Effects of intervention stage completion in an integrated behavioral health and primary care randomized pragmatic intervention trial.

Purpose: A pragmatic, cluster-randomized controlled trial of a comprehensive practice-level, multi-staged practice transformation intervention aimed to increase behavioral health integration in primary care practices and improve patient outcomes. We examined association between the completion of intervention stages and patient outcomes across a heterogenous national sample of primary care practices. Methods: Forty-two primary care practices across the U.S. with co-located behavioral health and 2,426 patients with multiple chronic medical and behavioral health conditions completed surveys at baseline, midpoint and two year follow-up. Effects of the intervention on patient health and primary care integration outcomes were examined using multilevel mixed-effects models, while controlling for baseline outcome measurements. Results: No differences were found associated with the number of intervention stages completed in patient health outcomes were found for depression, anxiety, fatigue, sleep disturbance, pain, pain interference, social function, patient satisfaction with care or medication adherence. The completion of each intervention stage was associated with increases in Practice Integration Profile (PIP) domain scores and were confirmed with modeling using multiple imputation for: Workflow 3.5 (95% CI: 0.9-6.1), Integration Methods 4.6 (95% CI: 1.5-7.6), Patient Identification 2.9 (95% CI: 0.9-5.0), and Total Integration 2.7 (95% CI: 0.7-4.7). Conclusion: A practice-centric flexible practice transformation intervention improved integration of behavioral health in primary care across heterogenous primary care practices treating patients with multiple chronic conditions. Interventions that allow practices to flexibly improve care have potential to help complex patient populations. Future research is needed to determine how to best target patient health outcomes at a population level.

The association of self-perceived changes due to COVID-19 with mental and physical health among adult primary care patients with multiple chronic conditions: A US-based longitudinal study.

Introduction: This study explores the association between self-perceived personal and community changes due to COVID-19 and health among vulnerable primary care patients experiencing multiple chronic conditions. Methods: Between September 2017 and February 2021, we obtained data from 2,426 primary care patients managing multiple chronic conditions from across the United States. We assessed the relationship between self-perceived personal and community changes due to COVID-19 and change in health measured by the PROMIS-29 mental and physical health summary scores, GAD-7 (anxiety), andPHQ-9 (depression), and DASI (functional capacity) adjusting for relevant demographic, neighborhood characteristics, and county covariates. Results: After adjustment, self-perceived personal and community changes due to COVID-19 were associated with significantly worse mental health summary scores (ß = -0.55; 95% Confidence Interval (CI) = -0.72, -0.37), anxiety (ß = 0.28; 95% CI = 0.16, 0.39), depression (ß = 0.35; 95% CI = 0.22, 0.47), and physical health summary scores (ß = -0.44; 95% CI = 0.88, 0.00). There was no association with functional capacity (ß = - 0.05; 95% CI = -0.16, 0.05). Discussion: Among adults managing multiple chronic conditions, self-perceived personal and community changes due to COVID-19 were associated with health. This vulnerable population may be particularly susceptible to the negative effects of COVID-19. As we do not know the long-term health effects of COVID, this paper establishes a baseline of epidemiological data on COVID-19 burden and health among primary care patients with multiple chronic conditions.

The impact of COVID-19 and long COVID on sexual function in cisgender women.

BACKGROUND: Research suggests that COVID-19 impairs sexual function in men, but little is known about the impact of COVID-19 (or long COVID) on sexual function in women. AIM: We sought to compare the sexual function of cisgender women who had never had COVID-19, who had COVID-19 but not long COVID, and who had long COVID, and assessed whether long COVID symptoms and/or emotional distress mediate the relationship between COVID-19 history and sexual function. METHODS: In total, 2329 adult cisgender women were recruited online as study participants. Half of these women reported having had COVID-19, and the other half reported never having had COVID-19. Of those who had COVID-19, 25% (n = 170) reported having long COVID. We compared the mean Female Sexual Function Index (FSFI) scores by using t-tests for each of the primary comparison categories (never COVID vs COVID and only COVID vs long COVID). Four path models were used to test the hypotheses that (1) long COVID symptoms or (2) depression, anxiety, and/or stress assessed with the subscales of the 21-item Depression, Anxiety, and Stress Scale (DASS-21) mediated the relationship between COVID-19 and sexual function. OUTCOMES: Sexual function was measured with the FSFI, long COVID symptoms were assessed using the Centers for Disease Control working symptom set, and emotional distress was measured with the DASS-21. RESULTS: In total, 1313 participants provided data suitable for analysis. The never-COVID group (n = 645, 49.1%) had higher scores on the Desire, Arousal, Lubrication, and Satisfaction subscales of the FSFI (mean [M] [SD] FSFI total Mnever COVID = 27.98 [4.84] vs MCOVID = 27.05 [5.21]) than the combined only-COVID (n = 498, 37.9%) and long-COVID (n = 170, 12.9%) groups. The FSFI subscale scores were significantly higher in the only-COVID group than in the long-COVID group for the Arousal, Lubrication, and Orgasm and lower for the Pain subscales and higher for overall sexual function (FSFI total Monly COVID = 27.49 [5.00] vs Mlong COVID = 25.77 [5.61]. None of the proposed mediation models had adequate model fit. CLINICAL IMPLICATIONS: Clinicians treating cisgender women who have COVID-19 should consider proactively discussing sexual function with their patients and offering available resources. STRENGTHS AND LIMITATIONS: In this study we used a large and diverse sample, but this sample did not include transgender or gender-diverse persons. This study was also correlational; as such, causal conclusions cannot be drawn. Further, the mechanism of action remains unexplained. CONCLUSIONS: The study findings suggest the following: (1) COVID-19 infection is associated with impaired sexual function in cisgender women, and (2) that women with long COVID experienced incrementally more impaired sexual function than women with COVID-19 who did not develop long COVID.

A Cluster Randomized Trial of Primary Care Practice Redesign to Integrate Behavioral Health for Those Who Need It Most: Patients With Multiple Chronic Conditions.

PURPOSE: Patient outcomes can improve when primary care and behavioral health providers use a collaborative system of care, but integrating these services is difficult. We tested the effectiveness of a practice intervention for improving patient outcomes by enhancing integrated behavioral health (IBH) activities. METHODS: We conducted a pragmatic, cluster randomized controlled trial. The intervention combined practice redesign, quality improvement coaching, provider and staff education, and collaborative learning. At baseline and 2 years, staff at 42 primary care practices completed the Practice Integration Profile (PIP) as a measure of IBH. Adult patients with multiple chronic medical and behavioral conditions completed the Patient-Reported Outcomes Measurement Information System (PROMIS-29) survey. Primary outcomes were the change in 8 PROMIS-29 domain scores. Secondary outcomes included change in level of integration. RESULTS: Intervention assignment had no effect on change in outcomes reported by 2,426 patients who completed both baseline and 2-year surveys. Practices assigned to the intervention improved PIP workflow scores but not PIP total scores. Baseline PIP total score was significantly associated with patient-reported function, independent of intervention. Active practices that completed intervention workbooks (n = 13) improved patient-reported outcomes and practice integration (P ≤ .05) compared with other active practices (n = 7). CONCLUSION: Intervention assignment had no effect on change in patient outcomes; however, we did observe improved patient outcomes among practices that entered the study with greater IBH. We also observed more improvement of integration and patient outcomes among active practices that completed the intervention compared to active practices that did not. Additional research is needed to understand how implementation efforts to enhance IBH can best reach patients.

Integrated Behavioral Health in Primary Care Residency and Nonresidency Practices.

BACKGROUND AND OBJECTIVES: Integrated behavioral health (BH) is becoming a preferred model of care for primary care because it improves patient outcomes and satisfaction. Little is known about whether residency practices are consistently modeling this preferred care model relative to real-world nonresidency practices. The study compared levels of BH integration, patient health outcomes, and satisfaction with care between residency practices and nonresidency practices with colocated BH providers. METHODS: Baseline data were collected in 2018-2019 from 44 practices and their adult patients with chronic conditions participating in a cluster-randomized, pragmatic trial to improve BH integration. The sample included 18 (40.9%) residency and 26 (59.1%) nonresidency practices, with 1,817 (45.3%) patients from residency practices and 2,190 (54.7%) patients from nonresidency practices. Outcomes including BH integration levels (the Practice Integration Profile), patient health outcomes (the PROMIS-29), and patient satisfaction with care (the Consultation and Relational Empathy scale) were compared between residency and nonresidency practices using multivariate regression analyses. RESULTS: No differences were found between BH integration levels, patient health outcomes, and patient satisfaction with care between residency and nonresidency practices. In a sample of primary care practices with colocated BH providers, residencies had BH integration and patient outcomes similar to real-world practices. CONCLUSIONS: Primary care practices with residency programs reported comparable levels of BH integration, patient health outcomes, and patient satisfaction compared to practices without residency programs. Both types of practices require interventions and resources to help them overcome challenges associated with dissemination of high levels of BH integration.

Econometric evaluation of implementing a behavioral health integration intervention in primary care settings.

Integrated behavioral health (IBH) is an approach to patient care that brings medical and behavioral health providers (BHPs) together to address both behavioral and medical needs within primary care settings. A large, pragmatic, national study aimed to test the effectiveness and measure the implementation costs of an intervention to improve IBH integration within primary care practices (IBH-PC). Assess the time and cost to practices of implementing a comprehensive practice-level intervention designed from the perspective of clinic owners to move behavioral service integration from co-location toward full integration as part of the IBH-PC study. IBH-PC program implementation costs were estimated in a representative sample of 8 practices using standard micro-econometric evaluation of activities outlined in the implementation workbook, including program implementation tasks, remote quality improvement coaching services, educational curricula, and learning community activities, over a 24-month period. The total median cost of implementing the IBH-PC program across all stages was $20,726 (range: $12,381 - $60,427). The median cost of the Planning Stage was $10,258 (range: $4,625 - $14,840), while the median cost of the Implementation Stage was $9,208 (range: $6,017 - 49,993). There were no statistically significant differences in practice or patient characteristics between the 8 selected practices and the larger IBH-PC practice sample (N=34). This study aimed to quantify the relative costs associated with integrating behavioral health into primary care. Although the cost assessment approach did not include all costs (fixed, variable, operational, and opportunity costs), the study aimed to develop a replicable and pragmatic measurement process with flexibility to adapt to emerging developments in each practice environment, providing a reasonable ballpark estimate of costs associated with implementation to help guide future executive decisions.

This study estimated the cost of implementing a program that helped 8 primary care practices transition from a co-located behavioral health services model to greater integration. Our study was part of a larger study across the United States. The authors found that the per-practice program implementation cost ranged between $12,381 and $60,427 and the median cost was $20,726. Leaders of healthcare organizations that participated in this study thought that these costs represented the work of program implementation and that they were reasonable and acceptable.

Intraclass Correlation and Variance in the Characteristics of Primary Care Patients Managing Chronic Medical and Behavioral Conditions.

Background To avoid statistical errors, researchers who recruit patients from selected medical practices and analyze them at the individual level need to account for the clustered nature of their sample. This is most often done using the intraclass correlation coefficients (ICCs), a measure of how strongly subjects recruited from the same cluster (in this case patients from a clinic) resemble each other. Aims The aim is to support the design of cluster-randomized studies by supplying estimates of variance and ICC of various measures using a population of patients from multiple primary care clinics. Materials and methods ICCs were extracted from a large cluster-randomized pragmatic clinical trial of adult primary care patients managing multiple chronic conditions, the Integrating Behavioral Health and Primary Care study (IBH-PC). IBH-PC collected demographics and patient-reported health outcomes on over 3,000 adults from 44 primary care practices in 13 states across the US. We present estimates of the standard deviation and ICC for gender, race, ethnicity, marital status, employment, income, education, social determinants of health, PROMIS-29 functional status, Duke Activity Status Index (DASI), nine-item Patient Health Questionnaire (PHQ-9) depression score, Generalized Anxiety Disorder (GAD-7) anxiety score, Asthma Symptom Utility Index, restricted activity days, medication adherence, health care visits in the past month, emergency room visits in the past year, hospital days in the past year, perception of quality and patient-centeredness of care, alcoholic drinks per month, and the GAIN substance use disorder screener. Results ICCs varied broadly with the highest values found for race and income and the lowest for short-term estimates of the GAIN. Conclusions These values can be used to inform the design, especially power estimates and sample size requirements, of future studies.

Urban-Rural Differences in Mental and Physical Health among Primary Care Patients with Multiple Chronic Conditions: A Secondary Analysis from a Randomized Clinical Trial.

PURPOSE: Rural health disparities are largely attributable to access to healthcare, socioeconomic status, and health behaviors. Little is known about the persistence of these disparities when differences in access to care are eliminated. We sought to investigate urban-rural differences in physical and mental health in primary care patients with demonstrated access to primary care. METHODS: We obtained cross-sectional survey responses from a multicenter randomized controlled trial on 2726 adult primary care patients with multiple chronic medical or behavioral conditions from 42 primary care practices in 13 states. Study outcomes include measures of mental health including: The Patient-Reported Outcomes Measurement Information System (PROMIS-29®), General Anxiety Disorder-7 (GAD-7), and Patient Health Questionnaire-9 (PHQ-9), as well as physical health including: the PROMIS-29® and the Duke Activity Status Index (DASI). Urban-rural residence was indicated by census-tract Rural Urban Commuting Areas of the participant's home address. Differences in mental and physical health outcomes attributable to rurality were assessed using multilevel models with a random intercept for census-tract. RESULTS: After adjustment for demographic and neighborhood characteristics, urban residents had significantly worse generalized anxiety disorder (GAD-7) (ß = 0.7; 95% CI = 0.1, 1.3; p = 0.027), depression (PHQ-9) (ß = 0.7; 95% CI = 0.1, 1.4; p = 0.024), and functional capacity (DASI) (ß = -0.4; 95% CI = -0.5, -0.2; p < 0.001) compared to rural residents. Urban residents also had significantly worse anxiety and depression as measured by the PROMIS-29® compared to their rural counterparts. There were no urban-rural differences in the other PROMIS-29® subdomains. CONCLUSIONS: Among adults with demonstrated access to care and multiple diagnosed chronic conditions, rural residents had better mental health and functional capacity than their urban counterparts. This finding is not consistent with prior research documenting rural health disparities and should be confirmed.

Outcomes of Delay of Care After the Onset of COVID-19 for Patients Managing Multiple Chronic Conditions.

PURPOSE: Many patients delayed health care during COVID-19. We assessed the extent to which patients managing multiple chronic conditions (MCC) delayed care in the first months of the pandemic, reasons for delay, and impact of delay on patient-reported physical and behavioral health (BH) outcomes. METHODS: As part of a large clinical trial conducted April 2016-June, 2021, primary care patients managing MCC were surveyed about physical and behavioral symptoms and functioning. Surveys administered between September 3, 2020, and March 16, 2021, included questions about the extent of and reasons for any delayed medical and BH care since COVID-19. Multivariable linear regression was used to assess health outcomes as a function of delay of care status. RESULTS: Among patients who delayed medical care, 58% delayed more than once. Among those who delayed behavioral health care, 63% delayed more than once. Participants who delayed multiple times tended to be younger, female, unmarried, and reported food, financial, and housing insecurities and worse health. The primary reasons for delaying care were lack of availability of in-person visits and perceived lack of urgency. Participants who delayed care multiple times had significantly worse outcomes on nearly every measure of physical and mental health, compared with participants who delayed care once or did not delay. CONCLUSIONS: Delay of care was substantial. Patients who delayed care multiple times were in poorer health and thus in need of more care. Effective strategies for reengaging patients in deferred care should be identified and implemented on multiple levels. TRIAL REGISTRATION: ClinicalTrials.gov NCT02868983. Registered on August 16, 2016.

The Relationship Between Mental and Physical Health and Walking During the COVID-19 Pandemic.

INTRODUCTION: COVID-19 policies such as quarantining, social isolation, and lockdowns are an essential public health measure to reduce the spread of disease but may lead to reduced physical activity. Little is known if these changes are associated with changes in physical or mental health. METHODS: Between September 2017 and December 2018 (baseline) and March 2020 and February 2021 (follow-up), we obtained self-reported demographic, health, and walking (only at follow-up) data on 2042 adults in primary care with multiple chronic health conditions. We examined whether the perceived amount of time engaged in walking was different compared with prepandemic levels and if this was associated with changes in Patient-Reported Outcomes Measurement Information System-29 mental and physical health summary scores. Multivariable linear regression controlling for demographic, health, and neighborhood information were used to assess this association. RESULTS: Of the 2042 participants, 9% reported more walking, 28% reported less, and 52% reported the same amount compared with prepandemic levels. Nearly 1/3 of participants reported less walking during the pandemic. Multivariable models revealed that walking less or not at all was associated with negative changes in mental (ß = -1.0; 95% CI [-1.6, -0.5]; ß = -2.2; 95% CI [-2.9, -1.4]) and physical (ß = -0.9; 95% CI [-1.5, -0.3]; ß = -3.1; 95% CI [-4.0, -2.3]) health, respectively. Increasing walking was significantly associated with a positive change in physical health (ß = 1.3; 95% CI [0.3, 2.2]). CONCLUSIONS: These findings demonstrate the importance of walking during the COVID-19 pandemic. Promotion of physical activity should be taken into consideration when mandating restrictions to slow the spread of disease. Primary care providers can assess patient's walking patterns and implement brief interventions to help patients improve their physical and mental health through walking.

Older adults' willingness to take magnesium to treat depression.

Context: Depression affects up to 15% of community-dwelling older adults. Late-life depression is frequently underdiagnosed and undertreated. When depression in older adults is identified, up to 80% of treatment occurs in primary care. Currently available treatments have significant limitations (e.g., modest effectiveness, high costs, adverse effects, poor adherence, and social stigma), therefore additional treatment options are essential. Over the counter magnesium chloride is inexpensive, widely available, generally safe, well-absorbed, and was efficacious in prior studies, often within 2 weeks. Objective: To collect background information on magnesium supplement use and acceptability in older adults with a depression. Study Design: Online survey. Dataset: National sample. Population Studied: Adults 65 and older living in the United States currently experiencing symptoms of depression based on Patient Health Questionnaire (PHQ- 2) results. Outcome Measures: The primary outcome was willingness to take magnesium supplements instead of prescription medication for the treatment of depression. Secondary measures included current supplement use, comfort level with taking magnesium to treat depression, and whether they think magnesium would help improve symptoms of depression. Results: Of 153 respondents, 97 (63%) were female, 143 (93%) identified as white, and 130 (85%) were between the ages 65 and 75 years. 112 (73%) took a supplement daily, including 15 (10%) taking magnesium. 50 (33%) were currently being treated for depression. On a 4-point Likert scale ranging from "Strongly Agree" to "Strongly Disagree," 83% of respondents "Agreed" or "Strongly Agreed" in terms of their willingness to take magnesium instead of a prescription medication. A majority also "Agreed" or "Strongly Agreed" that they were willing (89%) and comfortable (89%) with taking magnesium to treat depression and also that it would improve symptoms of depression (73%). Women were more likely to agree with these statements (p<0.05), but there were no differences based on age or current treatment for depression. Conclusions: A majority of older community-dwelling adults are willing to take magnesium for the treatment of depression. Many adults are already taking at least 1 over the counter supplement daily. Further research is needed to determine the efficacy of magnesium supplements as an alternative treatment option in this population.

Development and validation of the patient centeredness index for primary care.

AIMS AND OBJECTIVES: To describe the development of the Patient Centeredness Index (PCI), evaluate its psychometric characteristics and evaluate the relationships between scores on the PCI and an established measure of empathy. BACKGROUND: Patient centeredness helps patients manage multiple chronic conditions with their providers, nurses and other team members. However, no instrument exists for evaluating patient centeredness within primary care practices treating this population. DESIGN: Multi-site instrument development and validation. STROBE reporting guidelines were followed. METHODS: To identify themes, we consulted literature on patient centeredness and engaged stakeholders who had or were caring for people with multiple chronic conditions (n = 7). We composed and refined items to represent those themes with input from clinicians and researchers. To evaluate reliability and convergent validity, we administered surveys to participants (n = 3622) with chronic conditions recruited from 44 primary care practices for a large-scale cluster randomised clinical trial of the effects of a practice-level intervention on patient and practice-level outcomes. Participants chose to complete the 16-item survey online, on paper or by phone. Surveys assessed demographics, number of chronic conditions and ratings of provider empathy. We conducted exploratory factor analysis to model the interrelationships among items. RESULTS: A single factor explained 93% of total variance. Factor loadings ranged from 0.55-0.85, and item-test correlations were ≥.67. Cronbach's alpha was .93. A moderate, linear correlation with ratings of provider's empathy (r = .65) supports convergent validity. CONCLUSIONS: The PCI is a new tool for obtaining patient perceptions of the patient centeredness of their primary care practice. The PCI shows acceptable reliability and evidence of convergent validity among patients managing chronic conditions. RELEVANCE TO CLINICAL PRACTICE: The PCI rapidly identifies patients' perspectives on patient centeredness of their practice, making it ideal for administration in busy primary care settings that aim to efficiently address patient-identified needs. TRIAL REGISTRATION: Clinicaltrials.org Protocol ID: WLPS-1409-24372. TITLE: Integrating Behavioural Health and Primary Care for Comorbid Behavioural and Medical Problems (IBHPC).

Integrating behavioral health & primary care for multiple chronic diseases: Clinical trial of a practice redesign toolkit.

Context: Most patients in need of behavioral health (BH) care are seen in primary care, which often has difficulty responding. Some practices integrate behavioral health care (IBH), with medical and BH providers at the same location, working as a team. However, it is difficult to achieve high levels of integration. Objective: Test the effectiveness of a practice intervention designed to increase BH integration. Study Design: Pragmatic, cluster-randomized controlled trial. Setting: 43 primary care practices with on-site BH services in 13 states. Population: 2,460 adults with multiple chronic medical and behavioral conditions. Intervention: 24-month practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Outcomes: Primary outcomes were changes in the 8 Patient-Reported Outcomes Measurement Information System (PROMIS-29) domain scores. Secondary outcomes were changes in medication adherence, self-reported healthcare utilization, time lost due to disability, cardiovascular capacity, patient centeredness, provider empathy, and several condition-specific measures. A sample of practice staff completed the Practice Integration Profile at each time point to estimate the degree of BH integration in that site. Practice-level case studies estimated the typical costs of implementing the intervention. Results: The intervention had no significant effect on any of the primary or secondary outcomes. Subgroup analyses showed no convincing patterns of effect in any populations. COVID-19 was apparently not a moderating influence of the effect of the intervention on outcomes. The intervention had a modest effect on the degree of practice integration, reaching statistical significance in the Workflow domain. The median cost of the intervention was $18,204 per practice. In post-hoc analysis, level of BH integration was associated with improved patient outcomes independent of the intervention, both at baseline and longitudinally. Conclusions: The specific intervention tested in this study was inexpensive, but had only a small impact on the degree of BH integration, and none on patient outcomes. However, practices that had more integration at baseline had better patient outcomes, independent of the intervention. Although this particular intervention was ineffective, IBH remains an attractive strategy for improving patient outcomes.

Differences in Occupational Burnout Among Primary Care Professionals.

BACKGROUND: Occupational burnout is a major concern for personal well-being and patient care. We examined burnout among primary care providers (PCPs), medical residents, behavioral health providers (BHPs), nurses, and other clinical and nonclinical primary care team members. METHODS: This was a cross-sectional study, nested within a larger randomized trial. Participants completed a validated 9-item burnout measure with 3 domains: depersonalization, emotional exhaustion, and personal accomplishment. Multivariable multilevel linear regression with a random intercept for each practice was used to determine mean differences in burnout across professional roles. RESULTS: Overall burnout rates varied by professional role: PCPs 70%, medical residents 89%, BHPs 59%, nurses 66%, other clinicians 68%, and nonclinical professionals 70%. Compared with nonclinical professionals, residents experienced more burnout in more domains, followed by PCPs. PCPs, residents, and nurses reported significantly worse depersonalization and exhaustion scores. Nonclinical professionals had worse accomplishment scores than all clinical professionals except for residents. This study revealed moderate-to-high levels of burnout among primary care professionals. DISCUSSION: Clinicians may be experiencing aspects of burnout more intensely than their nonclinical colleagues, and this may be most true for residents and PCPs. Based on these variations, interventions to mitigate burnout may need to be tailored by professional role.

Integrating Behavioral Health and Primary Care (IBH-PC) to improve patient-centered outcomes in adults with multiple chronic medical and behavioral health conditions: study protocol for a pragmatic cluster-randomized control trial.

BACKGROUND: Chronic diseases that drive morbidity, mortality, and health care costs are largely influenced by human behavior. Behavioral health conditions such as anxiety, depression, and substance use disorders can often be effectively managed. The majority of patients in need of behavioral health care are seen in primary care, which often has difficulty responding. Some primary care practices are providing integrated behavioral health care (IBH), where primary care and behavioral health providers work together, in one location, using a team-based approach. Research suggests there may be an association between IBH and improved patient outcomes. However, it is often difficult for practices to achieve high levels of integration. The Integrating Behavioral Health and Primary Care study responds to this need by testing the effectiveness of a comprehensive practice-level intervention designed to improve outcomes in patients with multiple chronic medical and behavioral health conditions by increasing the practice's degree of behavioral health integration. METHODS: Forty-five primary care practices, with existing onsite behavioral health care, will be recruited for this study. Forty-three practices will be randomized to the intervention or usual care arm, while 2 practices will be considered "Vanguard" (pilot) practices for developing the intervention. The intervention is a 24-month supported practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Each practice's degree of behavioral health integration will be measured using the Practice Integration Profile. Approximately 75 patients with both chronic medical and behavioral health conditions from each practice will be asked to complete a series of surveys to measure patient-centered outcomes. Change in practice degree of behavioral health integration and patient-centered outcomes will be compared between the two groups. Practice-level case studies will be conducted to better understand the contextual factors influencing integration. DISCUSSION: As primary care practices are encouraged to provide IBH services, evidence-based interventions to increase practice integration will be needed. This study will demonstrate the effectiveness of one such intervention in a pragmatic, real-world setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT02868983 . Registered on August 16, 2016.

Impact of COVID-19 predicts perceived risk more strongly than known demographic risk factors.

OBJECTIVE: To identify the factors associated with perceived COVID-19 risk among people living in the US. METHODS: A cross-sectional representative sample of 485 US residents was collected in mid-April 2020. Participants were asked about (a) perceptions of COVID-19 risk, (b) demographic factors known to be associated with increased COVID-19 risk, and (c) the impact of COVID-19 on different life domains. We used a three-step hierarchical linear regression model to assess the differential contribution of the factors listed above on perceived COVID-19 risk. RESULTS: The final model accounted for 16% of variability in perceived risk, F(18,458) = 4.8, p < .001. Participants who were White reported twice as much perceived risk as participants of color (B = -2.1, 95% CI[-3.4,-0.8]. Higher perceived risk was observed among those who reported a negative impact of the pandemic on their sleep (B = 1.5, 95% CI[0.8,2.1]) or work (B = 0.7, 95%CI[0.1,1.3]). The number of cases per capita in their state of residence, age, or proximity to someone with a COVID-19 diagnosis were not found to meaningfully predict perceived risk. CONCLUSIONS: Perceived risk was not found to be associated with known demographic risk factors, except that the effect of race/ethnicity was in the opposite direction of existing evidence. Perception of COVID-19 risk was associated with the perceived personal impact of the pandemic.

Defining and measuring core processes and structures in integrated behavioral health in primary care: a cross-model framework.

A movement towards integrated behavioral health (IBH) in primary care continues to grow, among an accumulating evidence base for its effectiveness for improving care. However, healthcare organizations struggle to navigate where to target their limited resources for improving integration. We evaluated a cross-model framework of IBH core processes and structures. We used a mixed-methods approach for evaluation of the framework, which included (a) an evaluation survey of national experts and stakeholders, (b) crosswalks with common IBH measures, and (c) a real-world usability test. Five core IBH principles, mapping to 25 processes, and nine clinic structures were defined. Survey responses from 29 IBH domain and policy experts and stakeholders resulted in uniformly high ratings of importance and variable levels of feasibility for measurement, particularly with respect to electronic health record (EHR) systems. A real-world usability test resulted in good uptake and use of the framework across a state-wide effort. An IBH Cross-Model Framework of core principles, processes, and structures generated good acceptability and showed good real-world utility in a state-wide effort to improve IBH across disparate levels of integration in diverse primary care settings. Findings identify feasible areas of measurement, particularly with EHR systems. Next steps include testing the relationship between the individual framework components and patient outcomes to help guide clinics towards prioritizing efforts focused on improving integration.

An internet-based mind/body intervention to mitigate distress in women experiencing infertility: A randomized pilot trial.

OBJECTIVE: To determine if an internet-based mind/body program would lead to participants experiencing infertility (1) being willing to be recruited and randomized and (2) accepting and being ready to engage in a fertility-specific intervention. Secondary exploratory goals were to examine reduced distress over the course of the intervention and increased likelihood to conceive. METHODS: This was a pilot randomized controlled feasibility trial with a between-groups, repeated measure design. Seventy-one women self-identified as nulliparous and meeting criteria for infertility. Participants were randomized to the internet-based version of the Mind/Body Program for Fertility or wait-list control group and asked to complete pre-, mid- and post-assessments. Primary outcomes include retention rates, number of modules completed, and satisfaction with intervention. Secondary exploratory outcomes sought to provide preliminary data on the impact of the program on distress (anxiety and depression) and self-reported pregnancy rates relative to a quasi-control group. RESULTS: The retention, adherence, and satisfaction rates were comparable to those reported in other internet-based RCTs. Although time between pre- and post-assessment differed between groups, using intent-to-treat analyses, women in the intervention group (relative to the wait-list group) had significant reduction in distress (anxiety, p = .003; depression, p = .007; stress, p = .041 fertility-social, p = .018; fertility-sexual, p = .006), estimated as medium-to-large effect sizes (ds = 0.45 to 0.86). The odds of becoming pregnant was 4.47 times higher for the intervention group participants as compared to the wait-list group, OR 95% CI [1.56, 12.85], p = .005 and occurred earlier. The findings suggest that the research design and program specific to this population are feasible and acceptable. Replication efforts with an active control group are needed to verify distress reduction and conception promotion findings.

Emotional responding: Integration of multiple constructs and association with psychological health.

OBJECTIVE: Numerous psychological constructs exist to describe different facets of emotional responding, but they have rarely been examined together. We empirically modeled the associations between four psychological constructs (mindfulness, emotional nonacceptance, experiential avoidance, and anxiety sensitivity) of individuals' responses to their affective experience, hypothesizing that a bifactor model would fit the data best. METHOD: We used exploratory structural equation modeling, a novel latent variable modeling framework, to compare five measurement models of emotional responding in an online community sample (N = 307). RESULTS: A bifactor model including a general emotional responding factor had substantial factor loadings from nearly all items, with mixed results for specific factors. Exploratory analyses supported the significant association of avoidant emotional responding and psychopathology/well-being. CONCLUSION: The general avoidant emotional responding factor appears to overlap most directly with experiential avoidance and may be a transtheoretical construct relevant to mental health.

Practice makes perfect: Training the interpretation of emotional ambiguity.

The interpretation of emotionally ambiguous words, sentences, or scenarios can be altered through training procedures that are collectively called cognitive bias modification for interpretation (CBM-I). In three experiments, we systematically manipulated the nature of the training in order to discriminate between emotional priming and ambiguity resolution accounts of training effects. In Experiment 1 participants completed word fragments that were consistently related to either a negative or benign interpretation of an ambiguous sentence. In a subsequent semantic priming task they demonstrated an interpretation bias, in that they were faster to identify relatedness of targets that were associated with the training-congruent meaning of an emotionally ambiguous homograph. We then manipulated the training sentences to show that interpretation bias was eliminated when participants simply completed valenced word fragments following unrelated sentences (Experiment 2), or completed fragments that were related to emotional but unambiguous sentences (Experiment 3). Only when participants were required to actively resolve emotionally ambiguous sentences during training did changes in interpretation emerge at test. Findings suggest that CBM-I achieves its effects by altering a production rule that aids the selection of meaning from emotionally ambiguous alternatives, in line with an ambiguity resolution account.