What’s New? The top ten research topics chosen by community clinicians NAPCRG PEARLS for Clinicians from those presented at NAPCRG 2013 Nine David Hahn, MD MS

NAPCRG?? not this Craig but this

Objectives - Introduce CCAG and NAPCRG “Pearls” Present results of selected “Pearls” 9 of 17 Reflect on how much STFM conference themes and “Pearls” topics overlap

North American Primary Care Research Group (NAPCRG) - Multidisciplinary organization for primary care researchers Founded in 1972, over 1500 members Presentations ranked by the CCAG for clinical relevance (2013 NAPCRG meeting) CCAG = Community Clinician Advisory Group

Community Clinician Advisory Group - Goal: Bring practicing clinician voices to NAPCRG to inform the research agenda Composition: A clinician making a living providing direct care for patients (>75%). May do some teaching and practice-based research but these activities are not the primary factor determining pay or professional advancement.

Pearl Slides Outline The research question and why this study is important What the researchers did What the researchers found Why it is important for clinical practice

STFM Themes (N=4 Pearls) Patient-centered medical home (n=2) Team-based care (n=1) Continuous practice improvement (n=1) Practice redesign (n=2) Remaining Pearls were primarily point-of-care clinical topics

The four STFM-themed Pearls Relationship of PCMH Implementation to Primary Care Provider and Staff Burnout Cost of PCMH transformation Outcomes of a Randomized Trial for Multi-Morbidity Using Lean Management to Improve Opioid Prescribing for Pain in Ambulatory Care

The Patient Centered Medical Home (PCMH) is a model for advanced primary care that transitions from physician-centered care to patient-centered care, achieved through a team-based approach. Implementation of PCMH involves changes in care processes (reflected in new care delivery workflows), staff roles, and staffing levels. Implementation can directly impact provider and staff burnout. The Research Question Title: PCMH Implementation and Primary Care Provider and Staff Burnout: A Process Analysis Authors: Diana Carvajal MD, MPH, Elizabeth Alt MD, MPH, Claudia Lechuga MS, Stephanie Neves BS, MA, Arthur Blank PhD, M. Diane McKee MD, MS Question: What is the relationship between the PCMH Implementation process (change in care processes & staffing levels) and staff & provider burnout? Relevance: The PCMH is a model for advanced primary care, achieved through a team-based approach. Implementation involves changes in care processes, staff roles, and staffing levels. Implementation can directly impact provider and staff burnout. 9

What the Researchers Did PCMH implementation process evaluation of 2 primary care sites in the Bronx, NY: Site 1: Internal Med/Peds; non FQHC; non-teaching facility; 90,000 unique pts/yr Site 2: Family Medicine; FQHC; teaching facility; 52,000 unique pts/yr Methods: survey at 1 and 2 years post-implementation Measures: Burn-out: survey utilized the Maslach Burnout Index: measures professional efficacy, cynicism, & exhaustion Change in care processes: reflected in the # of care delivery workflows implemented Staffing levels: obtained from Human Resources & site administrators For the Maslach: Based on established threshold, scores were categorized as “at risk” for each of the following subscales: Professional Efficacy (low score denotes high burnout risk) Cynicism (high score denotes high burnout risk) Exhaustion (high score denotes high burnout risk) 10

What the Researchers Found For Burn-out: Levels of burnout is high at yr 1 and worsens at both sites Burnout is substantially higher at the teaching/FQHC site (site 2) What the Researchers Found Many workflows created, moving toward team-based care. Implementation involved a planned increase in staffing: Site 1 achieved and sustained the planned staffing levels Site 2 briefly achieved but did not sustain planned levels Burn-out, Site 1 Burn-out, Site 2 Burn-out, Site 1 11

What This Means for Clinical Practice Lack of improvement in burnout is likely multifactorial, including: Concurrent demands related to meaningful use Increasing responsibilities (workflows) and workload without a matched increase in staffing ratios. ***Maintenance of adequate provider and staffing ratios is crucial to mitigate burnout during PCMH implementation.

The Research Question PCMH Transformation - Rachel Hope, MD, The Christ Hospital/University of Cincinnati Family Medicine Residency ; Miranda Moore, PhD, & Andrew Bazemore, MD, The Robert Graham Center The Question: What is the cost to primary care practices of PCMH transformation? Why this is important? Although many studies have measured and calculated the long term cost savings of the Patient Centered Medical Home (PCMH), there is a lack of data on the estimated costs that primary care providers (PCPs) face in transforming how they deliver care to their patients. BP34 Adherence to Antibiotic Prescribing for LRTI and Association With Recovery (Oral Presentation On Completed Research) Nick Francis, MD, PhD, Cardiff University; David Gillespie; Jacqueline Nuttall; Paul Little; Theo Verheij; Samuel Coenen; Jochen Cals; Kerenza Hood; Herman Goossens; Christopher Butler 13

What the Researchers Did Design: Studies detailing cost of transformation were selected from comprehensive searches in PubMed and WebScience, supplemented by reference lists. These studies were reviewed for minimum and maximum costs per practice. Data Source: PubMed and WebScience, supplemented by reference lists Methods: lit review, NCQA PCMH elements divided into categories, min and max in each of 5 categories added together to define and a cost range of transformation aged ≥18 years, consulting with an illness where an acute or worsened cough was the main or dominant symptom, or had a clinical presentation that suggested a lower respiratory tract infection that had been present for ≥28 days. 14

What the Researchers Found We grouped the 27 elements of the NCQA PCMH into 5 categories Electronic Medical Records, After Hour Access, Culturally and Linguistically Appropriate Services, Quality Measure and Improvement, Reporting Performance 12 studies total that each fell into one of these 5 categories Estimation of Cost of Transformation: $119,000 - $419,000 (Median: $262,000)

What This Means for Clinical Practice This estimation does not include all 28 elements of the PCMH, so the range likely reflects a minimum cost to practices These results are helpful for determining the financial incentives needed for PCMH transformation

Outcomes of a randomized trial for multimorbidity - the TrueBlue study Morgan MAJ, Coates MJ, Dunbar JA, et al. The TrueBlue model of collaborative care using practice nurses as case managers for depression alongside diabetes or heart disease: a randomised trial. BMJ Open 2013;3 Research Question: How effective is collaborative care in depressed patients with diabetes or heart disease or both? Why this is important? Multimorbidity is the norm in patients with diabetes and complicates care. There is a need for timetabled, protocol driven care, with tasks shared between the team, a robust communication tool and a case-manager to coordinate. This is collaborative care. BP34 Adherence to Antibiotic Prescribing for LRTI and Association With Recovery (Oral Presentation On Completed Research) Nick Francis, MD, PhD, Cardiff University; David Gillespie; Jacqueline Nuttall; Paul Little; Theo Verheij; Samuel Coenen; Jochen Cals; Kerenza Hood; Herman Goossens; Christopher Butler 17

What the researchers did A two-arm open randomised cluster controlled trial with usual care as control. Subjects: Australian primary care patients with diabetes &/or Coronary Heart Disease + Depression (n=400) Intervention: Each 3 months Practice nurse (45 minutes): Physical measures, pathology results, PHQ9 (depression) responses and lifestyle. Goal setting and problem solving to develop or review up to three personal goals Case-management referrals and recall date Patient-held care plan Primary care physician (15 minutes) for clinical decisions aged ≥18 years, consulting with an illness where an acute or worsened cough was the main or dominant symptom, or had a clinical presentation that suggested a lower respiratory tract infection that had been present for ≥28 days. 18

What the researchers found Depression reduced (10.7 to 7.1 on PHQ9) Cardiovascular risk reduced (27.4% to 24.8%) Exercising increased (41% to 60% of patients) Goal setting (81%achieved,14% re-negotiated) Adherence to best-practice guidelines for diabetes, heart disease and depression

What this means for clinical practice Successful ingredients for collaborative care in multimorbidity: Combined guideline based on patient priorities Patient-held summary and plan Nurses skilled in goal setting, problem solving and depression assessment

The Research Question Using Lean Management to Improve Opioid Prescribing for Pain in Ambulatory Care Connie van Eeghen DrPH, Amanda Kennedy PharmD, Mark Pasanen MD, Benjamin Littenberg MD, Charles MacLean MD University of Vermont The Question: Is a structured, systems-based QI method, such as Lean, effective in helping practices implement a set of best practice strategies? Why this is important: Increased prescription pain relief drug diversion/addiction Structured problem-solving approaches such as Lean have potential to improve many primary care processes 21

What the Researchers Did Engaged 9 primary practices & 1 orthopaedic practice in Lean redesign of office work Mixed methods, prospective, observational Multiple case studies paired pre- and post-intervention surveys from providers and staff 155 study participants; 77% response rate 36 prescribers and 83 staff responded (n=119) Primary outcome: provider satisfaction with opioid prescription management 22

What the Researchers Found Satisfaction (2 bars), selected strategies (3 bars), prescriber confidence (4 bars) 23

What This Means for Clinical Practice The Lean approach embedded key strategies into office work successfully. Most common: Use of state-sponsored prescription data base Provider/staff team approach to managing Rx Consistent approach across entire practice Lean was effective and well-received regardless of the specific strategies selected A toolkit to guide the use of Lean in primary care may have broad application

The top ten clinical topics Developing Tools to Help Patients Understand Controversial Cancer Screening Recommendations: A Qualitative Study Does Risk Predict Statin Use? Performance of a rapid influenza detection test in ambulatory primary care - Wisconsin:2009-2012 Targets and Self-Management for the Control of Blood Pressure in Stroke and At-Risk Groups (Tasmin-SR): A Randomised Controlled Trial Montelukast for Persistent Cough in Young People and Adults: A Double-Blind Randomised Placebo-Controlled Trial

The top ten clinical topics The Potential Role of NT-proBNP in Screening for and Predicting Prognosis in Heart Failure Systematic Review of the Diagnostic Accuracy of Capillary Refill Time for Serious Illness in Children Management of Patients With Chronic Non-Malignant Pain and Mental Health Diagnoses: A Cincinnati Area Research and Improvement Group (CARING) Study Insight Into the Longitudinal Associations Between Affective Disorders and Pain Depression and Opioid use increase risk of incident myocardial infarction

The Research Question Helping Patients Reach a Balanced Understanding of Controversial Cancer Screening Recommendations: The Impossible Dream? B Saver, R Luckmann, M Hayes, K Mazor, G Bacigalupe, J Calista, N Esparza, T Gorodetsky Why this is important? The USPSTF has recently issued controversial recommendations about prostate cancer screening and mammography for women aged 40-49 Patients and some providers are confused by the counterintuitive recommendations and conflicting evidence Information alone rarely changes behavior – can a persuasive, evidence-based approach be effective? BP34 Adherence to Antibiotic Prescribing for LRTI and Association With Recovery (Oral Presentation On Completed Research) Nick Francis, MD, PhD, Cardiff University; David Gillespie; Jacqueline Nuttall; Paul Little; Theo Verheij; Samuel Coenen; Jochen Cals; Kerenza Hood; Herman Goossens; Christopher Butler 27

What the Researchers Did Participants: 27 men aged 50-74 and 28 women aged 40-49 recruited from academic & community health center clinics Design: For each topic, 2 English- and 1 Spanish-language focus group Basic Method/Intervention: Initial focus group on each topic presented information about tests, benefits, harms, guidelines and how generated Scripts for subsequent focus groups modified to focus more on persuading participants to trust/believe USPSTF recommendations Polled periodically during final groups for opinions about screening aged ≥18 years, consulting with an illness where an acute or worsened cough was the main or dominant symptom, or had a clinical presentation that suggested a lower respiratory tract infection that had been present for ≥28 days. 28

What the Researchers Found Neither men nor women aware of USPSTF No traction from distinguishing between processes used by USPSTF and other groups No traction without first making harms clear Men did not easily grasp cascade following abnormal PSA test, but readily understood and wished to avoid treatment harms Women had much greater difficulty appreciating mammography harms Socialization to the value of mammography is very strong, but providers are generally trusted

What This Means for Clinical Practice A persuasive approach, starting with making harms clear and then clarifying current knowledge about benefits, may help many men accept USPSTF recommendation against PSA screening This approach for women and mammography may be less accepted Provider recommendations are very important USPSTF recommendations likely to change patient behavior only as they affect provider recommendations

The Research Question Does Cardiovascular Risk Predict Statin Use? Michael Johansen MD MS, Ohio State University, Lee Green MD MPH, Ananda Sen PhD, Sheetal Kircher MD MS, Caroline Richardson MD MS.  Cardiovascular Risk and Statin Use in the United States. Ann Fam Med. (In Press) The Question: Does cardiovascular risk predict statin use? Why this is important? Statins are highly efficacious in reducing death in individuals with high cardiovascular risk BP34 Adherence to Antibiotic Prescribing for LRTI and Association With Recovery (Oral Presentation On Completed Research) Nick Francis, MD, PhD, Cardiff University; David Gillespie; Jacqueline Nuttall; Paul Little; Theo Verheij; Samuel Coenen; Jochen Cals; Kerenza Hood; Herman Goossens; Christopher Butler 31

What the Researchers Did Adults between 30-79 Cross-sectional study utilizing the nationally representative Medical Expenditure Panel Survey (MEPS). Basic Method/Intervention Determine the proportion of individuals who were on a statin (2 or more prescriptions in a year) Stratify by risk profiles Determine clinical conditions associated with use. aged ≥18 years, consulting with an illness where an acute or worsened cough was the main or dominant symptom, or had a clinical presentation that suggested a lower respiratory tract infection that had been present for ≥28 days. 32

What the Researchers Found 58% of individuals with reported coronary artery disease and 52% of individuals with diabetes over age 40 reported statin use. Hyperlipidemia, not cardiovascular risk, is most strongly associated with statin users.

What This Means for Clinical Practice There are large numbers of individuals with coronary artery disease and/or diabetes that benefit from statins who are not taking them. Getting more high-risk people on statins will save lives. Refocus statin use from being a cholesterol lowering medication to one that reduces cardiovascular events and mortality.

The Research Question Performance of a Rapid Influenza Detection Test (RIDT) in Ambulatory Primary Care Wisconsin: 2009-2013 Temte JL, Barlow S, Greene P, Haupt T, Reisdorf E, Wedig M, Shult P, Giorgi A, Fowlkes A. University of Wisconsin What patient, illness and pathogen characteristics affect performance of rapid influenza detection tests? Why this is important? RIDTs are designed to provide point-of-care diagnosis of influenza to inform treatment and guidance decisions in a meaningful timeframe RIDTs have been limited by some performance measures – primarily sensitivity Package inserts suggest that age can affect sensitivity BP34 Adherence to Antibiotic Prescribing for LRTI and Association With Recovery (Oral Presentation On Completed Research) Nick Francis, MD, PhD, Cardiff University; David Gillespie; Jacqueline Nuttall; Paul Little; Theo Verheij; Samuel Coenen; Jochen Cals; Kerenza Hood; Herman Goossens; Christopher Butler 35

What the Researchers Did Population/Subjects Primary care patients with acute respiratory infections N = 1,219 (age 0 to 88.1 years) November 2009 to April 2013 Four family medicine clinics in Wisconsin Design: Prospective respiratory virus surveillance Pragmatic (multiple sites, 90 clinicians, diverse ARIs) Basic Method/Intervention Comparison of sensitivity of RIDT to gold standard PCR RIDT: Quidel QuickVue Influenza A+B CDC influenza RT-PCR primers and Qiagen Resplex II Multiplex PCR Uniform demographic, epidemiologic and symptom data on all patients aged ≥18 years, consulting with an illness where an acute or worsened cough was the main or dominant symptom, or had a clinical presentation that suggested a lower respiratory tract infection that had been present for ≥28 days. 36

What the Researchers Found Factors associated with Sensitivity univariate analysis (Chi Square) Sex of Patient N.S Male > Female Age of patient P=0.001 younger > older (7 age groups) ILI vs. ARI N.S. ILI > ARI Days from onset P=0.001 earlier > later (5 time groups Vaccinated N.S. Unvaccinated > vaccinated Influenza strain N.S. B > AH3 > AH1 mulitvariate analysis (Binary Logistic Regression) Age of patient Sensitivity drops by 20% for each decade of life Odds ratio = 0.80 P = 0.004 Days from Onset Sensitivity drops by 26% for each passing day after onset Odds ratio = 0.74 P = 0.01

What This Means for Clinical Practice Rapid Influenza Diagnostic Test performance is complex and requires appropriate patient selection Patient Age and Time from Illness Onset are key parameters Sensitivity drops by 20% for each decade of life Sensitivity drops by 26% for each passing day after illness onset The messiness and chaos allowed by a Primary Care Surveillance Platform offers an excellent means to evaluate the effectiveness of diagnostic technology

The Research Question Is montelukast an effective treatment for postinfectious cough? Wang K, Birring SS, Taylor K, Fry NK, Hay AD, Moore, M, Jin J, Perera R, Farmer A, Little P, Harrison TG, Mant D, Harnden A. Montelukast for postinfectious cough in adults: a double-blind randomised placebo-controlled trial. Lancet Respir Med. 2014;2(1):35-43. Postinfectious cough following an acute respiratory tract infection is commonly encountered in primary care. However, there are no proven effective treatments. Postinfectious cough may be mediated by increased cysteinyl leukotriene production and cysteinyl leukotriene receptor expression (mouse and human models). 39

What the Researchers Did Population: Non-smoking adults aged 16 to 49 years with clinically diagnosed postinfectious cough of 2 to 8 weeks’ duration recruited from 25 UK general practices. Oral fluid test for pertussis (whooping cough). Laboratory-confirmed pertussis diagnosed if oral fluid anti-pertussis toxin IgG titre >= 70 arbitrary units. Randomised (1:1) to receive montelukast 10 mg daily or placebo for 2 weeks. Option to continue study medication for another 2 weeks. Primary outcomes: Change in cough-specific quality of life after 2 weeks and 4 weeks (measured using Leicester Cough Questionnaire [LCQ]). 40

What the Researchers Found 276 patients randomised to montelukast (n=137) or placebo (n=139). 70 patients had laboratory-confirmed pertussis (25%). Improvements in cough specific quality of life observed in both groups after 2 weeks (montelukast: mean LCQ score change 2·7, 95% CI 2·2–3·3; placebo: 3·6, 2·9–4·3) but difference between groups (mean difference -0.9, -1.7 to -0.04) did not reach minimal clinically important difference of LCQ (1.3). No significant difference between groups after 4 weeks (montelukast: 5·2, 4·5–5·9; placebo: 5·9, 5·1–6·7; mean difference –0·5, –1·5 to 0·6, p=0·38).

What This Means for Clinical Practice Montelukast is not an effective treatment for postinfectious cough in primary care. Pertussis is prevalent among adults who present in primary care with postinfectious cough. Better understanding of the mechanisms underlying postinfectious cough is needed to identify future potential treatments.

The Research Question The potential role of NT-proBNP in screening for heart failure and in predicting prognosis Richard Hobbs, Care Taylor, Andrea Roalfe, Rachel Iles, University of Oxford. Taylor CJ, Roalfe AK, Iles R, Hobbs FDR. The potential role of NT-proBNP in screening for and predicting prognosis in heart failure: a survival analysis. BMJ Open 2014; 4:4 e004675 doi:10.1136/bmjopen-2013-004675 The Question? To determine the potential role of N-terminal B type natriuretic peptide (NT-proBNP) in screening for and predicting prognosis in heart failure by examining diagnosis and ten year survival of patients with a raised NT-proBNP at screening. Why this is important? - Heart failure in 2013 is Common, very costly (to patients and healthcare systems), and has a large evidence base for management BUT is often diagnosed in late stage or misdiagnosed and often under-managed BP34 Adherence to Antibiotic Prescribing for LRTI and Association With Recovery (Oral Presentation On Completed Research) Nick Francis, MD, PhD, Cardiff University; David Gillespie; Jacqueline Nuttall; Paul Little; Theo Verheij; Samuel Coenen; Jochen Cals; Kerenza Hood; Herman Goossens; Christopher Butler 43

What the Researchers Did Population/Subjects 594 subjects with a baseline natiuretic peptide result in the ECHOES Study, which screened 6162 patients for HF or LVSD by screening patients from 16 practices in Central England between 1995–99 in 4 randomly sampled cohorts (general population, those with existing HF diagnosis, those at high risk of HF, those on diuretics). Design Prospective sub-study of subjects in the Echocardiographic Heart of England Screening study (ECHOES) in participants with a NT-proBNP level at baseline from all four cohorts and with validated diagnoses and long term follow up for mortality. Basic Method/Intervention Logistic regression to examine whether NT-proBNP is predictive of heart failure at screening after adjustment for age, sex and cohort. Kaplan Meier curves and log rank tests to compare survival times of participants according to NT-proBNP level. Cox regression to assess prognostic effect of NT-ProBNP, allowing for significant covariates. Receiver operator curves to determine test reliability. aged ≥18 years, consulting with an illness where an acute or worsened cough was the main or dominant symptom, or had a clinical presentation that suggested a lower respiratory tract infection that had been present for ≥28 days. 44

What the Researchers Found Risk of heart failure increased almost 18-fold when NT-proBNP was 150pg/ml or above (adjusted OR =17.7 (95% CI 4.9 to 63.5). Ten-year survival in the general population cohort was 61% (48% to 71%) for those with NT-proBNP>=150pg/ml and 89% (84% to 92%) for those below the cut-off at baseline. After adjustment for age, sex and risk factors for heart failure, NT-proBNP level >= 150pg/ml was associated with a 58% increase in the risk of death within 10 years (adjusted HR =1.58 95% CI 1.09 to 2.30).

What This Means for Clinical Practice Raised NT-proBNP levels, when screening the general population, are predictive of a diagnosis of heart failure. A lower threshold than guidelines currently advocate for diagnosing symptomatic presenting patients is needed for screening. Baseline NT-proBNP levels also predicted reduced survival at 10 years.

Conclusions - NAPCRG “Pearls” are one attempt to bridge the gap between research & practice Some “Pearls” address STFM conference themes; the majority address point-of-care clinical questions of interest to practicing clinicians The “family” of Family Medicine has many voices