N/A
N=115
Opioid Treatment and Recovery Through a Safe Pain Management Program
Depression · Opioid Use · Chronic Pain · Anxiety
Bottom Line
View on ClinicalTrials.gov: NCT03889418 ↗Enrolled (actual)
115
Serious AEs
15.5%
Results posted
Dec 2023
Primary outcome: Primary: Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg — 0.209; 0.417; 0.185; 0.364 odds of prescription high dose — p=0.956
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Electronic medical recorded clinical decision support [EMR CDS] (Behavioral); Stepped opioid collaborative care model [CCM] (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Ochsner Health System
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg |
0.209; 0.417; 0.185; 0.364 | 0.956 |
| SECONDARY Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods |
0.957; 0.863 | 0.039 sig |
| SECONDARY Inpatient Hospital Admission Per 1000 Participants |
528; 309; 413; 254 | 0.864 |
| SECONDARY Emergency Department Visits Per 1000 Participants |
1626; 1352; 1526; 1292 | 0.901 |
| SECONDARY Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression |
129 | — |
| SECONDARY Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety |
92 | — |
| SECONDARY Change in Patient Rating of Quality of Life |
34.001; 2.000; 35.815; 0.929 | — |
| SECONDARY Change in the Average Pain Score Among Participants Exposed to Collaborative Care |
6.5; -1.3 | — |
| SECONDARY New Post-index Documentation for Signed Pain Management Agreement (Pain Contract) |
21; 23 | — |
| SECONDARY New Post-index Order for Urine Drug Screen (UDS) |
23; 33 | — |
| SECONDARY New Post-index Naloxone Prescription Order |
10; 23 | — |
| SECONDARY Change in Rate of Patient Report of Opioid Misuse |
4.8; -1.1 | — |
| SECONDARY New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service |
40; 45 | — |
| SECONDARY New Post-index Orders for Antidepressant Medications |
37; 49 | — |
| SECONDARY Provider Experience With Managing Depression/Anxiety/Pain |
83; 10; 0; 45; 47; 1 | — |
Summary
Opioid prescription drug abuse has become a major public health concern in the United States with mortality rates from fatal overdoses reaching epidemic proportions. This opioid crisis coincides with national efforts to improve management of chronic non-cancer pain. The net result, however, has been ever-growing increases in medical expenditures related to prescription costs and increased healthcare service utilization among opioid abusers. Healthcare provider prescribing pattern, especially among non-pain management specialists such as primary care, is a major factor. Louisiana is a major contributor to the epidemic with the 7th highest opioid prescribing rates accompanied by a 12% increase in fatal overdoses.
Providers are overdue for implementing safe opioid management strategies in primary care to combat the opioid crisis. Recent practice guidelines provide recommendations on what to do for safe prescribing of opioids, but they do not provide guidance on how to translate them into practice. Health systems must find ways to accelerate guideline adoption in primary care in the face of an overdose crisis. Research that examines a combination workflow- and provider-focused strategies are needed. Given the high prevalence of psychiatric disorders among patients with chronic non-cancer pain, care team expansion with integration of collaborative mental/behavioral health services may be the solution. Collaborative care can extend opioid management beyond standardized monitoring of risk factors for opioid misuse or abuse and set clear protocols for next steps in management.
This study is aligned with the National Institute on Drug Abuse's interest in health systems research that examines approaches to screening, assessment, prevention, diagnosis and treatment for prescription drug abuse. It will examine the primary care practice redesign of managing chronic non-cancer pain within a large health system whose 40+ Accountable Care Network-affiliated, adult primary care clinics may serve as an example for transforming opioid management in primary care practices across the country. This four-year type 2 effectiveness-implementation hybrid stepped wedge cluster randomized control trial is designed to compare the clinical and cost effectiveness of electronic medical record-based clinical decision support guided care versus additional integrated, stepped collaborative care for opioid management of primary care patients with chronic non-cancer pain (clinical pharmacist for medication management; licensed clinical social worker for cognitive behavioral therapy and community health worker care coordination); and to examine facilitators and barriers to implementing this multi-component intervention. Investigators anticipate that our study results will elucidate the role of technology versus care team optimization in changing provider opioid prescribing behaviors. Investigators further anticipate that results of our study will demonstrate that integrated mental/behavioral health care for opioid management of chronic non-cancer pain increases value-based care and leads to greater efficiencies in the way that care is delivered.
Eligibility Criteria
Inclusion Criteria
- Age 18 and older
- Have a primary care provider at any of the study clinics
- Receiving chronic opioid prescriptions (3 of the prior 4 months) for chronic non-cancer pain
- Have a diagnosis of depression or anxiety
Exclusion Criteria
- Age less than 18 years
- Active cancer or undergoing cancer treatment
- Chronic cancer-related pain
- Having a terminal illness
- Receiving hospice care
Data sourced from ClinicalTrials.gov (NCT03889418). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.