Results Summary
What was the research about?
Multiple sclerosis, or MS, is a disease of the brain and spinal cord. There is no cure for MS, but people can live with the disease for many years. Two common health problems that people with MS may have are ongoing pain and depression.
In this study, the research team created a collaborative care program called MS Care. In the program, a care manager helped patients with MS learn how to manage their symptoms and treatments and coordinated patient care with different doctors and experts. Care managers also monitored patients’ symptoms and worked with care teams to change patients’ treatment plans if needed. The team wanted to learn if MS Care, compared with usual care, helped reduce pain and depression in people with MS.
What were the results?
At the end of the program, patients in MS Care and patients receiving usual care didn’t differ in control of pain and depression. However, six months later, patients who took part in MS Care were more likely to have both their pain and depression under control than were patients who received usual care.
At the end of the program, compared with patients who received usual care, patients in MS Care reported
- Less intense pain
- Fewer problems caused by pain
- Less severe depression
- Feeling less disabled and less fatigued
- Being more satisfied with their care
- More improvement in pain
Six months later, these differences remained for problems caused by pain, depression, fatigue, and improvement in pain. Also, after six months, fewer patients who took part in MS Care were diagnosed with depression compared with patients who received usual care.
Patients in MS Care and patients who received usual care didn’t differ in confidence in their abilities to manage MS or use of healthcare services, such as emergency room or physical therapy visits, at any time during the study.
Who was in the study?
The study included 173 patients with MS receiving care at one MS healthcare center in Seattle, Washington. Of these, 84 percent were white, and 10 percent were Hispanic. In addition, 72 percent had chronic pain, 5 percent had depression, and 23 percent had both. The average age was 50, and 78 percent were women.
What did the research team do?
The research team assigned patients, by chance, to receive either MS Care or usual care for MS.
In MS Care, patients met with care managers in person or by phone up to 12 times during four months. During meetings, patients and care managers talked about setting goals, meditation, relaxation training, and other ways to manage pain and mood. They also discussed taking medicines and treatments as instructed. In addition, care managers met weekly with pain and depression experts to talk about patients’ progress and adjust treatment plans based on patient preferences and changes in their health.
Patients getting usual care received routine care for MS. Usual care didn’t include services from a care manager. These patients also received a list of community and online resources for people with MS.
People with MS and staff from the MS healthcare center and the National MS Society gave input throughout this study.
What were the limits of the study?
Only 28 percent of patients had depression. Results might not apply to all patients with MS and depression. The study included one MS healthcare center. Results may differ for other centers. Most patients were white, non-Hispanic, and women; results might differ for patients from other backgrounds.
How can people use the results?
Healthcare centers could use these results when considering ways to help patients with MS control their pain and depression.
Professional Abstract
Objective
To examine the effectiveness of a collaborative care approach for treating and controlling chronic pain and depression in adults with multiple sclerosis (MS), compared with usual care
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 171 adults with MS plus chronic pain and/or major depressive disorder |
| Interventions/ Comparators |
|
| Outcomes |
Primary: concurrent pain and depression control Secondary: pain intensity, pain interference, depression severity, disability, fatigue, self-efficacy for managing MS, patient satisfaction, healthcare utilization |
| Timeframe | 6-month follow-up for primary outcome |
This randomized controlled trial examined the effectiveness of a collaborative care approach, called MS Care, in treating pain and depression in adults with MS, compared with usual care. In MS Care, care managers delivered and coordinated evidence-based medical and behavioral treatments in collaboration with patients and their healthcare providers.
Researchers randomly assigned patients to receive either MS Care or usual care. Patients in the MS Care group attended up to 12 collaborative care sessions in person or by phone for 16 weeks. During the 30- to 60-minute sessions, care managers and patients reviewed treatment adherence, barriers to adherence, and treatment options. Patients also learned behavioral self-management skills such as goal setting, mindfulness meditation, and relaxation training. Care managers met weekly with pain and depression experts to review patients’ treatment progress, chronic pain and depression outcomes, and treatment response trends. Healthcare providers adjusted patients’ treatments based on these reviews.
Patients in the usual care group received their usual care for MS. Usual care did not include telehealth, systematic monitoring, outreach, or treatment intensification. Additional services for pain and depression were available on a referral basis. These patients also received a list of community and web-based resources.
The study included 171 patients with MS receiving care at one MS specialty care center in Seattle, Washington. Of these, 84% were white, and 10% were Hispanic. In addition, 72% had chronic pain, 5% had major depressive disorder, and 23% had both. The average age was 50, and 78% were female.
Patients completed outcome assessments at baseline, at the end of the MS care treatment period, and six months later.
People with MS and staff from the MS specialty care center and the National MS Society provided input throughout the study.
Results
At the end of the treatment period, patients in MS Care and patients receiving usual care did not differ in concurrent pain and depression control. After six months, compared with patients receiving usual care, patients in MS Care were more likely to have both their pain and depression under control (p=0.04).
Compared with patients receiving usual care, patients in MS Care reported lower pain intensity, pain interference, depression severity, disability, and fatigue and higher satisfaction and improvement in pain at the end of the treatment period (all p<0.05). After six months, these differences remained for pain interference, disability, and fatigue (all p<0.05). Also, after six months, fewer patients who took part in MS Care were diagnosed with depression compared with patients who received usual care (p<0.05). Patients in MS Care and patients receiving usual care did not differ in self-efficacy for managing MS or overall healthcare utilization at either time point.
Limitations
Only 28% of patients had depression; therefore, results may not be generalizable to all patients with MS and depression. The study took place at one MS specialty care center. Most patients were white, non-Hispanic, and female. Results may differ for other care settings or locations or for people with other backgrounds.
Conclusions and Relevance
Although patients with MS Care and patients with usual care did not differ in concurrent pain and depression control after treatment, six months later, patients in MS Care were more likely to have both their pain and depression under control and experienced more improvement in other patient-centered outcomes.
Future Research Needs
Future research could focus on evaluating MS Care in other care settings or geographic locations or with diverse groups of patients.
Final Research Report
View this project's final research report.
Journal Citations
Related Journal Citations
Peer-Review Summary
Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.
The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments.
Peer reviewers commented, and the researchers made changes or provided responses. The comments and responses included the following:
- Since the primary outcomes of the study did not show group differences but the secondary outcomes did, reviewers asked for greater detail on some of the secondary outcome measures. Reviewers also asked for additional discussion of the clinical relevance of the observed improvements in secondary outcomes. The researchers added details about the secondary outcomes and clarified how they used measures, such as medication use in Table 1. They also expanded the discussion section to address clinical relevance of the secondary outcomes.
- Reviewers asked about self-reported pain and whether researchers verified patient reports of pain by reviewing medical charts. The researchers said they followed consensus guidelines for the assessment of pain in clinical trials and added that these guidelines recognize self-reporting as a valid method of measuring pain. The researchers did not review medical charts when assessing pain.
- Reviewers noted that telehealth delivery systems are not widely reimbursed and so they are not accessible to many patients. The researchers agreed that this is an important point and added it to their discussion section but said that payers are increasingly covering telehealth.
- Reviewers noted that the measures included two separate measures of depression and asked for the rationale to have two measures rather than one. The researchers explained that one of the measures, the Patient Health Questionnaire, is routinely used as a screening tool in medical offices because it is brief, easy to use, and has good specificity and sensitivity for current depressive episode. Their depression outcome measure, the Hopkins Symptom Checklist, is the gold standard used in depression clinical trials that include participants with multiple sclerosis