Patient engagement programs for recognition and initial treatment of depression in primary care: a randomized trial.

IMPORTANCE: Encouraging primary care patients to address depression symptoms and care with clinicians could improve outcomes but may also result in unnecessary treatment. OBJECTIVE: To determine whether a depression engagement video (DEV) or a tailored interactive multimedia computer program (IMCP) improves initial depression care compared with a control without increasing unnecessary antidepressant prescribing. DESIGN, SETTING, AND PARTICIPANTS: Randomized clinical trial comparing DEV, IMCP, and control among 925 adult patients treated by 135 primary care clinicians (603 patients with depression and 322 patients without depression, defined by Patient Health Questionnaire-9 [PHQ-9] score) conducted from June 2010 through March 2012 at 7 primary care clinical sites in California. INTERVENTIONS: DEV targeted to sex and income, an IMCP tailored to individual patient characteristics, and a sleep hygiene video (control). MAIN OUTCOMES AND MEASURES: Among depressed patients, superiority assessment of the composite measure of patient-reported antidepressant drug recommendation, mental health referral, or both (primary outcome); depression at 12-week follow-up, measured by the PHQ-8 (secondary outcome). Among nondepressed patients, noninferiority assessment of clinician- and patient-reported antidepressant drug recommendation (primary outcomes) with a noninferiority margin of 3.5%. Analyses were cluster adjusted. RESULTS: Of the 925 eligible patients, 867 were included in the primary analysis (depressed, 559; nondepressed, 308). Among depressed patients, rates of achieving the primary outcome were 17.5% for DEV, 26% for IMCP, and 16.3% for control (DEV vs control, 1.1 [95% CI, -6.7 to 8.9], P = .79; IMCP vs control, 9.9 [95% CI, 1.6 to 18.2], P = .02). There were no effects on PHQ-8 measured depression score at the 12-week follow-up: DEV vs control, -0.2 (95% CI, -1.2 to 0.8); IMCP vs control, 0.9 (95% CI, -0.1 to 1.9). Among nondepressed patients, clinician-reported antidepressant prescribing in the DEV and IMCP groups was noninferior to control (mean percentage point difference [PPD]: DEV vs control, -2.2 [90% CI, -8.0 to 3.49], P = .0499 for noninferiority; IMCP vs control, -3.3 [90% CI, -9.1 to 2.4], P = .02 for noninferiority); patient-reported antidepressant recommendation did not achieve noninferiority (mean PPD: DEV vs control, 0.9 [90% CI, -4.9 to 6.7], P = .23 for noninferiority; IMCP vs control, 0.3 [90% CI, -5.1 to 5.7], P = .16 for noninferiority). CONCLUSIONS AND RELEVANCE: A tailored IMCP increased clinician recommendations for antidepressant drugs, a mental health referral, or both among depressed patients but had no effect on mental health at the 12-week follow-up. The possibility that the IMCP and DEV increased patient-reported clinician recommendations for an antidepressant drug among nondepressed patients could not be excluded. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01144104.

Targeted versus tailored multimedia patient engagement to enhance depression recognition and treatment in primary care: randomized controlled trial protocol for the AMEP2 study.

BACKGROUND: Depression in primary care is common, yet this costly and disabling condition remains underdiagnosed and undertreated. Persisting gaps in the primary care of depression are due in part to patients' reluctance to bring depressive symptoms to the attention of their primary care clinician and, when depression is diagnosed, to accept initial treatment for the condition. Both targeted and tailored communication strategies offer promise for fomenting discussion and reducing barriers to appropriate initial treatment of depression. METHODS/DESIGN: The Activating Messages to Enhance Primary Care Practice (AMEP2) Study is a stratified randomized controlled trial comparing two computerized multimedia patient interventions -- one targeted (to patient gender and income level) and one tailored (to level of depressive symptoms, visit agenda, treatment preferences, depression causal attributions, communication self-efficacy and stigma)-- and an attention control. AMEP2 consists of two linked sub-studies, one focusing on patients with significant depressive symptoms (Patient Health Questionnaire-9 [PHQ-9] scores ≥ 5), the other on patients with few or no depressive symptoms (PHQ-9 < 5). The first sub-study examined effectiveness of the interventions; key outcomes included delivery of components of initial depression care (antidepressant prescription or mental health referral). The second sub-study tracked potential hazards (clinical distraction and overtreatment). A telephone interview screening procedure assessed patients for eligibility and oversampled patients with significant depressive symptoms. Sampled, consenting patients used computers to answer survey questions, be randomized, and view assigned interventions just before scheduled primary care office visits. Patient surveys were also collected immediately post-visit and 12 weeks later. Physicians completed brief reporting forms after each patient's index visit. Additional data were obtained from medical record abstraction and visit audio recordings. Of 6,191 patients assessed, 867 were randomized and included in analysis, with 559 in the first sub-study and 308 in the second. DISCUSSION: Based on formative research, we developed two novel multimedia programs for encouraging patients to discuss depressive symptoms with their primary care clinicians. Our computer-based enrollment and randomization procedures ensured that randomization was fully concealed and data missingness minimized. Analyses will focus on the interventions' potential benefits among depressed persons, and the potential hazards among the non-depressed. TRIAL REGISTRATION: ClinicialTrials.gov Identifier: NCT01144104.

Caught in the act? Prevalence, predictors, and consequences of physician detection of unannounced standardized patients.

Objective. To examine the prevalence, predictors, and consequences of physician detection of unannounced standardized patients (SPs) in a study of the impact of direct-to-consumer advertising on treatment for depression. Data Sources. Eighteen trained SPs were randomly assigned to conduct 298 unannounced audio-recorded visits with 152 primary care physicians in three U.S. cities between May 2003 and May 2004. Study Design. Randomized controlled trial using SPs. SPs portrayed six roles, created by crossing two clinical conditions (major depression or adjustment disorder) with three medication request scripts (brand-specific request, general request for an antidepressant, or no request). Data Collection. Within 2 weeks following the visit, physicians completed a form asking whether they "suspected" conducting an office visit with an SP during the past 2 weeks; 296 (99 percent) detection forms were returned. Physicians provided contextual data, a Clinician Background Questionnaire. SPs filled in a Standardized Patient Reporting Form for each visit and returned all written prescriptions and medication samples to the laboratory. Principal Findings. Depending on the definition, detection rates ranged from 5 percent (unambiguous detection) to 23.6 percent (any degree of suspicion) of SP visits. In 12.8 percent of encounters, physicians accurately detected the SP before or during the visit but they only rarely believed their suspicions affected their clinical behavior. In random effects logistic regression analyses controlling for role, actor, physician, and practice factors, suspected visits occurred less frequently in HMO settings than in solo practice settings (p<.05). Physicians more frequently referred SPs to mental health professionals when visits aroused high suspicion (p<.05). Conclusions. Trained actors portrayed patient roles conveying mood disorders at low levels of detection. There was some evidence for differential treatment of detected standardized patients by physicians with regard to referrals but not antidepressant prescribing or follow-up recommendations. Systematic assessment of detection is recommended when SPs are used in studies of clinical process and quality of care.

A new instrument to measure appropriateness of services in primary care.

OBJECTIVE: To develop a new instrument for judging the appropriateness of three key services (new prescription, diagnostic test, and referral) as delivered in primary care outpatient visits. DESIGN: Candidate items were generated by a seven-member expert panel, using a five-step nominal technique, for each of three service categories in primary care: new prescriptions, diagnostic tests, and referrals. Expert panelists and a convenience sample of 95 community-based primary care physicians ranked items for (i) importance and (ii) feasibility of ascertaining from a typical office chart record. Resulting items were used to construct a measure of appropriateness using principals of structured implicit review. Two physician reviewers used this measure to judge the appropriateness of 421 services from 160 outpatient visits. SETTING: Primary care practices in a staff model health maintenance organization and a large preferred provider network. MEASURES: Inter-rater agreement was measured using intraclass correlation coefficient (ICC) and kappa statistic. RESULTS: For overall appropriateness, the ICC and kappa were 0.52 and 0.44 for new medication, 0.35 and 0.32 for diagnostic test, and 0.40 and 0.41 for referral, respectively. Only 3% of services were judged to be inappropriate by either reviewer. The proportion of services judged to be less than definitely appropriate by one or both reviewers was 56% for new medication, 31% for diagnostic test, and 22% for referral. CONCLUSIONS: This new measure of appropriateness of primary care services has fair inter-rater agreement for new medications and referrals, similar to appropriateness measures of other general services, but poor agreement for diagnostic tests. It may be useful as a tool to assess the appropriateness of common primary care services in studies of health care quality, but is not suitable for evaluating performance of individual physicians.

Direct observation of requests for clinical services in office practice: what do patients want and do they get it?

BACKGROUND: Requests can influence the conduct and content of the medical visit. However, little is known about the nature, frequency, and impact of such requests. We performed this study to ascertain the prevalence, antecedents, and consequences of patients' requests for clinical services in ambulatory practice. METHODS: This observational study combined patient and physician surveys with audiotaping of 559 visits to 45 physicians in 2 health care systems between January and November 1999. All patients had a new problem or significant health concern. Main outcome measures included prevalence of 8 categories of requests for physician action; odds of patients' requesting tests, referrals, or new prescriptions; odds of physicians' ordering diagnostic tests, making specialty referrals, or writing new prescriptions; patient satisfaction; and physicians' perceptions of the visit. RESULTS: The 559 patients made 545 audiocoded requests for physician action; 23% requested at least 1 diagnostic test, specialty referral, or new prescription medication. Requests for diagnostic tests were more common among new patients (P<.001). Requests for any clinical service were more common among patients experiencing greater health-related distress (P<.05) and less common among patients of cardiologists (P<.001). After adjusting for predisposing, need, and contextual factors, referral requests were associated with higher odds of receiving specialty referrals (adjusted odds ratio [AOR], 4.1; 95% confidence interval [CI], 1.6-10.7) and prescription requests were associated with higher odds of receiving new prescription medications (AOR, 2.8; 95% CI, 1.2-6.3). Physicians reported that visits during which patients requested diagnostic tests were more demanding than visits in which no such requests were made (P =.02). CONCLUSIONS: Though more common in primary care than in cardiology, patients' requests for clinical services are both pervasive and influential. The results support placing greater emphasis on understanding and addressing the patient's role in determining health care utilization.

Request fulfillment in office practice: antecedents and relationship to outcomes.

BACKGROUND: Patients communicate their desires and expectations largely by making requests. However, the antecedents and consequences of request fulfillment have received limited attention. OBJECTIVE: To describe patient and physician characteristics associated with request fulfillment and to understand the consequences of request fulfillment and nonfulfillment on visit evaluations by patients and physicians, self-reported health care use, and health outcomes. DESIGN: Data were gathered from patient and physician surveys administered at several points before and after problem-driven outpatient visits. SETTING: The study was carried out in the office practices of 45 family practice, internal medicine, and cardiology physicians working either in a large multispecialty group practice or in a group-model health maintenance organization. PATIENTS: Data were collected at the index visit from 909 patients (cooperation rate, 68%; net response rate, 32%). A telephone follow-up survey was administered to 887 (98%) of these patients 2 weeks after the visit. MEASUREMENTS: Before the visit, patients provided ratings of their health concerns, physical functioning, role limitations, general health perceptions, and trust in the index physician. After the visit, patients reported on any request that they made, physician responses to these requests, and their satisfaction with care. At the 2-week follow-up evaluation, patients again reported on satisfaction, health concerns, health status, and self-reported postvisit health care use. RESULTS: Patients reported making at least one request in 84% of encounters; requests for medical information, examination, and tests or procedures were most common. Four-fifths of patients who made at least one request reported complete fulfillment of all requests. Perceived request fulfillment was significantly lower among patients with relatively low pr-visit trust in the treating physician. Higher request fulfillment was predictive of more positive patient evaluations of care. Visits in which requests could not be completely fulfilled were rated by physicians as more demanding and less satisfying. Request fulfillment was also positively associated with fewer health concerns and greater symptom improvement at follow up. Nonfulfillment of patient requests did not predict postvisit health care use. CONCLUSIONS: Request fulfillment affects patient and physician satisfaction and perceptions of health outcomes. New approaches that efficiently recognize and respond to patient requests are needed.