Outcome Measures for Interventions to Reduce Inappropriate Chronic Drugs: A Narrative Review.

BACKGROUND: Inappropriate prescribing is a highly important problem, given the growing aging multimorbid population with associated polypharmacy. An increasing number of studies have recently developed and tested interventions to withdraw inappropriate drugs, a process called deprescribing. However, we still lack complete information on the types and prevalence of measures used to assess the success of such interventions. OBJECTIVE: To categorize and synthesize the full spectrum of measures used in intervention studies focused on reducing inappropriate prescribing of chronic drugs in adults, to standardize measurements in future studies and help researchers design studies inclusive of the important measure types. DESIGN: We searched Ovid/MEDLINE to identify intervention studies focused on deprescribing chronic drugs in adults, published between 2010 and 2019. MEASUREMENTS: We extracted data on study characteristics, intervention components, and outcome measures. We categorized and synthesized the measures using a comprehensive and systematic framework, separating measures of intended and unintended consequences. RESULTS: Most (90/93) studies used measures of appropriate prescribing, such as drug cessation or dose reduction. The following measures were used infrequently across studies: patient-reported experience, preferences, and outcome (12 (13%), 2 (2%), and 25 (27%) studies, respectively); provider-reported experience (11 (12%) studies); patient-provider interaction (4 (4%) studies); and measures of unintended consequences (24 (26%) studies). Studies varied in the type and number of measures assessed, ranging from 1 to 20 different measures by study. CONCLUSION: To ensure initiation, success, and long-term sustainability of deprescribing, it is important to assess the success of intervention studies using clinically relevant patient- and provider-centered measures. This categorized synthesis of outcome measures used in deprescribing studies may facilitate implementation of important measure types (e.g., patient-reported measures and measures of unintended consequences) in future studies. J Am Geriatr Soc 68:2390-2398, 2020.

Measures Used to Assess the Impact of Interventions to Reduce Low-Value Care: a Systematic Review.

IMPORTANCE: Studies of interventions to reduce low-value care are increasingly common. However, little is known about how the effects of such interventions are measured. OBJECTIVE: To characterize measures used to assess interventions to reduce low-value care. EVIDENCE REVIEW: We searched PubMed and Web of Science to identify studies published between 2010 and 2016 that examined the effects of interventions to reduce low-value care. We also searched ClinicalTrials.gov to identify ongoing studies. We extracted data on characteristics of studies, interventions, and measures. We then developed a framework to classify measures into the following categories: utilization (e.g., number of tests ordered), outcome (e.g., mortality), appropriateness (e.g., overuse of antibiotics), patient-reported (e.g., satisfaction), provider-reported (e.g., satisfaction), patient-provider interaction (e.g., informed decision-making elements), value, and cost. We also determined whether each measure was designed to assess unintended consequences. FINDINGS: A total of 1805 studies were identified, of which 101 published and 16 ongoing studies were included. Of published studies (N = 101), 68% included at least one measure of utilization, 41% of an outcome, 52% of appropriateness, 36% of cost, 8% patient-reported, and 3% provider-reported. Funded studies were more likely to use patient-reported measures (17% vs 0%). Of ongoing studies (registered trials) (N = 16), 69% included at least one measure of utilization, 75% of an outcome, 50% of appropriateness, 19% of cost, 50% patient-reported, 13% provider-reported, and 6% patient-provider interaction. Of published studies, 34% included at least one measure of an unintended consequence as compared to 63% of ongoing studies. CONCLUSIONS AND RELEVANCE: Most published studies focused on reductions in utilization rather than on clinically meaningful measures (e.g., improvements in appropriateness, patient-reported outcomes) or unintended consequences. Investigators should systematically incorporate more clinically meaningful measures into their study designs, and sponsors should develop standardized guidance for the evaluation of interventions to reduce low-value care.

Perceived Barriers to Implementing Individual Choosing Wisely® Recommendations in Two National Surveys of Primary Care Providers.

BACKGROUND: While some research has examined general attitudes about efforts to reduce overutilization of services, such as the Choosing Wisely® (CW) initiative, little data exists regarding primary care providers' attitudes regarding individual recommendations. OBJECTIVE: We sought to identify whether particular CW recommendations were perceived by primary care providers as difficult to follow, difficult for patients to accept, or both. DESIGN: Two national surveys, one by mail to a random sample of 2000 U.S. primary care physicians in November 2013, and the second electronically to a random sample of 2500 VA primary care providers (PCPs) in October-December 2014. PARTICIPANTS: A total of 603 U.S. primary care physicians and 1173 VA primary care providers. Response rates were 34 and 48 %, respectively. MAIN MEASURES: PCP ratings of whether 12 CW recommendations for screening, testing and treatments applicable to adult primary care were difficult to follow and difficult for patients to accept; and ratings of potential barriers to reducing overutilization. KEY RESULTS: For four recommendations regarding not screening or testing in asymptomatic patients, less than 20 % of PCPs found the CW recommendations difficult to accept (range 7.2-16.6 %) or difficult for patients to follow (12.2-19.3 %). For five recommendations regarding testing or treatment for symptomatic conditions, however, there was both variation in reported difficulty to follow (9.8-32 %) and a high level of reported difficulty for patients to accept (35.7-87.1 %). The most frequently reported barriers to reducing overuse included malpractice concern, patient requests for services, lack of time for shared decision making, and the number of tests recommended by specialists. CONCLUSIONS: While PCPs found many CW recommendations easy to follow, they felt that some, especially those for symptomatic conditions, would be difficult for patients to accept. Overcoming PCPs' perceptions of patient acceptability will require approaches beyond routine physician education, feedback and financial incentives.

Monitoring performance for blood pressure management among patients with diabetes mellitus: too much of a good thing?

BACKGROUND: Performance measures that reward achieving blood pressure (BP) thresholds may contribute to overtreatment. We developed a tightly linked clinical action measure designed to encourage appropriate medical management and a marker of potential overtreatment, designed to monitor overly aggressive treatment of hypertension in the face of low diastolic BP. METHODS: We conducted a retrospective cohort study in 879 Department of Veterans Affairs (VA) medical centers and smaller community-based outpatient clinics. The clinical action measure for hypertension was met if the patient had a passing index BP at the visit or had an appropriate action. We examined the rate of passing the action measure and of potential overtreatment in the Veterans Health Administration during 2009-2010. RESULTS: There were 977,282 established VA patients, 18 years and older, with diabetes mellitus (DM). A total of 713,790 patients were eligible for the action measure; 94% passed the measure (82% because they had a BP <140/90 mm Hg at the visit and an additional 12% with a BP ≥140/90 mm Hg and appropriate clinical actions). Facility pass rates varied from 77% to 99% (P < .001). Among all patients with DM, 197,291 (20%) had a BP lower than 130/65 mm Hg; of these, 80 903 (8% of all patients with DM) had potential overtreatment. Facility rates of potential overtreatment varied from 3% to 20% (P < .001). Facilities with higher rates of meeting the current threshold measure (<140/90 mm Hg) had higher rates of potential overtreatment (P < .001). CONCLUSIONS: While 94% of diabetic veterans met the action measure, rates of potential overtreatment are currently approaching the rate of undertreatment, and high rates of achieving current threshold measures are directly associated with overtreatment. Implementing a clinical action measure for hypertension management, as the Veterans Health Administration is planning to do, may result in more appropriate care and less overtreatment.

Improving blood pressure control through a clinical pharmacist outreach program in patients with diabetes mellitus in 2 high-performing health systems: the adherence and intensification of medications cluster randomized, controlled pragmatic trial.

BACKGROUND: Even in high-performing health systems, some patients with diabetes mellitus have poor blood pressure (BP) control because of poor medication adherence and lack of medication intensification. We examined whether the Adherence and Intensification of Medications intervention, a pharmacist-led intervention combining elements found in efficacy studies to lower BP, improved BP among patients with diabetes mellitus with persistent hypertension and poor refill adherence or insufficient medication intensification in 2 high-performing health systems. METHODS AND RESULTS: We conducted a prospective, multisite cluster randomized pragmatic trial with randomization of 16 primary care teams at 5 medical centers (3 Veterans Affairs and 2 Kaiser Permanente) to the Adherence and Intensification of Medications intervention or usual care. The primary outcome was relative change in systolic BP (SBP), comparing 1797 intervention with 2303 control team patients, from 6 months preceding to 6 months after the 14-month intervention period. We examined shorter-term changes in SBP as a secondary outcome. The mean SBP decrease from 6 months before to 6 months after the intervention period was ≈9 mm Hg in both arms. Mean SBPs of eligible intervention patients were 2.4 mm Hg lower (95% CI: -3.4 to -1.5; P<0.001) immediately after the intervention than those achieved by control patients. CONCLUSIONS: The Adherence and Intensification of Medications program more rapidly lowered SBPs among intervention patients, but usual-care patients achieved equally low SBP levels by 6 months after the intervention period. These findings show the importance of evaluating in different real-life clinical settings programs found in efficacy trials to be effective before urging their widespread adoption in all settings. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00495794.

The impact of insurance on access to cancer clinical trials at a comprehensive cancer center.

PURPOSE: Cancer patients at Johns Hopkins undergo insurance clearance to verify coverage for enrollment to interventional clinical trials. We sought to explore the impact of insurance clearance on disparities in access to cancer clinical trials at this urban comprehensive cancer center. EXPERIMENTAL DESIGN: We evaluated the frequency of insurance-based denial of access to cancer clinical trials over a 5-year period after initiation of a formal insurance clearance process. We used a case-control design to compare demographic and clinical parameters of patients denied or approved for clinical trials participation by their insurance company in a 3-year interval. RESULTS: From July 2003 to July 2008, insurance requests for clinical trial participation were submitted on 4,617 consented cancer patients at Johns Hopkins. A total of 628 patients (13.6%) with health insurance were denied therapeutic trial enrollment owing to lack of insurance coverage for participation. A total of 254 patients denied enrollment from 2005 to 2007 were selected for further analysis. Two-hundred sixty randomly selected patients approved for clinical trial participation served as controls. Patients approved were on average older (59.2 versus 54.9 years) than patients denied (P = 0.0001). Residents of Pennsylvania, which lacks a state law mandating cancer clinical trial coverage for residents, were overrepresented among the denied patients (P = 0.0009). No statistically significant variance in the likelihood of insurance denial was found on the basis of sex, race, stage of disease, or presence of comorbidities. CONCLUSIONS: Denial of access to therapeutic clinical trials, even among insured patients, is a significant barrier to clinical cancer research. This barrier spans racial, ethnic, and gender categories.

Study protocol: the Adherence and Intensification of Medications (AIM) study--a cluster randomized controlled effectiveness study.

BACKGROUND: Many patients with diabetes have poor blood pressure (BP) control. Pharmacological therapy is the cornerstone of effective BP treatment, yet there are high rates both of poor medication adherence and failure to intensify medications. Successful medication management requires an effective partnership between providers who initiate and increase doses of effective medications and patients who adhere to the regimen. METHODS: In this cluster-randomized controlled effectiveness study, primary care teams within sites were randomized to a program led by a clinical pharmacist trained in motivational interviewing-based behavioral counseling approaches and authorized to make BP medication changes or to usual care. This study involved the collection of data during a 14-month intervention period in three Department of Veterans Affairs facilities and two Kaiser Permanente Northern California facilities. The clinical pharmacist was supported by clinical information systems that enabled proactive identification of, and outreach to, eligible patients identified on the basis of poor BP control and either medication refill gaps or lack of recent medication intensification. The primary outcome is the relative change in systolic blood pressure (SBP) measurements over time. Secondary outcomes are changes in Hemoglobin A1c, low-density lipoprotein cholesterol (LDL), medication adherence determined from pharmacy refill data, and medication intensification rates. DISCUSSION: Integration of the three intervention elements--proactive identification, adherence counseling and medication intensification--is essential to achieve optimal levels of control for high-risk patients. Testing the effectiveness of this intervention at the team level allows us to study the program as it would typically be implemented within a clinic setting, including how it integrates with other elements of care. TRIAL REGISTRATION: The ClinicalTrials.gov registration number is NCT00495794.