Project description:BackgroundThe ongoing volatile opioid epidemic remains a significant public health concern, alongside continued outbreaks of HIV and hepatitis C virus among people who inject drugs. The limited access to and scale-up of medications for opioid use disorder (MOUD) among people who inject drugs, coupled with multilevel barriers to pre-exposure prophylaxis (PrEP) uptake, makes it imperative to integrate evidence-based risk reduction and HIV prevention strategies in innovative ways. To address this need, we developed an integrated rapid access to HIV prevention program for people who inject drugs (iRaPID) that incorporates same-day PrEP and MOUD for this population.ObjectiveThe primary objective of this pilot study is to assess the feasibility and acceptability of the program and evaluate its preliminary efficacy on PrEP and MOUD uptake for a future randomized controlled trial (RCT). We also aim to explore information on the implementation of the program in a real-world setting using a type I hybrid implementation trial design.MethodsUsing a type I hybrid implementation trial design, we are pilot testing the nurse practitioner-led iRaPID program while exploring information on its implementation in a real-world setting. Specifically, we will assess the feasibility and acceptability of the iRaPID program and evaluate its preliminary efficacy on PrEP and MOUD uptake in a pilot RCT. The enrolled 50 people who inject drugs will be randomized (1:1) to either iRaPID or treatment as usual (TAU). Behavioral assessments will occur at baseline, and at 1, 3, and 6 months. Additionally, we will conduct a process evaluation of the delivery and implementation of the iRaPID program to collect information for future implementation.ResultsRecruitment began in July 2021 and was completed in August 2022. Data collection is planned through February 2023. The Institutional Review Boards at Yale University and the University of Connecticut approved this study (2000028740).ConclusionsThis prospective pilot study will test a nurse practitioner-led, integrated HIV prevention program that incorporates same-day PrEP and MOUD for people who inject drugs. This low-threshold protocol delivers integrated prevention via one-stop shopping under the direction of nurse practitioners. iRaPID seeks to overcome barriers to delayed PrEP and MOUD initiation, which is crucial for people who inject drugs who have had minimal access to evidence-based prevention.Trial registrationClinicalTrials.gov NCT04531670; https://clinicaltrials.gov/ct2/show/NCT04531670.International registered report identifier (irrid)DERR1-10.2196/42585.
Project description:A new strategy for oncology care delivery that includes increasing the numbers and expanding the roles of nonphysician practitioners is critically important to meet the current and potential cancer care needs of the US population.
Project description:The "nurse-led" oral and maxillofacial (OMFS) head and neck (H&N) clinic has been introduced and developed over the last decade, and we are now close to a point that this endeavour can potentially be implemented nationwide. This paper is a systematic review of the proposed OMFS H&N nurse-led clinic model. Literature on the topic is limited: only eight eligible papers were identified and reviewed. These were appraised focusing on four domains: requirement/necessity, true cost, patient safety and outcomes, and education and training. Most of the advantages/proposed benefits of these clinics have previously been discussed. This current review has revealed that the available published evidence on the concept of OMFS H&N nurse-led clinics demonstrates that they might not be necessary. The alleged cost savings have not been described in detail and might not be as significant as expected, more intense collaboration is required to establish watertight quality assurance processes concerning patient safety, and the clinics might have an impact on the education and training of OMFS trainees. The nurse-led clinic concept is interesting and exciting, but more discussion and planning is needed prior to it being launched nationwide.
Project description:PurposeThe purpose of this feasibility study was to improve and implement an intervention aimed at enhancing medication adherence in sub-optimally controlled and non-adherent type 2 diabetes (T2DM) patients in primary care.MethodsFour phases were completed: (1) context analysis, (2) collaboration protocol development, (3) digitalization, and (4) process evaluation. Two community pharmacies and seven general practices participated. In phase 1, two focus groups were conducted, of which one with healthcare providers (HCP, N = 5) and one with patients (N = 11). In phase 4, four semi-structured interviews and one focus group (N = 6) were conducted with healthcare providers. The goal of these focus groups and interviews was to obtain insights into current care to support medication adherence (phase 1), opportunities for collaboration (phase 2) and process evaluation (phase 4). Data were analyzed in Atlas.ti using thematic analyses.ResultsBoth T2DM patients and HCPs considered medication adherence vital. Suboptimal collaboration between HCPs and unreliable ways to monitor medication non-adherence appeared important barriers for adequate care to support medication adherence (phase 1). The nurse practitioner (NP) was chosen as the interventionist with supportive roles for other HCPs (phase 2). All components of the intervention were digitalized (phase 3). The implementation of the digitalized intervention was reported to be suboptimal (phase 4). Main reasons were that pharmacy refill data were unreliable, NPs experienced difficulties addressing medication non-adherence adequately and collaboration between HCPs was suboptimal.ConclusionsThe medication adherence enhancing intervention was successfully digitalized, but implementation of the digitalized intervention appeared not feasible as of yet.
Project description:ObjectiveTo measure the effect of nurse practitioner and pharmacist consultations on the appropriate use of medications by patients.DesignWe studied patients in the intervention arm of a randomized controlled trial. The main trial intervention was provision of multidisciplinary team care and the main outcome was quality and processes of care for chronic disease management.SettingPatients were recruited from a single publicly funded family health network practice of 8 family physicians and associated staff serving 10 000 patients in a rural area near Ottawa, Ont.ParticipantsA total of 120 patients 50 years of age or older who were on the practice roster and who were considered by their family physicians to be at risk of experiencing adverse health outcomes.InterventionA pharmacist and 1 of 3 nurse practitioners visited each patient at his or her home, conducted a comprehensive medication review, and developed a tailored plan to optimize medication use. The plan was developed in consultation with the patient and the patient's doctor. We assessed medication appropriateness at the study baseline and again 12 to 18 months later.Main outcome measuresWe used the medication appropriateness index to assess medication use. We examined associations between personal characteristics and inappropriate use at baseline and with improvements in medication use at the follow-up assessment. We recorded all drug problems encountered during the trial.ResultsAt baseline, 27.2% of medications were inappropriate in some way and 77.7% of patients were receiving at least 1 medication that was inappropriate in some way. At the follow-up assessments these percentages had dropped to 8.9% and 38.6%, respectively (P < .001). Patient characteristics that were associated with receiving inappropriate medication at baseline were being older than 80 years of age (odds ratio [OR] = 5.00, 95% CI 1.19 to 20.50), receiving more than 4 medications (OR = 6.64, 95% CI 2.54 to 17.4), and not having a university-level education (OR = 4.55, 95% CI 1.69 to 12.50).ConclusionWe observed large improvements in the appropriate use of medications during this trial. This might provide a mechanism to explain some of the reductions in mortality and morbidity observed in other trials of counseling and advice provided by pharmacists and nurses.Trial registration numberNCT00238836 (ClinicalTrials.gov).
Project description:Purpose: To determine the impact of a pharmacist-driven medication therapy management (MTM) program for patients receiving oral chemotherapy agents. Methods: We assessed the impact of MTM consultations with a pharmacist for patients who were receiving a new prescription for an oral chemotherapy agent. Data were assessed for outcomes including (1) number of medication errors identified in electronic medical records (EMRs), (2) number of interventions performed by the pharmacist, (3) time spent on the MTM process, and (4) patient satisfaction. Data were compared between patients who received their oral chemotherapy agents from the onsite specialty pharmacy or from a mail-order pharmacy. The data were also examined for correlations, and logistic regression was utilized to determine the largest variant cofactor to create an equation for estimating the number of errors in a patient's EMR. Results: Fifteen patients received an MTM consultation, and the pharmacists identified an average of 6 medication EMR errors per patient. There was an average of 3 pharmacist-led interventions per patient. Multiple significant correlations were noted between the variables: (1) total number of prescriptions a patient was taking, (2) total number of medication errors identified, (3) time spent on the MTM process, and (4) total number of interventions performed by the pharmacist. Patient satisfaction was favorable for the program. Conclusion: The implementation of a pharmacist-driven MTM program for patients receiving a prescription for an oral chemotherapy agent had a significant impact on patient care by improving medication reconciliation, identifying drug-related problems, and strengthening pharmacist-patient interactions in the oncology clinic.
Project description:National guidance for England recommends that cardiovascular disease (CVD) should be managed as a family of diseases in the community. Here, we describe the results of such an approach.Patients with established CVD or who were at high multifactorial risk (HRI) underwent a 12-week community-based nurse-led prevention programme (MyAction) that included lifestyle and risk factor management, prescription of medication and weekly exercise and education sessions.Over a 6-year period, 3232 patients attended an initial assessment; 63% were male, and 48% belonged to black and minority ethnic groups. 56% attended an end-of-programme assessment, and 33% attended a one year assessment. By the end of the programme, there was a significant reduction in smoking prevalence but only in HRI (-3.7%, p<0.001). Mediterranean diet score increased in both CVD (+1.2, p<0.001) and HRI (+1.5; p<0.001), as did fitness levels (CVD +0.8 estimated Mets maximum, p<0.001, HRI +0.9 estimated Mets maximum, p<0.001) and the proportions achieving their physical activity targets (CVD +40%, p<0.001, HRI +37%, p<0.001). There were significant increases in proportions achieving their blood pressure (CVD +15.4%, p<0.001, HRI +25%, p<0.001 and low-density lipoprotein cholesterol targets (CVD +6%, p=0.004, HRI +23%, p<0.001). Statins and antihypertensive medications significantly increased in HRI. Significant improvements in depression scores and quality-of-life measures were also seen. The majority of improvements were maintained at 1 year.These results demonstrate that an integrated vascular prevention programme is feasible in practice and reduces cardiovascular risk in patients with established CVD and in those at high multifactorial risk.
Project description:ImportanceGuidelines recommend early specialty palliative care for all patients with advanced cancer, but most patients lack access to such services.ObjectiveTo assess the effect of CONNECT (Care Management by Oncology Nurses to Address Supportive Care Needs), a primary palliative care intervention delivered by oncology nurses, on patient outcomes.Design, setting, and participantsThis cluster randomized clinical trial of the CONNECT intervention vs standard care was conducted from July 25, 2016, to October 6, 2020. Participants were adult patients with metastatic solid tumors who were undergoing oncological care and for whom an oncologist would agree with the statement "would not be surprised if the patient died in the next year." The trial was conducted at 17 community oncology practices in western Pennsylvania. Data analyses adhered to the intention-to-treat principle.InterventionsThe CONNECT intervention included 3 monthly visits with an existing infusion room nurse who was trained to address symptoms, provide emotional support, engage in advance care planning, and coordinate care.Main outcomes and measuresThe primary outcome was quality of life. At baseline and 3 months, participants completed assessments of quality of life (Functional Assessment of Chronic Illness Therapy-Palliative care: score range, 0-184, with higher scores indicating better quality of life), symptom burden (Edmonton Symptom Assessment Scale: score range, 0-90, with higher scores indicating greater symptom burden), and mood symptoms (Hospital Anxiety and Depression Scale [HADS]: score range, 0-21, with higher scores indicating substantial anxiety and depression). Linear mixed-effects models were used to estimate adjusted mean differences in 3-month outcomes. Preplanned, intensity-adjusted analyses were conducted.ResultsA total of 672 patients were enrolled (mean [SD] age, 69.3 [10.2] years; 360 women [53.6%]). The mean (SD) number of CONNECT visits completed was 2.2 (1.0). At 3 months, no difference in mean (SD) quality-of-life score was found between the CONNECT and standard care groups (130.7 [28.2] vs 134.1 [28.1]; adjusted mean difference, 1.20; 95% CI, -2.75 to 5.15; P = .55). Similarly, there was no difference between groups in 3-month mean (SD) symptom burden (23.2 [16.6] vs 24.0 [16.1]; adjusted mean difference, -2.64; 95% CI, -5.85 to 0.58; P = .11) or mood symptoms (HADS depression subscale score: 5.1 [3.4] vs 4.8 [3.7], adjusted mean difference, -0.08 [95% CI, -0.71 to 0.57], P = .82; HADS anxiety subscale score: 5.7 [3.9] vs 5.4 [4.2], adjusted mean difference, -0.31 [95% CI, -0.96 to 0.33], P = .34). Intensity-adjusted analyses revealed a larger estimated treatment effect for patients who received a full dose (3 visits) of the CONNECT intervention.Conclusions and relevanceThis cluster randomized clinical trial found that a primary palliative care intervention that was delivered by oncology nurses did not improve patient-reported outcomes at 3 months. Primary palliative care interventions with a higher dose intensity may be beneficial for most patients with advanced cancer who lack access to palliative care specialists.Trial registrationClinicalTrials.gov Identifier: NCT02712229.
Project description:The progress made over the past 50 years in disease-directed clinical trials has significantly increased cure rates for children and adolescents with cancer. The Children's Oncology Group (COG) is now conducting more studies that emphasize improving quality of life for young people with cancer. These types of clinical trials are classified as cancer control (CCL) studies by the National Cancer Institute and require different resources and approaches to facilitate adequate accrual and implementation at COG institutions. Several COG institutions that had previously experienced problems with low accruals to CCL trials have successfully implemented local nursing leadership for these types of studies. Successful models of nurses as institutional leaders and "champions" of CCL trials are described.
Project description:AimTo assess randomized controlled trials evaluating the impact of nurse practitioner-led cardiovascular care.BackgroundSystematic review of nurse practitioner-led care in patients with cardiovascular disease has not been completed.DesignSystematic review and meta-analysis.Data sourcesThe Cochrane Central Register of Controlled Trials (CENTRAL), Medline, Embase, CINAHL, Web of Science, Scopus and ProQuest were systematically searched for studies published between January 2007 - June 2017.Review methodsCochrane methodology was used for risk of bias, data extraction and meta-analysis. The quality of evidence was assessed using Grading of Recommendations Assessment, Development and Evaluation approach.ResultsOut of 605 articles, five articles met the inclusion criteria. There was no statistical difference between nurse practitioner-led care and usual care for 30-day readmissions, health-related quality of life and length of stay. A 12% reduction in Framingham risk score was identified.ConclusionThere are a few randomized control trials assessing nurse practitioner-led cardiovascular care.ImpactLow to moderate quality evidence was identified with no statistically significant associated outcomes of care. Nurse practitioner roles need to be supported to conduct and publish high-quality research.