Engaging nurses in research for a randomized clinical trial of a behavioral health intervention.
Ontology highlight
ABSTRACT:
SUBMITTER: Roll L
PROVIDER: S-EPMC3786524 | biostudies-literature | 2013
REPOSITORIES: biostudies-literature
Publications
Engaging nurses in research for a randomized clinical trial of a behavioral health intervention.
Roll Lona L Stegenga Kristin K Hendricks-Ferguson Verna V Barnes Yvonne J YJ Cherven Brooke B Docherty Sharron L SL Robb Sheri L SL Haase Joan E JE
Nursing research and practice 20130911
Nurse involvement in research is essential to the expansion of nursing science and improved care for patients. The research participation challenges encountered by nurses providing direct care (direct care nurses) include balancing patient care demands with research, adjusting to fluctuating staff and patient volumes, working with interdisciplinary personnel, and feeling comfortable with their knowledge of the research process. The purpose of this paper is to describe efforts to engage nurses in ...[more]
Similar Datasets
Project description:ObjectiveNearly 80% of cancer patients struggle with insomnia, which is associated with decreased heart rate variability (HRV) and quality of life (QOL). The aim of this secondary analysis was to evaluate the possible effects of Brief Behavioral Therapy for Cancer-Related Insomnia (BBT-CI), delivered during chemotherapy visits, on QOL and HRV in patients with breast cancer (BC).MethodQOL and HRV data were obtained during a pilot clinical trial assessing the feasibility and effects of BBT-CI on insomnia. A total of 71 BC patients (mean age = 52.5 years) were randomly assigned to either BBT-CI or a healthy-eating control intervention (HEAL). BBT-CI and HEAL were delivered over 6 weeks (2 face-to-face sessions plus 4 phone calls) by trained staff at 4 National Cancer Institute-funded Community Oncology Research Program clinics. QOL was measured with the Functional Assessment of Cancer Therapy (FACT-G) and HRV with the Firstbeat device at baseline and after intervention.ResultsThere were significant improvements in QOL after intervention for BBT-CI (FACT-G, p = .009; FACT-B, p = .016; ANCOVA) and 5-min supine HRV measures (SDNN, p = .005; rMSSD, p = .004; HF, p = .009; ANCOVA) compared with HEAL.ConclusionsPatients randomized to BBT-CI showed improvements in QOL and HRV, providing support for BBT-CI's possible benefit when delivered in the community oncology setting by trained staff. A more definitive efficacy trial of BBT-CI is currently being planned with sufficient statistical power to evaluate the intervention's clinical utility. (PsycINFO Database Record (c) 2019 APA, all rights reserved).
| S-EPMC6892630 | biostudies-literature
Project description:ImportanceGiven minority patients' unequal access to quality care, patient activation and self-management strategies have been suggested as a promising approach to improving mental health care.ObjectiveTo determine whether the DECIDE (Decide the problem; Explore the questions; Closed or open-ended questions; Identify the who, why, or how of the problem; Direct questions to your health care professional; Enjoy a shared solution) intervention, an educational strategy that teaches patients to ask questions and make collaborative decisions with their health care professional, improves patient activation and self-management, as well as engagement and retention in behavioral health care.Design, setting, and patientsIn this multisite randomized clinical trial performed from February 1, 2009, through October 9, 2011 (date of last follow-up interview), we recruited 647 English- or Spanish-speaking patients 18 to 70 years old from 13 outpatient community mental health clinics across 5 states and 1 US territory. A total of 722 patients were included in analyses of secondary outcomes.InterventionsThree DECIDE training sessions delivered by a care manager vs giving patients a brochure on management of behavioral health.Main outcomes and measuresPrimary outcomes were patient assessment of activation (Patient Activation Scale) and self-management (Perceived Efficacy in Patient-Physician Interactions). Secondary outcomes included patient engagement (proportion of visits attended of those scheduled) and retention (attending at least 4 visits in the 6 months after the baseline research assessment), collected through medical record review or electronic records.ResultsPatients assigned to DECIDE reported significant increases in activation (mean β = 1.74, SD = 0.58; P = .003) and self-management (mean β = 2.42, SD = 0.90; P = .008) relative to control patients, but there was no evidence of an effect on engagement or retention in care.Conclusions and relevanceThe DECIDE intervention appears to help patients learn to effectively ask questions and participate in decisions about their behavioral health care, but a health care professional component might be needed to augment engagement in care. DECIDE appears to have promise as a strategy for changing the role of minority patients in behavioral health care.Trial registrationclinicaltrials.gov Identifier: NCT01226329
| S-EPMC4311517 | biostudies-literature
Project description:PurposeA pragmatic, cluster-randomized controlled trial of a comprehensive practice-level, multi-staged practice transformation intervention aimed to increase behavioral health integration in primary care practices and improve patient outcomes. We examined association between the completion of intervention stages and patient outcomes across a heterogenous national sample of primary care practices.MethodsForty-two primary care practices across the U.S. with co-located behavioral health and 2,426 patients with multiple chronic medical and behavioral health conditions completed surveys at baseline, midpoint and two year follow-up. Effects of the intervention on patient health and primary care integration outcomes were examined using multilevel mixed-effects models, while controlling for baseline outcome measurements.ResultsNo differences were found associated with the number of intervention stages completed in patient health outcomes were found for depression, anxiety, fatigue, sleep disturbance, pain, pain interference, social function, patient satisfaction with care or medication adherence. The completion of each intervention stage was associated with increases in Practice Integration Profile (PIP) domain scores and were confirmed with modeling using multiple imputation for: Workflow 3.5 (95% CI: 0.9-6.1), Integration Methods 4.6 (95% CI: 1.5-7.6), Patient Identification 2.9 (95% CI: 0.9-5.0), and Total Integration 2.7 (95% CI: 0.7-4.7).ConclusionA practice-centric flexible practice transformation intervention improved integration of behavioral health in primary care across heterogenous primary care practices treating patients with multiple chronic conditions. Interventions that allow practices to flexibly improve care have potential to help complex patient populations. Future research is needed to determine how to best target patient health outcomes at a population level.
| S-EPMC10871364 | biostudies-literature
Project description:BackgroundDespite effective psychosocial interventions, gaps in access to care persist for youth and families in need. Behavioral intervention technologies (BITs) that apply psychosocial intervention strategies using technological features represent a modality for targeted prevention that is promising for the transformation of primary care behavioral health by empowering parents to take charge of the behavioral health care of their children. To realize the potential of BITs for parents, research is needed to understand the status quo of parental self-help and parent-provider collaboration to address behavioral health challenges and unmet parental needs that could be addressed by BITs.ObjectiveThe aim of this study is to conduct foundational research with parents and health care stakeholders (HCS) to discover current practices and unmet needs related to common behavioral health challenges to inform the design, build, and testing of BITs to address these care gaps within a predominantly rural health system.MethodsWe conducted a convergent mixed-parallel study within a large, predominantly rural health system in which the BITs will be developed and implemented. We analyzed data from parent surveys (N=385) on current practices and preferences related to behavioral health topics to be addressed in BITs along with focus group data of 48 HCS in 9 clinics regarding internal and external contextual factors contributing to unmet parental needs and current practices. By comparing and relating the findings, we formed interpretations that will inform subsequent BIT development activities.ResultsParents frequently endorsed several behavioral health topics, and several topics were relatively more or less frequently endorsed based on the child's age. The HCS suggested that BITs may connect families with evidence-based guidance sooner and indicated that a web-based platform aligns with how parents already seek behavioral health guidance. Areas of divergence between parents and HCS were related to internalizing problems and cross-cutting issues such as parenting stress, which may be more difficult for health care HCS to detect or address because of the time constraints of routine medical visits.ConclusionsThese findings provide a rich understanding of the complexity involved in meeting parents' needs for behavioral health guidance in a primary care setting using BITs. User testing studies for BIT prototypes are needed to successfully design, build, and test effective BITs to empower parents to take charge of promoting the behavioral health of their children.
| S-EPMC8527378 | biostudies-literature
Project description:ObjectivesIn this study, we evaluate the efficacy of Families Talking Together (FTT), a triadic intervention to reduce adolescent sexual risk behavior.MethodsAdolescents aged 11 to 14 and their female caregivers were recruited from a pediatric clinic; 900 families were enrolled; 84 declined. Families were randomly assigned to FTT or 1 of 2 control conditions. The FTT triadic intervention consisted of a 45-minute face-to-face session for mothers, health care provider endorsement of intervention content, printed materials for families, and a booster call for mothers. The primary outcomes were ever having had vaginal intercourse, sexual debut within the past 12 months, and condom use at last sexual intercourse. Assessments occurred at baseline, 3 months post baseline, and 12 months post baseline.ResultsOf enrolled families, 73.4% identified as Hispanic, 20.4% as African American, and 6.2% as mixed race. Mean maternal age was 38.8 years, and mean adolescent grade was seventh grade. At the 12-month follow-up, 5.2% of adolescents in the experimental group reported having had sexual intercourse, compared with 18% of adolescents in the control groups (P < .05). In the experimental group, 4.7% of adolescents reported sexual debut within the past 12 months, compared with 14.7% of adolescents in the control group (P < .05). In the experimental group, 74.2% of sexually active adolescents indicated using a condom at last sexual intercourse, compared with 49.1% of adolescents in the control group (P < .05).ConclusionsThis research suggests that the FTT triadic intervention is efficacious in delaying sexual debut and reducing sexual risk behavior among adolescents.
| S-EPMC7193976 | biostudies-literature
Project description:BackgroundDepression is common among adults who smoke cigarettes. Existing depression-specific cessation interventions have limited reach and are unlikely to improve smoking prevalence rates among this large subgroup of smokers.ObjectiveThis study aimed to determine whether a mobile app-based intervention tailored for depression paired with a mailed sample of nicotine replacement therapy (NRT) is efficacious for treating depression and promoting smoking cessation.MethodsA 2-arm nationwide remote randomized clinical trial was conducted in the United States. Adults (N=150) with elevated depressive symptoms (Patient Health Questionnaire-8≥10) who smoked were enrolled. The mobile app ("Goal2Quit") provided behavioral strategies for treating depression and quitting smoking based on Behavioral Activation Treatment for Depression. Goal2Quit participants also received a 2-week sample of combination NRT. Treatment as usual participants received a self-help booklet for quitting smoking that was not tailored for depression. Primary end points included Goal2Quit usability, change in depression (Beck Depression Inventory-II) across 12 weeks, and smoking cessation including reduction in cigarettes per day, incidence of 24-hour quit attempts, floating abstinence, and 7-day point prevalence abstinence (PPA).ResultsIn total, 150 participants were enrolled between June 25, 2020, and February 23, 2022, of which 80 were female (53.3%) and the mean age was 38.4 (SD 10.3) years. At baseline, participants on average reported moderate depressive symptoms and smoked a mean of 14.7 (SD 7.5) cigarettes per day. Goal2Quit usability was strong with a mean usability rating on the System Usability Scale of 78.5 (SD 16.9), with 70% scoring above the ≥68 cutoff for above-average usability. Retention data for app use were generally strong immediately following trial enrollment and declined in subsequent weeks. Those who received Goal2Quit and the NRT sample reported lower mean depressive symptoms over the trial duration as compared to treatment as usual (difference of mean 3.72, SE 1.37 points less; P=.01). Across time points, all cessation outcomes favored Goal2Quit. Regarding abstinence, Goal2Quit participants reported significantly higher rates of 7-day PPA at weeks 4 (11% vs 0%; P=.02), 8 (7-day PPA: 12% vs 0%; P=.02), and 12 (16% vs 2%; P=.02).ConclusionsA mobile app intervention tailored for depression paired with a sample of NRT was effective for depression treatment and smoking cessation. Findings support the utility of this intervention approach for addressing the currently unmet public health treatment need for tailored, scalable depression-specific cessation treatments.Trial registrationClinicalTrials.gov NCT03837379; https://clinicaltrials.gov/ct2/show/NCT03837379.
| S-EPMC10652199 | biostudies-literature
Project description:ObjectiveTo test the effect on diabetes management outcomes of a low-intensity, clinic-integrated behavioral intervention for families of youth with type 1 diabetes.MethodsFamilies (n = 390) obtaining care for type 1 diabetes participated in a 2-year randomized clinical trial of a clinic-integrated behavioral intervention designed to improve family diabetes management practices. Measurement of hemoglobin A1c, the primary outcome, was obtained at each clinic visit and analyzed centrally. Blood glucose meter data were downloaded at each visit. Adherence was assessed by using a semistructured interview at baseline, mid-study, and follow-up. Analyses included 2-sample t tests at predefined time intervals and mixed-effect linear-quadratic models to assess for difference in change in outcomes across the study duration.ResultsA significant overall intervention effect on change in glycemic control from baseline was observed at the 24-month interval (P = .03). The mixed-effect model showed a significant intervention by age interaction (P < .001). Among participants aged 12 to 14, a significant effect on glycemic control was observed (P = .009 for change from baseline to 24-month interval; P = .035 for mixed-effect model across study duration), but there was no effect among those aged 9 to 11. There was no intervention effect on child or parent report of adherence; however, associations of change in adherence with change in glycemic control were weak.ConclusionsThis clinic-integrated behavioral intervention was effective in preventing the deterioration in glycemic control evident during adolescence, offering a potential model for integrating medical and behavioral sciences in clinical care.
| S-EPMC3313642 | biostudies-literature
Project description:ImportanceVirtual home-based interventions may bolster protective factors, such as family health and resilience, during stressors such as the COVID-19 pandemic; however, their effectiveness is unknown.ObjectiveTo examine the effectiveness of a virtual health coaching intervention on family health and resilience during the pandemic.Design, setting, and participantsIn this parallel-group, single-site randomized clinical trial, 123 parents and their 2- to 8-year-old children were enrolled at a pediatric clinic or community partner site in Tennessee from March 10 to August 11, 2021. Follow-up surveys were completed between June 29 and November 11, 2021.InterventionsAll participants received 11 weekly cooking videos and associated home-delivered groceries. The intervention group also received 12 weekly, 30-minute virtual health coach sessions.Main outcomes and measuresThe primary outcome was the validated 6-item (range, 6-30) Family Healthy Lifestyle Subscale (FHLS) scores. The secondary outcome was the validated 6-item (range, 0-6) Family Resilience and Connection Index (FRCI) scores. Outcomes were determined a priori and evaluated at baseline and 12-week follow-up. A priori independent t tests and multivariable tobit regression models assessed intervention effects, and post hoc, secondary interaction models assessed whether effects differed over baseline outcomes.ResultsAmong the 123 enrolled families, 110 (89%) were included in the primary analyses (parent mean [SD] age, 35.1 [8.2] years; 104 [95%] female; 55 [50%] non-Hispanic Black; child mean [SD] age, 5.2 [1.7] years; 62 [56%] male). Intervention-control group mean differences were nonsignificant for follow-up FHLS scores (0.7; 95% CI, -0.6 to 2.0; P = .17) and FRCI scores (0.1; 95% CI, -0.5 to 0.6; P = .74). Tobit regression model intervention effects were nonsignificant for FHLS scores (0.9; 95% CI, -0.3 to 2.2; P = .15) and FRCI scores (0.4; 95% CI, -0.2 to 1.1; P = .17). Post hoc, secondary models found no significant interaction for FHLS scores (1.3 increase per 5-point decrease; 95% CI, -0.2 to 2.7; P = .09), with significant intervention associations for baseline scores of 6 to 23. The interaction was significant for FRCI scores (0.4 increase per 1-point decrease; 95% CI, 0.01 to 0.8; P = .047), with significant intervention associations for baseline scores of 0 to 3.Conclusions and relevanceIn this randomized clinical trial of families with young children, weekly virtual health coaching did not detectably improve family health and resilience. Post hoc, secondary results provided preliminary evidence of potential effectiveness among families with low baseline scores.Trial registrationClinicalTrials.gov Identifier: NCT05328193.
| S-EPMC9856707 | biostudies-literature
Project description:ObjectiveTo evaluate whether opt out framing, messaging incorporating behavioral science concepts, or electronic communication increases the uptake of hepatitis C virus (HCV) screening in patients born between 1945 and 1965.DesignPragmatic randomized controlled trial.Setting43 primary care practices from one academic health system (Philadelphia, PA, USA) between April 2019 and May 2020.ParticipantsPatients born between 1945 and 1965 with no history of screening and at least two primary care visits in the two years before the enrollment period.InterventionsThis multilevel trial was divided into two studies. Substudy A included 1656 eligible patients of 17 primary care clinicians who were randomized in a 1:1 ratio to a mailed letter about HCV screening (letter only), or a similar letter with a laboratory order for HCV screening (letter+order). Substudy B included the remaining 19 837 eligible patients followed by 417 clinicians. Active electronic patient portal users were randomized 1:5 to receive a mailed letter about HCV screening (letter), or an electronic patient portal message with similar content (patient portal); inactive patient portal users were mailed a letter. In a factorial design, patients in substudy B were also randomized 1:1 to receive standard content (usual care), or content based on principles of social norming, anticipated regret, reciprocity, and commitment (behavioral content).Main outcome measuresProportion of patients who completed HCV testing within four months.Results21 303 patients were included in the intention-to-treat analysis. Among the 1642 patients in substudy A, 19.2% (95% confidence interval 16.5% to 21.9%) completed screening in the letter only arm and 43.1% (39.7% to 46.4%) in the letter+order arm (P<0.001). Among the 19 661 patients in substudy B, 14.6% (13.9% to 15.3%) completed screening with usual care content and 13.6% (13.0% to 14.3%) with behavioral science content (P=0.06). Among active patient portal users, 17.8% (16.0% to 19.5%) completed screening after receiving a letter and 13.8% (13.1% to 14.5%) after receiving a patient portal message (P<0.001).ConclusionsOpt out framing and effort reduction by including a signed laboratory order with outreach increased screening for HCV. Behavioral science messaging content did not increase uptake, and mailed letters achieved a greater response rate than patient portal messages.Trial registrationClinicalTrials.gov NCT03712553.
| S-EPMC8129827 | biostudies-literature
Project description:BackgroundObesity often occurs co-morbid with chronic, non-cancer pain. While behavioral treatments have proved effective for pain management and weight loss independently, integrated interventions are lacking. The study Simultaneously Targeting Obesity and Pain (STOP) is a prospective, pragmatic, randomized controlled trial that aims to determine whether overweight/obese individuals with chronic pain who are randomized to receive an integrated treatment Simultaneously Targeting Obesity and Pain (STOP) will show more weight loss and greater reduction in pain intensity over a 6-month period and greater maintenance at 12 months than those who receive standard care behavioral weight loss or standard care behavioral pain management. We hypothesize that individuals randomized to receive the STOP treatment will demonstrate improved weight loss, pain reduction, and maintenance compared to standard care treatment approaches.Methods/designAdults aged ≥ 18 with a body mass index ≥ 25 and who report persistent pain (≥4 out of 0-10 for > 6 months) will be recruited for treatment at the Health Behavior Research Lab at the University of the Sciences. After baseline assessments and goal setting, participants will be randomized to receive one of three treatments. Participants will receive eleven treatment sessions delivered during 1 hour, weekly individual meetings with a clinic therapist. Follow-up will occur at 3, 6 and 12-month time points; assessments will include measures of weight and pain intensity (primary outcomes). A mixed-method approach to evaluating study outcomes will include individual interviews with participants about their treatment experience. These interviews will be led by a research staffer who was not involved in study intervention or assessment using a semi-structured discussion guide.DiscussionThis study fills an important gap in intervention research, evaluating best-practices for behavioral management of a highly prevalent co-morbidity that has sub-optimal outcomes with currently-implemented approaches. STOP's pragmatic focus builds upon treatments already in use in clinical practice. Should STOP be found efficacious in achieving the dual outcomes of pain management and weight loss, such an approach could be integrated into practice with minimal additional cost or training.Trial registrationClinical Trials.gov NCT02100995 Date of Registration: March 2014.
| S-EPMC4078390 | biostudies-literature