Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial
Pain is the most common presenting symptom in medical outpatients, and depression and anxiety are the two most common mental disorders. All three conditions are often inadequately treated and result in substantial disability, reduced health-related quality of life, and increased health care costs and utilization. Additionally, pain, anxiety, and depression (PAD) are frequently comorbid with one another and have reciprocal negative effects on treatment response and additive effects on adverse health outcomes. The PAD triad is especially burdensome in Veterans, with their high prevalence of chronic pain, depression, PTSD, and other anxiety disorders. The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of veterans suffering from with pain, anxiety and/or depression.
Other: Comprehensive Symptom Management (CSM)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Comprehensive vs. Assisted Management of Mood and Pain Symptoms (CAMMPS) Trial|
- Composite T-score of pain, anxiety and depression scales from the PROMIS-57 Profile [ Time Frame: 12 months ] [ Designated as safety issue: No ]These 3 symptom scales total 25 items: 8 items each for depression and anxiety, and 9 items for pain. Conversion tables allow direct conversion of simple summed raw scores from PROMIS symptom scales into T-score values. T-Score distributions are standardized such that a score of 50 represents the average (mean) for the US general population, and the standard deviation around that mean is 10 points. A high score represents greater symptom severity.
- PEG (3-item validated version of the Brief Pain Inventory) [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- PHQ-9 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- GAD-7 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||July 2013|
|Estimated Study Completion Date:||June 2017|
|Estimated Primary Completion Date:||March 2017 (Final data collection date for primary outcome measure)|
No Intervention: Assisted Symptom Management
There will be 3 principal components to assisted symptom management (ASM): automated symptom monitoring, a pain self-management manual, and assisted mental health referrals.
Experimental: Comprehensive Symptom Management (CSM)
This arm couples nurse care management with ASM, thus testing �combined� therapy vs. �monotherapy� (ASM only).
Other: Comprehensive Symptom Management (CSM)
This arm couples nurse care management with ASM, thus testing "combined" therapy vs. "monotherapy" (ASM only).
The Comprehensive vs. Assisted Management of Mood and Physical Symptoms (CAMMPS) study is a randomized comparative effectiveness trial designed to test the relative effectiveness of a lower-resource vs. a higher-resource enhancement of usual primary care in the management of veterans suffering from with pain, anxiety and/or depression.
This will be a single-site study enrolling Veterans. Patients followed in primary care clinics at the Roudebush VAMC will be eligible if they have clinically significant levels of at least 2 of the PAD (pain, anxiety, depression) symptoms. A total of 300 eligible patients who provide informed consent will be randomized to one of two treatment arms. One group (n=150) will receive assisted symptom management (ASM) consisting of automated symptom monitoring by interactive voice recording or Internet, prompted pain self-management guided by symptom levels, and assisted mental health referrals. The second group (n=150) will receive comprehensive symptom management (CSM) which combines ASM with optimized medication management delivered by a nurse-physician specialist team. This team will partner with both VA primary care physicians and psychologists embedded in primary care to monitor and adjust treatments using evidence-based analgesic and antidepressant algorithms, reinforced self-management, and care coordination. We postulate that although both interventions are likely to be beneficial, CSM will be superior to ASM.
In short, this trial compares: 1) usual care plus assisted symptom management (ASM) vs. 2) usual care plus ASM plus optimized medication and care management (CSM). Outcomes will be assessed at 1, 3, 6, and 12 months. The primary outcome is a composite pain-anxiety-depression severity score. Secondary outcomes include individual pain, anxiety, and depression scores; functional status and health-related quality of life; treatment satisfaction; and perceived barriers and facilitators of the CSM and ASM interventions. The rationale for ASM is preliminary evidence of its effectiveness and its lower use of resources. The rationale for CSM is that the addition of optimized medication management, reinforced self-management, and care coordination with both primary care physicians and psychologists for the PAD symptoms should substantially enhance the benefits of ASM.
|Contact: Jessica M Coffing, MA CRA||(317) 988-4078||Jessica.firstname.lastname@example.org|
|United States, Indiana|
|Richard Roudebush VA Medical Center, Indianapolis||Not yet recruiting|
|Indianapolis, Indiana, United States, 46202-2884|
|Contact: Jessica M Coffing, MA CRA 317-988-4078 Jessica.email@example.com|
|Contact: Kurt Kroenke, MD Kurt.Kroenke@va.gov|
|Principal Investigator: Kurt Kroenke, MD|
|Principal Investigator:||Kurt Kroenke, MD||Richard Roudebush VA Medical Center, Indianapolis|