Comprehensive Opioid Management in Patient Aligned Care Teams

OBJECTIVES: The objectives of the study are to: 1) test the effectiveness of COMPACT for
improving pain-relevant outcomes including physical functioning and pain intensity; 2)
determine whether opioid monitoring promotes guideline concordant care; and 3) examine key
components of the intervention process to inform future implementation.

RESEARCH DESIGN: This study is a randomized, controlled, multi-site, 2x2 factorial design
trial of a technology supported treatment program called COMPACT relative to enhanced usual
care (EUC).

METHODOLOGY: Participants will include 380 Veterans receiving COT and reporting chronic
musculoskeletal pain of at least moderate severity. Enrolled participants will be randomized
in a 1:1:1:1 ratio to one of the four treatment arms 1) IVR-CBT plus opioid monitoring, 2)
IVR-CBT, 3) opioid monitoring, and 4) enhanced usual care. COMPACT treatment contains two
elements; telephone CBT and automated, monthly opioid monitoring. In telephone CBT
participants will learn a series of pain self-management skills via a patient handbook
supplemented with weekly telephone calls from a nurse case manager. Opioid monitoring will
include monthly automated telephone calls which will assess opioid adherence, safety, and
pain treatment effectiveness. At baseline, 12 weeks (post-treatment), 24 weeks (follow-up)
and 36 weeks (follow-up) all participants will undergo an assessment of all outcome
variables.

Inclusion Criteria:

- presence of at least moderate non-cancer, non-headache pain (i.e., pain scores of ≥ 4
as measured by the Numeric Rating Scale) for a period of ≥ 3 months;

- receipt of chronic opioid therapy as defined by ≥ 90 continuous days out of any 104
day period in the prior 12 month;

- ability to participate safely in the walking portion of the intervention as evidenced
by ability to walk at least one block;

- availability of a land line or cellular telephone

Exclusion Criteria:

- active psychosis or suicidality that could impair participation as defined by their
response during the baseline assessment interview (e.g., presence of suicidal intent
or uncontrolled psychotic symptoms). Presence of suicidal ideation or intent will
require immediate psychiatric attention to assure safety and institution of
appropriate treatment;

- life threatening or acute medical condition that could impair participation;

- dementia defined by a score of 20 or greater on the St. Louis University Mental
Status;

- sensory deficits that would impair participation (e.g., hearing loss to a degree that
telephone usage is not possible