Closing the Loop: Re-engineering the Assessment and Tracking of Symptoms in Primary Care.

Reliable systems that track the continuation, progression, or resolution of a patient's symptoms over time are essential for reliable diagnosis and ensuring that patients harboring more worrisome diagnoses are safely followed up. Given their first-contact role and increasing stresses on busy primary care clinicians and practices, new processes that make these tasks easier rather than creating more work for busy clinicians are especially needed.Some symptoms are sufficiently worrisome that they demand an urgent diagnosis and treatment while others result in a differential that can be more safely explored over time, or less differentiated and worrisome that they are best managed with the "test of time" to see if they resolve, worsen, or evolve into symptoms that are more worrisome. Regardless, it is essential that clinicians are able to reliably track symptoms over time, yet this capacity is rarely available or explicit. Working with systems engineers, we are developing prototypes for such systems and are working on their implementation and evaluation. In this commentary, we describe approaches to this essential, but underappreciated, problem in primary care.

Terminations in Primary Care: a Retrospective Observational Study of 16 Primary Care Clinics.

BACKGROUND: The relationship between clinician and patient is the cornerstone of primary care. Breakdown and termination of this relationship are understudied yet important, undesirable outcomes. OBJECTIVE: To better understand the nature and extent of provider and clinic termination of the primary care relationship. DESIGN: Retrospective observational case-control study. SUBJECTS: Adult patients in Eastern Massachusetts who received primary care at hospital- and community-based clinics and health centers participating in a practice-based research network between January 2013 and June 2017. MAIN MEASURES: Formal termination by primary care physician (PCP), reasons for termination, independent predictors of termination based on mixed-effects logistic regression, and documentation of a new PCP after termination. KEY RESULTS: We identified 158,192 patients who received primary care from 182 PCPs across 16 clinics. We found 536 cases of formal termination. Clinics ranged from 4 to 119 terminations per 10,000 patients (intraclass correlation coefficient [ICC]=0.21; 95% CI: 0.18-0.24). Patient age, race/ethnicity, educational attainment, relationship status, employment status, and insurance type were independent predictors of termination (e.g., compared to patients employed full-time, patients unemployed due to disability were more likely to be terminated [adjusted OR:9.26; 95% CI: 6.74-12.74]). The most common cause for termination (38%) was appointment "no-shows" with some PCPs/clinics found to enforce a policy of dismissal following three no-shows. At the time of chart review, 201 patients (38%) had no documentation of a new PCP. Among patients who re-established care within the network, 134 (25%) had a primary care visit within 6 months of termination. CONCLUSIONS: Detailed chart review found that, unlike previous survey-based studies, dismissal was often for missed appointments based on enforcement of no-show policies. Many sociodemographic factors were associated with termination. Variability among clinics highlights the need for further research to better understand circumstances surrounding terminations, with the principal goals of improving patient-provider relationships and providing equitable care.

Randomized Trial of Reducing Ambulatory Malpractice and Safety Risk: Results of the Massachusetts PROMISES Project.

OBJECTIVE: Evaluate application of quality improvement approaches to key ambulatory malpractice risk and safety areas. STUDY SETTING: In total, 25 small-to-medium-sized primary care practices (16 intervention; 9 control) in Massachusetts. STUDY DESIGN: Controlled trial of a 15-month intervention including exposure to a learning network, webinars, face-to-face meetings, and coaching by improvement advisors targeting "3+1" high-risk domains: test result, referral, and medication management plus culture/communication issues evaluated by survey and chart review tools. DATA COLLECTION METHODS: Chart reviews conducted at baseline and postintervention for intervention sites. Staff and patient survey data collected at baseline and postintervention for intervention and control sites. PRINCIPAL FINDINGS: Chart reviews demonstrated significant improvements in documentation of abnormal results, patient notification, documentation of an action or treatment plan, and evidence of a completed plan (all P<0.001). Mean days between laboratory test date and evidence of completed action/treatment plan decreased by 19.4 days (P<0.001). Staff surveys showed modest but nonsignificant improvement for intervention practices relative to controls overall and for the 3 high-risk domains that were the focus of PROMISES. CONCLUSIONS: A consortium of stakeholders, quality improvement tools, coaches, and learning network decreased selected ambulatory safety risks often seen in malpractice claims.

Patient-centered medical home transformation with payment reform: patient experience outcomes.

OBJECTIVE: To examine changes in patient experience across key domains of the patient-centered medical home (PCMH) following practice transformation with Lean quality improvement methodology inclusive of payment reform. STUDY DESIGN: Pre-intervention/post-intervention analysis of intervention with a comparison group, a quasi-experimental design. We surveyed patients following office visits at the intervention (n = 2502) and control (n = 1622) practices during the 15-month period before and 14-month period after PCMH Lean transformation (April-October 2009). METHODS: We measured and compared pre-intervention and post-intervention levels of patient satisfaction and other indicators of patient-centered care. Propensity weights adjusted for potential case-mix differences in intervention and control groups; propensity-adjusted proportions accounted for physician-level clustering. RESULTS: More intervention patients were very satisfied with their care after the PCMH Lean intervention (68%) compared with pre-intervention (62%). Among control patients, there was no corresponding increase in satisfaction (63% very satisfied pre-intervention vs 64% very satisfied post-intervention). This comparison resulted in a statistical trend (P = .10) toward greater overall satisfaction attributable to the intervention. Post-intervention, patients in the intervention practice consistently rated indicators of patient-centered care higher than patients in the control practice, particularly in the personal physician and communication domain. In this domain, intervention patients reported superior provider explanations, time spent, provider concern, and follow-up instructions compared with control participants, whereas control group ratings fell in the post-intervention period (P for difference <.05). CONCLUSIONS: In a pilot PCMH transformation including Lean enhancement with payment reform, patient experience was sustained or improved across key PCMH domains.

Primary care closed claims experience of Massachusetts malpractice insurers.

IMPORTANCE: Despite prior focus on high-impact inpatient cases, there are increasing data and awareness that malpractice in the outpatient setting, particularly in primary care, is a leading contributor to malpractice risk and claims. OBJECTIVE: To study patterns of primary care malpractice types, causes, and outcomes as part of a Massachusetts ambulatory malpractice risk and safety improvement project. DESIGN, SETTING, AND PARTICIPANTS: Retrospective review of pooled closed claims data of 2 malpractice carriers covering most Massachusetts physicians during a 5-year period (January 1, 2005, through December 31, 2009). Data were harmonized between the 2 insurers using a standardized taxonomy. Primary care practices in Massachusetts. All malpractice claims that involved primary care practices insured by the 2 largest insurers in the state were screened. A total of 551 claims from primary care practices were identified for the analysis. MAIN OUTCOMES AND MEASURES: Numbers and types of claims, including whether claims involved primary care physicians or practices; classification of alleged malpractice (eg, misdiagnosis or medication error); patient diagnosis; breakdown in care process; and claim outcome (dismissed, settled, verdict for plaintiff, or verdict for defendant). RESULTS: During a 5-year period there were 7224 malpractice claims of which 551 (7.7%) were from primary care practices. Allegations were related to diagnosis in 397 (72.1%), medications in 68 (12.3%), other medical treatment in 41 (7.4%), communication in 15 (2.7%), patient rights in 11 (2.0%), and patient safety or security in 8 (1.5%). Leading diagnoses were cancer (n = 190), heart diseases (n = 43), blood vessel diseases (n = 27), infections (n = 22), and stroke (n = 16). Primary care cases were significantly more likely to be settled (35.2% vs 20.5%) or result in a verdict for the plaintiff (1.6% vs 0.9%) compared with non-general medical malpractice claims (P < .001). CONCLUSIONS AND RELEVANCE: In Massachusetts, most primary care claims filed are related to alleged misdiagnosis. Compared with malpractice allegations in other settings, primary care ambulatory claims appear to be more difficult to defend, with more cases settled or resulting in a verdict for the plaintiff.

Off the hamster wheel? Qualitative evaluation of a payment-linked patient-centered medical home (PCMH) pilot.

CONTEXT: Many primary care practices are moving toward the patient-centered medical home (PCMH) model and increasingly are offering payment incentives linked to PCMH changes. Despite widespread acceptance of general PCMH concepts, there is still a pressing need to examine carefully and critically what transformation means for primary care practices and their patients and the experience of undergoing such change in a practice. METHODS: We used a qualitative case study approach to explore the underlying dynamics of change at five practices participating in PCMH transformation efforts linked to payment reform. The evaluation consisted of structured site visits, interviews, observations, and artifact reviews followed by a structured review of transcripts and documents for patterns, themes, and insights related to PCMH implementation. FINDINGS: We describe both the detailed components of each practice's transformation efforts and a grounded taxonomy of eight insights stemming from the experiences of these medical homes. We identified specific contextual factors related to wide variations in change tactics. We also observed widely varying approaches to catalyzing change using (or not) external consultants, specific challenges regarding health information technology implementation, team and staff role restructuring, compensation, and change fatigue, and several unexpected potential confounders or alternative explanations for practice success. CONCLUSIONS: Our evaluation affirms the value and necessity of qualitative methods for understanding primary care practice transformation, and it should encourage ongoing and future pilots to include assessments of the PCMH change process beyond clinical markers and claims data. The results raise insights into the heterogeneity of medical home transformation, the central but complex role of payment reform in creating a space for change, the ability of small practices to achieve substantial change in a short time period, and the challenges of sustaining it.

Do package inserts reflect symptoms experienced in practice?: assessment using an automated phone pharmacovigilance system with varenicline and zolpidem in a primary care setting.

BACKGROUND: While the US FDA maintains a voluntary reporting system, postmarketing adverse drug events (ADEs) are underreported, and this case report-based system does not allow accurate determination of incidence. OBJECTIVE: The aim of the study was to assess the usefulness of an automated phone pharmacovigilance system for ambulatory patients by comparing systematically collected, patient-reported symptoms to reflect possible ADEs with those reported on the package inserts of two drugs with postmarketing safety concerns, varenicline and zolpidem. METHODS: English-speaking adults who received a prescription for zolpidem (n = 370) or varenicline (n = 107) from a primary care physician at one of 11 participating clinics, and who participated in the pharmacovigilance system during 2008-2010, were included in the study. Patients were called approximately 4 weeks following their visit and asked to complete a standard script that asked about adherence and pre-specified symptoms. MAIN OUTCOME MEASURES: The main outcome measures were elicited rates of pre-specified symptoms or possible ADEs. RESULTS: Compared with the package insert, patients taking zolpidem were significantly (p < 0.001) more likely to report fatigue (9.0% vs 1.0%), itching (4.5% vs 1.0%) and muscle aches (5.6% vs 1.0%). Elicited rates of depression and hallucination were similar to those reported in the package insert. Patients taking varenicline were significantly more likely to report confusion (1.7% vs 0.1%), depression (3.4% vs 0.1%), fatigue (6.0% vs 1.0%), hallucinations (1.7% vs 0.1%), muscle aches (6.0% vs 1.0%) and sexual dysfunction (4.3% vs 0.1%). CONCLUSIONS: Automated phone pharmacovigilance can provide estimates of possible ADEs in clinical practice. In the case of varenicline, these data support some of the safety concerns that have come to light postmarketing, while others such as depression and hallucination related to zolpidem were not detected. These data highlight the potential value of, and innovative ways of collecting, information about possible ADEs directly from patients.

System dynamics and dysfunctionalities: levers for overcoming emergency department overcrowding.

Overcrowding of U.S. emergency departments (EDs) is a widely recognized and growing problem. This presentation offers the perspectives of a primary care physician (PCP) examining the problem at three levels: global health policy, quality process improvement, and more intimate clinical caring. It posits that ED overcrowding is actually a symptom of 10 more fundamental problems in U.S. health care and EDs: variations/supply-demand mismatch; primary care provider shortfalls; limited after-hours access; admission throughput challenges; clinical challenges related to discontinuity patients; clinical challenges related to those with special needs; interruptions; testing logistical challenges; suboptimal information systems; and fragmented/dysfunctional health insurance system, leaving many un- and underinsured.

Participation in an ambulatory e-pharmacovigilance system.

PURPOSE: There is growing concern about whether passive surveillance can detect adverse drug events (ADEs). Our objective was to demonstrate the reach of an interactive voice response system (IVRS) to systematically monitor symptoms experienced by ambulatory patients prescribed one of 31 medications, and to document whether there were differences in our ability to contact certain populations. METHODS: Patients receiving a prescription for a target medication at one of 11 clinics were eligible for a cross-sectional IVRS survey, "e-pharmacovigilance," with a follow-up survey done 3 months later if the target medication was still listed on the patient's active medication list. RESULTS: 902 patients participated, representing 43.3% of contacted and 25.7% of potentially eligible patients with a working phone. After adjustment for demographics and drug class, patients >66 years were more likely to participate than those 56-65 years (odds ratio 1.47; 95% confidence interval 1.19-1.81). Hispanics were less likely than whites (0.56; 0.42-0.76), and those in low-income communities less likely to participate than those in high-income communities (0.69; 0.58-0.82). Patients prescribed asthma, or seizure medications were more likely to participate than those prescribed medications for insomnia. Of patients reached by the system, those prescribed medications were erectile dysfunction and smoking cessation were less likely, and those prescribed seizure medication were more likely to participate. CONCLUSIONS: IVRS technology can be used to perform ambulatory e-pharmacovigilance for a broad spectrum of patients, particularly older individuals who may at particular risk for ADEs.

Linking laboratory and pharmacy: opportunities for reducing errors and improving care.

A myriad of errors and lost improvement opportunities result from failure of clinical laboratory and pharmacy information systems to effectively communicate. Pharmacotherapy could benefit from enhanced laboratory-pharmacy linkage with respect to (1) drug choice (laboratory-based indications and contraindications), (2) drug dosing (renal or hepatic, blood level-guided adjustments), (3) laboratory monitoring (laboratory signals of toxicity, baseline and ongoing monitoring), (4) laboratory result interpretation (drug interfering with test), and (5) broader quality improvement (surveillance for unrecognized toxicity, monitoring clinician response delays). Linkages can be retrospective or real-time. Many organizations could benefit now by linking existing pharmacy and laboratory data. Greater improvement is possible through implementation of electronic order entry with real-time decision support incorporating linked laboratory and pharmacy data. While many guidelines, admonitions, and rules exist regarding drugs and the laboratory, substantial new knowledge and evidence in this area are needed. Focusing on these unmet needs and accompanying logistical challenges is a priority.