Clinical trial NCT04388592: The Effect of Nurse Practitioner (NP-led) Care Upon Mood in People With Multiple Sclerosis
Official title: MS Wellness Navigator: The Effect of Nurse Practitioner (NP-led) Care on Mood, Anxiety and Health Related Quality of Life in People With Multiple Sclerosis - A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Nurse's Role
Keywords: multiple sclerosis
nurse's role
depression and anxiety
quality of life
patient satisfaction
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: University Hospital Foundation
First posted: 2020-05-14
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A parallel prospective randomized controlled trial with two equal groups, testing for superiority, with the patient as the unit of randomization.
Primary purpose: SUPPORTIVE_CARE

Brief summary: MS is the leading cause of non-traumatic disability in young adults. Canada and Alberta, have the highest prevalence of people with multiple sclerosis (PwMS) in the world. To keep PwMS as functional as possible, a multi-disciplinary team is considered essential in the approach to treating people with MS. Because of the high numbers of PwMS in Northern Alberta, private-practice general neurologists provide care to a large number of PwMS outside of a multi-disciplinary tertiary care setting. It is challenging for these general neurologists with busy office practices to deliver optimal care to PwMS who have high care needs. The investigators wish to evaluate the effects of nurse practitioner (NP) led care for PwMS on their depression and anxiety levels at 3 and 6 months compared to "usual care' (community neurologists and MS registered nurses) in addition to measuring quality of life for PwMS and their caregivers, fatigue levels, monitor their outpatient healthcare usage and patient's satisfaction of care provided. The investigators wish to conduct a prospective randomized controlled trial examining NP intervention care for PwMS. It is hypothesized that PwMS whose care is managed by an NP will have less depression and anxiety (as measured by the Hospital Anxiety and Depression Scale - HADS) at 3 months.

Detailed description: Background:

MS is the leading cause of non-traumatic disability in young adults. It is most commonly diagnosed in people between the ages of 20 to 50, causing visible and invisible disability that limits functioning and progresses over time. Canada has one of the highest prevalence of MS in the world; Alberta has the highest rate of MS in Canada (340/100 000 population). Having MS is associated with significant economic, physical and psychological burdens on the individual with corresponding burden upon society.

Global approach to treating and supporting PwMS has become multidisciplinary, multi-pronged and increasingly complex; MS impacts a person's physical, psychological and social well-being. Despite advances in healthcare for PwMS in the 21st century, multiple studies have reported a number of unmet care needs for PwMS: in areas of healthcare delivery, education, counselling and psychological support, and in supporting their informal caregivers. Recently, a study of over 1000 PwMS, reported that a higher number of reported health and social care-related unmet needs predicted lower health related quality of life, with all domains of the EQ5D-3L as being important.

PwMS prefer multidisciplinary care, recommended as essential by international multiple sclerosis experts. It has been reported that NPs are well-placed providers for PwMS, with their expertise in chronic disease management and quality of life approach. A recent integrative review identified three themes to the role of the MS nurse specialist: (1) longitudinal care co-coordinator; (2) care provider; and (3) expert resource. In one questionnaire study, PwMS indicated that they preferred contacting the specialized MS nurse above other health professionals. In addition, having NPs to enhance the multi-disciplinary team could potentially provide healthcare cost-savings: in the United States, NP-led care was reported to be cost-saving in comparison to physician-led care.

Private-practice general neurologists and family doctors provide care to approximately 2000 PwMS outside of a tertiary multi-disciplinary clinic setting with a wide catchment area extending across Central and Northern Alberta, Northern BC, Saskatchewan and Northwest Territories. It is challenging for general neurologists and family doctors to balance care of PwMS with the pressures of busy office practices in a fee-for-service setting.

There have been few controlled randomized trials comparing NP-led care vs usual care for people with chronic diseases. One demonstrated clear benefits of NP involvement in managing people with chronic pain, reporting better pain control, coping, and use of pain medication by those followed by an NP, while another trial reported better outcomes for people with Parkinson's disease randomized to multidisciplinary team care with an NP vs care by a general neurologist. The investigators wish to follow a similar protocol to Smigorowsky et al, who studied the impact of NP-led care for people with atrial fibrillation.

The study's aim is to evaluate the effects of NP-led care for PwMS on their depression and anxiety levels at 3 months and 6 months compared to 'usual care' (community neurologists' care and MS registered nurses), in addition to measuring quality of life for PwMS and their caregivers, fatigue levels, outpatient healthcare visits and phone calls, and to measure patients' satisfaction of the care provided.

Design: The investigators will conduct a prospective randomized controlled trial with two equal groups. It is hypothesized that PwMS whose care is managed by an NP would have less depression and anxiety (as measured by the Hospital Anxiety and Depression Scale - HADS) at 3 months.

The randomized controlled trial will be conducted in a distributed, outreach model, in the offices of seven community neurologists who follow PwMS as a part of their general neurology private practices. Family doctors will be able to refer patients with MS directly to the NP, if not followed by any neurologist, through the MS clinic referral process already established. The research team will randomize consented participants who meet inclusion criteria on a 1:1 ratio on a centralized secure website.

Participants will be randomized to NP intervention of providing care for 6 months vs usual care provided by their regular neurologist, a MS registered nurse or their family doctors.

3.10 Primary and Secondary Outcomes: The primary outcome will be the difference in change in HADS-D and HADS-A scores between intervention and control groups at 3 months. Secondary outcomes will include difference in change in: (a) HADS-D and HADS-A scores at 6 months; (b) Euro Quality of Life 5D (EQ5D) at 3 and 6 months; (c) Modified Fatigue Impact Scale (MFIS) score at 3 and 6 months; CAREQOL-MS - caregiver health-related quality of life in MS questionnaire for those participant caregivers, who agree to participate in a questionnaire at baseline, 3 months and 6 months, and number of healthcare outpatient visits/interactions during the study period.

Participants' satisfaction with the level of care provided to them will be measured at 6 months using a validated Consultant Satisfaction Questionnaire (CSQ).

3.11 Recruitment, consent and data collection: Recruitment will be done through a few methods, due to potential participants being recruited from various community neurologists' offices and family doctors' practices in Northern Alberta: (1)There are seven community neurologists who will participate in recruitment through their practices. (2) PwMS who are followed primarily by a family physician will be referred by their family physicians directly to the NP via the tertiary MS Clinic fax (3) Caregivers will be approached through the PwMS, if the PwMS consents to participating in the study. After informed consent, PwMS and their informal caregivers (where applicable) will be invited to complete the questionnaires (HADS-D/HADS-A, EQ5D, MSIF, CAREQOL-MS at baseline, 3 months and 6 months with a participant diary of outpatient visits and phone calls with healthcare providers submitted at 3 and 6 months, and a consultant satisfaction questionnaire completed at 6 months. The questionnaires will take around 10 to 15 minutes each time to complete.

3.12 Sample Size: Using the information from Honarmand and Feinstein \[Baseline scores and standard deviation (SD)\], and the following assumptions 90% power and a two-sided alpha of 0.05, a total sample size of 200 (100 in each group) will be required to detect 1.5 difference between the intervention and the control groups.

3.14 Statistical Analyses: Data analysis will be performed. Categorical variables will be reported using frequency and percentage and continuous variables will be reported using mean (SD) or median \[Interquartile range (IQR)\] as appropriate. Univariable analysis will be conducted to determine if there was a statistical significance between the outcomes from baseline to three months and six months, respectively. All test assumptions will be checked during the data analysis process. Independent T-test will be used to assess the primary (HADS-D and HADS-A at 3 months) and secondary outcomes (HADS-D and HADS-A at 6 months, EQ5D, and MFIS). The consultant satisfaction survey will be analyzed as continuous variables, with the overall satisfaction score being calculated as a sum of the scales of each question.

3.15 Validity and Reliability: The questionnaires used in the study have been tested for validity and reliability in studies involving PwMS. Three papers report total HADS scores in PwMS.The EQ5D quality of life measure is commonly used in the MS population, and the MSIF is a standard measurement of fatigue in MS, as has the CAREQOL-MS, a caregiver quality of life survey for those caring for PwMS. Satisfaction with healthcare provider care will be measured by the overall mean score of the consultation satisfaction questionnaire (CSQ) completed at the 6 month follow-up visit. The CSQ is a self-administered tool with 18 questions using a 5-point Likert scale, ranging from strongly agree to strongly disagree. It measures 3 factors of the healthcare provider interaction: (1) professional aspects; (2) depth of patient relationship with provider; and (3) perceived length of consultation. Higher scores indicate higher satisfaction. We will reduce biases through using objective measures to examine the effects of NP-led care intervention. It is impossible to blind the participants for the intervention. It is important that all participants are offered NP intervention to minimize bias from those in either the intervention or control arm, by having those participants randomized to the control arm being seen by the NP at 6 months, after their involvement in the study has concluded. That way, all participants in the study are offered appointment with the NP, either within 4 weeks for the intervention arm vs at 6 months for the control arm.

3.16 Ethical considerations: The research protocol was reviewed and approved by the Health Research Ethics Board of the University of Alberta.(approval number Pro00069595) PwMS will be able to be referred to the NP by community neurologists and family doctors outside of participating in the study, if they decline to participate in the study.

3.17 Conclusion: To the investigators' knowledge, there have been no studies examining effects of NP-intervention of care for PwMS in a prospective, randomized and controlled clinical trial. Findings of this study will contribute to ways in which the multi-disciplinary care for PwMS and their caregivers could be enhanced by the addition of a specialized NP to aid general community neurologist practices in care delivery to PwMS outside of tertiary MS clinic settings. This study will evaluate the effects of nurse practitioner intervention depression and anxiety levels in PwMS and their informal caregivers. The evidence gained from this study will provide information on how nurse practitioners enhance the care and potentially resolve identified unmet needs for PwMS when introduced as part of a multi-disciplinary team approach for general neurologists working in a distributed community setting.

Eligibility criteria: Inclusion Criteria:

* \>/= 18 years of age
* a MS diagnosis (by 2010 MacDonald MS criteria (Polman et al 2011)
* Followed by a private-practice general neurologist and/or family doctor in the Northern Alberta region
* Willingness to give consent
* Ability to complete questionnaires
* Willingness to attend outpatient visits with NP
* English-speaking
* Were able to use a computer
* Initially, we limited inclusion to those who are experiencing disability from their MS (Expanded Disability status Scale (EDSS) 3.0 to 8.5 . In 2018, due to poor recruitment, the inclusion criteria were opened to include any PwMS and was not limited to disability level.

Exclusion Criteria:

* Under the age of 18 years old
* Unable to provide consent
* Unable to attend appointments with the NP
* Did not speak English
* Referred to or followed by neurologists within the tertiary University MS clinic setting
* Those who had central nervous system inflammatory disorders other than MS

Primary outcomes:
measure: Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores
timeFrame: 3 months
Secondary outcomes:
measure: Difference in Change in Hospital Anxiety & Depression Scale - Depression (HADS-D) and Hospital Anxiety & Depression Scale-Anxiety (HADS-A) scores
timeFrame: 6 months
measure: Difference in Change in Euro Quality of Life Measurement (EQ5D)
timeFrame: 3 and 6 months
measure: Difference in Change Modified Fatigue Impact Scale (MFIS) score
timeFrame: 3 and 6 months
measure: Qualitative Consultant Satisfaction Questionnaire (CSQ)
timeFrame: 6 months
measure: Difference in Change in Caregiver Health-Related Quality of Life in MS (CAREQOL-MS)
timeFrame: 3 and 6 months
measure: Number of Participant Outpatient Healthcare Interactions/Visits
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Penelope Smyth, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alberta
name: Ross Tsuyuki, PharmD, MSc
role: PRINCIPAL_INVESTIGATOR
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