enhanced health care system sustainability of pragmatic trial results.

Trial registration

ClinicalTrials.gov NCT02655354. Registered 27 July 2015.

^{**This abstract is posted with permission under the Creative Commons Attribution 4.0 International License**}

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Research and Practice

Abstract:

Background

Method

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal Trials

Abstract:

Background

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal BMC Health Services Research

Abstract:

Background

Methods

Results

Conclusions

Authors:

✪ Open Access

Read the full text in the open access journal Implementation Science

Abstract:

Background

Methods/Design

Discussion

Trial registration