Multiple SclerosisMS-CARENCT02137044
Multiple Sclerosis-Collaborative Approach to Rehabilitation Effectiveness Study
A study testing Collaborative Care (CC) in people with Multiple Sclerosis and Pain, run by University of Washington at 3 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Multiple Sclerosis, Pain, Depression
- What is being tested?
- Collaborative Care (CC)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 195 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2014to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Washington- Harborview Medical Center
Seattle, Washington, 98104
University of Washington Medicine MS Center
Seattle, Washington, 98133
University of Washington-Health Sciences Building
Seattle, Washington, 98195
About this study
Official title: Improving the Quality of Care for Pain and Depression in Persons With Multiple Sclerosis
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.
Read the 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
- Being tested
- Collaborative Care (CC)
- Keywords
- multiple sclerosis, pain, depression
- Medical subject headings
- Multiple Sclerosis, Pain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative Care (CC)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Collaborative Care (CC) | Experimental | 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. Receives: Behavioral: Collaborative Care (CC) |
| Usual Care | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Secondary outcomes (6)
Change in Depression Severity
Depression severity, as measured by the SCL-20, will be assessed as a continuous measure of depression symptom severity.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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."
Measured: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Dawn Ehde, University of Washington
- Investigators
- Dawn M Ehde, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02137044
- Sponsor's protocol ID
- 46597
- Other IDs
- 46597
- Acronym
- MS-CARE
- Status last verified
- Dec 2017
- First submitted
- 22 Apr 2014
- Last updated
- 6 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28987615
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving the Quality of Care for Pain and Depression in Persons With Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT02137044
- Acronym / sponsor ID
- MS-CARE / 46597
- Conditions
- Multiple Sclerosis, Pain, Depression
- Keywords
- multiple sclerosis, pain, depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 195 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Jul 2014 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 13 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Collaborative Care (CC) | Experimental | Behavioral: 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. |
| Usual Care | No intervention | –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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Collaborative Care (CC) |
Primary outcome
Change in Control of Pain
Time frame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
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.
Change in Control Of Depression
Time frame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
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.
6 secondary outcomes
Change in Depression Severity
Time frame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Change in Quality of Depression Care
Time frame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Change in Pain Severity
Time frame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Change in Disability
Time frame: 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
Time frame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Improvement and Satisfaction with Care
Time frame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2017.
- Derived from this study: PubMed 28987615Ehde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn M Ehde, PhD principal investigator
University of Washington
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Collaborative Care (CC) in people with Multiple Sclerosis and Pain, run by University of Washington at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Control of Pain (time frame: Within 2 weeks following study enrollment, about 4 Months following study enrollment, about 10 months following study enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02137044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2017.