Browsing by Author "Datta, Santanu K"
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Item Open Access A Combined Patient and Provider Intervention for Management of Osteoarthritis in Veterans: A Randomized Clinical Trial.(Annals of internal medicine, 2016-01) Allen, Kelli D; Yancy, William S; Bosworth, Hayden B; Coffman, Cynthia J; Jeffreys, Amy S; Datta, Santanu K; McDuffie, Jennifer; Strauss, Jennifer L; Oddone, Eugene ZBackground
Management of osteoarthritis requires both medical and behavioral strategies, but some recommended therapies are underused.Objective
To examine the effectiveness of a combined patient and provider intervention for improving osteoarthritis outcomes.Design
Cluster randomized clinical trial with assignment to osteoarthritis intervention and usual care groups. (ClinicalTrials.gov: NCT01130740).Setting
Department of Veterans Affairs Medical Center in Durham, North Carolina.Participants
30 providers (clusters) and 300 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 delivery of patient-specific osteoarthritis treatment recommendations to primary care providers through the electronic medical record.Measurements
The primary outcome was total score on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) at 12 months. Secondary outcomes were WOMAC function and pain subscale scores, physical performance (Short Physical Performance Battery), and depressive symptoms (Patient Health Questionnaire-8). Linear mixed models that were adjusted for clustering of providers assessed between-group differences in improvement in outcomes.Results
At 12 months, WOMAC scores were 4.1 points lower (indicating improvement) in the osteoarthritis intervention group versus usual care (95% CI, -7.2 to -1.1 points; P = 0.009). WOMAC function subscale scores were 3.3 points lower in the intervention group (CI, -5.7 to -1.0 points; P = 0.005). WOMAC pain subscale scores (P = 0.126), physical performance, and depressive symptoms did not differ between groups. Although more patients in the osteoarthritis intervention group received provider referral for recommended osteoarthritis treatments, the numbers who received them did not differ.Limitation
The study was conducted in a single Veterans Affairs medical center.Conclusion
The combined patient and provider intervention resulted in modest improvement in self-reported physical function in patients with hip and knee osteoarthritis.Primary funding source
Department of Veterans Affairs, Health Services Research and Development Service.Item Open Access Comparison of referral methods into a smoking cessation program.(Journal of comparative effectiveness research, 2020-08-14) Davis, James M; Thomas, Leah C; Dirkes, Jillian Eh; Datta, Santanu K; Dennis, Paul ARational, aims & objectives: The goal of this observational study was to compare three referral methods and determine which led to the highest utilization of the Duke Smoking Cessation Program (DSCP). Materials & methods: We conducted two assessments within the Duke health system: a 12-month assessment of Traditional Referral (a provider refers a patient during a patient visit) and Best Practice Advisory (BPA) (a provider refers a patient after responding to an alert within the electronic health record); and a 30-day assessment of Population Outreach (a list of smokers is generated through the electronic health record and patients are contacted directly). Results: Over the 12-month assessment, a total of 13,586 smokers were seen throughout health system clinics receiving services from the DSCP. During this period, the service utilization rate was significantly higher for Traditional Referral (3.8%) than for BPA (0.6%); p < 0.005. The 30-day pilot assessment of showed a service utilization rate for Population Outreach of 6.3%, significantly higher than Traditional Referral (3.8%); p < 0.005 and BPA (0.6%; p < 0.005). Conclusion: Population Outreach appears to be an effective referral method for increasing utilization of the DSCP.Item Open Access Economic analysis of a tailored behavioral intervention to improve blood pressure control for primary care patients.(American heart journal, 2010-08) Datta, Santanu K; Oddone, Eugene Z; Olsen, Maren K; Orr, Melinda; McCant, Felicia; Gentry, Pam; Bosworth, Hayden BBackground
Few telemedicine programs have undergone cost analyses, impeding their implementation into practice. We report on the economic analysis of a nurse-administered intervention designed to improve blood pressure control among hypertensive veterans.Methods
We randomized hypertensive patients at the Durham Veterans Affairs Medical Center primary care clinic to behavioral (n = 294) or nonbehavioral (n = 294) interventions. Behavioral intervention patients received tailored information bimonthly for 2 years via telephone. To calculate intervention cost, we microcosted the nurse's labor cost and computer hardware and software costs, applied a direct-to-indirect cost ratio, and distributed the costs over an estimated cohort of patients. We analyzed data from the Veterans Affairs Decision Support System to assess whether the intervention impacted overall health care utilization and costs. We used life expectancy estimates from the literature to develop decision models to calculate cost per life-year saved.Results
The mean annual intervention cost was $112 (range $61-$259). During 2 years of follow-up, patients in the intervention group incurred $7,800 in inpatient costs and $9,741 in outpatient costs; the nonintervention group incurred $6,866 in inpatient costs and $9,599 in outpatient costs. The total cost difference was not statistically significant (P = .56). Cost-effectiveness of the behavioral intervention ranged from $42,457 per life-year saved for normal-weight women to $87,300 per life-year saved for normal-weight men.Conclusions
The study results suggest that a nurse-administered, tailored behavioral intervention can be implemented at nominal cost and be cost-effective; however, there was no apparent lowering of health care utilization and costs during the 2 years of follow-up.Item Open Access Group physical therapy for veterans with knee osteoarthritis: study design and methodology.(Contemporary clinical trials, 2013-03) Allen, Kelli D; Bongiorni, Dennis; Walker, Tessa A; Bartle, John; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Hansen, Gloria; Jennings, Caroline; Lindquist, Jennifer H; Oddone, Eugene Z; Senick, Margaret J; Sizemore, John C; St John, Jamie; Hoenig, HelenPhysical therapy (PT) is a key component of treatment for knee osteoarthritis (OA) and can decrease pain and improve function. Given the expected rise in prevalence of knee OA and the associated demand for treatment, there is a need for models of care that cost-effectively extend PT services for patients with this condition. This manuscript describes a randomized clinical trial of a group-based physical therapy program that can potentially extend services to more patients with knee OA, providing a greater number of sessions per patient, at lower staffing costs compared to traditional individual PT. Participants with symptomatic knee OA (n = 376) are randomized to either a 12-week group-based PT program (six 1 h sessions, eight patients per group, led by a physical therapist and physical therapist assistant) or usual PT care (two individual visits with a physical therapist). Participants in both PT arms receive instruction in an exercise program, information on joint care and protection, and individual consultations with a physical therapist to address specific functional and therapeutic needs. The primary outcome is the Western Ontario and McMasters Universities Osteoarthritis Index (self-reported pain, stiffness, and function), and the secondary outcome is the Short Physical Performance Test Protocol (objective physical function). Outcomes are assessed at baseline and 12-week follow-up, and the primary outcome is also assessed via telephone at 24-week follow-up to examine sustainability of effects. Linear mixed models will be used to compare outcomes for the two study arms. An economic cost analysis of the PT interventions will also be conducted.Item Open Access Group Versus Individual Physical Therapy for Veterans With Knee Osteoarthritis: Randomized Clinical Trial.(Physical therapy, 2016-05) Allen, Kelli D; Bongiorni, Dennis; Bosworth, Hayden B; Coffman, Cynthia J; Datta, Santanu K; Edelman, David; Hall, Katherine S; Lindquist, Jennifer H; Oddone, Eugene Z; Hoenig, HelenBackground
Efficient approaches are needed for delivering nonpharmacological interventions for management of knee osteoarthritis (OA).Objective
This trial compared group-based versus individual physical therapy interventions for management of knee OA.Design and methods
Three hundred twenty patients with knee OA at the VA Medical Center in Durham, North Carolina, (mean age=60 years, 88% male, 58% nonwhite) were randomly assigned to receive either the group intervention (group physical therapy; six 1-hour sessions, typically 8 participants per group) or the individual intervention (individual physical therapy; two 1-hour sessions). Both programs included instruction in home exercise, joint protection techniques, and individual physical therapist evaluation. The primary outcome measure was the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC; range=0-96, higher scores indicate worse symptoms), measured at baseline, 12 weeks, and 24 weeks. The secondary outcome measure was the Short Physical Performance Battery (SPPB; range=0-12, higher scores indicate better performance), measured at baseline and 12 weeks. Linear mixed models assessed the difference in WOMAC scores between arms.Results
At 12 weeks, WOMAC scores were 2.7 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% confidence interval [CI]=-5.9, 0.5; P=.10), indicating no between-group difference. At 24 weeks, WOMAC scores were 1.3 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-4.6, 2.0; P=.44), indicating no significant between-group difference. At 12 weeks, SPPB scores were 0.1 points lower in the group physical therapy arm compared with the individual physical therapy arm (95% CI=-0.5, 0.2; P=.53), indicating no difference between groups.Limitations
This study was conducted in one VA medical center. Outcome assessors were blinded, but participants and physical therapists were not blinded.Conclusions
Group physical therapy was not more effective than individual physical therapy for primary and secondary study outcomes. Either group physical therapy or individual physical therapy may be a reasonable delivery model for health care systems to consider.Item Open Access Health benefits and economic advantages associated with increased utilization of a smoking cessation program.(Journal of comparative effectiveness research, 2020-08-20) Datta, Santanu K; Dennis, Paul A; Davis, James MRationale, aim & objective: The goal of this study was to examine the health and economic impacts related to increased utilization of the Duke Smoking Cessation Program resulting from the addition of two relatively new referral methods - Best Practice Advisory and Population Outreach. Materials & methods: In a companion paper 'Comparison of Referral Methods into a Smoking Cessation Program', we report results from a retrospective, observational, comparative effectiveness study comparing the impact of three referral methods - Traditional Referral, Best Practice Advisory and Population Outreach on utilization of the Duke Smoking Cessation Program. In this paper we take the next step in this comparative assessment by developing a Markov model to estimate the improvement in health and economic outcomes when two referral methods - Best Practice Advisory and Population Outreach - are added to Traditional Referral. Data used in this analysis were collected from Duke Primary Care and Disadvantaged Care clinics over a 1-year period (1 October 2017-30 September 2018). Results: The addition of two new referral methods - Best Practice Advisory and Population Outreach - to Traditional Referral increased the utilization of the Duke Smoking Cessation Program in Primary Care clinics from 129 to 329 smokers and in Disadvantaged Care clinics from 206 to 401 smokers. The addition of these referral methods was estimated to result in 967 life-years gained, 408 discounted quality-adjusted life-years saved and total discounted lifetime direct healthcare cost savings of US$46,376,285. Conclusion: Health systems may achieve increased patient health and decreased healthcare costs by adding Best Practice Advisory and Population Outreach strategies to refer patients to smoking cessation services.Item Open Access Measuring sustainability of a grassroots program in a large integrated health care delivery system: the Warrior to Soul Mate Program.(Journal of military, veteran and family health, 2018-01) Stolldorf, Deonni P; Fortune-Britt, Alice G; Nieuwsma, Jason A; Gierisch, Jennifer M; Datta, Santanu K; Angel, Clyde; Millspaugh, Dick D; Jackson, George LIntroduction:Veterans experience many physical and psychosocial adjustment problems that challenge personal relationships and social functioning and successful social reintegration. The Warrior to Soul Mate (W2SM) program uses a structured curriculum [i.e., the Practical Application of Intimate Relationships Skills (PAIRS)] to address veterans' interpersonal needs by teaching participants effective interpersonal skills. Veterans who attended the W2SM program reported lower anxiety levels, improvements in marital alterations and satisfaction, and increased intimacy, cohesion, and affection. Therefore, sustaining the W2SM program can have long-term positive effects for veterans, families, and the greater society. The purpose of this paper is to describe the sustainability of the W2SM program. Methods:The Model of Community-based Program Sustainability conceptually guided the evaluation. Twenty-three VA hospitals in the U.S. that offer W2SM programs completed a self-report survey to measure sustainability. Results:The highest scoring sustainability elements were "Demonstrating program results" (M=5.82, SD=1.23), "Staff involvement and integration" (M= 5.79, SD= 1.34), and "Program responsivity" (M=4.39, SD= 1.16); the lowest scoring element was "Strategic funding" (M=2.78, SD=1.75). Statistically significant associations were found between the global middle-range program results and three sustainability elements: leadership competence (r = .472, p = .023), effective collaboration (r = .470, p = .024), and strategic funding (r = .507, p = .014). Discussion:Efforts to sustain programs should focus on leaders planning for sustainability at the onset of program implementation, collaborators must be involved in program design, implementation and evaluation, and long-term funding sources must be secured to support program operations and continuation.Item Open Access Patient and provider interventions for managing osteoarthritis in primary care: protocols for two randomized controlled trials.(BMC musculoskeletal disorders, 2012-04) Allen, Kelli D; Bosworth, Hayden B; Brock, Dorothea S; Chapman, Jennifer G; Chatterjee, Ranee; Coffman, Cynthia J; Datta, Santanu K; Dolor, Rowena J; Jeffreys, Amy S; Juntilla, Karen A; Kruszewski, Jennifer; Marbrey, Laurie E; McDuffie, Jennifer; Oddone, Eugene Z; Sperber, Nina; Sochacki, Mary P; Stanwyck, Catherine; Strauss, Jennifer L; Yancy, William SBackground
Osteoarthritis (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 / design
One 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.Discussion
Results 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 registration
NCT01130740 (VA); NCT 01435109 (NIH).Item Open Access Patient, Provider, and Combined Interventions for Managing Osteoarthritis in Primary Care: A Cluster Randomized Trial.(Annals of internal medicine, 2017-03) Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Jeffreys, Amy S; Bosworth, Hayden B; Chatterjee, Ranee; McDuffie, Jennifer; Strauss, Jennifer L; Yancy, William S; Datta, Santanu K; Corsino, Leonor; Dolor, Rowena JBackground
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.Item Open Access Tailored Case Management for Diabetes and Hypertension (TEACH-DM) in a community population: study design and baseline sample characteristics.(Contemporary clinical trials, 2013-09) Crowley, Matthew J; Bosworth, Hayden B; Coffman, Cynthia J; Lindquist, Jennifer H; Neary, Alice M; Harris, Amy C; Datta, Santanu K; Granger, Bradi B; Pereira, Katherine; Dolor, Rowena J; Edelman, DavidBackground
Despite recognition of the benefits associated with well-controlled diabetes and hypertension, control remains suboptimal. Effective interventions for these conditions have been studied within academic settings, but interventions targeting both conditions have rarely been tested in community settings. We describe the design and baseline results of a trial evaluating a behavioral intervention among community patients with poorly-controlled diabetes and comorbid hypertension.Methods
Tailored Case Management for Diabetes and Hypertension (TEACH-DM) is a 24-month randomized, controlled trial evaluating a telephone-delivered behavioral intervention for diabetes and hypertension versus attention control. The study recruited from nine community practices. The nurse-administered intervention targets 3 areas: 1) cultivation of healthful behaviors for diabetes and hypertension control; 2) provision of fundamentals to support attainment of healthful behaviors; and 3) identification and correction of patient-specific barriers to adopting healthful behaviors. Hemoglobin A1c and blood pressure measured at 6, 12, and 24 months are co-primary outcomes. Secondary outcomes include self-efficacy, self-reported medication adherence, exercise, and cost-effectiveness.Results
Of 377 randomized patients, 193 were allocated to the intervention and 184 to attention control. The cohort is balanced in terms of gender, race, education level, and income. The cohort's mean baseline hemoglobin A1c and blood pressure are above goal, and mean baseline body mass index falls in the obese range. Baseline self-reported non-adherence is high for diabetes and hypertension medications. Trial results are pending.Conclusions
If effective, the TEACH-DM intervention's telephone-based delivery strategy and nurse administration make it well-suited for rapid implementation and broad dissemination in community settings.Item Open Access Telephone-based self-management of osteoarthritis: A randomized trial.(Annals of internal medicine, 2010-11) Allen, Kelli D; Oddone, Eugene Z; Coffman, Cynthia J; Datta, Santanu K; Juntilla, Karen A; Lindquist, Jennifer H; Walker, Tessa A; Weinberger, Morris; Bosworth, Hayden BBackground
Osteoarthritis is a leading cause of pain and disability, and self-management behaviors for osteoarthritis are underutilized.Objective
To examine the effectiveness of a telephone-based self-management intervention for hip or knee osteoarthritis in a primary care setting.Design
Randomized clinical trial with equal assignment to osteoarthritis self-management, health education (attention control), and usual care control groups. (ClinicalTrials.gov registration number: NCT00288912)Setting
Primary care clinics in a Veterans Affairs Medical Center.Patients
515 patients with symptomatic hip or knee osteoarthritis.Intervention
The osteoarthritis self-management intervention involved educational materials and 12 monthly telephone calls to support individualized goals and action plans. The health education intervention involved nonosteoarthritis educational materials and 12 monthly telephone calls related to general health screening topics.Measurements
The primary outcome was score on the Arthritis Impact Measurement Scales-2 pain subscale (range, 0 to 10). Pain was also assessed with a 10-cm visual analog scale. Measurements were collected at baseline and 12 months.Results
461 participants (90%) completed the 12-month assessment. The mean Arthritis Impact Measurement Scales-2 pain score in the osteoarthritis self-management group was 0.4 point lower (95% CI, -0.8 to 0.1 point; P = 0.105) than in the usual care group and 0.6 point lower (CI, -1.0 to -0.2 point; P = 0.007) than in the health education group at 12 months. The mean visual analog scale pain score in the osteoarthritis self-management group was 1.1 points lower (CI, -1.6 to -0.6 point; P < 0.001) than in the usual care group and 1.0 point lower (CI, -1.5 to -0.5 point; P < 0.001) than in the health education group. Health care use did not differ across the groups.Limitation
The study was conducted at 1 Veterans Affairs Medical Center, and the sample consisted primarily of men.Conclusion
A telephone-based osteoarthritis self-management program produced moderate improvements in pain, particularly compared with a health education control group.Primary funding source
U.S. Department of Veterans Affairs Health Services Research and Development Service.