BACKGROUND: Diabetes self-management education and support can be effectively and efficiently delivered in primary care in the form of shared medical appointments (SMAs). Comparative effectiveness of SMA delivery features such as topic choice, multi-disciplinary care teams, and peer mentor involvement is not known.
OBJECTIVE: To compare effects of standardized and patient-driven models of diabetes SMAs on patient-level diabetes outcomes.
METHODS: Pragmatic cluster randomized trial.
METHODS: A total of 1060 adults with type 2 diabetes in 22 primary care practices.
METHODS: Practice personnel delivered the 6-session Targeted Training in Illness Management (TTIM) curriculum using either standardized (set content delivered by a health educator) or patient-driven SMAs (patient-selected topic order delivered by health educators, behavioral health providers [BHPs], and peer mentors).
METHODS: Outcomes included self-reported diabetes distress and diabetes self-care behaviors from baseline and follow-up surveys (assessed at 1st and final SMA session), and HbA1c, BMI, and blood pressure from electronic health records. Analyses used descriptive statistics, linear regression, and linear mixed models.
RESULTS: Both standardized and patient-driven SMAs effectively improved diabetes distress, self-care behaviors, BMI (- 0.29 on average), and HbA1c (- 0.45% (mmol/mol) on average, 8.3 to 7.8%). Controlling for covariates, there was a small, significant effect of condition on overall diabetes distress in favor of standardized SMAs (F(1,841) = 4.3, p = .04), attributable to significant effects of condition on emotion and regimen distress subscales. There was a small, significant effect of condition on diastolic blood pressure in favor of standardized SMAs (F(1,5199) = 4.50, p = .03). There were no other differences between conditions.
CONCLUSIONS: Both SMA models using the TTIM curriculum yielded significant improvement in diabetes distress, self-care, and HbA1c. Patient-driven diabetes SMAs involving BHPs and peer mentors and topic selection did not lead to better clinical or patient-reported outcomes than standardized diabetes SMAs facilitated by a health educator following a set topic order.
UNASSIGNED: NCT03590041.

UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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).
UNASSIGNED: 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.

OBJECTIVE: Pediatric primary care is a promising setting in which to deliver preventive behavioral health services to young children and their families. Integrated behavioral health care models typically emphasize treatment rather than prevention. This pilot study examined the efficacy of an integrated behavioral health preventive (IBH-P) intervention delivered by psychologists and focused on supporting parenting in low-income mothers of infants as part of well-child visits in the first 6 months of life.
METHODS: Using a mixed-methods approach that included a pilot randomized clinical trial and post-intervention qualitative interviews, 137 mothers were randomly assigned to receive IBH-P or usual care. Self-report measures of parenting, child behavior, and stress were obtained at pre- and/or post-intervention. Direct observation of mother-infant interactions was conducted at post-intervention.
RESULTS: No differences between groups were found on maternal attunement, knowledge of child development, nurturing parenting, or infant behavior. A secondary analysis on a subsample with no prior exposure to IBH-P with older siblings found that mothers in IBH-P reported increased self-efficacy relative to controls. In the qualitative interviews, mothers stated that they valued IBH-P, learning about their baby, liked the integration in primary care, and felt respected and comfortable with their provider.
CONCLUSIONS: Findings are discussed in terms of the next steps in refining IBH-P approaches to prevention in primary care.

Integrating behavioral health services into primary care has a strong evidence base, but how primary care training programs incorporate integrated behavioral health (IBH) into care delivery and training has not been well described. The goal of this study was to evaluate factors related to successful IBH implementation in family medicine (FM) residency programs and assess perspectives and attitudes on IBH among program leaders.
FM residency programs, all which are required to provide IBH training, were recruited from the American Academy of Family Physicians National Research Network. After completing eligibility screening that included the Integrated Practice Assessment Tool (IPAT) questionnaire, 14 training programs were included. Selected practices identified 3 staff in key roles to be interviewed: medical director or similar, behavioral health professional (BHP), and chief medical officer or similar.
Forty-one individuals from 14 FM training programs were interviewed. IPAT scores ranged from 4 (Close Collaboration Onsite) to 6 (Full Collaboration). Screening, outcome tracking, and treatment differed among and within practices. Use of curricula and trainee experience also varied with little standardization. Most participants described similar approaches to communication and collaboration between primary care clinicians and BHPs and believed that IBH should be standard practice. Participants reported space, staff, and billing support as critical for sustainability.
Delivery and training experiences in IBH varied widely despite recognition of the value and benefits to patients and care delivery processes. Standardizing resources and training and simplifying and assuring reimbursement for services may promote sustainable and high quality IBH implementation.

Integrated behavioral health can improve primary care and mental health outcomes. Access to behavioral health and primary care services in Texas is in crisis because of high uninsurance rates, regulatory restrictions, and lack of workforce. To address gaps in access to care, a partnership formed among a large local mental health authority in central Texas, a federally designated rural health clinic, and the Texas A&M University School of Nursing to create an interprofessional team-based health care delivery model led by nurse practitioners in rural and medically underserved areas of central Texas. Academic-practice partners identified 5 clinics for an integrated behavioral health care delivery model. From July 1, 2020, through December 31, 2021, a total of 3183 patient visits were completed. Patients were predominantly female (n = 1719, 54%) and Hispanic (n = 1750, 55%); 1050 (33%) were living at or below the federal poverty level; and 1400 (44%) were uninsured. The purpose of this case study was to describe the first year of implementation of the integrated health care delivery model, barriers to implementation, challenges to sustainability, and successes. We analyzed data from multiple sources, including meeting minutes and agendas, grant reports, direct observations of clinic flow, and interviews with clinic staff, and identified common qualitative themes (eg, challenges to integration, sustainability of integration, outcome successes). Results revealed implementation challenges with the electronic health record, service integration, low staffing levels during a global pandemic, and effective communication. We also examined 2 patient cases to illustrate the success of integrated behavioral health and highlighted lessons learned from the implementation process, including the need for a robust electronic health record and organizational flexibility.

Many individuals with behavioral health challenges receive services in primary care, and integrated behavioral health (IBH) programs can help increase access to evidence-based interventions. IBH programs can benefit substantially from integrating standardized tracking databases that allow for the implementation of measurement-based care to evaluate patient-, clinician-, and practice-level outcomes. We describe the development and integration of Mayo Clinic\'s pediatric and adult primary care psychotherapy tracking database.
IBH practice leaders directed the development of a large psychotherapy tracking database that continuously populates from Mayo Clinic\'s electronic health record system. The database captures numerous patient variables including demographics, behavioral health and substance use issues, psychotherapy principles used, and self-reported symptoms. We retrieved current data for patients empaneled in Mayo Clinic\'s pediatric and adult primary care psychotherapy programs from June 2014 to June 2022.
The tracking database contained data for 16,923 adult patients and 6,298 pediatric patients. The mean age of adult patients was 43.2 years (SD 18.3), 88.1% were non-Latine White, and 66.7% identified as female. The mean age of pediatric patients was 11.6 years (SD 4.2), 82.5% were non-Latine White, and 56.9% identified as female. We provide examples of practical applications of the database across clinical, educational, research, and administrative domains.
The development and integration of a psychotherapy tracking database supports clinician communication, examination of patient outcomes, practice quality improvement efforts, and clinically relevant research. Our description of Mayo Clinic\'s IBH database may serve as a model for other IBH practices.

Rapid infant weight gain is associated with later obesity. Novel interventions to prevent rapid infant weight gain that are accessible to infants and families are needed, especially for those at the highest risk. Our aims were to examine: (a) feasibility and acceptability of a responsive parenting intervention delivered via Integrated Behavioral Health (IBH) in pediatric primary care and (b) preliminary effects on infant weight gain from birth to 6 (post-treatment) and 9 (follow-up) months.
A parallel design, proof-of-concept randomized control trial was conducted with 65 mother-infant dyads (32 randomized to intervention, 33 randomized an IBH attention control focused on promoting healthy mental health), in which the majority identify as Black (80%) and low income (91% receiving Medicaid). Participants and assessors were masked to treatment condition. Outcomes included feasibility (enrollment), acceptability (retention and adherence), and conditional weight gain (CWG), an indicator of rapid weight gain.
The intervention was feasible (90% of eligible families enrolled) and acceptable (89% of families retained), with 81% receiving ≥3 of 4 treatment sessions. A medium effect was found on CWG (d = -0.54 post-treatment, d = -0.57 follow-up), with the infants in the treatment group showing significantly lower CWG (mean = -0.27, 95% CI, -0.63, 0.09) compared to the control group (mean = 0.29, 95% CI, -0.17, 0.76) at 9 months (p = .04).
This study demonstrates the feasibility of implementing a responsive parenting obesity prevention intervention within primary care. Delivery in pediatric primary care is advantageous for implementation and reaching at-risk populations. The preliminary effects on CWG are promising and support testing in a larger trial.

BACKGROUND: Less than 10% of the individuals seeking behavioral health care receive measurement-based care (MBC). Technology has the potential to implement MBC in a secure and efficient manner. To test this idea, a mobile health (mHealth) platform was developed with the goal of making MBC easier to deliver by clinicians and more accessible to patients within integrated behavioral health care. Data from over 3000 users of the mHealth platform were used to develop an output severity score, a robust screening measure for depression and anxiety.
OBJECTIVE: The aim of this study is to compare severity scores with scores from validated assessments for depression and anxiety and scores from clinician review to evaluate the potential added value of this new measure.
METHODS: The severity score uses patient-reported and passively collected data related to behavioral health on an mHealth platform. An artificial intelligence-derived algorithm was developed that condenses behavioral health data into a single, quantifiable measure for longitudinal tracking of an individual\'s depression and anxiety symptoms. Linear regression and Bland-Altman analyses were used to evaluate the relationships and differences between severity scores and Personal Health Questionnaire-9 (PHQ-9) or Generalized Anxiety Disorder-7 (GAD-7) scores from over 35,000 mHealth platform users. The severity score was also compared with a review by a panel of expert clinicians for a subset of 250 individuals.
RESULTS: Linear regression results showed a strong correlation between the severity score and PHQ-9 (r=0.74; P<.001) and GAD-7 (r=0.80; P<.001) changes. A strong positive correlation was also found between the severity score and expert panel clinical review (r=0.80-0.84; P<.001). However, Bland-Altman analysis and the evaluation of outliers on regression analysis showed that the severity score was significantly different from the PHQ-9.
CONCLUSIONS: Clinicians can reliably use the mHealth severity score as a proxy measure for screening and monitoring behavioral health symptoms longitudinally. The severity score may identify at-risk individuals who are not identified by the PHQ-9. Further research is warranted to evaluate the sensitivity and specificity of the severity score.

Parenting interventions like the Family Check-Up have demonstrated effects on child physical and behavioral health outcomes. However, access to these programs is limited, particularly for populations experiencing health disparities. Primary care settings have become recognized as a potential delivery system in which these programs may be implemented at scale. The purpose of this trial is to test the effectiveness of the Family Check-Up 4 Health (FCU4Health) program, an adaptation of the FCU for primary care, and assess program implementation in an integrated primary care setting.
We will conduct a hybrid type 2 effectiveness-implementation trial in partnership with a primary care clinic in a low-income, majority Latino community. Families with 2- to 5-year-old children will be eligible to participate. Families will be randomized to receive the intervention (n = 130) or services as usual (n = 70) and will be assessed annually over three years. Outcomes are informed by the RE-AIM framework (i.e., reach, effectiveness, adoption, implementation, and maintenance). Effectiveness outcomes include child health behaviors (e.g., Dietary Screener Questionnaire), behavioral health (e.g., Strengths and Difficulties Questionnaire), and parenting (e.g., Proactive Parenting). Early stage implementation outcomes are also included (e.g., cost, acceptability, appropriateness, and feasibility). Effectiveness outcomes will be assessed via intent-to-treat (ITT) analyses. Implementation outcomes will be primarily descriptive with comparisons to prior trials of FCU4Health and the original FCU.
This trial will provide evidence related to the potential of integrated primary care settings to deliver evidence-based preventive interventions with a dual focus on behavioral and physical health.

Due to limited access to specialist services, most patients with common mental disorders (depression or anxiety, or both) usually receive treatment in primary care. More recently, innovative technology-based care models (eg, video consultations) have been proposed to facilitate access to specialist services. Against this background, the PROVIDE (Improving Cross-Sectoral Collaboration Between Primary and Psychosocial Care: An Implementation Study on Video Consultations) project aims to improve the provision of psychosocial care through implementing video consultations integrated into routine primary care.
From the patients\' perspective, this qualitative preimplementation study explored (1) anticipated benefits from and (2) barriers to implementing mental health specialist video consultations embedded in primary care services and (3) prerequisites for interacting with therapists via video consultations.
Using a purposive (ie, stratified) sampling strategy, we recruited 13 patients from primary care practices and a tertiary care hospital (psychosomatic outpatient clinic) for one-off semistructured interviews. In a computer-assisted thematic analysis, we inductively (bottom-up) derived key themes concerning the practicability of mental health specialist video consultations. To validate our results, we discussed our findings with the interviewees as part of a systematic member checking.
Overall, we derived 3 key themes and 10 subthemes. Participants identified specific benefits in 2 areas: the accessibility of mental health specialist care (shorter waiting times: 11/13, 85%; lower threshold for seeking specialist mental health care: 6/13, 46%; shorter travel distances: 3/13, 23%); and the environment in primary care (familiar travel modalities, premises, and employees: 5/13, 38%). The main barriers to the implementation of mental health video consultations from the patients\' perspective were the lack of face-to-face contact (13/13, 100%) and technical challenges (12/13, 92%). Notably, participants\' prerequisites for interacting with therapists (12/13, 92%) did not seem to differ much from those concerning face-to-face contacts.
Mental health service users mostly welcomed mental health specialist video consultations in primary care. Taking a pragmatic stance, service users, who are often frustrated about uncoordinated care, particularly valued the embedment of the consultations in the familiar environment of the primary care practice. With respect to interventional studies and implementation, our findings underscore the need to minimize technical disruptions during video consultations and to ensure optimal resemblance to face-to-face settings (eg, by training therapists in consistently reacting to nonverbal cues).
German Clinical Trials Register DRKS00012487; https://tinyurl.com/uhg2one.