Tool to improve patient-provider interactions in adult primary care: Randomized controlled pilot study.

OBJECTIVE: To assess whether an intervention to help patients prioritize goals for their visit would improve patient-provider communication and clinical outcomes. DESIGN: Randomized controlled pilot study. SETTING: Primary care clinic. PARTICIPANTS: There were 120 adult hypertensive patients enrolled. INTERVENTION: Patients were randomized to receive either usual care or a previsit patient activation card developed through a series of focus groups that prompted patients to articulate their needs and set priorities for their clinic visit. Encounters were audiorecorded, transcribed, and assessed using duplicate ratings of patient activation and decision making. MAIN OUTCOME MEASURES: The primary outcome was change in medication adherence as measured by pill count at 4 and 12 weeks after the initial visit. Secondary outcomes evaluated patient-provider interaction quality (patient satisfaction, patient activation, shared decision making, patient trust, and physicians' perceived difficulty of the encounter), functional status, and blood pressure control. RESULTS: Of the 120 enrolled patients, 106 completed the baseline visit (mean age of 66 years, 53% women, 57% Black, 36% White). Participants had multiple comorbidities (median number of medications = 8). During the visit, there was greater patient activation in the intervention arm than in the control arm (4.4 vs 3.8, P = .047; ratings were based on a scale from 1 to 10). However, after the visit there were no differences in medication adherence (4 weeks: 45.8% vs 49.5%; 12 weeks: 49.4% vs 51.1%), blood pressure control (4 weeks: 133/78 mm Hg vs 131/77 mm Hg; 12 weeks: 129/77 mm Hg vs 129/76 mm Hg), or encounter satisfaction (78.6% vs 73.8% fully satisfied; P = .63). There were also no differences in shared decision making, patients' trust, or perceived difficulty of the encounter. CONCLUSION: A single previsit tool designed to prompt patients to set a prioritized agenda improved patient activation during the visit, but did not affect the quality of the interaction or postvisit patient-centred outcomes.

Direct-Observation Cohort Study of Shared Decision Making in a Primary Care Clinic.

Background. Observational studies suggest that shared medical decision making (SMDM) is suboptimal. Our objective was to assess patient preferences, ratings, and objective measurements of decision making and their impact on patient outcomes. Methods. Hypertensive adults presenting for routine care with their primary care physician completed previsit surveys assessing SMDM preferences. Postvisit surveys assessed the degree of SMDM during the encounter, patient satisfaction, and trust. Encounters were audiotaped and transcripts were coded for type of decisions made as well as SMDM quality using OPTION-5. Adherence and blood pressure were measured at baseline and at 4 weeks. Results. Among 105 encounters, there were 7.4 decisions per visit; most were basic, such as refills and routine testing. Objective measures of decision making indicated that the degree of SMDM was lower than reported by patients or physicians, although physician ratings were more accurate. Previsit, 54% of patients expressed a desire for equally shared medical decision making, 24% preferred physician dominated decision making, and 18% preferred that they make the decisions. Postvisit, patients reported experiencing SMDM in 57% of encounters, with high concordance between desired and perceived decision making. Discordance between the patient's desired and experienced SMDM reduced trust and satisfaction. The quality of shared decisions had no impact on adherence or blood pressure at 4 weeks. Limitations. Single site, small sample. Conclusions. Decisions are common during internal medicine primary care visits, and most are basic. Most patients preferred SMDM, and their perceptions of the visit decision-making style were concordant with their preferences although higher than objective measures suggested. Physician ratings of the quality of SMDM were more accurate than patient ratings. Discordance between patients' expected and experienced SMDM lowered satisfaction and trust.

Electronic physiologic and subjective data acquisition in home-dwelling heart failure patients: An assessment of patient use and perception of usability.

BACKGROUND: The current approach to the outpatient management of heart failure involves patients recollecting what has happened to them since their last clinic visit. But patients' recollection of their symptoms may not be sufficiently accurate to optimally manage their disease. Most of what is known about heart failure is related to patients' diurnal symptoms and activities. Some mobile electronic technologies can operate continuously to collect data from the time patients go to bed until they get up in the morning. We were therefore interested to evaluate if patients would use a system of selected patient-facing devices to collect physiologic and subjective state data in and around the patients' period of sleep, and if there were differences in device use and perceptions of usability at the device level METHODS: This descriptive observational study of home-dwelling patients with heart failure, between 21 and 90 years of age, enrolled in an outpatient heart failure clinic was conducted between December 2014 and June 2015. Patients received five devices, namely, body weight scale, blood pressure device, an iPad-based subjective states assessment, pulse oximeter, and actigraph, to collect their physiologic (body weight, blood pressure, heart rate, blood oxygen saturation, and physical activity) and subjective state data (symptoms and subjective states) at home for the next six consecutive nights. Use was defined as the ratio of observed use over expected use, where 1.0 is observed equals expected. Usability was determined by the overall System Usability Scale score. RESULTS: Participants were 39 clinical heart failure patients, mean age 68.1 (SD, 12.3), 72% male, 62% African American. The ratio of observed over expected use for the body weight scale, blood pressure device, iPad application, pulse oximeter and actigraph was 0.8, 1.0, 1.1, 0.9, and 1.9, respectively. The mean overall System Usability Scale score for each device were 84.5, 89.7, 85.7, 87.6, and 85.2, respectively. CONCLUSIONS: Patients were able to use all of the devices and they rated the usability of all the devices higher than expected. Our study provides support for at-home patient-collected physiologic and subjective state data. To our knowledge, this is the first study to assess the use and usability of electronic objective and subjective data collection devices in heart failure patients' homes overnight.

The adoption of an electronic health record did not improve A1c values in Type 2 diabetes.

BACKGROUND: A major justification for the clinical adoption of electronic health records (EHRs) was the expectation that it would improve the quality of medical care. No longitudinal study has tested this assumption. OBJECTIVE: We used hemoglobin A1c, a recognized clinical quality measure directly related to diabetes outcomes, to assess the effect of EHR use on clinical quality. METHODS: We performed a five-and-one-half-year multicentre longitudinal retrospective study of the A1c values of 537 type 2 diabetic patients. The same patients had to have been seen on at least three occasions: once approximately six months prior to EHR adoption (before-EHR), once approximately six monthsafter EHR adoption (after-EHR) and once approximately five years after EHR adoption (five-years), for a total of 1,611 notes. RESULTS: The overall mean confidence interval (CI) A1c values for the before- EHR, after-EHR and five-years were 7.07 (6.91 - 7.23), 7.33 (7.14 - 7.52) and 7.19 (7.06 - 7.32), respectively. There was a small but significant increase in A1c values between before-EHR and after-EHR, p = .04; there were no other significant differences. There was a significant decrease in notes missing at least one A1c value, from 42% before-EHR to 16% five-years (p < .001). CONCLUSION: We found that based on patient's A1c values, EHRs did not improve the clinical quality of diabetic care in six months and five years after EHR adoption. To our knowledge, this is the first longitudinal study to directly assess the relationshipbetween the use of an EHR and clinical quality.

Electronic health records improve clinical note quality.

BACKGROUND AND OBJECTIVE: The clinical note documents the clinician's information collection, problem assessment, clinical management, and its used for administrative purposes. Electronic health records (EHRs) are being implemented in clinical practices throughout the USA yet it is not known whether they improve the quality of clinical notes. The goal in this study was to determine if EHRs improve the quality of outpatient clinical notes. MATERIALS AND METHODS: A five and a half year longitudinal retrospective multicenter quantitative study comparing the quality of handwritten and electronic outpatient clinical visit notes for 100 patients with type 2 diabetes at three time points: 6 months prior to the introduction of the EHR (before-EHR), 6 months after the introduction of the EHR (after-EHR), and 5 years after the introduction of the EHR (5-year-EHR). QNOTE, a validated quantitative instrument, was used to assess the quality of outpatient clinical notes. Its scores can range from a low of 0 to a high of 100. Sixteen primary care physicians with active practices used QNOTE to determine the quality of the 300 patient notes. RESULTS: The before-EHR, after-EHR, and 5-year-EHR grand mean scores (SD) were 52.0 (18.4), 61.2 (16.3), and 80.4 (8.9), respectively, and the change in scores for before-EHR to after-EHR and before-EHR to 5-year-EHR were 18% (p<0.0001) and 55% (p<0.0001), respectively. All the element and grand mean quality scores significantly improved over the 5-year time interval. CONCLUSIONS: The EHR significantly improved the overall quality of the outpatient clinical note and the quality of all its elements, including the core and non-core elements. To our knowledge, this is the first study to demonstrate that the EHR significantly improves the quality of clinical notes.

QNOTE: an instrument for measuring the quality of EHR clinical notes.

BACKGROUND AND OBJECTIVE: The outpatient clinical note documents the clinician's information collection, problem assessment, and patient management, yet there is currently no validated instrument to measure the quality of the electronic clinical note. This study evaluated the validity of the QNOTE instrument, which assesses 12 elements in the clinical note, for measuring the quality of clinical notes. It also compared its performance with a global instrument that assesses the clinical note as a whole. MATERIALS AND METHODS: Retrospective multicenter blinded study of the clinical notes of 100 outpatients with type 2 diabetes mellitus who had been seen in clinic on at least three occasions. The 300 notes were rated by eight general internal medicine and eight family medicine practicing physicians. The QNOTE instrument scored the quality of the note as the sum of a set of 12 note element scores, and its inter-rater agreement was measured by the intraclass correlation coefficient. The Global instrument scored the note in its entirety, and its inter-rater agreement was measured by the Fleiss κ. RESULTS: The overall QNOTE inter-rater agreement was 0.82 (CI 0.80 to 0.84), and its note quality score was 65 (CI 64 to 66). The Global inter-rater agreement was 0.24 (CI 0.19 to 0.29), and its note quality score was 52 (CI 49 to 55). The QNOTE quality scores were consistent, and the overall QNOTE score was significantly higher than the overall Global score (p=0.04). CONCLUSIONS: We found the QNOTE to be a valid instrument for evaluating the quality of electronic clinical notes, and its performance was superior to that of the Global instrument.

Pharmacologic treatment of pediatric headaches: a meta-analysis.

OBJECTIVE To assess the effectiveness of prophylactic headache treatment in children and adolescents. DATA SOURCES PubMed, EMBASE, Cochrane Database of Clinical Trials, and bibliography of retrieved articles through August 11, 2012. STUDY SELECTION Randomized trials of headache treatment among children and adolescents (<18 years old). INTERVENTION Any placebo-controlled trial or comparisons between 2 or more active medications. MAIN OUTCOME MEASURE Number of headaches per month. RESULTS Among 21 included trials, there were 13 placebo-controlled and 10 active comparator trials (2 also included placebo). Twenty trials focused on episodic migraines and 1 on chronic daily headaches. Drugs more effective than placebo for episodic migraines (<15 headaches per month) included topiramate (difference in headaches per month, -0.71; 95% CI, -1.19 to -0.24) and trazodone (-0.60; 95% CI, -1.09 to -0.11). Ineffective drugs included clonidine, flunarizine, pizotifen, propranolol, and valproate. A single trial of fluoxetine for chronic daily headaches found it ineffective. Patients given placebo experienced a significant (P = .03) decline in headaches, from 5.6 (95% CI, 4.52-6.77; Q = 8.14 [Cochran Q is a measure of the heterogeneity of the included studies]) to 2.9 headaches per month (95% CI, 1.66-4.08; Q = 4.72). Among the 10 active comparator trials, flunarizine was more effective than piracetam (difference in headaches per month, -2.20; 95% CI, -3.93 to -0.47) but no better than aspirin, dihydroergotamine, or propranolol. Propranolol was compared with valproate as well as behavioral treatment, and 2 studies compared different doses of topiramate; none of these trials showed significant differences. CONCLUSIONS Topiramate and trazodone have limited evidence supporting efficacy for episodic migraines. Placebo was effective in reducing headaches. Other commonly used drugs have no evidence supporting their use in children and adolescents. More research is needed.

Tricyclic antidepressants and headaches: systematic review and meta-analysis.

OBJECTIVE: To evaluate the efficacy and relative adverse effects of tricyclic antidepressants in the treatment of migraine, tension-type, and mixed headaches. DESIGN: Meta-analysis. DATA SOURCES: Medline, Embase, the Cochrane Trials Registry, and PsycLIT. Studies reviewed Randomised trials of adults receiving tricyclics as only treatment for a minimum of four weeks. DATA EXTRACTION: Frequency of headaches (number of headache attacks for migraine and number of days with headache for tension-type headaches), intensity of headache, and headache index. RESULTS: 37 studies met the inclusion criteria. Tricyclics significantly reduced the number of days with tension-type headache and number of headache attacks from migraine than placebo (average standardised mean difference -1.29, 95% confidence interval -2.18 to -0.39 and -0.70, -0.93 to -0.48) but not compared with selective serotonin reuptake inhibitors (-0.80, -2.63 to 0.02 and -0.20, -0.60 to 0.19). The effect of tricyclics increased with longer duration of treatment (ß=-0.11, 95% confidence interval -0.63 to -0.15; P<0.0005). Tricyclics were also more likely to reduce the intensity of headaches by at least 50% than either placebo (tension-type: relative risk 1.41, 95% confidence interval 1.02 to 1.89; migraine: 1.80, 1.24 to 2.62) or selective serotonin reuptake inhibitors (1.73, 1.34 to 2.22 and 1.72, 1.15 to 2.55). Tricyclics were more likely to cause adverse effects than placebo (1.53, 95% confidence interval 1.11 to 2.12) and selective serotonin reuptake inhibitors (2.22, 1.52 to 3.32), including dry mouth (P<0.0005 for both), drowsiness (P<0.0005 for both), and weight gain (P<0.001 for both), but did not increase dropout rates (placebo: 1.22, 0.83 to 1.80, selective serotonin reuptake inhibitors: 1.16, 0.81 to 2.97). CONCLUSIONS: Tricyclic antidepressants are effective in preventing migraine and tension-type headaches and are more effective than selective serotonin reuptake inhibitors, although with greater adverse effects. The effectiveness of tricyclics seems to increase over time.