scholarly journals Low-touch, team-based care for co-morbidity management in cancer patients: the ONE TEAM randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Leah L. Zullig ◽  
Mohammad Shahsahebi ◽  
Benjamin Neely ◽  
Terry Hyslop ◽  
Renee A. V. Avecilla ◽  
...  
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Cancer Survivors ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Care Providers ◽  
Patient Level ◽  
Randomized Controlled ◽  
Team Based Care ◽  
To Receive

Abstract Background As treatments for cancer have improved, more people are surviving cancer. However, compared to people without a history of cancer, cancer survivors are more likely to die of cardiovascular disease (CVD). Increased risk for CVD-related mortality among cancer survivors is partially due to lack of medication adherence and problems that exist in care coordination between cancer specialists, primary care physicians, and cardiologists. Methods/Design The Onco-primary care networking to support TEAM-based care (ONE TEAM) study is an 18-month cluster-randomized controlled trial with clustering at the primary care clinic level. ONE TEAM compares the provision of the iGuide intervention to patients and primary care providers versus an education-only control. For phase 1, at the patient level, the intervention includes video vignettes and a live webinar; provider-level interventions include electronic health records-based communication and case-based webinars. Participants will be enrolled from across North Carolina one of their first visits with a cancer specialist (e.g., surgeon, radiation or medical oncologist). We use a sequential multiple assignment randomized trial (SMART) design. Outcomes (measured at the patient level) will include Healthcare Effectiveness Data and Information Set (HEDIS) quality measures of management of three CVD comorbidities using laboratory testing (glycated hemoglobin [A1c], lipid profile) and blood pressure measurements; (2) medication adherence assessed pharmacy refill data using Proportion of Days Covered (PDC); and (3) patient-provider communication (Patient-Centered Communication in Cancer Care, PCC-Ca-36). Primary care clinics in the intervention arm will be considered non-responders if 90% or more of their participating patients do not meet the modified HEDIS quality metrics at the 6-month measurement, assessed once the first enrollee from each practice reaches the 12-month mark. Non-responders will be re-randomized to either continue to receive the iGuide 1 intervention, or to receive the iGuide 2 intervention, which includes tailored videos for participants and specialist consults with primary care providers. Discussion As the population of cancer survivors grows, ONE TEAM will contribute to closing the CVD outcomes gap among cancer survivors by optimizing and integrating cancer care and primary care teams. ONE TEAM is designed so that it will be possible for others to emulate and implement at scale. Trial registration This study (NCT04258813) was registered in clinicaltrals.gov on February 6, 2020.

scholarly journals A Randomized Controlled Trial of the Effects of Online Pain Management Education on Primary Care Providers

Pain Medicine ◽  
2016 ◽  
pp. pnw271 ◽  
Author(s):  
Kimberlee J. Trudeau ◽  
Cristina Hildebrand ◽  
Priyanka Garg ◽  
Emil Chiauzzi ◽  
Kevin L. Zacharoff
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Pain Management ◽  
Management Education ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Care Providers ◽  
Randomized Controlled

scholarly journals The influence of a MOBile-based video Instruction for Low back pain (MOBIL) on initial care decisions made by primary care providers: a randomized controlled trial

2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Daniel I. Rhon ◽  
Rachel J. Mayhew ◽  
Tina A. Greenlee ◽  
Julie M. Fritz
Keyword(s):  
Primary Care ◽  
Randomized Controlled Trial ◽  
Low Back Pain ◽  
Back Pain ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Low Back ◽  
Care Providers ◽  
Randomized Controlled ◽  
Initial Care

Abstract Background Adherence to guidelines for back pain continues to be a challenge, prompting strategies focused on improving education around biopsychosocial frameworks. Objective Assess the influence of an interactive educational mobile app for patients on initial care decisions made for low back pain by the primary care provider. The secondary aim was to compare changes in self-reported pain and function between groups. Methods This was a randomized controlled trial involving patients consulting for an initial episode of low back pain. The intervention was a mobile video-based education session (Truth About Low Back Pain) compared to usual care. The app focused on addressing maladaptive beliefs typically associated with higher risk of receiving low-value care options. The primary outcome was initial medical utilization decisions made by primary care practitioners (x-rays, MRIs, opioid prescriptions, injections, procedures) and secondary outcomes included PROMIS pain interference and physical function subscales at 1 and 6 months, and total medical costs. Results Of 208 participants (71.2% male; mean age 35.4 years), rates of opioid prescriptions, advanced imaging, analgesic patches, spine injections, and physical therapy use were lower in the education group, but the differences were not significant. Total back-related medical costs for 1 year (mean diff = $132; P = 0.63) and none of the 6-month PROMIS subscales were significantly different between groups. Results were no different in opioid-naïve subjects. Instead, prior opioid use and high-risk of poor prognosis on the STarT Back Screening Tool predicted 1-year back pain-related costs and healthcare utilization, regardless of intervention. Conclusion Factors that influence medical treatment decisions and guideline-concordant care are complex. This particular patient education approach directed at patients did not appear to influence healthcare decisions made by primary care providers. Future studies should focus on high-risk populations and/or the impact of including the medical provider as an active part of the educational process. Trial Registration clinicaltrials.gov NCT02777983.

Documenting Patients’ and Providers’ Preferences When Proposing a Randomized Controlled Trial: A Qualitative Exploration

2021 ◽  
Author(s):  
Devesh Oberoi ◽  
Cynthia Kwok ◽  
Yong Li ◽  
Cindy Railton ◽  
Susan Horsman ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Study Design ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
Referral Letter ◽  
Care Providers ◽  
Randomized Controlled ◽  
Number Of Patients ◽  
Follow Up Care

Abstract Background With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we sought to explore patients’ and OPs’ reactions to our proposed recruitment methods. Methods We used a qualitative study design with content analysis, and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial. Results OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers. Conclusion OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials.

scholarly journals A randomized controlled trial to evaluate the effectiveness of an integrated engagement support system to facilitate patient use of digital diabetes prevention programs: a study protocol (Preprint)

2020 ◽  
Author(s):  
Katharine Lawrence ◽  
Danissa V Rodriguez ◽  
Dawn M Feldthouse ◽  
Donna Shelley ◽  
Jonathan L Yu ◽  
...  
Keyword(s):  
Primary Care ◽  
Patient Engagement ◽  
Diabetes Prevention ◽  
Digital Health ◽  
Controlled Trial ◽  
Primary Care Providers ◽  
User Centered Design ◽  
Care Providers ◽  
Randomized Controlled ◽  
Engagement System

BACKGROUND Digital diabetes prevention programs (dDPP) are effective behavior change tools to prevent disease progression in patients at risk for diabetes. Currently these programs are poorly integrated into existing health information technology (HIT) infrastructure and clinical workflows, resulting in barriers to provider-level knowledge, interaction, and support of patients who use dDPP. Tools that can facilitate patient-provider interaction around dDPP may contribute to improved patient engagement and adherence to these programs, as well as improved health outcomes. OBJECTIVE This study aims to utilize a rigorous, user-centered design methodology to develop a theory-driven system that supports patient engagement with dDPP and their primary care providers with their care. METHODS This study will be conducted in three phases. In phase 1, we will utilize systematic user-centered design, Agile software development, and qualitative research methods to identify “key user” (patients, providers, clinical staff, digital health technologists, content experts) requirements, constraints, and prioritization of high-impact features to design, develop, and refine a viable intervention prototype for the engagement system. In phase 2, we will conduct a single-arm feasibility pilot of the engagement system among patients with prediabetes and their primary care providers. In phase 3, we will conduct a two-arm randomized controlled trial utilizing the engagement system. Primary outcomes will be weight, BMI, and A1c at 6 and 12 months. Secondary outcomes will be patient engagement (utilization, activity) in dDPP. Mediator variables (self-efficacy, digital health literacy, patient-provider relationship) will be measured. RESULTS The project was initiated in 2018, and enrollment and data analysis are underway. First results are expected to be submitted for publication in early 2021. CONCLUSIONS Our findings will provide guidance for the design and development of technology to integrate dDPP platforms into existing clinical workflows. This will facilitate patient engagement in digital behavior change interventions and provider engagement in patients’ use of dDPP. Integrated clinical tools that can facilitate patient-provider interaction around dDPP may contribute to improved patient adherence to these programs, as well as improved health outcomes, by addressing barriers faced by both patients and providers. Further evaluation with pilot testing and a clinical trial will assess the effectiveness and implementation of these tools.

Sign in / Sign up

Export Citation Format

Share Document