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A randomized trial to improve patient-centered care and hypertension control in underserved primary care patients.

ABSTRACT: African Americans and persons with low socioeconomic status (SES) are disproportionately affected by hypertension and receive less patient-centered care than less vulnerable patient populations. Moreover, continuing medical education (CME) and patient-activation interventions have infrequently been directed to improve the processes of care for these populations.To compare the effectiveness of patient-centered interventions targeting patients and physicians with the effectiveness of minimal interventions for underserved groups.Randomized controlled trial conducted from January 2002 through August 2005, with patient follow-up at 3 and 12 months, in 14 urban, community-based practices in Baltimore, Maryland.Forty-one primary care physicians and 279 hypertension patients.Physician communication skills training and patient coaching by community health workers.Physician communication behaviors; patient ratings of physicians' participatory decision-making (PDM), patient involvement in care (PIC), reported adherence to medications; systolic and diastolic blood pressure (BP) and BP control.Visits of trained versus control group physicians demonstrated more positive communication change scores from baseline (-0.52 vs. -0.82, p = 0.04). At 12 months, the patient+physician intensive group compared to the minimal intervention group showed significantly greater improvements in patient report of physicians' PDM (? = +6.20 vs. -5.24, p = 0.03) and PIC dimensions related to doctor facilitation (? = +0.22 vs. -0.17, p = 0.03) and information exchange (? = +0.32 vs. -0.22, p = 0.005). Improvements in patient adherence and BP control did not differ across groups for the overall patient sample. However, among patients with uncontrolled hypertension at baseline, non-significant reductions in systolic BP were observed among patients in all intervention groups-the patient+physician intensive (-13.2 mmHg), physician intensive/patient minimal (-10.6 mmHg), and the patient intensive/physician minimal (-16.8 mmHg), compared to the patient+physician minimal group (-2.0 mmHg).Interventions that enhance physicians' communication skills and activate patients to participate in their care positively affect patient-centered communication, patient perceptions of engagement in care, and may improve systolic BP among urban African-American and low SES patients with uncontrolled hypertension.

SUBMITTER: Cooper LA

PROVIDER: S-EPMC3208476 | biostudies-literature | 2011 Nov

REPOSITORIES: biostudies-literature

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A randomized trial to improve patient-centered care and hypertension control in underserved primary care patients.

Cooper Lisa A LA Roter Debra L DL Carson Kathryn A KA Bone Lee R LR Larson Susan M SM Miller Edgar R ER Barr Michael S MS Levine David M DM

Journal of general internal medicine 20110706 11

<h4>Background</h4>African Americans and persons with low socioeconomic status (SES) are disproportionately affected by hypertension and receive less patient-centered care than less vulnerable patient populations. Moreover, continuing medical education (CME) and patient-activation interventions have infrequently been directed to improve the processes of care for these populations.<h4>Objective</h4>To compare the effectiveness of patient-centered interventions targeting patients and physicians wi ...[more]

PMID: 21732195

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Project description:It is important to understand which components of successful multifaceted interventions are responsible for study outcomes, since some components may be more important contributors to the intervention effect than others.We conducted a mediation analysis to determine which of seven factors had the greatest effect on change in systolic blood pressure (BP) after 6 months in a trial to improve hypertension control.The study was a preplanned secondary analysis of a cluster-randomized clinical trial. Eight clinics in an integrated health system were randomized to provide usual care to their patients (n?=?222), and eight were randomized to provide a telemonitoring intervention (n?=?228).Four hundred three of 450 trial participants completing the 6-month follow-up visit were included.Intervention group participants received home BP telemonitors and transmitted measurements to pharmacists, who adjusted medications and provided advice to improve adherence to medications and lifestyle modification via telephone visits.Path analytic models estimated indirect effects of the seven potential mediators of intervention effect (defined as the difference between the intervention and usual care groups in change in systolic BP from baseline to 6 months). The potential mediators were change in home BP monitor use, number of BP medication classes, adherence to BP medications, physical activity, salt intake, alcohol use, and weight.The difference in change in systolic BP was 11.3 mmHg. The multivariable mediation model explained 47 % (5.3 mmHg) of the intervention effect. Nearly all of this was mediated by two factors: an increase in medication treatment intensity (24 %) and increased home BP monitor use (19 %). The other five factors were not significant mediators, although medication adherence and salt intake improved more in the intervention group than in the usual care group.Most of the explained intervention effect was attributable to the combination of self-monitoring and medication intensification. High adherence at baseline and the relatively low intensity of resources directed toward lifestyle change may explain why these factors did not contribute to the improvement in BP.

Project description:BackgroundUncontrolled hypertension contributes to disparities in cardiovascular outcomes. Patient intervention strategies informed by behavioral economics and social psychology could improve blood pressure (BP) control in disadvantaged minority populations.ObjectiveTo assess the impact on BP control of an intervention combining short-term financial incentives with promotion of intrinsic motivation among highly disadvantaged patients.DesignRandomized controlled trial.ParticipantsTwo hundred seven adults (98% African American or Latino) aged 18 or older with uncontrolled hypertension attending Federally Qualified Health Centers.InterventionSix-month intervention, combining financial incentives for measuring home BP, recording medication use, BP improvement, and achieving target BP values with counseling linking hypertension control efforts to participants' personal reasons to stay healthy.Main measuresPrimary outcomes: percentage achieving systolic BP (SBP) < 140 mmHg, percentage achieving diastolic BP (DBP) < 90 mmHg, and changes in SBP and DBP, all after 6 months. Priority secondary outcomes were SBP < 140 mmHg, DBP < 90 mmHg, and BP change at 12 months, 6 months after the intervention ended.Key resultsAfter 6 months, rates of achieving target BP values for intervention and control subjects respectively was 57.1% vs. 40.2% for SBP < 140 mmHg (adjusted odds ratio (AOR) 2.53 (1.13-5.70)), 79.8% vs 70.1% for DBP < 90 mmHg (AOR 2.50 (0.84-7.44)), and 53.6% vs 40.2% for achieving both targets (AOR 2.04 (0.92-4.52)). However, at 12 months, the groups did not differ significantly in these 3 measures: 39.5% vs 35.0% for SBP (AOR 1.20 (0.51-2.83)), 68.4% vs 75.0% for DBP (AOR 0.70 (0.24-2.09)), and 35.5% vs 33.8% for both (AOR 1.03 (0.44-2.42)). Change in absolute SBP and DBP did not differ significantly between the groups at 6 or 12 months. Exploratory post hoc analysis revealed intervention benefit only occurred among individuals whose providers intensified their regimens, but not among those with intensification but no intervention.ConclusionsThe intervention achieved short-term improvement in SBP control in a highly disadvantaged population. Despite attempts to enhance intrinsic motivation, the effect was not sustained after incentives were withdrawn. Future research should evaluate combined patient/provider strategies to enhance such interventions and sustain their benefit.Trial registrationNCT01402453; http://clinicaltrials.gov/show/NCT01402453.

Project description:BackgroundChronic diseases that drive morbidity, mortality, and health care costs are largely influenced by human behavior. Behavioral health conditions such as anxiety, depression, and substance use disorders can often be effectively managed. The majority of patients in need of behavioral health care are seen in primary care, which often has difficulty responding. Some primary care practices are providing integrated behavioral health care (IBH), where primary care and behavioral health providers work together, in one location, using a team-based approach. Research suggests there may be an association between IBH and improved patient outcomes. However, it is often difficult for practices to achieve high levels of integration. The Integrating Behavioral Health and Primary Care study responds to this need by testing the effectiveness of a comprehensive practice-level intervention designed to improve outcomes in patients with multiple chronic medical and behavioral health conditions by increasing the practice's degree of behavioral health integration.MethodsForty-five primary care practices, with existing onsite behavioral health care, will be recruited for this study. Forty-three practices will be randomized to the intervention or usual care arm, while 2 practices will be considered "Vanguard" (pilot) practices for developing the intervention. The intervention is a 24-month supported practice change process including an online curriculum, a practice redesign and implementation workbook, remote quality improvement coaching services, and an online learning community. Each practice's degree of behavioral health integration will be measured using the Practice Integration Profile. Approximately 75 patients with both chronic medical and behavioral health conditions from each practice will be asked to complete a series of surveys to measure patient-centered outcomes. Change in practice degree of behavioral health integration and patient-centered outcomes will be compared between the two groups. Practice-level case studies will be conducted to better understand the contextual factors influencing integration.DiscussionAs primary care practices are encouraged to provide IBH services, evidence-based interventions to increase practice integration will be needed. This study will demonstrate the effectiveness of one such intervention in a pragmatic, real-world setting.Trial registrationClinicalTrials.gov NCT02868983 . Registered on August 16, 2016.

Project description:BackgroundExperts recommend that alcohol-related care be integrated into primary care (PC) to improve prevention and treatment of unhealthy alcohol use. However, few healthcare systems offer such integrated care. To address this gap, implementation researchers and clinical leaders at Kaiser Permanente Washington (KPWA) partnered to design a high-quality program of evidence-based care for unhealthy alcohol use: the Sustained Patient-centered Alcohol-related Care (SPARC) program. SPARC implements systems of clinical care designed to increase both prevention and treatment of unhealthy alcohol use. This clinical care for unhealthy alcohol use was implemented using three strategies: electronic health record (EHR) decision support, performance monitoring and feedback, and front-line support from external practice coaches with expertise in alcohol-related care ("SPARC implementation intervention" hereafter). The purpose of this report is to describe the protocol of the SPARC trial, a pragmatic, cluster-randomized, stepped-wedge implementation trial to evaluate whether the SPARC implementation intervention increased alcohol screening and brief alcohol counseling (so-called brief interventions), and diagnosis and treatment of alcohol use disorders (AUDs) in 22 KPWA PC clinics.Methods/designThe SPARC trial sample includes all adult patients who had a visit to any of the 22 primary care sites in the trial during the study period (January 1, 2015-July 31, 2018). The 22 sites were randomized to implement the SPARC program on different dates (in seven waves, approximately every 4 months). Primary outcomes are the proportion of patients with PC visits who (1) screen positive for unhealthy alcohol use and have documented brief interventions and (2) have a newly recognized AUD and subsequently initiate and engage in alcohol-related care. Main analyses compare the rates of these primary outcomes in the pre- and post-implementation periods, following recommended approaches for analyzing stepped-wedge trials. Qualitative analyses assess barriers and facilitators to implementation and required adaptations of implementation strategies.DiscussionThe SPARC trial is the first study to our knowledge to use an experimental design to test whether practice coaches with expertise in alcohol-related care, along with EHR clinical decision support and performance monitoring and feedback to sites, increase both preventive care-alcohol screening and brief intervention-as well as diagnosis and treatment of AUDs.Trial registrationThe trial is registered at ClinicalTrials.Gov: NCT02675777. Registered February 5, 2016, https://clinicaltrials.gov/ct2/show/NCT02675777 .

Project description:BackgroundPatient safety is a leading item on the policy agenda of both major international health organizations and advanced countries generally. The quantitative description of the phenomena has given rise to intense concern with the issue in institutions and organizations, leading to a number of initiatives and research projects and the promotion of patient safety culture, with training becoming a priority both in Spain and internationally. To date, most studies have been conducted in a hospital setting, even though primary care is the type most commonly used by the public, in our experience. Our study aims to achieve the following:--Assess the registry of adverse events as an education tool to improve patient safety culture in the Family and Community Teaching Units of Galicia.--Find and analyze educational tools to improve patient safety culture in primary care.--Evaluate the applicability of the Hospital Survey on Patient Safety Culture by the Agency for Healthcare Research and Quality, Spanish version, in the context of primary health care.Design and methodsDesignExperimental unifactorial study of two groups, control and intervention.Study populationTutors and residents in Family and Community Medicine in last year of studies in Galicia, Spain.SampleFrom the population universe through voluntary participation. Twenty-seven tutor-resident units in each group required, randomly assigned.InterventionResidents and their respective tutor (tutor-resident pair) in teaching units on Family and Community Medicine from throughout Galicia will be invited to participate. Tutor-resident pair that agrees to participate will be sent the Hospital Survey on Patient Safety Culture. Then, tutor-resident pair will be assigned to each group--either intervention or control--through simple random sampling. The intervention group will receive specific training to record the adverse effects found in patients under their care, with subsequent feedback, after receiving instruction on the process. No action will be taken in the control group. After the intervention has ended, the survey will once again be provided to all participants.Outcome measuresChange in safety culture as measured by Hospital Survey on Patient Safety CultureCONSORT Extension for Non-Pharmacologic Treatments 2008 was applied.DiscussionThe most significant limitations on the project are related to selecting a tool to measure the safety environment, the training calendar of residents in Family and Community Medicine in last year of studies and the no-answer bias inherent to research conducted through self-administered surveys.The development and application of a safety culture in the health sector, specifically in primary care, is as yet limited. Thus, identifying the strengths and weaknesses in the safety environment may assist in designing strategies for improvement in the primary care health centers of our region.Trial registrationISRCTN: ISRCTN41911128.

Project description:BackgroundMost patients with alcohol use disorders (AUDs) never receive alcohol treatment, and experts have recommended management of AUDs in primary care. The Choosing Healthier Drinking Options In primary CarE (CHOICE) trial was a randomized controlled effectiveness trial of a novel intervention for primary care patients at high risk for AUDs. This report describes the conceptual and scientific foundation of the CHOICE model of care, critical elements of the CHOICE trial design consistent with the Template for Intervention Description and Replication (TIDieR), results of recruitment, and baseline characteristics of the enrolled sample.MethodsThe CHOICE intervention is a multi-contact, extended counseling intervention, based on the Chronic Care Model, shared decision-making, motivational interviewing, and evidence-based options for managing AUDs, designed to be practical in primary care. Outpatients who received care at 3 Veterans Affairs primary care sites in the Pacific Northwest and reported frequent heavy drinking (≥4 drinks/day for women; ≥5 for men) were recruited (2011-2014) into a trial in which half of the participants would be offered additional alcohol-related care from a nurse. CHOICE nurses offered 12 months of patient-centered care, including proactive outreach and engagement, repeated brief motivational interventions, monitoring with and without alcohol biomarkers, medications for AUDs, and/or specialty alcohol treatment as appropriate and per patient preference. A CHOICE nurse practitioner was available to prescribe medications for AUDs.ResultsA total of 304 patients consented to participate in the CHOICE trial. Among consenting participants, 90% were men, the mean age was 51 (range 22-75), and most met DSM-IV criteria for alcohol abuse (14%) or dependence (59%). Many participants also screened positive for tobacco use (44%), depression (45%), anxiety disorders (30-41%) and non-tobacco drug use disorders (19%). At baseline, participants had a median AUDIT score of 18 [Interquartile range (IQR) 14-24] and a median readiness to change drinking score of 5 (IQR 2.75-6.25) on a 1-10 Likert scale.ConclusionThe CHOICE trial tested a patient-centered intervention for AUDs and recruited primary care patients at high risk for AUDs, with a spectrum of severity, co-morbidity, and readiness to change drinking. Trial registration The trial is registered at clinicaltrial.gov (NCT01400581).

Project description:Drug-drug interactions (DDIs) are a serious problem in the healthcare system, leading to excess healthcare utilization and costs. We conducted a second prospective randomized, controlled trial to further establish the real-world clinical utility of a novel assay that objectively identifies potentially serious DDIs in real-world patients. Re-recruiting primary care physicians (PCPs) from our first randomized, controlled, simulated-patients study on DDIs, we experimentally introduced a definitive, urine-based mass spectrometry test intervention that the physicians could use when caring for their eligible patients. Patients were eligible if taking four or more prescription medications or suspected of taking other non-prescribed substances with potential medication interactions. The primary outcome was whether DDI testing changed clinical care. We explored a secondary outcome to see if the change in practice improved symptoms in patients with potential DDIs. A total of 169 control and 162 intervention patients were enrolled in the study, and their medical records were abstracted. In real-world patients, intervention physicians identified and/or treated a DDI at 3.0x the rate in their patient population compared to controls (21.6% vs. 7.1%, p < 0.001). Intervention physicians were more likely to discontinue or adjust the interacting agent compared to controls (62.9% vs. 8.3%, p = 0.001), and patient-reported symptoms also significantly declined (29.6% vs. 20.1%, p = 0.045). These results were nearly identical to concurrent measurements that used simulated patients, wherein intervention was more likely to both make a DDI diagnosis (56.3% vs. 21.6%, p < 0.001) and stop the interacting medications (58.3% versus 26.6%, p < 0.001). Bringing a new diagnostic test to market, particularly for an under-recognized clinical problem, requires robust data on both clinical validity and clinical utility. The results of this follow-up study showed that the use of DDI testing in real-world patients significantly improved (1) primary care patient management of drug interactions and (2) patient outcomes.

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A randomized trial to improve patient-centered care and hypertension control in underserved primary care patients.

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A randomized trial to improve patient-centered care and hypertension control in underserved primary care patients.

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