Opioid Treatment and Recovery Through a Safe Pain Management Program

Not Applicable

Completed

Conditions: Chronic Pain
Depression
Opioid Use
Anxiety

Interventions: Behavioral: Electronic medical recorded clinical decision support [EMR CDS]
Behavioral: Stepped opioid collaborative care model [CCM]

Registration Number: NCT03889418

Lead Sponsor: Ochsner Health System

Brief 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 490

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Electronic medical recorded clinical decision support	Electronic medical recorded clinical decision support [EMR CDS]	Usual care only
stepped opioid collaborative care model	Electronic medical recorded clinical decision support [EMR CDS]	Usual care AND collaborative care with behavioral health integration
stepped opioid collaborative care model	Stepped opioid collaborative care model [CCM]	Usual care AND collaborative care with behavioral health integration

Primary Outcome Measures

Name	Time	Method
Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg	12 months prior to index event (pre-index period) and 12 months following index event (post-index period)	Participants' opioid medication orders were monitored for 12 months prior to and following entry into study (index event). This outcome represents the odds of having an average MEDD ≥ 50 mg in the pre-index and post-index periods for the collaborative care and usual care groups. Odds of an event is defined as the ratio of the probability that the event will happen (prescribed high dose opioid) to the probability that the event will not happen (not prescribed high dose opioid)

Secondary Outcome Measures

Name	Time	Method
Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety	12 months following index event (post-index period)	Participants in the collaborative care group were administered the Generalized Anxiety Disorder (GAD)-7 questionnaire at baseline and every 4 weeks following date of enrollment in study. The GAD-7 is a seven item questionnaire. The total score ranges from 0 to 21 (scores of 5-9 mild anxiety; 10-14 moderate anxiety; 15-21 severe anxiety).This single-group outcome represents the number of participants who entered the study with symptoms of moderate to severe anxiety (GAD-7 score ≥ 10) and achieved a GAD-7 score \< 10 on the last completed questionnaire
Inpatient Hospital Admission Per 1000 Participants	12 months prior to index event (pre-index period) and 12 months following index event (post-index period)	Participants' non-elective inpatient hospital admissions were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of admissions in the pre-index and post-index periods for the study groups
Change in the Average Pain Score Among Participants Exposed to Collaborative Care	12 months following index event (post-index period)	Participants in the collaborative care group were administered the Pain Enjoyment of Life General Activity (PEG)-3 questionnaire at baseline and every 4 weeks during the acute phase of treatment. THE PEG-3 consists of 3 questions - each with a rating scale 0 (no pain; no interference) to 10 (worse pain; completely interferes). The score is generated by summing the score of the 3 scales (max 30 points) and then dividing by 3. The measure is reliable with construct validity and responsive among primary care patients. This single-group outcome represents the average change in PEG-3 score from the first to the last completed questionnaire during the acute phase.
New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service	12 months following index event (post-index period)	Participants' non-mental/behavioral health specialty service referrals (e.g. physical therapy, orthopedics) were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with referrals in the post-index period among those with no referrals in the pre-index period
New Post-index Orders for Antidepressant Medications	12 months following index event (post-index period)	Participants' medication orders were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with a new order for antidepressants in the post-index period among those with no orders in the pre-index period
Provider Experience With Managing Depression/Anxiety/Pain	Baseline	Provider ratings of their experience with managing depression/anxiety/pain
Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods	12 months prior to index event (pre-index period) and 12 months following index event (post-index period)	Participants' opioid medication orders were monitored for 12 months prior to and following entry into study (index event). This outcome represents the rate ratio of average MEDD in the post-index versus pre-index periods for the Behavioral Collaborative Care (BHI-CCM + EMR-CDS) and Usual Care (EMR-CDS only) groups. The rate ratio compares the average dose of opioid prescription in the post-index period to the pre-index period. A rate ratio less than 1 indicates that the average dose decreased.
Emergency Department Visits Per 1000 Participants	12 months prior to index event (pre-index period) and 12 months following index event (post-index period)	Participants' emergency department (ED) visits were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of ED visits in the pre-index and post-index periods for the study groups
Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression	12 months following index event (post-index period)	Participants in the collaborative care group were administered the Patient Health Questionnaire (PHQ)-9 questionnaire at baseline and every 4 weeks following date of enrollment in study. The PHQ-9 is a nine item questionnaire. The total score ranges from 0 to 27 (scores of 5-9 mild depression; 10-14 moderate depression; 15-19 moderately severe depression; ≥ 20 severe depression). This single-group outcome represents the number of participants who entered the study with symptoms of moderate to severe depression (PHQ-9 score ≥ 10) and achieved a PHQ-9 score \< 10 on the last completed questionnaire.
New Post-index Documentation for Signed Pain Management Agreement (Pain Contract)	12 months following index event (post-index period)	Participants' pain contracts were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with a documented pain contract in the post-index period among those with no pain contract in the pre-index period
New Post-index Order for Urine Drug Screen (UDS)	12 months following index event (post-index period)	Participants' UDS were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with a documented UDS order in the post-index period among those with no UDS order in the pre-index period
New Post-index Naloxone Prescription Order	12 months following index event (post-index period)	Participants' medication orders were monitored for 12 months prior to and following date of enrollment in study. This outcome represents the number of participants with naloxone orders in the post-index period among those with no naloxone orders in the pre-index period
Change in Rate of Patient Report of Opioid Misuse	Baseline, 12 months following index event (post-index period)	Change in Current Opioid Misuse Measure-9 (COMM-9) scores: The COMM-9 is a 9-item questionnaire with a 5-item response scale (0=never; 4=very often) that captures a 30-day period and only includes behaviors that can change over time (score range 0 to 36). Scoring greater than 4 are identified as being at risk for medication misuse. Participants in the Collaborative Care group were administered the COMM-9 questionnaire at baseline and every 4 weeks during the acute phase of treatment. This single-group outcome represents the average change in COMM-9 score from the first to the last completed questionnaire during the acute phase.
Change in Patient Rating of Quality of Life	Baseline, 12-months following index event (post-index period)	Participants in the Collaborative Care group were administered the Patient Reported Outcomes Measurement Information System (PROMIS) 10 item questionnaire at baseline and every 12 weeks following enrollment in study. A PROMIS score of 50 is the average (or mean) score for the U.S. general population. This single-group outcome represents the average change in PROMIS-10 global mental health score from the first to the last completed questionnaire during the acute phase.