Partnered research in healthcare delivery redesign for high-need, high-cost patients: development and feasibility of an Intensive Management Patient-Aligned Care Team (ImPACT).

OBJECTIVES: We employed a partnered research healthcare delivery redesign process to improve care for high-need, high-cost (HNHC) patients within the Veterans Affairs (VA) healthcare system. METHODS: Health services researchers partnered with VA national and Palo Alto facility leadership and clinicians to: 1) analyze characteristics and utilization patterns of HNHC patients, 2) synthesize evidence about intensive management programs for HNHC patients, 3) conduct needs-assessment interviews with HNHC patients (n = 17) across medical, access, social, and mental health domains, 4) survey providers (n = 8) about care challenges for HNHC patients, and 5) design, implement, and evaluate a pilot Intensive Management Patient-Aligned Care Team (ImPACT) for a random sample of 150 patients. RESULTS: HNHC patients accounted for over half (52 %) of VA facility patient costs. Most (94 %) had three or more chronic conditions, and 60 % had a mental health diagnosis. Formative data analyses and qualitative assessments revealed a need for intensive case management, care coordination, transitions navigation, and social support and services. The ImPACT multidisciplinary team developed care processes to meet these needs, including direct access to team members (including after-hours), chronic disease management protocols, case management, and rapid interventions in response to health changes or acute service use. Two-thirds of invited patients (n = 101) enrolled in ImPACT, 87 % of whom remained actively engaged at 9 months. ImPACT is now serving as a model for a national VA intensive management demonstration project. CONCLUSIONS: Partnered research that incorporated population data analysis, evidence synthesis, and stakeholder needs assessments led to the successful redesign and implementation of services for HNHC patients. The rigorous design process and evaluation facilitated dissemination of the intervention within the VA healthcare system. IMPACT STATEMENT: Employing partnered research to redesign care for high-need, high-cost patients may expedite development and dissemination of high-value, cost-saving interventions.

Characterizing HIV transmission networks across the United States.

BACKGROUND: Clinically, human immunodeficiency virus type 1 (HIV-1) pol sequences are used to evaluate for drug resistance. These data can also be used to evaluate transmission networks and help describe factors associated with transmission risk. METHODS: HIV-1 pol sequences from participants at 5 sites in the CFAR Network of Integrated Clinical Systems (CNICS) cohort from 2000-2009 were analyzed for genetic relatedness. Only the first available sequence per participant was included. Inferred transmission networks ("clusters") were defined as ≥2 sequences with ≤1.5% genetic distance. Clusters including ≥3 patients ("networks") were evaluated for clinical and demographic associations. RESULTS: Of 3697 sequences, 24% fell into inferred clusters: 155 clusters of 2 individuals ("dyads"), 54 clusters that included 3-14 individuals ("networks"), and 1 large cluster that included 336 individuals across all study sites. In multivariable analyses, factors associated with being in a cluster included not using antiretroviral (ARV) drugs at time of sampling (P < .001), sequence collected after 2004 (P < .001), CD4 cell count >350 cells/mL (P < .01), and viral load 10,000-100,000 copies/mL (P < .001) or >100,000 copies/mL (P < .001). In networks, women were more likely to cluster with other women (P < .001), and African Americans with other African Americans (P < .001). CONCLUSIONS: Molecular epidemiology can be applied to study HIV transmission networks in geographically and demographically diverse cohorts. Clustering was associated with lack of ARV use and higher viral load, implying transmission may be interrupted by earlier diagnosis and treatment. Observed female and African American networks reinforce the importance of diagnosis and prevention efforts targeted by sex and race.

A randomized noninferiority trial of standard versus enhanced risk reduction and adherence counseling for individuals receiving post-exposure prophylaxis following sexual exposures to HIV.

BACKGROUND: The National HIV/AIDS Strategy proposes to scale-up post-exposure prophylaxis (PEP). Intensive risk reduction and adherence counseling appear to be effective but are resource intensive. Identifying simpler interventions that maximize the HIV prevention potential of PEP is critical. METHODS: A randomized noninferiority study comparing 2 (standard) or 5 (enhanced) risk reduction counseling sessions was performed. Adherence counseling was provided in the enhanced arm. We measured changes in unprotected sexual intercourse acts at 12 months, compared with baseline; HIV acquisition; and PEP adherence. Outcomes were stratified by degree of baseline risk. RESULTS: We enrolled 457 individuals reporting unprotected intercourse within 72 h with an HIV-infected or at-risk partner. Participants were 96% male and 71% white. There were 1.8 and 2.3 fewer unprotected sex acts in the standard and enhanced groups. The maximum potential risk difference, reflected by the upper bound of the 95% confidence interval, was 3.9 acts. The difference in the riskier subset may have been as many as 19.6 acts. The incidence of HIV seroconversion was 2.9% and 2.6% among persons randomized to standard and enhanced counseling, respectively, with a maximum potential difference of 3.4%. The absolute and maximal HIV seroconversion incidence was 9.9% and 20.4% greater in the riskier group randomized to standard, compared with enhanced, counseling. Adherence outcomes were similar, with noninferiority in the lower risk group and concerning differences among the higher-risk group. CONCLUSIONS: Risk assessment is critical at PEP initiation. Standard counseling is only noninferior for individuals with lower baseline risk; thus, enhanced counseling should be targeted to individuals at higher risk.

The effect of AIDS Clinical Trials Group Protocol 5164 on the time from Pneumocystis jirovecii pneumonia diagnosis to antiretroviral initiation in routine clinical practice: a case study of diffusion, dissemination, and implementation.

BACKGROUND: Diffusion, dissemination, and implementation of scientific evidence into routine clinical practice is not well understood. The Adult AIDS Clinical Trials Group (ACTG) Protocol 5164 showed that early antiretroviral therapy (ART; ie, within 14 days) after diagnosis of an opportunistic infection improved clinical outcomes, compared with later initiation. Subsequently, the San Francisco General Hospital (SFGH) HIV/AIDS Service performed the SFGH 5164 Initiative to disseminate and implement the findings of ACTG 5164. METHODS: We evaluated patients who received a diagnosis of Pneumocystis jirovecii pneumonia (PCP) from 1 January 2001 through 30 March 2011. Survival analyses were used to assess changes in the time to initiation of ART after PCP, and logistic regression was used to evaluate changes in the odds of early ART (ie, within 14 days) because of ACTG 5164 and SFGH 5164 Initiative. RESULTS: Among 162 patients, the adjusted hazard of ART initiation increased by 3.05 (95% confidence interval [CI], 1.86-5.02) after ACTG 5164 and by 4.89 (95% CI, 2.76-8.67) after the SFGH Initiative, compared with before ACTG 5164. When compared with before ACTG 5164, the proportion of patients who received ART within the 14 days after PCP diagnosis increased from 7.4% to 50.0% (P < .001) after ACTG 5164 and from 50.0% to 83.0% (P = .02) after the SFGH 5164 Initiative. CONCLUSIONS: Diffusion of findings from of a randomized trial changed practice at an academic medical center, but dissemination and implementation efforts were required to establish early ART at acceptable levels. Early ART initiation can be achieved in real-world patient populations.

Mentoring early-career scientists for HIV research careers.

Mentoring is important for early-career HIV researchers; it is key for work satisfaction, productivity, workforce diversity, and retention of investigators in a variety of research settings. Establishment of multidisciplinary research projects often is accomplished through mentoring. The work of early-career HIV investigators frequently requires networks of collaborators, and networking is regularly facilitated by mentors. A structured mentoring program that avoids unnecessary conflicts or time burdens and connects early-career investigators with senior mentors from different disciplines may stimulate new networking possibilities and lead to effective collaborations among investigators with different skills and perspectives. Effective mentoring by focused mentors will likely contribute to the skills and networks of investigators necessary for the next generation of HIV investigators.

Effect of a Lay Health Worker Intervention on Goals-of-Care Documentation and on Health Care Use, Costs, and Satisfaction Among Patients With Cancer: A Randomized Clinical Trial.

Importance: Although lay health workers (LHWs) improve cancer screening and treatment adherence, evidence on whether they can enhance other aspects of care is limited. Objective: To determine whether an LHW program can increase documentation of patients' care preferences after cancer diagnosis. Design, Setting, and Participants: Randomized clinical trial conducted from August 13, 2013, through February 2, 2015, among 213 patients with stage 3 or 4 or recurrent cancer at the Veterans Affairs Palo Alto Health Care System. Data analysis was by intention to treat and performed from January 15 to August 18, 2017. Interventions: Six-month program with an LHW trained to assist patients with establishing end-of-life care preferences vs usual care. Main Outcomes and Measures: The primary outcome was documentation of goals of care. Secondary outcomes were patient satisfaction on the Consumer Assessment of Health Care Providers and Systems "satisfaction with provider" item (on a scale of 0 [worst] to 10 [best possible]), health care use, and costs. Results: Among the 213 participants randomized and included in the intention-to-treat analysis, the mean (SD) age was 69.3 (9.1) years, 211 (99.1%) were male, and 165 (77.5%) were of non-Hispanic white race/ethnicity. Within 6 months of enrollment, patients randomized to the intervention had greater documentation of goals of care than the control group (97 [92.4%] vs 19 [17.5%.]; P < .001) and larger increases in satisfaction with care on the Consumer Assessment of Health Care Providers and Systems "satisfaction with provider" item (difference-in-difference, 1.53; 95% CI, 0.67-2.41; P < .001). The number of patients who died within 15 months of enrollment did not differ between groups (intervention, 60 of 105 [57.1%] vs control, 60 of 108 [55.6%]; P = .68). In the 30 days before death, patients in the intervention group had greater hospice use (46 [76.7%] vs 29 [48.3%]; P = .002), fewer emergency department visits (mean [SD], 0.05 [0.22] vs 0.60 [0.76]; P < .001), fewer hospitalizations (mean [SD], 0.05 [0.22] vs 0.50 [0.62]; P < .001), and lower costs (median [interquartile range], $1048 [$331-$8522] vs $23 482 [$9708-$55 648]; P < .001) than patients in the control group. Conclusions and Relevance: Incorporating an LHW into cancer care increases goals-of-care documentation and patient satisfaction and reduces health care use and costs at the end of life. Trial Registration: ClinicalTrials.gov Identifier: NCT02966509.

A 15-year review of the Stanford Internal Medicine Residency Program: predictors of resident satisfaction and dissatisfaction.

INTRODUCTION: Satisfaction with training and with educational experiences represents important internal medicine (IM) programmatic goals. Graduates from IM residency programs are uniquely poised to provide insights into their educational and training experiences and to assess whether these experiences were satisfactory and relevant to their current employment. METHODS: We surveyed former IM residents from the training program held during the years 2000-2015 at the Department of Medicine, Stanford University. The first part of the survey reviewed the IM residency program and the second part sought identifying data regarding gender, race, ethnicity, work, relationships, and financial matters. The primary outcome was satisfaction with the residency experience. RESULTS: Of the 405 individuals who completed the Stanford IM residency program in the study period, we identified 384 (95%) former residents with a known email address. Two hundred and one (52%) former residents responded to the first part and 185 (48%) answered both the parts of the survey. The mean age of the respondents was 36.9 years; 44% were female and the mean time from IM residency was 6.1 (±4.3) years. Fifty-eight percent reported extreme satisfaction with their IM residency experience. Predictors associated with being less than extremely satisfied included insufficient outpatient experience, insufficient international experience, insufficient clinical research experience, and insufficient time spent with family and peers. CONCLUSION: The residents expressed an overall high satisfaction rate with their IM training. The survey results provided insights for improving satisfaction with IM residency training that includes diversifying and broadening IM training experiences.

Effect of an Intensive Outpatient Program to Augment Primary Care for High-Need Veterans Affairs Patients: A Randomized Clinical Trial.

Importance: Many organizations are adopting intensive outpatient care programs for high-need patients, yet little is known about their effectiveness in integrated systems with established patient-centered medical homes. Objective: To evaluate how augmenting the Veterans Affairs (VA) medical home (Patient Aligned Care Teams [PACT]) with an Intensive Management program (ImPACT) influences high-need patients' costs, health care utilization, and experience. Design, Setting, and Participants: Randomized clinical trial at a single VA facility. Among 583 eligible high-need outpatients whose health care costs or hospitalization risk were in the top 5% for the facility, 150 were randomly selected for ImPACT; the remaining 433 received standard PACT care. Interventions: The ImPACT multidisciplinary team addressed health care needs and quality of life through comprehensive patient assessments, intensive case management, care coordination, and social and recreational services. Main Outcomes and Measures: Primary difference-in-difference analyses examined changes in health care costs and acute and extended care utilization over a 16-month baseline and 17-month follow-up period. Secondary analyses estimated the intervention's effect on ImPACT participants (using randomization as an instrument) and for patients with key sociodemographic and clinical characteristics. ImPACT participants' satisfaction and activation levels were assessed using responses to quality improvement surveys administered at baseline and 6 months. Results: Of 140 patients assigned to ImPACT, 96 (69%) engaged in the program (mean [SD] age, 68.3 [14.2] years; 89 [93%] male; mean [SD] number of chronic conditions, 10 [4]; 62 [65%] had a mental health diagnosis; 21 [22%] had a history of homelessness). After accounting for program costs, adjusted person-level monthly health care expenditures decreased similarly for ImPACT and PACT patients (difference-in-difference [SE] -$101 [$623]), as did acute and extended care utilization rates. Among respondents to the ImPACT follow-up survey (n = 54 [56% response rate]), 52 (96%) reported that they would recommend the program to others, and pre-post analyses revealed modest increases in satisfaction with VA care (mean [SD] increased from 2.90 [0.72] to 3.16 [0.60]; P = .04) and communication (mean [SD] increased from 2.99 [0.74] to 3.18 [0.60]; P = .03). Conclusions and Relevance: Intensive outpatient care for high-need patients did not reduce acute care utilization or costs compared with standard VA care, although there were positive effects on experience among patients who participated. Implementing intensive outpatient care programs in integrated settings with well-established medical homes may not prevent hospitalizations or achieve substantial cost savings. Trial Registration: clinicaltrials.gov Identifier: NCT02932228.

Development and implementation of a workshop to enhance the effectiveness of mentors working with diverse mentees in HIV research.

Abstract A growing body of evidence highlights the importance of competent mentoring in academic research in the field of HIV, particularly for early stage investigators from diverse, underrepresented backgrounds. We describe the development and implementation of a 2-day intensive workshop to train mid-level and senior-level investigators conducting HIV-related clinical and translational research across multiple academic institutions on more effective mentoring, with an emphasis on techniques to foster mentees of diversity. The workshop was focused on training mentors in techniques designed to improve the effectiveness of the mentor-mentee relationship, and included didactic presentations, interactive discussions, and small-group problem-based learning activities. Mid-level or senior-level faculty involved or planning to be involved in significant mentorship activities related to HIV research were eligible. Surveys and formal actions plans allowed for workshop evaluation and laid the groundwork for subsequent workshops. Twenty-six faculty from 16 U.S.-based institutions participated, with good representation across discipline, gender, and race/ethnicity. The sessions were highly rated and discussions and evaluations revealed important barriers and facilitators to mentoring, challenges and solutions related to mentoring mentees from diverse backgrounds, and specific tools to enhance mentoring effectiveness. The Mentoring the Mentors training program for HIV researchers focusing on early career investigators of diversity was the first of its kind and was well attended, was rated highly, and provided guidance for improving the program in the future. This training program fills an important gap in the HIV researcher community and offers guidance for training mentors interested in diversity issues in settings outside of HIV.

Evidence for risk stratification when monitoring for toxicities following initiation of combination antiretroviral therapy.

OBJECTIVE: Laboratory monitoring is recommended during combination antiretroviral therapy (cART), but the pattern of detected abnormalities and optimal monitoring are unknown. We assessed laboratory abnormalities during initial cART in 2000-2010 across the United States. DESIGN: Observational study in the Centers for AIDS Research Network of Integrated Clinical Systems Cohort. METHODS: Among patients with normal results within a year prior to cART initiation, time to first significant abnormality was assessed by Kaplan-Meier curves stratified by event type, with censoring at first of regimen change, loss to follow-up, or 104 weeks. Incidence rates of first events were estimated using Poisson regression; multivariable analyses identified associated factors. Results were stratified by time (16 weeks) from therapy initiation. RESULTS: A total of 3470 individuals contributed 3639 person-years. Median age, pre-cART CD4, and follow-up duration were 40 years, 206 cells/µl, and 51 weeks, respectively. Incidence rates for significant abnormalities (per 100 person-years) in the first 16 weeks post-cART initiation were as follows: lipid=49 [95% confidence interval (CI) 41-58]; hematologic=44 (40-49); hepatic=24 (20-27); and renal=9 (7-11), dropping substantially during weeks 17-104 of cART to lipid=23 (18-29); hematologic=5 (4-6); hepatic=6 (5-8); and renal=2 (1-3) (all P<0.05). Among patients receiving initial cART with no prior abnormality (N=1889), strongest associations for hepatic abnormalities after 16 weeks were hepatitis B and C [hazard ratio=2.3 (95% CI 1.2-4.5) and hazard ratio=3.0 (1.9-4.5), respectively]. The strongest association for renal abnormalities was hypertension [hazard ratio=2.8 (1.4-5.6)]. CONCLUSION: New abnormalities decreased after week 16 of cART. For abnormalities not present by week 16, subsequent monitoring should be guided by comorbidities.

A mentor development program for clinical translational science faculty leads to sustained, improved confidence in mentoring skills.

Mentorship is crucial for academic productivity and advancement for clinical and translational (CT) science faculty. However, little is known about the long-term effects of mentor training programs. The University of California, San Francisco (UCSF), Clinical and Translational Science Institute launched a Mentor Development Program (MDP) in 2007 for CT faculty. We report on an evaluation of the first three cohorts of graduates from the MDP. In 2010, all Mentors in Training (MITs) who completed the MDP from 2007 to 2009 (n= 38) were asked to complete an evaluation of their mentoring skills and knowledge; all MITs (100%) completed the evaluation. Two-thirds of MDP graduates reported that they often apply knowledge, attitudes, or skills obtained in the MDP to their mentoring. Nearly all graduates (97%) considered being a mentor important to their career satisfaction. Graduates were also asked about the MDP's impact on specific mentoring skills; 95% agreed that the MDP helped them to become a better mentor and to focus their mentoring goals. We also describe a number of new initiatives to support mentoring at UCSF that have evolved from the MDP. To our knowledge, this is the first evaluation of the long-term impact of a mentor training program for CT researchers.