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.

Final Research Report

View this project's final research report.

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

Conflict of Interest Disclosures

Project Information

Dawn Marie Ehde, PhD
University of Washington
$2,079,394
10.25302/06.2020.IH.13046379
Improving the Quality of Care for Pain and Depression in Persons with Multiple Sclerosis -- MS-CARE

Key Dates

September 2013
May 2019
2013
2019

Study Registration Information

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Last updated: January 25, 2023