Written informed consent and selection bias in observational studies using medical records: systematic review

Objectives To determine whether informed consent introduces selection bias in prospective observational studies using data from medical records, and consent rates for such studies

Primary Care Delivery by Associate Care Providers in the Patient Centered Medical Home.

INTRODUCTION: The Patient Centered Medical Home (PCMH) requires collaboration and task delegation among primary care providers (PCPs: physicians, nurse practitioners, physician assistants, and medical residents) and associate care providers (ACPs: nurses, pharmacists, social workers, dietitians, and behavioral health providers). Within PCMH, ACPs have expanded roles in clinical care delivery. However, PCMH evaluations have primarily focused on the performance of PCPs. AIMS: 1) To assess the extent to which PCMH measures encompass ACP-delivered care; 2) To determine trends in care delivery across different types of providers before and during PCMH implementation; and 3) To examine relationships between PCMH implementation, ACP care delivery, and resource utilization. METHODS: Study 1 was a systematic literature review of PCMH access and care coordination measures to assess their inclusion of ACP-delivered care. Study 2 analyzed five years of retrospective, in-person, clinical patient encounters by PCPs and ACPs among 764 Veterans Health Administration (VHA) primary care sites. Negative binomial regression estimated monthly rates of provider-delivered encounters among sites before and during PCMH implementation. Study 3 was a cross-sectional analysis of VHA primary care sites during two twelve-month periods, before (n=688) and during (n=684) PCMH implementation. Structural equation modeling tested whether the rate of nurse-delivered encounters mediated the effect of PCMH implementation on inpatient hospitalization. RESULTS: Review of 42 PCMH studies found wide variability in the inclusion of ACP care in measurement approaches, and limited information about ACP impact on outcomes. Study 2 showed that ACPs delivered 29% of in-person encounters in fiscal year (FY) 2009 (pre-PCMH), and 35% in FY2013 (during PCMH implementation). Monthly rates of PCP encounters decreased, while those for some ACPs increased during PCMH implementation. Mediation analyses demonstrated a significant positive relationship between the level of PCMH implementation and the rate of nurse-delivered encounters, and a significant negative relationship between nurse-delivered encounters and the rate of hospitalizations during PCMH. CONCLUSIONS: Findings suggest that a shift in care delivery from PCPs to some ACPs occurred in VHA primary care sites after the introduction of PCMH. ACP-delivered care may be an important mechanism of how PCMH impacts outcomes and should be included in PCMH evaluations.PhDNursingUniversity of Michigan, Horace H. Rackham School of Graduate Studieshttp://deepblue.lib.umich.edu/bitstream/2027.42/116732/1/aannis_1.pd

The association between primary care quality and healthcare utilisation, costs and outcomes for people with serious mental illness: retrospective observational study

Background Serious mental illness (SMI), including schizophrenia, bipolar disorder and other psychoses, is linked with high disease burden, poor outcomes, high treatment costs and lower life expectancy. In the UK, most people with SMI are treated in primary care by general practitioners (GPs), who are financially incentivised to meet quality targets for patients with chronic conditions, including SMI, under the Quality and Outcomes Framework (QOF). The QOF, however, omits important aspects of quality. Objective(s) We examined whether better quality of primary care for people with SMI improved a range of outcomes. Design and setting We used administrative data from English primary care practices that contribute to the Clinical Practice Research Datalink GOLD database, linked to Hospital Episode Statistics, Accident & Emergency (A&E) attendances, Office for National Statistics mortality data, and community mental health records in the Mental Health Minimum Dataset. We used survival analysis to estimate whether selected quality indicators affect the time until patients experience an outcome. Participants Four cohorts of people with SMI depending on the outcomes examined and inclusion criteria. Interventions Quality of care was measured with: i) QOF indicators: care plans and annual physical reviews ;and ii) non-QOF indicators identified through a systematic review (antipsychotic polypharmacy and continuity of care provided by GPs). Main outcome measures Several outcomes were examined: emergency admissions for i) SMI and ii) ambulatory care sensitive conditions (ACSCs); iii) all unplanned admissions; iv) A&E attendances; v) mortality; vi) re-entry into specialist mental health services; vii) costs attributed to primary, secondary and community mental healthcare. Results Care plans were associated with lower risk of A&E attendance (Hazard ratio (HR) 0.74, 95%CI 0.69-0.80), SMI admission (HR 0.67, 95%CI 0.59-0.75), ACSC admission (HR 0.73, 95%CI 0.64-0.83), and lower overall healthcare (£53), primary care (£9), hospital (£26), and mental healthcare costs (£12). Annual reviews were associated with reduced risk of A&E attendance (HR 0.80, 95%CI 0.76-0.85), SMI admission (HR 0.75, 95%CI 0.67-0.84), ACSC admission (HR 0.76, 95%CI 0.67-0.87), and lower overall healthcare (£34), primary care (£9), and mental healthcare costs (£30). Higher GP continuity was associated with lower risk of A&E presentation (HR 0.89, 95%CI 0.83-0.97), ACSC admission (HR 0.77, 95%CI 0.65-0.92), but not SMI admission. High continuity was associated with lower primary care costs (£3). Antipsychotic polypharmacy was not statistically significantly associated with the risk of unplanned admission, death or A&E presentation. None of the quality measures were statistically significantly associated with risk of re-entry into specialist mental healthcare. Limitations There is risk of bias from unobserved factors. To mitigate this, we controlled for observed patient characteristics at baseline and adjusted for the influence of time-invariant unobserved patient differences. Conclusions Better performance on QOF measures and continuity of care are associated with better outcomes and lower resource utilisation and could generate moderate cost savings. Future work Future research should examine the impact of primary care quality on measures that capture broader aspects of health and functioning

Impact of hemoglobin levels and anemia on mortality in acute stroke: analysis of UK regional registry data, systematic review and meta-analysis

Background: The impact of hemoglobin levels and anemia on stroke mortality remains controversial. We aimed to systematically assess this association and quantify the evidence. Methods and Results: We analysed data from a cohort of 8,013 stroke patients (mean (sd) 77.81±11.83 years) consecutively admitted over 11 years (January 2003–May 2015) using a UK Regional Stroke Register. The impact of hemoglobin levels and anemia on mortality was assessed by sex-specific values at different time points (7-day, 14-day, 1-month, 3-month, 6-month, 1 year), using multiple regression models controlling for confounders. Anemia was present in 24.5% of the cohort on admission and was associated with increased odds of mortality at most of the time points examined up to 1 year following stroke. The association was less consistent for males with hemorrhagic stroke. Elevated haemoglobin was also associated with increased mortality, mainly within the first month. We then conducted a systematic review using the EMBASE and Medline databases. Twenty studies met the inclusion criteria. When combined with the cohort from the current study, this gave a pooled population of 29,943 patients with stroke. The evidence base was quantified in a meta-analysis. Anemia on admission was found to be associated with an increased risk of mortality in both ischemic stroke (8 studies); OR 1.97(1.56– 2.47) and hemorrhagic stroke (4 studies); OR 1.46(1.23–1.74). Conclusions: There is strong evidence that patients with anemia have increased mortality in stroke. Targeted interventions in this patient population may improve outcomes and therefore require further evaluation

Doctor of Philosophy

dissertationIndividuals diagnosed with serious mental illness have higher rates of comorbid physical illness than people without serious mental illness. This dissertation, provided in the Multiple Article Path format, explores how comorbidities in this population have historically been addressed and examines effectiveness of interventions to address comorbidity in primary care. This research also describes the development and implementation of a specific primary care-based program to address comorbidities and patient perspectives on that program. Theoretical frameworks of this dissertation include social constructionism, labeling theory and critical theory. The first article in this project is a qualitative study exploring patient perspectives on care. The second article describes the primary care-based implementation of a care program. The third article is a systematic review of primary care-based behavioral and educational interventions to address comorbidity

Rehabilitation Using Mobile Health for Older Adults With Ischemic Heart Disease in the Home Setting (RESILIENT): Protocol for a Randomized Controlled Trial

BACKGROUND: Participation in ambulatory cardiac rehabilitation remains low, especially among older adults. Although mobile health cardiac rehabilitation (mHealth-CR) provides a novel opportunity to deliver care, age-specific impairments may limit older adults\u27 uptake, and efficacy data are currently lacking. OBJECTIVE: This study aims to describe the design of the rehabilitation using mobile health for older adults with ischemic heart disease in the home setting (RESILIENT) trial. METHODS: RESILIENT is a multicenter randomized clinical trial that is enrolling patients aged \u3e /=65 years with ischemic heart disease in a 3:1 ratio to either an intervention (mHealth-CR) or control (usual care) arm, with a target sample size of 400 participants. mHealth-CR consists of a commercially available mobile health software platform coupled with weekly exercise therapist sessions to review progress and set new activity goals. The primary outcome is a change in functional mobility (6-minute walk distance), which is measured at baseline and 3 months. Secondary outcomes are health status, goal attainment, hospital readmission, and mortality. Among intervention participants, engagement with the mHealth-CR platform will be analyzed to understand the characteristics that determine different patterns of use (eg, persistent high engagement and declining engagement). RESULTS: As of December 2021, the RESILIENT trial had enrolled 116 participants. Enrollment is projected to continue until October 2023. The trial results are expected to be reported in 2024. CONCLUSIONS: The RESILIENT trial will generate important evidence about the efficacy of mHealth-CR among older adults in multiple domains and characteristics that determine the sustained use of mHealth-CR. These findings will help design future precision medicine approaches to mobile health implementation in older adults. This knowledge is especially important in light of the COVID-19 pandemic that has shifted much of health care to a remote, internet-based setting. TRIAL REGISTRATION: ClinicalTrials.gov NCT03978130; https://clinicaltrials.gov/ct2/show/NCT03978130. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/32163