Using Patient-Reported Outcomes To Improve the Care of People With Multiple Sclerosis: A Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 1
- 主要终点
- Difference in Change in Depression score in the Hospital Anxiety and Depression Scale (HADS-D) scores
研究概览
简要总结
The proposed trial is a prospective, randomized (1:1) trial plan examining whether more routine and frequent measurement of Patient Related Outcome Measures (PROMs) in the care of patients with MS improves patient depression and anxiety outcomes in addition to patient care satisfaction. The investigators plan to randomize people with MS (PwMS) to an intensive arm of filling out patient reported outcome measures every 6 months, with communication to their neurologist about their scores, versus a control arm, where participants fill out patient reported outcomes less frequently (annually) and their scores are not released to their MS Clinic/Neurologist. The primary outcome is to see if more frequent PROM completion leads to less depression and anxiety for people with MS. The investigators also plan to measure their satisfaction of care with their MS Clinic/neurologist and satisfaction in a shared decision-making process.
Whether this improves care in patients with MS is currently unknown, and the investigators want to explore this with the current study. The investigators plan to randomize people with MS (PwMS) to an intensive arm of filling out patient reported outcome measures every 6 months, with communication to their neurologist about their scores, versus a control arm, where participants fill out patient reported outcomes less frequently (annually) and their scores are not released to their MS Clinic/Neurologist. The primary outcome is to see if more frequent PROM completion leads to less anxiety for people with MS. The investigators also plan to measure their satisfaction of care with their MS Clinic/neurologist and satisfaction in a shared decision-making process.
详细描述
Multiple sclerosis (MS) is a disease that can affect physical, cognitive, psychological, and social functioning. Patient reported outcomes measures (PROMs) are playing an increasingly important role in healthcare as they give patients the opportunity to describe the quality and the impact of care from their perspective in a consistent and systematic way. PROMs are important in optimizing the management of people with MS (PwMS) in providing the patient's perspective of their disease. Additionally, use of PROMs between clinic visits could provide real-time information about how well patients are doing between visits, in a disease with episodic disability and with symptoms that fluctuate over time. Electronic data capture could help overcome these difficulties, as patients will have the flexibility to provide the information from anywhere and the data will automatically be saved in an electronic database that can be accessed anytime by patients and their healthcare providers. This will allow patients to be fully informed about their condition, be more engaged in their care, track their progress, and receive any notifications or alerts regarding their care. It will also allow healthcare providers to systematically track the patient's progress, better prepare for their visit and provide care based on their individual needs - the epitome of patient-centred care. Even though such information could help clinicians provide patient-centred care and patients track their progress, it is not collected on a routine basis during clinical care due to time limitations, and system issues within clinics amongst other factors.
The investigators' objective is to evaluate the impact of the systematic and more frequent use of PROMs in PwMS on depression and anxiety levels and satisfaction with care.
The investigators will be conducting a randomized controlled trial with the participant as the unit of randomization. They will include PwMS (relapsing-remitting, secondary progressive, primary progressive, etc.) who are being managed by an Alberta-based neurologist in the Northern and Central regions. Recruited participants will be randomized 1:1 to an interventional group or a control group. The interventional group will complete PROM questionnaires at baseline, 6 months, and 12 months in addition to their treating neurologist alerted to and having access to their questionnaire results and text response to the question "What are the top 3 things you would like your MS Neurologist to know about you right now?"; the control group will complete PROM questionnaires at baseline and at 12 months, and while their neurologist will be able to view their text response to the question "What are the top 3 things you would like your MS Neurologist to know about you right now?", the neurologist will not have routine access to their PROM questionnaire results.
All participants will be asked to complete the following validated PROMs questionnaires at intervals designated by their assigned experimental group:
- Hospital Anxiety and Depression Scale (HADS) score
- Quality of Life as measured by EuroQol Five-Dimensions (EQ5D) questionnaire
- Fatigue as measured by Modified Fatigue Impact Scale (MFIS)
- The Patient Determined Disease Steps (PDDS)
- Patient Health Questionnaire-9 (PHQ-9)
- Open ended text response to (limit 280 characters) "What are the top 3 things you would like your MS Neurologist to know about you right now?"
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The participants will know if they have been randomized to the intensive arm or the control arm, by whether they are completing PROMs every 6 months versus 1 year. The treating neurologists will know which arm their patients are enrolled into by whether they receive all PROM measurements every 6 months on their patients versus solely a text response of the "top 3 things their patient would like their neurologist to know" at that time.
Data analysis will be anonymized and aggregated for the research team in analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persons with multiple sclerosis [relapsing-remitting, secondary progressive, primary progressive, etc.] being managed by a Northern or Central Alberta-based neurologist.
- •Able/willing to complete informed consent and the questionnaires.
- •Able to use a computer.
- •Greater or equal to the age of 18 years old.
- •English-speaking.
排除标准
- •Unwilling/unable to provide consent.
- •Unwilling/unable to complete the questionnaires.
- •Does not speak English.
- •Under the age of
- •Has a central nervous system inflammatory disorder other than MS.
- •PwMS not being managed by the participating neurologist (a neurologist practicing in Northern and Central Alberta).
研究组 & 干预措施
Intensive PROMs Intervention Arm
The intervention group will be asked to complete PROM questionnaires at baseline, 6 months, and 12 months via an online web-based delivery system. The treating neurologist will be prompted to view the text response to the 3-item prompt in addition to the PROM questionnaire scores for participants in the interventional group. Treating neurologist will also be alerted if participates reach certain critical threshold scores or decrement on their PROM questionnaires. Participants randomized to the intervention group will be asked to complete CSQ and CollaboRATE questionnaires at baseline and at 12 months.
干预措施: Intensive Use of Patient Reported Outcome Measures and Open PROM Availability to Treating Neurologist (Other)
Control Arm
The control group will be asked to complete PROM questionnaires at baseline and 12 months via an online web-based delivery system. The treating neurologist will only be prompted to view the text response to the 3-item prompt, and will not be able to access the PROM questionnaire scores for participants in the control group (unless critical values are reached on questionnaires - see below). Treating neurologist will also be alerted if participates reach certain critical threshold scores or decrement on their PROM questionnaires. Participants randomized to the intervention group will be asked to complete CSQ and CollaboRATE questionnaires at baseline and at 12 months.
干预措施: Conservative Use of Patient Reported Outcome Measures and Blinded PROM Availability to Treating Neurologist (Other)
结局指标
主要结局
Difference in Change in Depression score in the Hospital Anxiety and Depression Scale (HADS-D) scores
时间窗: 12 months
Hospital Anxiety \& Depression Scale (D subcategory for depression levels, A subcategory for anxiety levels). This is a common depression and anxiety measurement instrument used in multiple sclerosis (Jones et al, PLoS One 2012). Minimum score is 0, and maximum score is 21. Higher scores indicate worse outcome. Three papers report total HADS scores in PwMS. Using the information from Honarmand and Feinstein (Mult Scler, 2009) \[Baseline scores and standard deviation (SD)\] and the following assumptions 90% power and a two-sided alpha of 0.05, a total sample size of 200 (100 in each group) was required to detect 1.5 difference between the intervention and the control groups. This sample size was inflated to 220 to account for possible dropouts, losses to follow-up and withdrawals of consent.
Difference in Change in Anxiety score in the Hospital Anxiety and Depression Scale (HADS-A) scores
时间窗: 12 months
Hospital Anxiety \& Depression Scale (D subcategory for depression levels, A subcategory for anxiety levels). This is a common depression and anxiety measurement instrument used in multiple sclerosis (Jones et al, PLoS One 2012). Minimum score is 0, and maximum score is 21. Higher scores indicate worse outcome. Three papers report total HADS scores in PwMS. Using the information from Honarmand and Feinstein (Mult Scler, 2009) \[Baseline scores and standard deviation (SD)\] and the following assumptions 90% power and a two-sided alpha of 0.05, a total sample size of 200 (100 in each group) was required to detect 1.5 difference between the intervention and the control groups. This sample size was inflated to 220 to account for possible dropouts, losses to follow-up and withdrawals of consent.
次要结局
- The Patient Determined Disease Steps (PDDS) Stability of Score(12 months)
- Difference in change in the CollaboRATE shared decision-making survey(12 months)
- Difference in Change in the Euro Quality of Life Measurement (EQ5D)(12 months)
- Difference in Change in the Modified Fatigue Impact Scale (MFIS) score(12 months)
- Scores on Qualitative Consultant Satisfaction Questionnaire (CSQ)(12 months)
- Difference in Change in the Patient Health Questionnaire-9 (PHQ-9)(12 months)