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Application of the FRAME-IS to a multifaceted implementation strategy

Schoenthaler, Antoinette; De La Calle, Franze; De Leon, Elaine; Garcia, Masiel; Colella, Doreen; Nay, Jacalyn; Dapkins, Isaac
BACKGROUND:Research demonstrates the importance of documenting adaptations to implementation strategies that support integration of evidence-based interventions into practice. While studies have utilized the FRAME-IS [Framework for Reporting Adaptations and Modifications for Implementation Strategies] to collect structured adaptation data, they are limited by a focus on discrete implementation strategies (e.g., training), which do not reflect the complexity of multifaceted strategies like practice facilitation. In this paper, we apply the FRAME-IS to our trial evaluating the effectiveness of PF on implementation fidelity of an evidence-based technology-facilitated team care model for improved hypertension control within a federally qualified health center (FQHC). METHODS:Three data sources are used to document adaptations: (1) implementation committee meeting minutes, (2) narrative reports completed by practice facilitators, and (3) structured notes captured on root cause analysis and Plan-Do-Study-Act worksheets. Text was extracted from the data sources according to the FRAME-IS modules and inputted into a master matrix for content analysis by two authors; a third author conducted member checking and code validation. RESULTS:We modified the FRAME-IS to include part 2 of module 2 (what is modified) to add greater detail of the modified strategy, and a numbering system to track adaptations across the modules. This resulted in identification of 27 adaptations, of which 88.9% focused on supporting practices in identifying eligible patients and referring them to the intervention. About half (52.9%) of the adaptations were made to modify the context of the PF strategy to include a group-based format, add community health workers to the strategy, and to shift the implementation target to nurses. The adaptations were often widespread (83.9%), affecting all practices within the FQHC. While most adaptations were reactive (84.6%), they resulted from a systematic process of reviewing data captured by multiple sources. All adaptations included the FQHC in the decision-making process. CONCLUSION/CONCLUSIONS:With modifications, we demonstrate the ability to document our adaptation data across the FRAME-IS modules, attesting to its applicability and value for a range of implementation strategies. Based on our experiences, we recommend refinement of tracking systems to support more nimble and practical documentation of iterative, ongoing, and multifaceted adaptations. TRIAL REGISTRATION/BACKGROUND:Clinicaltrials.gov NCT03713515, Registration date: October 19, 2018.
PMCID:11143702
PMID: 38822342
ISSN: 1472-6963
CID: 5664082

Evaluating associations of bisphenol and phthalate exposure with time to pregnancy and subfecundity in a New York City pregnancy cohort

Charifson, Mia; Seok, Eunsil; Wang, Yuyan; Mehta-Lee, Shilpi S; Gordon, Rachel; Liu, Mengling; Trasande, Leonardo; Kahn, Linda G
It is important to understand the impact of consumer chemical exposure and fecundity, a couple's measure of probability of successful conception, given approximately 15% of couples experience infertility. Prior research has generally found null associations between bisphenol and phthalate exposure and fecundability, measured via time to pregnancy (TTP). However, this research has not been updated with current chemical exposures and have often lacked diversity in their study populations. We evaluated the associations between common bisphenol and phthalate chemical exposure groups and TTP as well as subfecundity (TTP>12 months) in the New York University Children's Health Study, a diverse pregnancy cohort from 2016 onward. Using first-trimester spot-urine samples to measure chemical exposure and self-reported TTP from first-trimester questionnaires, we observed a significant adverse association between total bisphenol exposure and certain phthalate groups on TTP and odds of subfecundity. Furthermore, in a mixtures analysis to explore the joint effects of the chemical groups on the outcomes, we found evidence of a potential interaction between total bisphenol exposure and low-molecular weight phthalates on TTP. Future research should continue to update our knowledge regarding the complex and potentially interacting effects of these chemicals on reproductive health.
PMID: 38830524
ISSN: 1873-6424
CID: 5665072

Impact of jail-based methadone or buprenorphine treatment on non-fatal opioid overdose after incarceration

Cherian, Teena; Lim, Sungwoo; Katyal, Monica; Goldfeld, Keith S; McDonald, Ryan; Wiewel, Ellen; Khan, Maria; Krawczyk, Noa; Braunstein, Sarah; Murphy, Sean M; Jalali, Ali; Jeng, Philip J; Rosner, Zachary; MacDonald, Ross; Lee, Joshua D
BACKGROUND:Non-fatal overdose is a leading predictor of subsequent fatal overdose. For individuals who are incarcerated, the risk of experiencing an overdose is highest when transitioning from a correctional setting to the community. We assessed if enrollment in jail-based medications for opioid use disorder (MOUD) is associated with lower risk of non-fatal opioid overdoses after jail release among individuals with opioid use disorder (OUD). METHODS:This was a retrospective, observational cohort study of adults with OUD who were incarcerated in New York City jails and received MOUD or did not receive any MOUD (out-of-treatment) within the last three days before release to the community in 2011-2017. The outcome was the first non-fatal opioid overdose emergency department (ED) visit within 1 year of jail release during 2011-2017. Covariates included demographic, clinical, incarceration-related, and other characteristics. We performed multivariable cause-specific Cox proportional hazards regression analysis to compare the risk of non-fatal opioid overdose ED visits within 1 year after jail release between groups. RESULTS:MOUD group included 8660 individuals with 17,119 incarcerations; out-of-treatment group included 10,163 individuals with 14,263 incarcerations. Controlling for covariates and accounting for competing risks, in-jail MOUD was associated with lower non-fatal opioid overdose risk within 14 days after jail release (adjusted HR=0.49, 95% confidence interval=0.33-0.74). We found no significant differences 15-28, 29-56, or 57-365 days post-release. CONCLUSION/CONCLUSIONS:MOUD group had lower risk of non-fatal opioid overdose immediately after jail release. Wider implementation of MOUD in US jails could potentially reduce post-release overdoses, ED utilization, and associated healthcare costs.
PMCID:11111329
PMID: 38643529
ISSN: 1879-0046
CID: 5653972

Protocol for a prospective, randomized, controlled trial of Mental Contrasting with Implementation Intentions (MCII) to enhance the effectiveness of VA's MOVE! weight management program: WOOP (Wish, Outcome, Obstacle, Plan) VA

Vandyousefi, Sarvenaz; Oettingen, Gabriele; Wittleder, Sandra; Moin, Tannaz; Sweat, Victoria; Aguilar, Adrian D; Ruan, Andrea; Angelotti, Gina; Wong, Laura; Orstad, Stephanie L; Illengberger, Nicholas; Nicholson, Andrew; Lim, Sahnah; Cansler, Rachel; Portelli, Dilara; Sherman, Scott; Jay, Melanie R
INTRODUCTION:Intensive weight management programs are effective but often have low enrollment and high attrition. Lack of motivation is a key psychological barrier to enrollment, engagement, and weight loss. Mental Contrasting with Implementation Intentions (MCII) is a unique imagery technique that increases motivation for behavior change. We describe our study protocol to assess the efficacy and implementation of MCII to enhance the effectiveness of VA's MOVE! or TeleMOVE! weight management programs using a procedure called "WOOP" (Wish, Outcome, Obstacle, Plan) for Veterans. We hypothesize that WOOP+MOVE! or TeleMOVE! (intervention) will lead to greater MOVE!/TeleMOVE! program engagment and consequently weight loss than MOVE!/TeleMOVE! alone (control). METHOD:Veterans are randomized to either the intervention or control. Both arms receive the either MOVE! or TeleMOVE! weight management programs. The intervention group receives an hour long WOOP training while the control group receives patient education. Both groups receive telephone follow up calls at 3 days, 4 weeks, and 2 months post-baseline. Eligible participants are Veterans (ages 18-70 years) with either obesity (BMI ≥ 30 kg/m2) or overweight (BMI ≥ 25 kg/m2) and an obesity-associated co-morbidity. At baseline, 6 and 12 months, we assess weight, diet, physical activity in both groups. The primary outcome is mean percent weight change at 6 months. Secondary outcomes include changes in waist circumference, diet, physical activity, and dieting self-efficacy and engagement in regular physical activity. We assess implementation using the RE-AIM framework. CONCLUSION:If WOOP VA is found to be efficacious, it will be an important tool to facilitate weight management and improve weight outcomes. CLINICAL TRIAL REGISTRATION:NCT05014984.
PMID: 38608752
ISSN: 1559-2030
CID: 5655772

Corrigendum to "Randomized trial protocol for remote monitoring for equity in advancing the control of hypertension in safety net systems (REACH-SNS) study" [Contemporary Clinical Trials Volume 126 (2023) 107112]

Fontil, Valy; Khoong, Elaine C; Green, Beverly B; Ralston, James D; Zhou, Crystal; Garcia, Faviola; McCulloch, Charles E; Sarkar, Urmimala; Lyles, Courtney R
PMID: 38599995
ISSN: 1559-2030
CID: 5725872

Fentanyl Test Strips for Harm Reduction: A Scoping Review

Kutscher, Eric; Barber Grossi, Marco; LaPolla, Fred; Lee, Joshua D
BACKGROUND:High potency synthetic opioids like fentanyl have continued to replace or contaminate the supply of illicit drugs in North America, with fentanyl test strips (FTSs) often used as a harm reduction tool for overdose prevention. The available evidence to support FTS for harm reduction has yet to be summarized. METHODS:A search of PubMed, Ovid Embase, and Web of Science was conducted in March 2023. A 2-stage review was conducted to screen by title and abstract and then by full text by 2 reviewers. Data were extracted from each study using a standardized template. RESULTS:A total of 91 articles were included, mostly from North America, predominantly reporting on FTS along with other harm reduction tools, and all conducted after 2016. No randomized controlled trials are reported. Robust evidence exists supporting the sensitivity and specificity of FTS, along with their acceptability and feasibility of use for people who use drugs and as a public health intervention. However, limited research is available on the efficacy of FTS as a harm reduction tool for behavior change, engagement in care, or overdose prevention. CONCLUSIONS:Though FTSs are highly sensitive and specific for point of care testing, further research is needed to assess the association of FTS use with overdose prevention. Differences in FTS efficacy likely exist between people who use opioids and nonopioid drugs, with additional investigation strongly needed. As drug testing with point-of-care immunoassays is embraced for nonfentanyl contaminants such as xylazine and benzodiazepines, increased investment in examining overdose prevention is necessary.
PMID: 38829042
ISSN: 1935-3227
CID: 5664922

'It Just Makes Sense to Me': A qualitative study exploring patient decision-making and experiences with prostate MRI during active surveillance for prostate cancer

Sutherland, Ryan; Gross, Cary P; Ma, Xiaomei; Jeong, Farah; Seibert, Tyler M; Cooperberg, Matthew R; Catalona, William J; Ellis, Shellie D; Loeb, Stacy; Schulman-Green, Dena; Leapman, Michael S
INTRODUCTION/UNASSIGNED:Although prostate magnetic resonance imaging (MRI) is commonly used in the diagnosis, staging and active surveillance of prostate cancer, little is known about patient perspectives on MRI. METHODS/UNASSIGNED:We performed a qualitative study consisting of in-depth, semi-structured interviews of patients with low- and intermediate-risk prostate cancer managed with active surveillance. Interviews focused on experiences with and knowledge of prostate MRI and MRI-ultrasound fusion biopsy during active surveillance. We purposively sampled patients who received prostate MRI as part of their clinical care, conducted interviews until reaching thematic saturation and performed conventional content analysis to analyse data. RESULTS/UNASSIGNED:Twenty patients aged 51-79 years (mean = 68 years) participated in the study. At diagnosis, 17 (85%) had a Gleason grade group 1, and three (15%) had a grade group 2 tumour. Overall, participants viewed prostate MRI as a valuable tool that accurately localizes and monitors prostate cancer over time, and they considered prostate MRI central to active surveillance monitoring. We identified five thematic categories related to MRI use: (1) the experiential aspects of undergoing an MRI scan; (2) the experience of visualizing one's own prostate and prostate cancer; (3) adequacy of provider explanations of MRI results; (4) confidence in prostate MRI in decision-making; and (5) the role of prostate MRI in longitudinal follow-up, including an interest in using MRI to modify the timing of, or replace, prostate biopsy. CONCLUSION/UNASSIGNED:Patients value prostate MRI as a tool that enhances their confidence in the initial diagnosis and monitoring of prostate cancer. This work can inform future studies to optimize patient experience, education and counselling during active surveillance for prostate cancer.
PMCID:11168777
PMID: 38873351
ISSN: 2688-4526
CID: 5669442

Mechanisms for mindfulness in migraine: Does catastrophizing matter? [Editorial]

Wells, Rebecca Erwin; O'Connell, Nathaniel; Minen, Mia T
PMID: 38842246
ISSN: 1526-4610
CID: 5665582

Despite Higher Rates of Minimally Recommended Depression Treatment, Transgender and Gender Diverse Medicare Beneficiaries with Depression Have Poorer Mental Health Outcomes: Analysis of 2009-2016 Medicare Data

Progovac, Ana M; Mullin, Brian O; Yang, Xinyu; Kibugi, Lauryn Trisha; Mwizerwa, Diane; Hatfield, Laura A; Schuster, Mark A; McDowell, Alex; Cook, Benjamin L
PURPOSE/UNASSIGNED:Little is known about depression treatment for transgender and gender diverse (TGD) older adults or TGD people with disabilities. The purpose of this study was to characterize receipt of minimally recommended depression treatment and outcomes for TGD Medicare beneficiaries. METHODS/UNASSIGNED:=287,583 who qualified due to disability). We estimated disparities in outcomes between TGD and non-TGD beneficiaries (separately by original reason for Medicare eligibility: age 65+ years vs. a disability) using a rank-and-replace method to adjust for health needs. RESULTS/UNASSIGNED:<0.001). CONCLUSION/UNASSIGNED:Despite higher mental health treatment rates, TGD beneficiaries with depression in this study had more adverse mental health outcomes. Minimum recommended treatment definitions derived in general population samples may not capture complex mental health needs of specific marginalized populations.
PMCID:11299097
PMID: 39109255
ISSN: 2688-4887
CID: 5724232

Determinants of remote measurement-based care uptake in a safety net outpatient psychiatry department as part of learning health system transition

Aldis, Rajendra; Rosenfeld, Lisa C; Mulvaney-Day, Norah; Lanca, Margaret; Zona, Kate; Lam, Jeffrey A; Asfour, Julia; Meltzer, Jonah C; Leff, H Stephen; Fulwiler, Carl; Wang, Philip; Progovac, Ana M
INTRODUCTION/UNASSIGNED:Behavioral measurement-based care (MBC) can improve patient outcomes and has also been advanced as a critical learning health system (LHS) tool for identifying and mitigating potential disparities in mental health treatment. However, little is known about the uptake of remote behavioral MBC in safety net settings, or possible disparities occurring in remote MBC implementation. METHODS/UNASSIGNED:This study uses electronic health record data to study variation in completion rates at the clinic and patient level of a remote MBC symptom measure tool during the first 6 months of implementation at three adult outpatient psychiatry clinics in a safety net health system. Provider-reported barriers to MBC adoption were also measured using repeated surveys at one of the three sites. RESULTS/UNASSIGNED:Out of 1219 patients who were sent an MBC measure request, uptake of completing at least one measure varied by clinic: General Adult Clinic, 38% (n = 262 of 696); Substance Use Clinic, 28% (n = 73 of 265); and Transitions Clinic, 17% (n = 44 of 258). Compared with White patients, Black and Portuguese or Brazilian patients had lower uptake. Older patients also had lower uptake. Spanish language of care was associated with much lower uptake at the patient level. Significant patient-level disparities in uptake persisted after adjusting for the clinic, mental health diagnoses, and number of measure requests sent. Providers cited time within visits and bandwidth in their workflow as the greatest consistent barriers to discussing MBC results with patients. CONCLUSIONS/UNASSIGNED:There are significant disparities in MBC uptake at the patient and clinic level. From an LHS data infrastructure perspective, safety net health systems may need to address the need for possible ways to adapt MBC to better fit their populations and clinical needs, or identify targeted implementation strategies to close data gaps for the identified disparity populations.
PMCID:11176570
PMID: 38883875
ISSN: 2379-6146
CID: 5724222