Multiple Sclerosis-Collaborative Approach to Rehabilitation Effectiveness Study

Study Overview
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Brief Summary
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The purpose of this study is to: (1) test the benefits of the patient-centered collaborative care treatment approach for persons with MS who also have depression and/or pain; and also (2) test whether this approach improves quality of life, patient satisfaction, adherence to other treatments, and quality of care in the MS care system.

Detailed Description
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Background: It is common for people with multiple sclerosis (MS) to have depression and chronic pain. Individuals with MS who have depression and/or pain often use more health care services, benefit less from treatment, and have poorer quality of life. While evidence-based medical and behavioral treatments for depression and pain exist, they are often not offered or accessible to persons with MS. As a result, chronic pain and depression are under-treated in people with MS. One way to better treat these problems is through a Collaborative Care approach. In this approach a care manager (nurse supervised by expert physicians, psychiatrists, and psychologists) helps coordinate and provide high-quality, evidence-based treatments for depression and pain. The care manager also makes sure that the care is focused on the patient's goals and preferences. The care is provided by phone or in person based on the patient's preference. Although this approach has been used successfully with patients with many different conditions, it has never been tested in patients with MS, pain, and depression. Objectives: The investigators' objectives are to (1) test the benefits of the patient-centered collaborative care treatment approach for persons with MS who also have depression and/or pain; and also (2) test whether this approach improves quality of life, patient satisfaction, adherence to other treatments, and quality of care in the MS care system. Methods: Participants were 195 outpatients with MS from a specialty MS Center who had depression and/or chronic pain. Half of the participants received the treatment that was typical for patients in the MS Center (usual care), while the other half received treatment using the Collaborative Care approach. Participants in the collaborative care group met regularly in-person or by telephone with a social worker who coordinated their depression and pain treatments and provided strategies for better managing their symptoms. The treatment phase of the study lasted for 16 weeks and began within 2 weeks of study enrollment. Participants completed telephone interviews within 2 weeks of enrollment, approximately 4 months after study enrollment, and approximately 10 months after study enrollment. During these interviews participants were asked questions about their pain, depression, satisfaction with care, and quality of life to compare the two care approaches. Projected Patient Outcomes: The investigators anticipate that those in the collaborative care approach will have better controlled pain and depression and better quality of life, satisfaction with care, adherence to other MS treatments, and quality of care compared to those in the usual care approach. The results of this study may help patients, clinicians, healthcare system leaders, and policy makers make decisions about the benefits of this type of coordinated care approach for depression and pain in MS care.

Official Title
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Improving the Quality of Care for Pain and Depression in Persons With Multiple Sclerosis

Conditions
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Multiple Sclerosis, Pain, Depression

Intervention / Treatment
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* Behavioral: Collaborative Care (CC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has a definitive diagnosis of MS confirmed by subjects' MS physician in the University of Washington (UW) MS Center; Patient has received care and plans to continue to receive care at the UW MS Center during enrollment period; Patient has access to and is able to communicate over the telephone (we will provide phone headsets if needed) to allow participation in the telehealth components of the study; Patient can read, speak and understand English; Patient is at least 18 years of age. Patient reports a clinically significant problem with pain and/or depression. Exclusion Criteria: Patient represents a high suicide risk; Patient reports symptoms of a current psychotic disorder or diagnosis of bipolar disorder with current psychotic features at time of screening; Subject attends appointments more than once per month with a psychiatrist for treatment of depression; Patient reports planning major surgery in the next ten months; Patient reports alcohol or psycho-active substance dependence within past month; Patient has moderate to severe cognitive impairment.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Collaborative Care (CC)<br>Collaborative care (CC) is a systematic and integrated approach to improving the delivery and utilization of effective treatments for chronic pain and depression. The care was delivered through an interdisciplinary team, organized around a CC manager (CCM) who guided the patient through various aspects of care during the 16-week treatment phase. The team also included the patient's MS physician and the CC Supervisors, a group of clinicians who were experts of the study domain . The CCM offered all subjects care management, collaborative medical management, and psychosocial treatment appropriate to their problem area (i.e., pain, depression, or both) described below. If the patient had both pain and depression, he or she received care management and collaborative medical management for both. | Behavioral: Collaborative Care (CC)<br>* Collaborative care (CC) is a systematic and integrated approach to improving the delivery and utilization of effective treatments for chronic pain and depression. The care was delivered through an interdisciplinary team, organized around a CC manager (CCM) who guided the patient through various aspects of care during the 16-week treatment phase. The team also included the patient's MS physician and the CC Supervisors, a group of clinicians who were experts of the study domain . The CCM offered all subjects care management, collaborative medical management, and psychosocial treatment appropriate to their problem area (i.e., pain, depression, or both) described below. If the patient had both pain and depression, he or she received care management and collaborative medical management for both.<br>|
| No Intervention: Usual Care<br>Subjects assigned to usual care were informed by the CCM of their depressive and pain symptoms and that they should consult with their MS or primary care provider about possible care for these conditions. Study personnel did not make any further attempts to influence usual care participants' depression or pain management unless a psychiatric emergency arose (e.g., suicidal ideation was detected at baseline or any of the outcome assessments). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Control of Pain | Control of pain is defined as either average pain severity score of less than 3 in the past week on the Brief Pain Inventory, or obtaining a 30% or greater reduction in average pain severity from baseline. Pain severity will be assessed using the Brief Pain Inventory 0-10 numerical rating scale. | Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment | 
| Change in Control Of Depression | Control of depression is defined as a reduction of at least 50% depression severity or a score of < 0.5 on the SCL-20. Depression severity will be assessed with the Symptom Checklist Depression Subscale (SCL-20), a brief self-report measure of cognitive, emotional and somatic symptoms of depression commonly used in treatment outcome studies. | Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depression Severity | Depression severity, as measured by the SCL-20, will be assessed as a continuous measure of depression symptom severity. | Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment | 
| Change in Quality of Depression Care | The investigators will assess the proportion of participants who achieve guideline-level depression care. For depression this is defined as: use of antidepressant at therapeutic dose 25 of the past 30 days, or at least 4 evidence-based psychotherapy sessions since the last assessment period (or 6 months, whichever is shorter). The investigators will also determine whether participants have a diagnosis of major depressive disorder or dysthymia using modules from the Mini International Neuropsychiatric Interview (MINI), which will be administered by telephone by trained staff. | Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment | 
| Change in Pain Severity | Pain severity, as measured by the Brief Pain Inventory 0-10 NRS scale, will be assessed as a continuous measure of pain severity. | Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment | 
| Change in Disability | The investigators will use the Sheehan Disability Scale, a 3-item measure that assesses how diminished health status interferes with work/school, family life, and social life and activities. | Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment | 
| Change in Health-Related Quality of Life | The investigators will administer the EuroQol EQ-5D, a standardized measure of health status. It is comprised of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. | Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment | 
| Improvement and Satisfaction with Care | The investigators will use the Patient Global Impression of Change scale, a single question which asks participants to rate their improvement with treatment on a 7-point scale that ranges from very much improved to very much worse, with no change as the mid-point. In addition, a single question will be used to ask participants to rate their overall satisfaction with their care on a 0 to 4 scale that ranges from very dissatisfied to very satisfied. | Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, multiple sclerosis, depression