Browsing by Subject "Telephone"
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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 Economic evaluation of telephone self-management interventions for blood pressure control.(American heart journal, 2012-06) Wang, Virginia; Smith, Valerie A; Bosworth, Hayden B; Oddone, Eugene Z; Olsen, Maren K; McCant, Felicia; Powers, Benjamin J; Van Houtven, Courtney HaroldBackground
Half of patients with hypertension have poor blood pressure (BP) control. Recent models for treating hypertension have integrated disease monitoring and telephone-based interventions delivered in patients' homes. This study evaluated the costs of the Hypertension Intervention Nurse Telemedicine Study (HINTS), aimed to improve BP control in veterans.Methods
Eligible veterans were randomized to either usual care or 1 of 3 telephone-based intervention groups using home BP telemonitoring: (1) behavioral management, (2) medication management, or (3) combined. Intervention costs were derived from information collected during the trial. Direct medical costs (inpatient, outpatient, and outpatient pharmacy, including hypertension-specific pharmacy) at 18 months by group were calculated using Veterans Affairs (VA) Decision Support System data. Bootstrapped CIs were computed to compare intervention and medical costs between intervention groups and usual care.Results
Patients receiving behavior or medication management showed significant gains in BP control at 12 months; there were no differences in BP control at 18 months. In subgroup analysis, patients with poor baseline BP control receiving combined intervention significantly improved BP at 12 and 18 months. In overall and subgroup samples, average intervention costs were similar in the 3 study arms, and at 18 months, there were no statistically significant differences in direct VA medical costs or total VA costs between treatment arms and usual care.Conclusions
To optimize investment in telephone-based home interventions such as the HINTS, it is important to identify groups of patients who are most likely to benefit from more intensive home BP management.Item Open Access Effectiveness of Acute Care Remote Triage Systems: a Systematic Review.(Journal of general internal medicine, 2020-07) Boggan, Joel C; Shoup, John Paul; Whited, John D; Van Voorhees, Elizabeth; Gordon, Adelaide M; Rushton, Sharron; Lewinski, Allison A; Tabriz, Amir A; Adam, Soheir; Fulton, Jessica; Kosinski, Andrzej S; Van Noord, Megan G; Williams, John W; Goldstein, Karen M; Gierisch, Jennifer MBackground
Technology-based systems can facilitate remote decision-making to triage patients to the appropriate level of care. Despite technologic advances, the effects of implementation of these systems on patient and utilization outcomes are unclear. We evaluated the effects of remote triage systems on healthcare utilization, case resolution, and patient safety outcomes.Methods
English-language searches of MEDLINE (via PubMed), EMBASE, and CINAHL were performed from inception until July 2018. Randomized and nonrandomized comparative studies of remote triage services that reported healthcare utilization, case resolution, and patient safety outcomes were included. Two reviewers assessed study and intervention characteristics independently for study quality, strength of evidence, and risk of bias.Results
The literature search identified 5026 articles, of which eight met eligibility criteria. Five randomized, two controlled before-and-after, and one interrupted time series study assessed 3 categories of remote triage services: mode of delivery, triage professional type, and system organizational level. No study evaluated any other delivery mode other than telephone and in-person. Meta-analyses were unable to be performed because of study design and outcome heterogeneity; therefore, we narratively synthesized data. Overall, most studies did not demonstrate a decrease in primary care (PC) or emergency department (ED) utilization, with some studies showing a significant increase. Evidence suggested local, practice-based triage systems have greater case resolution and refer fewer patients to PC or ED services than regional/national systems. No study identified statistically significant differences in safety outcomes.Conclusion
Our review found limited evidence that remote triage reduces the burden of PC or ED utilization. However, remote triage by telephone can produce a high rate of call resolution and appears to be safe. Further study of other remote triage modalities is needed to realize the promise of remote triage services in optimizing healthcare outcomes.Protocol registration
This study was registered and followed a published protocol (PROSPERO: CRD42019112262).Item Open Access Home blood pressure management and improved blood pressure control: results from a randomized controlled trial.(Archives of internal medicine, 2011-07) Bosworth, Hayden B; Powers, Benjamin J; Olsen, Maren K; McCant, Felicia; Grubber, Janet; Smith, Valerie; Gentry, Pamela W; Rose, Cynthia; Van Houtven, Courtney; Wang, Virginia; Goldstein, Mary K; Oddone, Eugene ZBackground
To determine which of 3 interventions was most effective in improving blood pressure (BP) control, we performed a 4-arm randomized trial with 18-month follow-up at the primary care clinics at a Veterans Affairs Medical Center.Methods
Eligible patients were randomized to either usual care or 1 of 3 telephone-based intervention groups: (1) nurse-administered behavioral management, (2) nurse- and physician-administered medication management, or (3) a combination of both. Of the 1551 eligible patients, 593 individuals were randomized; 48% were African American. The intervention telephone calls were triggered based on home BP values transmitted via telemonitoring devices. Behavioral management involved promotion of health behaviors. Medication management involved adjustment of medications by a study physician and nurse based on hypertension treatment guidelines.Results
The primary outcome was change in BP control measured at 6-month intervals over 18 months. Both the behavioral management and medication management alone showed significant improvements at 12 months-12.8% (95% confidence interval [CI], 1.6%-24.1%) and 12.5% (95% CI, 1.3%-23.6%), respectively-but not at 18 months. In subgroup analyses, among those with poor baseline BP control, systolic BP decreased in the combined intervention group by 14.8 mm Hg (95% CI, -21.8 to -7.8 mm Hg) at 12 months and 8.0 mm Hg (95% CI, -15.5 to -0.5 mm Hg) at 18 months, relative to usual care.Conclusions
Overall intervention effects were moderate, but among individuals with poor BP control at baseline, the effects were larger. This study indicates the importance of identifying individuals most likely to benefit from potentially resource intensive programs.Trial registration
clinicaltrials.gov Identifier: NCT00237692.Item Open Access Lessons learned when innovations go awry: a baseline description of a behavioral trial-the Enhancing Fitness in Older Overweight Veterans with Impaired Fasting Glucose study.(Translational behavioral medicine, 2011-11) Hall, KS; Pieper, CF; Edelman, DE; Yancy Jr, WS; Green, JB; Lum, H; Peterson, MJ; Sloane, R; Cowper, PA; Bosworth, HB; Huffman, KM; Cavanaugh, JT; Chapman, JG; Pearson, MP; Howard, TA; Ekelund, CC; McCraw, BL; Burrell, JB; Taylor, GA; Morey, MCIndividuals diagnosed with impaired glucose tolerance (i.e., prediabetes) are at increased risk for developing diabetes. We proposed a clinical trial with a novel adaptive randomization designed to examine the impact of a home-based physical activity (PA) counseling intervention on metabolic risk in prediabetic elders. This manuscript details the lessons learned relative to recruitment, study design, and implementation of a 12-month randomized controlled PA counseling trial. A detailed discussion on how we responded to unforeseen challenges is provided. A total of 302 older patients with prediabetes were randomly assigned to either PA counseling or usual care. A novel adaptive design that reallocated counseling intensity based on self-report of adherence to PA was initiated but revised when rates of non-response were lower than projected. This study presents baseline participant characteristics and discusses unwelcome adaptations to a highly innovative study design to increase PA and enhance glucose metabolism when the best-laid plans went awry.Item Open Access Mindfulness training for smokers via web-based video instruction with phone support: a prospective observational study.(BMC complementary and alternative medicine, 2015-03-29) Davis, James M; Manley, Alison R; Goldberg, Simon B; Stankevitz, Kristin A; Smith, Stevens SBACKGROUND:Many smokers are unable to access effective behavioral smoking cessation therapies due to location, financial limitations, schedule, transportation issues or other reasons. We report results from a prospective observational study in which a promising novel behavioral intervention, Mindfulness Training for Smokers was provided via web-based video instruction with telephone-based counseling support. METHODS:Data were collected on 26 low socioeconomic status smokers. Participants were asked to watch eight video-based classes describing mindfulness skills and how to use these skills to overcome various core challenges in tobacco dependence. Participants received eight weekly phone calls from a smoking cessation coach who provided general support and answered questions about the videos. On the quit day, participants received two weeks of nicotine patches. RESULTS:Participants were a mean of 40.5 years of age, smoked 16.31 cigarettes per day for 21.88 years, with a mean of 6.81 prior failed quit attempts. Participants completed a mean of 5.55 of 8 online video classes with a mean of 23.33 minutes per login, completed a mean of 3.19 of 8 phone coach calls, and reported a mean meditation practice time of 12.17 minutes per day. Smoking abstinence was defined as self-reported abstinence on a smoking calendar with biochemical confirmation via carbon monoxide breath-test under 7 parts per million. Intent-to-treat analysis demonstrated 7-day point prevalence smoking abstinence at 4 and 6-months post-quit of 23.1% and 15.4% respectively. Participants showed a significant pre- to post-intervention increase in mindfulness as measured by the Five-Factor Mindfulness Questionnaire, and a significant pre- to post-intervention decrease in the Anxiety Sub-scale of the Depression Anxiety and Stress Scale. CONCLUSIONS:Results suggest that Mindfulness Training for Smokers can be provided via web-based video instruction with phone support and yield reasonable participant engagement on intervention practices and that intervention efficacy and mechanism of effect deserve further study. TRIAL REGISTRATION:ClinicalTrials.gov: NCT02164656 , Registration Date June 13, 2014.Item Open Access Participant evaluation of a telephone-based osteoarthritis self-management program, 2006-2009.(Preventing chronic disease, 2012-01) Sperber, Nina R; Bosworth, Hayden B; Coffman, Cynthia J; Juntilla, Karen A; Lindquist, Jennifer H; Oddone, Eugene Z; Walker, Tessa A; Weinberger, Morris; Allen, Kelli DIntroduction
Self-management support interventions can help improve osteoarthritis outcomes but are underused. Little is known about how participants evaluate the helpfulness of these programs. We describe participants' evaluations of a telephone-based, osteoarthritis self-management support intervention that yielded improved outcomes in a clinical trial.Methods
Participants were 140 people in the intervention arm of the trial who completed an end-of-trial survey. We used mixed methods to describe participants' perceived helpfulness of the program and its components. We compared ratings of helpfulness according to participant characteristics and analyzed themes from open-ended responses with a constant comparison approach. We calculated Pearson correlation coefficients between perceived helpfulness and changes in pain, function, affect, and self-efficacy.Results
The average rating of overall helpfulness on a scale from 1 to 10 was 7.6 (standard deviation, 2.3), and more than 80% of participants agreed that each component (phone calls, educational material, setting goals and action plans) was helpful. Participants had better perceived helpfulness ratings than their counterparts if they were nonwhite, had limited health literacy, had no college education, had perceived inadequate income, were older, had a spouse or were living together in a committed relationship, and had greater symptom duration and less pain. Ratings of helpfulness increased with greater improvement in outcomes. Participants frequently mentioned the health educator's calls as being helpful for staying on task with self-management behaviors.Conclusion
Participants viewed this intervention and each of its components as helpful for improving osteoarthritis symptoms. In addition to the improvements in objective outcomes seen in the clinical trial, these results provide further support for the dissemination of self-management support interventions.Item Open Access Patient experiences with a phone-based cardiovascular risk reduction intervention: Are there differences between women and men?(Patient education and counseling, 2021-11) Goldstein, KM; Zullig, LL; Andrews, SM; Sperber, N; Lewinski, AA; Voils, CI; Oddone, EZ; Bosworth, HBObjectives
To explore gender-based differences in experiences with a telehealth-delivered intervention for reduction of cardiovascular risk.Methods
We conducted 23 semi-structured qualitative interviews by telephone with 11 women and 12 men who received a 12-month, pharmacist-delivered, telephone-based medication and behavioral management intervention. We used content analysis to identify themes.Results
We identified three common themes for both men and women: ease and convenience of phone support, preference for proactive outreach, and need for trust building in the context of telehealth. While both genders appreciated the social support from the intervention pharmacist, women voiced appreciation for accountability whereas men generally spoke about encouragement.Conclusions
Rapport building may differ between telehealth and in-person healthcare visits; our work highlights how men and women's experiences can differ with telehealth care and which can inform the development of future, purposeful rapport building activities to strengthen the clinician-patient interaction.Practice implications
Clinicians should seek opportunities to provide frequent and routine support for patients with chronic disease. Telehealth interventions may benefit from gender-specific tailoring of social support.Item Open Access Patient-reported medication adherence barriers among patients with cardiovascular risk factors.(Journal of managed care & specialty pharmacy, 2015-06) Zullig, Leah L; Stechuchak, Karen M; Goldstein, Karen M; Olsen, Maren K; McCant, Felicia M; Danus, Susanne; Crowley, Matthew J; Oddone, Eugene Z; Bosworth, Hayden BBackground
Many patients experience barriers that make it difficult to take cardiovascular disease (CVD)-related medications as prescribed. The Cardiovascular Intervention Improvement Telemedicine Study (CITIES) was a tailored behavioral pharmacist-administered and telephone-based intervention for reducing CVD risk.Objectives
To (a) describe patient-reported barriers to taking their medication as prescribed and (b) evaluate patient-level characteristics associated with reporting medication barriers.Methods
We recruited patients receiving care at primary care clinics affiliated with Durham Veterans Affairs Medical Center. Eligible patients were diagnosed with hypertension and/or hyperlipidemia that were poorly controlled (blood pressure of > 150/100 mmHg and/or low-density lipoprotein value > 130 mg/dL). At the time of enrollment, patients completed an interview with 7 questions derived from a validated medication barriers measure. Patient characteristics and individual medication treatment barriers are described. Multivariable linear regression was used to examine the association between a medication barrier score and patient characteristics.Results
Most patients (n = 428) were married or living with their partners (57%) and were men (85%) who were diagnosed with hypertension and hyperlipidemia (64%). The most commonly reported barriers were having too much medication to take (31%) and forgetting whether medication was taken at a particular time (24%). In adjusted analysis, those who were not employed (1.32, 95% CI = 0.50-2.14) or did not have someone to help with tasks, if needed (1.66, 95% CI = 0.42-2.89), reported higher medication barrier scores. Compared with those diagnosed with hypertension and hyperlipidemia, those with only hypertension (0.91, 95% CI = 0.04-1.79) reported higher medication barrier scores.Conclusions
Barriers to medication adherence are common. Evaluating and addressing barriers may increase medication adherence.Item Open Access Racial Differences in the Effect of a Telephone-Delivered Hypertension Disease Management Program.(Journal of general internal medicine, 2012-08) Jackson, GL; Oddone, EZ; Olsen, MK; Powers, BJ; Grubber, JM; McCant, F; Bosworth, HBBACKGROUND: African Americans are significantly more likely than whites to have uncontrolled hypertension, contributing to significant disparities in cardiovascular disease and events. OBJECTIVE: The goal of this study was to examine whether there were differences in change in blood pressure (BP) for African American and non-Hispanic white patients in response to a medication management and tailored nurse-delivered telephone behavioral program. PARTICIPANTS: Five hundred and seventy-three patients (284 African American and 289 non-Hispanic white) primary care patients who participated in the Hypertension Intervention Nurse Telemedicine Study (HINTS) clinical trial. INTERVENTIONS: Study arms included: 1) nurse-administered, physician-directed medication management intervention, utilizing a validated clinical decision support system; 2) nurse-administered, behavioral management intervention; 3) combined behavioral management and medication management intervention; and 4) usual care. All interventions were activated based on poorly controlled home BP values. MAIN MEASURES: Post-hoc analysis of change in systolic and diastolic blood pressure. General linear models (PROC MIXED in SAS, version 9.2) were used to estimate predicted means at 6-month, 12-month, and 18-month time points, by intervention arm and race subgroups (separate models for systolic and diastolic blood pressure). KEY RESULTS: Improvement in mean systolic blood pressure post-baseline was greater for African American patients in the combined intervention, compared to African American patients in usual care, at 12 months (6.6 mmHg; 95 % CI: -12.5, -0.7; p = 0.03) and at 18 months (9.7 mmHg; -16.0, -3.4; p = 0.003). At 18 months, mean diastolic BP was 4.8 mmHg lower (95 % CI: -8.5, -1.0; p = 0.01) among African American patients in the combined intervention arm, compared to African American patients in usual care. There were no analogous differences for non-Hispanic white patients. CONCLUSIONS: The combination of home BP monitoring, remote medication management, and telephone tailored behavioral self-management appears to be particularly effective for improving BP among African Americans. The effect was not seen among non-Hispanic white patients.Item Open Access Racial Differences in the Effectiveness of a Multifactorial Telehealth Intervention to Slow Diabetic Kidney Disease.(Medical care, 2020-11) Kobe, Elizabeth A; Diamantidis, Clarissa J; Bosworth, Hayden B; Davenport, Clemontina A; Oakes, Megan; Alexopoulos, Anastasia-Stefania; Pendergast, Jane; Patel, Uptal D; Crowley, Matthew JBackground
African Americans are significantly more likely than non-African Americans to have diabetes, chronic kidney disease, and uncontrolled hypertension, increasing their risk for kidney function decline.Objective
The objective of this study was to compare how African Americans and non-African Americans with diabetes responded to a multifactorial telehealth intervention designed to slow kidney function decline.Research design
Secondary analysis of a randomized trial. Primary care patients (N=281, 56% African American) were allocated to either: (1) a multifactorial, pharmacist-delivered phone-based telehealth intervention focused on behavioral and medication management of diabetic kidney disease; or (2) an education control.Measures
The primary study outcome was change in estimated glomerular filtration rate (eGFR). Linear mixed models were used to explore the moderating effect of race on the relationship between study arm and eGFR decline over time; the mean annual rate of eGFR decline was estimated by race and study arm.Results
Findings demonstrated a differential intervention effect on kidney function over time by race (Pinteraction=0.005). Among African Americans, the intervention arm had significantly greater preservation of eGFR over time than the control arm (difference in the annual rate of eGFR decline=1.5 mL/min/1.73 m; 95% confidence interval: 0.04, 3.02). For non-African Americans, the intervention arm had a faster decline in eGFR over time than the control arm (difference in the annual rate of eGFR decline=-1.7 mL/min/1.73 m; 95% confidence interval: -3.3, -0.02).Conclusion
A multifactorial, pharmacist-delivered telehealth intervention for diabetic kidney disease may be more effective for slowing eGFR decline among African Americans than non-African Americans.Item Open Access Racial differences in two self-management hypertension interventions.(The American journal of medicine, 2011-05) Bosworth, Hayden B; Olsen, Maren K; Grubber, Janet M; Powers, Benjamin J; Oddone, Eugene ZBackground
Only one half of Americans have their blood pressure controlled, and there are significant racial differences in blood pressure control. The goal of this study was to examine the effectiveness of 2 patient-directed interventions designed to improve blood pressure control within white and non-white subgroups (African Americans, 49%).Methods
Post hoc analysis of a 2 by 2 randomized trial with 2-year follow-up in 2 university-affiliated primary care clinics was performed. Within white and non-white patients (n=634), 4 groups were examined: 1) usual care; 2) home blood pressure monitoring (3 times per week); 3) tailored behavioral self-management intervention administered via telephone by a nurse every other month; and 4) a combination of the 2 interventions.Results
The overall race by time by treatment group effect suggested differential intervention effects on blood pressure over time for whites and non-whites (systolic blood pressure, P=. 08; diastolic blood pressure, P=.01). Estimated trajectories indicated that among the 308 whites, there was no significant effect on blood pressure at 12 or 24 months for any intervention compared with the control group. At 12 months, the non-whites (n=328) in all 3 intervention groups had systolic blood pressure decreases of 5.3 to 5.7 mm Hg compared with usual care (P <.05). At 24 months, in the combined intervention, non-whites had sustained lower systolic blood pressure compared with usual care (7.5 mm Hg; P <.02). A similar pattern was observed for diastolic blood pressure.Conclusion
Combined home blood pressure monitoring and a tailored behavioral phone intervention seem to be particularly effective for improving blood pressure in non-white patients.Item Restricted Study protocol: home-based telehealth stroke care: a randomized trial for veterans.(Trials, 2010-06-30) Chumbler, NR; Rose, DK; Griffiths, P; Quigley, P; McGee Hernandez, N; Carlson, KA; Vandenberg, P; Morey, MC; Sanford, J; Hoenig, HBACKGROUND: Stroke is one of the most disabling and costly impairments of adulthood in the United States. Stroke patients clearly benefit from intensive inpatient care, but due to the high cost, there is considerable interest in implementing interventions to reduce hospital lengths of stay. Early discharge rehabilitation programs require coordinated, well-organized home-based rehabilitation, yet lack of sufficient information about the home setting impedes successful rehabilitation. This trial examines a multifaceted telerehabilitation (TR) intervention that uses telehealth technology to simultaneously evaluate the home environment, assess the patient's mobility skills, initiate rehabilitative treatment, prescribe exercises tailored for stroke patients and provide periodic goal oriented reassessment, feedback and encouragement. METHODS: We describe an ongoing Phase II, 2-arm, 3-site randomized controlled trial (RCT) that determines primarily the effect of TR on physical function and secondarily the effect on disability, falls-related self-efficacy, and patient satisfaction. Fifty participants with a diagnosis of ischemic or hemorrhagic stroke will be randomly assigned to one of two groups: (a) TR; or (b) Usual Care. The TR intervention uses a combination of three videotaped visits and five telephone calls, an in-home messaging device, and additional telephonic contact as needed over a 3-month study period, to provide a progressive rehabilitative intervention with a treatment goal of safe functional mobility of the individual within an accessible home environment. Dependent variables will be measured at baseline, 3-, and 6-months and analyzed with a linear mixed-effects model across all time points. DISCUSSION: For patients recovering from stroke, the use of TR to provide home assessments and follow-up training in prescribed equipment has the potential to effectively supplement existing home health services, assist transition to home and increase efficiency. This may be particularly relevant when patients live in remote locations, as is the case for many veterans. TRIAL REGISTRATION: Clinical Trials.gov Identifier: NCT00384748.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 Telemedicine cardiovascular risk reduction in veterans.(American heart journal, 2013-04) Melnyk, S Dee; Zullig, Leah L; McCant, Felicia; Danus, Susanne; Oddone, Eugene; Bastian, Lori; Olsen, Maren; Stechuchak, Karen M; Edelman, David; Rakley, Susan; Morey, Miriam; Bosworth, Hayden BBackground
Patients with co-occurrence of hypertension, hyperlipidemia, and diabetes have an increased risk of cardiovascular disease (CVD) events. Comprehensive programs addressing both tailored patient self-management and pharmacotherapy are needed to address barriers to optimal cardiovascular risk reduction. We are examining a Clinical pharmacy specialist-, telephone-administered intervention, relying on home monitoring, with a goal of providing tailored medication and behavioral intervention to Veterans with CVD risk.Methods
Randomized controlled trial including patients with hypertension (blood pressure >150/100 mm Hg) or elevated low density liporotein (>130 mg/dL). Longitudinal changes in CVD risk profile and improvement in health behaviors over time will be examined.Conclusion
Given the national prevalence of CVD and the dismal rates of risk factor control, intensive but easily disseminated interventions are required to treat this epidemic. This study will be an important step in testing the effectiveness of a behavioral and medication intervention to improve CVD control among Veterans.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.Item Open Access Testing a behavioral intervention to improve adherence to adjuvant endocrine therapy (AET).(Contemporary clinical trials, 2019-01) Shelby, Rebecca A; Dorfman, Caroline S; Bosworth, Hayden B; Keefe, Francis; Sutton, Linda; Owen, Lynda; Corsino, Leonor; Erkanli, Alaattin; Reed, Shelby D; Arthur, Sarah S; Somers, Tamara; Barrett, Nadine; Huettel, Scott; Gonzalez, Juan Marcos; Kimmick, GretchenAdjuvant endocrine therapy (AET) is used to prevent recurrence and reduce mortality for women with hormone receptor positive breast cancer. Poor adherence to AET is a significant problem and contributes to increased medical costs and mortality. A variety of problematic symptoms associated with AET are related to non-adherence and early discontinuation of treatment. The goal of this study is to test a novel, telephone-based coping skills training that teaches patients adherence skills and techniques for coping with problematic symptoms (CST-AET). Adherence to AET will be assessed in real-time for 18 months using wireless smart pill bottles. Symptom interference (i.e., pain, vasomotor symptoms, sleep problems, vaginal dryness) and cost-effectiveness of the intervention protocol will be examined as secondary outcomes. Participants (N = 400) will be recruited from a tertiary care medical center or community clinics in medically underserved or rural areas. Participants will be randomized to receive CST-AET or a general health education intervention (comparison condition). CST-AET includes ten nurse-delivered calls delivered over 6 months. CST-AET provides systematic training in coping skills for managing symptoms that interfere with adherence. Interactive voice messaging provides reinforcement for skills use and adherence that is tailored based on real-time adherence data from the wireless smart pill bottles. Given the high rates of non-adherence and recent recommendations that women remain on AET for 10 years, we describe a timely trial. If effective, the CST-AET protocol may not only reduce the burden of AET use but also lead to cost-effective changes in clinical care and improve breast cancer outcomes. Trials registration: ClinicalTrials.gov, NCT02707471, registered 3/3/2016.Item Unknown Track: A randomized controlled trial of a digital health obesity treatment intervention for medically vulnerable primary care patients.(Contemporary clinical trials, 2016-05) Foley, Perry; Steinberg, Dori; Levine, Erica; Askew, Sandy; Batch, Bryan C; Puleo, Elaine M; Svetkey, Laura P; Bosworth, Hayden B; DeVries, Abigail; Miranda, Heather; Bennett, Gary GIntroduction
Obesity continues to disproportionately affect medically vulnerable populations. Digital health interventions may be effective for delivering obesity treatment in low-resource primary care settings.Methods
Track is a 12-month randomized controlled trial of a digital health weight loss intervention in a community health center system. Participants are 351 obese men and women aged 21 to 65years with an obesity-related comorbidity. Track participants are randomized to usual primary care or to a 12-month intervention consisting of algorithm-generated tailored behavior change goals, self-monitoring via mobile technologies, daily self-weighing using a network-connected scale, skills training materials, 18 counseling phone calls with a Track coach, and primary care provider counseling. Participants are followed over 12months, with study visits at baseline, 6, and 12months. Anthropometric data, blood pressure, fasting lipids, glucose and HbA1C and self-administered surveys are collected. Follow-up data will be collected from the medical record at 24months.Results
Participants are 68% female and on average 50.7years old with a mean BMI of 35.9kg/m(2). Participants are mainly black (54%) or white (33%); 12.5% are Hispanic. Participants are mostly employed and low-income. Over 20% of the sample has hypertension, diabetes and hyperlipidemia. Almost 27% of participants currently smoke and almost 20% score above the clinical threshold for depression.Conclusions
Track utilizes an innovative, digital health approach to reduce obesity and chronic disease risk among medically vulnerable adults in the primary care setting. Baseline characteristics reflect a socioeconomically disadvantaged, high-risk patient population in need of evidence-based obesity treatment.