Clinical trial NCT02137044: Multiple Sclerosis-Collaborative Approach to Rehabilitation Effectiveness Study
Official title: Improving the Quality of Care for Pain and Depression in Persons With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Pain
Depression
Keywords: multiple sclerosis
pain
depression
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2014-05-13
Enrollment: 195
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Control of Pain
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Change in Control Of Depression
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Secondary outcomes:
measure: Change in Depression Severity
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Change in Quality of Depression Care
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Change in Pain Severity
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Change in Disability
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Change in Health-Related Quality of Life
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Improvement and Satisfaction with Care
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Other outcomes:
measure: Change in Fatigue
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Change in Healthcare Utilization
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Change in Self-Efficacy
timeFrame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
measure: Change in Pain Severity
timeFrame: During each treatment session for subjects randomized to collaborative care intervention assignment. These subjects will participate in 10-12 treatment sessions over a 16-week period that starts about 1-2 weeks after study enrollment.
measure: Change in Depression Severity
timeFrame: During each treatment session for subjects randomized to collaborative care intervention assignment. These subjects will participate in 10-12 treatment sessions over a 16-week period that starts about 1-2 weeks after study enrollment.
measure: Descriptive Characteristics
timeFrame: Within 2 weeks of enrollment
Locations:
city: Seattle
country: United States
facility: University of Washington- Harborview Medical Center
state: Washington
city: Seattle
country: United States
facility: University of Washington Medicine MS Center
state: Washington
city: Seattle
country: United States
facility: University of Washington-Health Sciences Building
state: Washington
Study officials:
affiliation: University of Washington
name: Dawn M Ehde, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ehde DM, Alschuler KN, Sullivan MD, Molton IP, Ciol MA, Bombardier CH, Curran MC, Gertz KJ, Wundes A, Fann JR. Improving the quality of depression and pain care in multiple sclerosis using collaborative care: The MS-care trial protocol. Contemp Clin Trials. 2018 Jan;64:219-229. doi: 10.1016/j.cct.2017.10.001. Epub 2017 Oct 5.