Dataset Information

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

ABSTRACT: Background:A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions. Objective:To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes. Design:Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT01435109). Setting:10 Duke University Health System community-based primary care clinics. Participants:537 outpatients with symptomatic hip or knee osteoarthritis. Intervention:The telephone-based patient intervention focused on weight management, physical activity, and cognitive behavioral pain management. The provider intervention involved electronic delivery of patient-specific osteoarthritis treatment recommendations to providers. Measurements:The primary outcome was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) total score at 12 months. Secondary outcomes were objective physical function (Short Physical Performance Battery) and depressive symptoms (Patient Health Questionnaire). Linear mixed models assessed the difference in improvement among groups. Results:No difference was observed in WOMAC score changes from baseline to 12 months in the patient (-1.5 [95% CI, -5.1 to 2.0]; P = 0.40), provider (2.5 [CI, -0.9 to 5.9]; P = 0.152), or patient-provider (-0.7 [CI, -4.2 to 2.8]; P = 0.69) intervention groups compared with usual care. All groups had improvements in WOMAC scores at 12 months (range, -3.7 to -7.7). In addition, no differences were seen in objective physical function or depressive symptoms at 12 months in any of the intervention groups compared with usual care. Limitations:The study involved 1 health care network. Data on provider referrals were not collected. Conclusion:Contrary to a previous study of a combined patient and provider intervention for osteoarthritis in a Department of Veterans Affairs medical center, this study found no statistically significant improvements in the osteoarthritis intervention groups compared with usual care. Primary Funding Source:National Institute of Arthritis and Musculoskeletal and Skin Diseases.

SUBMITTER: Allen KD

PROVIDER: S-EPMC6862719 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

Allen Kelli D KD Oddone Eugene Z EZ Coffman Cynthia J CJ Jeffreys Amy S AS Bosworth Hayden B HB Chatterjee Ranee R McDuffie Jennifer J Strauss Jennifer L JL Yancy William S WS Datta Santanu K SK Corsino Leonor L Dolor Rowena J RJ

Annals of internal medicine 20170117 6

<h4>Background</h4>A single-site study showed that a combined patient and provider intervention improved outcomes for patients with knee osteoarthritis, but it did not assess separate effects of the interventions.<h4>Objective</h4>To examine whether patient-based, provider-based, and patient-provider interventions improve osteoarthritis outcomes.<h4>Design</h4>Cluster randomized trial with assignment to patient, provider, and patient-provider interventions or usual care. (ClinicalTrials.gov: NCT ...[more]

PMID: 28114648

Similar Datasets

Project description:BackgroundOsteoarthritis (OA) of the hip and knee are among the most common chronic conditions, resulting in substantial pain and functional limitations. Adequate management of OA requires a combination of medical and behavioral strategies. However, some recommended therapies are under-utilized in clinical settings, and the majority of patients with hip and knee OA are overweight and physically inactive. Consequently, interventions at the provider-level and patient-level both have potential for improving outcomes. This manuscript describes two ongoing randomized clinical trials being conducted in two different health care systems, examining patient-based and provider-based interventions for managing hip and knee OA in primary care.Methods / designOne study is being conducted within the Department of Veterans Affairs (VA) health care system and will compare a Combined Patient and Provider intervention relative to usual care among n?=?300 patients (10 from each of 30 primary care providers). Another study is being conducted within the Duke Primary Care Research Consortium and will compare Patient Only, Provider Only, and Combined (Patient + Provider) interventions relative to usual care among n?=?560 patients across 10 clinics. Participants in these studies have clinical and / or radiographic evidence of hip or knee osteoarthritis, are overweight, and do not meet current physical activity guidelines. The 12-month, telephone-based patient intervention focuses on physical activity, weight management, and cognitive behavioral pain management. The provider intervention involves provision of patient-specific recommendations for care (e.g., referral to physical therapy, knee brace, joint injection), based on evidence-based guidelines. Outcomes are collected at baseline, 6-months, and 12-months. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and secondary outcomes are the Short Physical Performance Test Protocol (objective physical function) and the Patient Health Questionnaire-8 (depressive symptoms). Cost effectiveness of the interventions will also be assessed.DiscussionResults of these two studies will further our understanding of the most effective strategies for improving hip and knee OA outcomes in primary care settings.Trial registrationNCT01130740 (VA); NCT 01435109 (NIH).

Project description:BackgroundEnd-stage kidney disease (ESKD) is treated with dialysis or kidney transplantation, with most patients with ESKD receiving in-center hemodialysis treatment. This life-saving treatment can result in cardiovascular and hemodynamic instability, with the most common form being low blood pressure during the dialysis treatment (intradialytic hypotension [IDH]). IDH is a complication of hemodialysis that can involve symptoms such as fatigue, nausea, cramping, and loss of consciousness. IDH increases risks of cardiovascular disease and ultimately hospitalizations and mortality. Provider-level and patient-level decisions influence the occurrence of IDH; thus, IDH may be preventable in routine hemodialysis care.ObjectiveThis study aims to evaluate the independent and comparative effectiveness of 2 interventions-one directed at hemodialysis providers and another for patients-in reducing the rate of IDH at hemodialysis facilities. In addition, the study will assess the effects of interventions on secondary patient-centered clinical outcomes and examine factors associated with a successful implementation of the interventions.MethodsThis study is a pragmatic, cluster randomized trial to be conducted in 20 hemodialysis facilities in the United States. Hemodialysis facilities will be randomized using a 2 × 2 factorial design, such that 5 sites will receive a multimodal provider education intervention, 5 sites will receive a patient activation intervention, 5 sites will receive both interventions, and 5 sites will receive none of the 2 interventions. The multimodal provider education intervention involved theory-informed team training and the use of a digital, tablet-based checklist to heighten attention to patient clinical factors associated with increased IDH risk. The patient activation intervention involves tablet-based, theory-informed patient education and peer mentoring. Patient outcomes will be monitored during a 12-week baseline period, followed by a 24-week intervention period and a 12-week postintervention follow-up period. The primary outcome of the study is the proportion of treatments with IDH, which will be aggregated at the facility level. Secondary outcomes include patient symptoms, fluid adherence, hemodialysis adherence, quality of life, hospitalizations, and mortality.ResultsThis study is funded by the Patient-Centered Outcomes Research Institute and approved by the University of Michigan Medical School's institutional review board. The study began enrolling patients in January 2023. Initial feasibility data will be available in May 2023. Data collection will conclude in November 2024.ConclusionsThe effects of provider and patient education on reducing the proportion of sessions with IDH and improving other patient-centered clinical outcomes will be evaluated, and the findings will be used to inform further improvements in patient care. Improving the stability of hemodialysis sessions is a critical concern for clinicians and patients with ESKD; the interventions targeted to providers and patients are predicted to lead to improvements in patient health and quality of life.Trial registrationClinicalTrials.gov NCT03171545; https://clinicaltrials.gov/ct2/show/NCT03171545.International registered report identifier (irrid)PRR1-10.2196/46187.

Project description:ImportanceUntreated tooth decay is disproportionately present among low-income young children. While American Academy of Pediatrics (AAP) guidelines require pediatric clinicians to implement oral health care, the effectiveness of these oral health interventions has been inconclusive.ObjectiveTo test the effectiveness of multilevel interventions in increasing dental attendance and reducing untreated decay among young children attending well-child visits (WCVs).Design, setting, and participantsThe Pediatric Providers Against Cavities in Children's Teeth study is a cluster randomized clinical trial that was conducted at 18 pediatric primary care practices in northeast Ohio. The trial data were collected between November 2017 and July 2022, with data analyses conducted from August 2022 to March 2023. Eligible participants included Medicaid-enrolled preschoolers aged 3 to 6 years attending WCVs at participating practices who were enrolled at baseline (WCV 1) and followed-up for 2 consecutive examinations (WCV 2 and WCV 3).InterventionsClinicians in the intervention group received both the practice-level (electronic medical record changes to document oral health) and clinician-level (common-sense model of self-regulation theory-based oral health education and skills training) interventions. Control group clinicians received AAP-based standard oral health education alone.Main outcomes and measuresDental attendance was determined through clinical dental examinations conducted by hygienists utilizing International Caries Detection and Assessment System criteria and also from Medicaid claims data. Untreated decay was determined through clinical examinations. A generalized estimating equations (GEE) approach was used for both clinical examinations and Medicaid claims data.ResultsEighteen practices were randomized to either intervention or control. Participants included 63 clinicians (mean [SD] age, 47.0 [11.3] years; 48 female [76.2%] and 15 male [23.8%]; 28 in the intervention group [44.4%]; 35 in the control group [55.6%]) and 1023 parent-child dyads (mean [SD] child age, 56.1 [14.0] months; 555 male children [54.4%] and 466 female children [45.6%]; 517 in the intervention group [50.5%]; 506 in the control group [49.5%]). Dental attendance from clinical examinations was significantly higher in the intervention group (170 children [52.0%]) vs control group (150 children [43.1%]) with a difference of 8.9% (95% CI, 1.4% to 16.4%; P = .02). The GEE model using clinical examinations showed a significant increase in dental attendance in the intervention group vs control group (adjusted odds ratio, 1.34; 95% CI, 1.07 to 1.69). From Medicaid claims, the control group had significantly higher dental attendance than the intervention group at 2 years (332 children [79.6%] vs 330 children [73.7%]; P = .04) but not at 3 years. A clinically but not statistically significant reduction in mean number of untreated decay was found in the intervention group compared with controls (B = -0.27; 95% CI, -0.56 to 0.02).Conclusions and relevanceIn this cluster randomized clinical trial, children in the intervention group had better dental outcomes as was evidenced by increased dental attendance and lower untreated decay. These findings suggest that intervention group clinicians comprehensively integrated oral health services into WCVs.Trial registrationClinicalTrials.gov Identifier: NCT03385629.

Project description:Several studies document disparities in access to care and quality of care for depression for African Americans. Research suggests that patient attitudes and clinician communication behaviors may contribute to these disparities. Evidence links patient-centered care to improvements in mental health outcomes; therefore, quality improvement interventions that enhance this dimension of care are promising strategies to improve treatment and outcomes of depression among African Americans. This paper describes the design of the BRIDGE (Blacks Receiving Interventions for Depression and Gaining Empowerment) Study. The goal of the study is to compare the effectiveness of two interventions for African-American patients with depression--a standard quality improvement program and a patient-centered quality improvement program. The main hypothesis is that patients in the patient-centered group will have a greater reduction in their depression symptoms, higher rates of depression remission, and greater improvements in mental health functioning at six, twelve, and eighteen months than patients in the standard group. The study also examines patient ratings of care and receipt of guideline-concordant treatment for depression.A total of 36 primary care clinicians and 132 of their African-American patients with major depressive disorder were recruited into a cluster randomized trial. The study uses intent-to-treat analyses to compare the effectiveness of standard quality improvement interventions (academic detailing about depression guidelines for clinicians and disease-oriented care management for their patients) and patient-centered quality improvement interventions (communication skills training to enhance participatory decision-making for clinicians and care management focused on explanatory models, socio-cultural barriers, and treatment preferences for their patients) for improving outcomes over 12 months of follow-up.The BRIDGE Study includes clinicians and African-American patients in under-resourced community-based practices who have not been well-represented in clinical trials to improve depression care. The patient-centered and culturally targeted approach to depression care is a relatively new one that has not been tested in most previous studies. The study will provide evidence about whether patient-centered accommodations improve quality of care and outcomes to a greater extent than standard quality improvement strategies for African Americans with depression.ClinicalTrials.gov NCT00243425.

Project description:Background. A culture of stringent drug policy, one-size-fits-all treatment approaches, and drug-related stigma has clouded clinical HIV practice in the United States. The result is a series of missed opportunities in the HIV care environment. An approach which may address the broken relationship between patient and provider is harm reduction-which removes judgment and operates at the patient's stage of readiness. Harm reduction is not a routine part of care; rather, it exists outside clinic walls, exacerbating the divide between compassionate, stigma-free services and the medical system. Methods. Qualitative, phenomenological, semi-structured, individual interviews with patients and providers were conducted in three publicly-funded clinics in Chicago, located in areas of high HIV prevalence and drug use and serving African-American patients (N = 38). A deductive thematic analysis guided the process, including: the creation of an index code list, transcription and verification of interviews, manual coding, notation of emerging themes and refinement of code definitions, two more rounds of coding within AtlasTi, calculation of Cohen's Kappa for interrater reliability, queries of major codes and analysis of additional common themes. Results. Thematic analysis of findings indicated that the majority of patients felt receptive to harm reduction interventions (safer injection counseling, safer stimulant use counseling, overdose prevention information, supply provision) from their provider, and expressed anticipated gratitude for harm reduction information and/or supplies within the HIV care visit, although some were reluctant to talk openly about their drug use. Provider results were mixed, with more receptivity reported by advanced practice nurses, and more barriers cited by physicians. Notable barriers included: role-perceptions, limited time, inadequate training, and the patients themselves. Discussion. Patients are willing to receive harm reduction interventions from their HIV care providers, while provider receptiveness is mixed. The findings reveal critical implications for diffusion of harm reduction into HIV care, including the need to address cited barriers for both patients and providers to ensure feasibility of implementation. Strategies to address these barriers are discussed, and recommendations for further research are also shared.

Project description:ObjectiveTo determine the effectiveness of interventions designed to improve outcomes in patients with multimorbidity in primary care and community settings.DesignSystematic review.Data sourcesMedline, Embase, CINAHL, CAB Health, Cochrane central register of controlled trials, the database of abstracts of reviews of effectiveness, and the Cochrane EPOC (effective practice and organisation of care) register (searches updated in April 2011).Eligibility criteriaRandomised controlled trials, controlled clinical trials, controlled before and after studies, and interrupted time series analyses reporting on interventions to improve outcomes for people with multimorbidity in primary care and community settings. Multimorbidity was defined as two or more chronic conditions in the same individual. Outcomes included any validated measure of physical or mental health and psychosocial status, including quality of life outcomes, wellbeing, and measures of disability or functional status. Also included were measures of patient and provider behaviour, including drug adherence, utilisation of health services, acceptability of services, and costs.Data selectionTwo reviewers independently assessed studies for eligibility, extracted data, and assessed study quality. As meta-analysis of results was not possible owing to heterogeneity in participants and interventions, a narrative synthesis of the results from the included studies was carried out.Results10 studies examining a range of complex interventions totalling 3407 patients with multimorbidity were identified. All were randomised controlled trials with a low risk of bias. Two studies described interventions for patients with specific comorbidities. The remaining eight studies focused on multimorbidity, generally in older patients. Consideration of the impact of socioeconomic deprivation was minimal. All studies involved complex interventions with multiple components. In six of the 10 studies the predominant component was a change to the organisation of care delivery, usually through case management or enhanced multidisciplinary team work. In the remaining four studies, intervention components were predominantly patient oriented. Overall the results were mixed, with a trend towards improved prescribing and drug adherence. The results indicated that it is difficult to improve outcomes in this population but that interventions focusing on particular risk factors in comorbid conditions or functional difficulties in multimorbidity may be more effective. No economic analyses were included, although the improvements in prescribing and risk factor management in some studies could provide potentially important cost savings.ConclusionsEvidence on the care of patients with multimorbidity is limited, despite the prevalence of multimorbidity and its impact on patients and healthcare systems. Interventions to date have had mixed effects, although are likely to be more effective if targeted at risk factors or specific functional difficulties. A need exists to clearly identify patients with multimorbidity and to develop cost effective and specifically targeted interventions that can improve health outcomes.

Dataset Information

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

Publications

Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets