Multiple Sclerosis-Collaborative Approach to Rehabilitation Effectiveness Study

NCT ID: NCT02137044

Last Updated: 2017-12-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-07-31
• Study Completion Date: 2017-04-30

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.

Conditions

Multiple Sclerosis; Pain; Depression

Keywords

multiple sclerosis; pain; depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Collaborative Care (CC)

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.

Group Type: EXPERIMENTAL

Collaborative Care (CC)

Intervention Type: BEHAVIORAL

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.

Usual Care

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).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Collaborative Care (CC)

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Dawn Ehde

Professor, Rehabilitation Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dawn M Ehde, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

University of Washington- Harborview Medical Center

Seattle, Washington, United States

University of Washington Medicine MS Center

Seattle, Washington, United States

University of Washington-Health Sciences Building

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 28987615 (View on PubMed)

Other Identifiers

46597

Identifier Type: OTHER

Identifier Source: secondary_id

46597

Identifier Type: -

Identifier Source: org_study_id