Dataset Information

The effect of nurse practitioner (NP-led) care on health-related quality of life in people with multiple sclerosis - a randomized trial.

ABSTRACT:

Background

Care for People with Multiple Sclerosis (PwMS) is increasingly complex, requiring innovations in care. Canada has high rates of MS; it is challenging for general neurologists to optimally care for PwMS with busy office practices. The aim of this study was to evaluate the effects of add-on Nurse Practitioner (NP)-led care for PwMS on depression and anxiety (Hospital Anxiety and Depression Scale, HADS), compared to usual care (community neurologist, family physician).

Methods

PwMS followed by community neurologists were randomized to add-on NP-led or Usual care for 6 months. Primary outcome was the change in HADS at 3 months. Secondary outcomes were HADS (6 months), EQ5D, MSIF, CAREQOL-MS, at 3 and 6 months, and Consultant Satisfaction Survey (6 months).

Results

We recruited 248 participants; 228 completed the trial (NP-led care arm n = 120, Usual care arm n = 108). There were no significant baseline differences between groups. Study subjects were highly educated (71.05%), working full-time (41.23%), living independently (68.86%), with mean age of 47.32 (11.09), mean EDSS 2.53 (SD 2.06), mean duration since MS diagnosis 12.18 years (SD 8.82) and 85% had relapsing remitting MS. Mean change in HADS depression (3 months) was: -0.41 (SD 2.81) NP-led care group vs 1.11 (2.98) Usual care group p = 0.001, sustained at 6 months; for anxiety, - 0.32 (2.73) NP-led care group vs 0.42 (2.82) Usual care group, p = 0.059. Other secondary outcomes were not significantly different. There was no difference in satisfaction of care in the NP-led care arm (63.83 (5.63)) vs Usual care (62.82 (5.45)), p = 0.194).

Conclusion

Add-on NP-led care improved depression compared to usual neurologist care and 3 and 6 months in PwMS, and there was no difference in satisfaction with care. Further research is needed to explore how NPs could enrich care provided for PwMS in healthcare settings.

Trial registration

Retrospectively registered on clinicaltrials.gov ( ClinicalTrials.gov Identifier: NCT04388592 , 14/05/2020).

SUBMITTER: Smyth P

PROVIDER: S-EPMC9310450 | biostudies-literature |

REPOSITORIES: biostudies-literature

ACCESS DATA

Similar Datasets

Project description:BackgroundCanada has one of the highest rates of multiple sclerosis (MS) in the world. Treatments and supports for people with MS (PwMS) have become increasingly complex, requiring individualized and adaptive care. Specialized NPs provide advanced skills to those with complex medical conditions, with potential to enhance the health, functioning, and quality of life for PwMS. This study aims to determine the effect of a Nurse Practitioner (NP) on depression and anxiety levels in PwMS.MethodsWe will perform a parallel randomized controlled trial. PwMS who are followed by general private-practice neurologists will be randomly assigned to the intervention group (NP-led care) or the 'usual care' control group (general neurologist or family physician and registered nurse support). In the intervention group, the NP will assess and provide care to the MS patient and their caregiver at a baseline visit, with 3-month and 6-month follow-up visits. PwMS in the control group will receive usual care provided by their community neurologists or family physicians with the standard assistance provided by registered nurses experienced in MS care. The primary outcome will be the difference in change in the patient's anxiety and depression scores as measured by the validated Hospital Anxiety and Depression Scale (HADS) questionnaire at 3 months. Secondary outcomes will include difference in change in HADS at 6 months; Modified Fatigue Impact Scale scores (MSIF) at 3 and 6 months; EQ-5D scores at 3 and 6 months; caregiver health-related quality of life in MS measures (CAREQOL-MS) at 3 and 6 months; number of visits and phone calls to healthcare professionals recorded by patient, and satisfaction with NP-led care vs usual care measured by the validated Consultant Satisfaction Questionnaire.DiscussionFindings from this study will contribute to exploring benefits of advanced nursing practitioner interventions for PwMS followed by general neurologists and family physicians in a community setting. It will provide evidence of the benefits of NP-led care for PwMS and offer an alternative healthcare resource for management of MS.Trial registrationClinicalTrials.gov Pro00069595 . Retrospectively registered on June 26, 2020. Protocol version: January 2017, version 1.

Project description:Atrial fibrillation (AF) is a common arrhythmia associated with significant morbidity, mortality, and healthcare resource use. The prevalence of AF is increasing with a growing and aging population, and timely access to care for these patients is a concern. Nontraditional models of care delivery, such as nurse practitioner (NP)-led clinics, may improve access to care and quality of care, but they require formal assessment. The objective of this study is to assess the effect of NP-led care on the health-related quality of life (HRQoL) of adult patients with AF.We plan a randomized controlled trial comparing NP-led care vs. standard care. Inclusion criteria are ?18 years of age, documented nonvalvular AF, willingness to give informed consent, and capacity to complete questionnaires. Patients referred for electrophysiological intervention who are clinically unstable or unable to attend follow-up visits will not be eligible to participate. Patients will be asked for verbal consent during the initial triage phone call from the nurse. Randomization will occur via a secure website. The intervention includes an NP consult, including medical history, physical examination, patient teaching, treatment plan, and follow-up at 3 and 6 months. The control arm involves usual cardiologist consultation with follow-up determined by the cardiologist's practice pattern. The primary outcome will be the difference in change in Atrial Fibrillation Effect on Quality of Life Survey scores at 6 months between groups. Secondary outcomes will include difference in change of EQ-5D scores at 6 months between groups, difference in composite outcomes of death resulting from cardiovascular cause, hospitalizations and emergency department visits between groups, and satisfaction with NP-led care measured by the Consultant Satisfaction Questionnaire. A sample size of 70 per group will ensure adequate power despite a potential 10% loss to follow-up.Our study will determine the effect of NP-led AF care on HRQoL in patients with AF, as well as measure its impact on relevant outcomes such as death, hospitalization, and emergency department visits. Our findings may have implications for delivery of care to patients with AF.ClincalTrials.gov, NCT02745236 . Registered on 16 April 2016.

Project description:BackgroundThe shortage of primary care providers and the provisions of the Affordable Care Act (ACA) have spurred discussion about expanding the number, scope of practice (SOP), and independence of primary care nurse practitioners (NPs). Such discussions in the media and among professional organizations may insinuate that changes to the laws governing NP practice will engender acrimony between practicing physicians and NPs. However, we lack empirical, descriptive data on how practicing professionals view NP independence in primary care.ObjectiveThe aim of the present study was to explore and describe the attitudes about NP independence among physicians and NPs working in primary care.DesignA qualitative study based on the principles of grounded theory.ParticipantsThirty primary care professionals in Missouri, USA, including 15 primary care physicians and 15 primary care NPs.ApproachSemi-structured, in-depth interviews, with data analysis guided by grounded theory.Key resultsParticipants had perspectives that were not well represented by professional organizations or the media. Physicians were supportive of a wide variety of NP roles and comfortable with high levels of NP independence and autonomy. Physicians and NPs described prerequisites to NP independence that were complementary. Physicians generally believed that NPs needed some association with physicians for patient safety, and NPs preferred having a physician readily accessible as needed. The theme "knowing your limits" was important to both NPs and physicians regarding NP independence, and has not been described previously in the literature.ConclusionsNP and physician views about NP practice in primary care are not as divergent as their representative professional organizations and the news media would suggest. The significant agreement among NPs and physicians, and some of the nuances of their perspectives, supports recommendations that may reduce the perceived acrimony surrounding discussions of NP independent practice in primary care.