Text Messaging Improves Participation in Laboratory Testing in Adolescent Liver Transplant Patients.
ABSTRACT: BACKGROUND:In solid organ transplant patients, non-participation in all aspects of the medical regimen is a prevalent problem associated with adverse consequences particularly in the adolescent and young adult (AYA) age group. This study is the first to evaluate the feasibility, utility and impact of a text messaging (TM) intervention to improve participation in laboratory testing in adolescent liver transplant patients. METHODS:AYA patients, aged 12 to 21 years, were recruited for a prospective pilot trial evaluating a TM intervention delivered over a 1-year period. The intervention involved automated TM reminders with feedback administered according to a prescribed laboratory testing frequency. Participation rate in laboratory testing after the intervention was compared to the year prior. Patient responses and feedback by text and survey were used to assess feasibility, acceptability and use of the intervention. RESULTS:Forty-two patients were recruited and 33 patients remained enrolled for the study duration. Recipients of the TM intervention demonstrated a significant improvement in participation rate in laboratory testing from 58% to 78% (P<.001). This rate was also significantly higher than in non-intervention controls (P=.003). There was a high acceptability, response rate and a significant correlation with reported versus actual completion of laboratory tests by TM. CONCLUSIONS:TM reminders significantly improved participation in laboratory testing in AYA liver transplant patients. The intervention demonstrated feasibility, acceptability, and use with a high proportion of patients who engaged in and perceived a benefit from using this technology.
Project description:BACKGROUND:Adolescents and young adults (AYAs) with cancer have poor psychosocial outcomes, in part because their limited participation in clinical trials precludes intervention-testing. We previously reported results of a successful randomized trial testing an AYA-targeted psychosocial intervention. Here, we aimed to describe strategies learned during the trial's conduct. METHODS:We summarized data from the medical record and staff field notes regarding reasons for participation/non-participation. We conducted two focus groups with study staff; directed content analyses identified strategies for success. RESULTS:92 AYAs enrolled (77% of approached; n = 50 Usual Care (control), n = 49 PRISM (intervention)). In eligible families who declined participation (n = 22 AYAs, n = 8 parents), the AYAs more commonly had advanced cancer (n = 11 (37%) declined vs. n = 25 (26%) enrolled). AYA reasons for non-enrollment were predominantly "not interested"; parents worried participation was "too burdensome." Staff strategies for accrual included having significant time to introduce the study and underscoring a desire to learn from the patient. After enrollment, AYAs who discontinued participation were more commonly assigned to control (n = 5 (10%) control vs. n = 2 (4%) intervention). Only n = 1 AYA chose to discontinue participation after receiving the intervention. CONCLUSIONS:Efforts to engage AYAs prior to and during studies may help with accrual and retention.
Project description:Background:Adolescent and young adult (AYA) cancer survivors (i.e. individuals diagnosed with cancer between 15 and 39?years and who completed treatment) may benefit from physical activity. Yet, few researchers have explored the effects of physical activity on physical and psychological outcomes among AYA cancer survivors. A pilot study exploring the feasibility and acceptability of a physical activity intervention and proposed trial methods to inform a definitive randomized controlled trial (RCT) is therefore necessary to fill this gap. Methods:A two-arm, mixed-methods pilot RCT was conducted. Participants were randomized to a wait-list control group or a 12-week physical activity intervention comprised of 4 weekly aerobic and strength training sessions (intervention group). Feasibility measures included: number of AYA cancer survivors referred/self-referred, eligible, and recruited, retention to the trial (i.e. assessment completion), adherence to the physical activity intervention, and percentage of missing data for baseline (week 0), mid- (week 6), and post-intervention assessments (week 12). The acceptability of trial methods (all participants) and the intervention (intervention group only) was assessed via qualitative interviews post-intervention. Results:Over a 12-month period, 31 AYA cancer survivors were referred/self-referred and 16 were eligible and consented to participate. Retention to the trial was 94% and adherence to the physical activity intervention ranged from 50 to 92%. With the exception of the assessment of aerobic capacity and directly measured physical activity behaviour, there were no missing data. Participants generally reported being satisfied with the trial methods and intervention; however, issues related to delivery of the physical activity intervention were identified. Conclusions:The methods and intervention piloted require modification and further pilot testing in advance of a definitive RCT. Recruitment strategies identifying a greater number of younger AYA cancer survivors who have different types of cancers and who lack motivation to participate in physical activity-based studies should be explored. Refining the assessments of directly measured physical activity behaviour and aerobic capacity and incorporating behavioural support into the intervention may improve feasibility and acceptability. This study highlights the value of doing pilot work and provides critically useful data that can be used to refine studies seeking to assess causation and optimize physical activity interventions for AYA cancer survivors. Trial registration:clinicaltrials.gov, NCT03016728. Registered January 11, 2017.
Project description:BACKGROUND:The Human Immunodeficiency Virus (HIV) epidemic is growing rapidly among South African adolescents and young adults (AYA). Although HIV counselling and testing, HIV prevention and treatment options are widely available, many AYA delay health-seeking until illness occurs, demonstrating a need for youth responsive, integrated sexual and reproductive health services (SRHS). While feasibility and cost-effectiveness have been evaluated, acceptability of mobile clinics among AYA has yet to be established. The objective of this study was to investigate patient acceptability of mobile AYA SRHS and compare mobile clinic usage and HIV outcomes with nearby conventional clinics. METHODS:Patients presenting to a mobile clinic in Cape Town were invited to participate in an acceptability study of a mobile clinic after using the service. A trained researcher administered an acceptability questionnaire. Mobile clinic medical records during the study period were compared with the records of AYA attending four clinics in the same community. RESULTS:Three hundred three enrolled participants (16-24?years, 246 (81.2%) female) rated mobile AYA SRHS acceptability highly (median?= 4,6 out of 5), with 90% rating their experience as better or much better than conventional clinics. The mobile clinic, compared to conventional clinics, attracted more men (26% v 13%, p <?0,000), younger patients (18 v 19?years, p <?0,000), and yielded more HIV diagnoses (4% v 2%, p <?0,000). CONCLUSIONS:Given the high ratings of acceptability, and the preference for mobile clinics over conventional primary health clinics, the scalability of mobile clinics should be investigated as part of a multipronged approach to improve the uptake of SRHS diagnostic, prevention and treatment options for AYA.
Project description:Cervical cancer, nearly all cases of which are caused by one of several high-risk strains of the human papillomavirus (hr-HPV), leads to significant morbidity and mortality in individuals with a cervix. Trans masculine (TM) individuals were born with female reproductive organs and identify as male, man, transgender man, or another diverse gender identity different from their female assigned sex at birth. Routine preventive sexual health screening of TM patients is recommended, including screening for cervical cancer and other sexually transmitted infections (STIs); however, as many as one in three TM patients are not up-to-date per recommended U.S.Among cisgender (non-transgender) women, self-swab hr.-HPV DNA testing as a primary cervical cancer screening method and self-swab specimen collection for other STIs have high levels of acceptability. No study has yet been conducted to compare the performance and acceptability of self- and provider-collected swabs for hr.-HPV DNA testing and other STIs in TM patients.This article describes the study protocol for a mixed-methods biobehavioral investigation enrolling 150 sexually active TM to (1) assess the clinical performance and acceptability of a vaginal self-swab for hr.-HPV DNA testing compared to provider cervical swab and cervical cytology, and (2) gather acceptability data on self-collected specimens for other STIs. Study participation entails a one-time clinical visit at Fenway Health in Boston, MA comprised of informed consent, quantitative assessment, venipuncture for syphilis testing and HIV (Rapid OraQuick) testing, randomization, collection of biological specimens/biomarkers, participant and provider satisfaction survey, and qualitative exit interview. Participants are compensated $100. The primary study outcomes are concordance (kappa statistic) and performance (sensitivity and specificity) of self-collected vaginal HPV DNA specimens vs provider-collected cervical HPV swabs as a gold standard.This study addresses critical gaps in current clinical knowledge of sexual health in TM patients, including comparing alternative strategies for screening and diagnosis of cervical cancer, hr.-HPV, and other STIs. Findings have implications for improving the delivery of sexual health screening to this often overlooked and underserved patient population. Less-invasive patient-centered strategies may also generalize to other at-risk cisgender female populations that face barriers to timely and needed STI and cervical cancer screening.ClinicalTrials.gov ID: NCT02401867.
Project description:BACKGROUND:Mobile phone based programs for kidney transplant recipients are promising tools for improving long-term graft outcomes and better managing comorbidities (eg, hypertension, diabetes). These tools provide an easy to use self-management framework allowing optimal medication adherence that is guided by the patients' physiological data. This technology is also relatively inexpensive, has an intuitive interface, and provides the capability for real-time personalized feedback to help motivate patient self-efficacy. Automated summary reports of patients' adherence and blood pressure can easily be uploaded to providers' networks helping reduce clinical inertia by reducing regimen alteration time. OBJECTIVE:The aim of this study was to assess the feasibility, acceptability, and preliminary outcomes of a prototype mobile health (mHealth) medication and blood pressure (BP) self-management system for kidney transplant patients with uncontrolled hypertension. METHODS:A smartphone enabled medication adherence and BP self-management system was developed using a patient and provider centered design. The development framework utilized self-determination theory with iterative stages that were guided and refined based on patient/provider feedback. A 3-month proof-of-concept randomized controlled trial was conducted in 20 hypertensive kidney transplant patients identified as non-adherent to their current medication regimen based on a month long screening using an electronic medication tray. Participants randomized to the mHealth intervention had the reminder functions of their electronic medication tray enabled and received a bluetooth capable BP monitor and a smartphone that received and transmitted encrypted physiological data and delivered reminders to measure BP using text messaging. Controls received standard of care and their adherence continued to be monitored with the medication tray reminders turned off. Providers received weekly summary reports of patient medication adherence and BP readings. RESULTS:Participation and retention rates were 41/55 (75%) and 31/34 (91%), respectively. The prototype system appears to be safe, highly acceptable, and useful to patients and providers. Compared to the standard care control group (SC), the mHealth intervention group exhibited significant improvements in medication adherence and significant reductions in clinic-measured systolic blood pressures across the monthly evaluations. Physicians made more anti-hypertensive medication adjustments in the mHealth group versus the standard care group (7 adjustments in 5 patients versus 3 adjustments in 3 patients) during the 3-month trial based on the information provided in the weekly reports. CONCLUSIONS:These data support the acceptability and feasibility of the prototype mHealth system. Further trials with larger sample sizes and additional biomarkers (eg, whole blood medication levels) are needed to examine efficacy and effectiveness of the system for improving medication adherence and blood pressure control after kidney transplantation over longer time periods. TRIAL REGISTRATION:Clinicaltrials.gov NCT01859273; http://clinicaltrials.gov/ct2/show/NCT01859273 (Archived by WebCite at http://www.webcitation.org/6IqfCa3A3).
Project description:<h4>Importance</h4>Increasing participation in fecal screening tests is a major challenge in countries that have implemented colorectal cancer (CRC) screening programs.<h4>Objective</h4>To determine whether providing general practitioners (GPs) a list of patients who are nonadherent to CRC screening enhances patient participation in fecal immunochemical testing (FIT).<h4>Design, setting, and participants</h4>A 3-group, cluster-randomized study was conducted from July 14, 2015, to July 14, 2016, on the west coast of France, with GPs in 801 practices participating and involving adult patients (50-74 years) who were at average risk of CRC and not up-to-date with CRC screening. The final follow-up date was July 14, 2016.<h4>Interventions</h4>General practitioners were randomly assigned to 1 of 3 groups: 496 received a list of patients who had not undergone CRC screening (patient-specific reminders group, 10 476 patients), 495 received a letter describing region-specific CRC screening adherence rates (generic reminders group, 10 606 patients), and 455 did not receive any reminders (usual care group, 10 147 patients).<h4>Main outcomes and measures</h4>The primary end point was patient participation in CRC screening 1 year after the intervention.<h4>Results</h4>Among 1482 randomized GPs (mean age, 53.4 years; 576 women [38.9%]), 1446 participated; of the 33 044 patients of these GPs (mean age, 59.7 years; 17 949 women [54.3%]), follow-up at 1 year was available for 31 229 (94.5%). At 1 year, 24.8% (95% CI, 23.4%-26.2%) of patients in the specific reminders group, 21.7% (95% CI, 20.5%-22.8%) in the generic reminders group, and 20.6% (95% CI, 19.3%-21.8%) in the usual care group participated in the FIT screening. The between-group differences were 3.1% (95% CI, 1.3%-5.0%) for the patient-specific reminders group vs the generic reminders group, 4.2% (95% CI, 2.3%-6.2%) for the patient-specific reminders group vs the usual care group, and 1.1% (95% CI, -0.6% to 2.8%) for generic reminders group vs the usual care group.<h4>Conclusions and relevance</h4>Providing French GPs caring for adults at average risk of CRC with a list of their patients who were not up-to-date with their CRC screening resulted in a small but significant increase in patient participation in FIT screening at 1 year compared with patients who received usual care. Providing GPs with generic reminders about regional rates of CRC screening did not increase screening rates compared with usual care.<h4>Trial registration</h4>clinicaltrials.gov Identifier: NCT02515344.
Project description: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 research for the Stories and Music for Adolescent/Young Adult Resilience during Transplant (SMART) study. SMART was an NIH-funded, multisite, randomized, behavioral clinical trial of a music therapy intervention for adolescents/young adults (AYA) undergoing stem cell transplant for an oncology condition. The study was conducted at 8 sites by a large multidisciplinary team that included direct care nurses, advanced practice nurses, and nurse researchers, as well as board-certified music therapists, clinical research coordinators, and physicians. Efforts to include direct care nurses in the conduct of this study fostered mutual respect across disciplines in both academic and clinical settings.
Project description:Over the past 30 years, adolescents and young adults (AYA, 15-39 years of age) with cancer have shown significantly less improvement in survival than younger and older patients. Because evidence suggests this may be related to their low participation in cancer clinical trials, increasing accrual to these trials has become a priority for closing this "AYA gap." This paper reviews data documenting low AYA enrollment, presents a conceptual framework for research and intervention (Clinical Trials Pathway to Enrollment) and summarizes recent developments in the United States National Cancer Institute-sponsored clinical trials enterprise that are expected to improve AYA enrollment, including the National Clinical Trials Network (NCTN) and expanded scientific collaboration between the Children's Oncology Group and adult NCTN groups. While time will be required for the effects of these changes to be fully realized, they offer a mechanism for facilitating the breadth of clinical/translational research needed for advancing AYA oncology and measuring its impact.
Project description:To evaluate the impact of clinician-targeted computer-generated reminders on compliance with HIV care guidelines in a resource-limited setting.We conducted this randomized, controlled trial in an HIV referral clinic in Kenya caring for HIV-infected and HIV-exposed children (<14 years of age). For children randomly assigned to the intervention group, printed patient summaries containing computer-generated patient-specific reminders for overdue care recommendations were provided to the clinician at the time of the child's clinic visit. For children in the control group, clinicians received the summaries, but no computer-generated reminders. We compared differences between the intervention and control groups in completion of overdue tasks, including HIV testing, laboratory monitoring, initiating antiretroviral therapy, and making referrals.During the 5-month study period, 1611 patients (49% female, 70% HIV-infected) were eligible to receive at least 1 computer-generated reminder (ie, had an overdue clinical task). We observed a fourfold increase in the completion of overdue clinical tasks when reminders were availed to providers over the course of the study (68% intervention vs 18% control, P < .001). Orders also occurred earlier for the intervention group (77 days, SD 2.4 days) compared with the control group (104 days, SD 1.2 days) (P < .001). Response rates to reminders varied significantly by type of reminder and between clinicians.Clinician-targeted, computer-generated clinical reminders are associated with a significant increase in completion of overdue clinical tasks for HIV-infected and exposed children in a resource-limited setting.
Project description:BACKGROUND:The Venous Thromboembolism Prophylaxis (VTE-PRO) randomized trial is a pilot study evaluating the impact of extended-duration prophylaxis on venous thromboembolic events in patients undergoing lung cancer resection. Enrolled VTE-PRO participants self-inject either low-molecular weight heparin or a saline placebo for 30?days postoperatively. Study outcomes include feasibility, incidence of venous thromboembolism, and venous thromboembolism-related morbidity and mortality. Initial analyses demonstrated low rates of accrual and retention for the VTE-PRO pilot. Therefore, the purpose of the current study was to develop a knowledge translation intervention to improve VTE-PRO pilot trial accrual and retention. METHODS:Eligible participants were surveyed to identify the barriers to VTE-PRO participation. The Theoretical Domains Framework was used to categorize these barriers. Barriers were mapped to the capabilities, opportunities, and behavior (COM-B) behavioral change wheel to identify potential interventions to support trial accrual and retention. The resulting knowledge translation intervention was titled Inform, Remind, Involve and Support to improve Accrual and Retention (IRIS-AR). Key informant interviews with patients were held to refine and confirm the validity of identified barriers and perceived acceptability of the proposed IRIS-AR intervention. Institutional Review Board approval was granted for this study. RESULTS:The resulting intervention included: information booklets and counseling sessions to identify unique participant challenges to trial participation (Inform); daily reminders to administer injections (Remind); involvement of family/caregivers in study processes (Involve); and leverage of an existing home-care nursing program to provide injection support when needed (Support). Twenty-six key informant participants were interviewed. The most common barriers to trial participation included lack of social support and fear of needle injection. Participants generally supported use of information booklets, involvement of family/caregivers, and support by a home-care nursing program; however, not all supported the use of daily reminders. CONCLUSION:Developed using theory and integrated knowledge translation, the IRIS-AR presents a patient-centered intervention that leverages existing programs to promote trial engagement. The proposed strategy can likely be adapted to improve compliance with other patient-directed interventions. TRIAL REGISTRATION:ClinicalTrials.gov, NCT02334007 . Registered on 8 January 2015.