Anxiety, Chronic Pain, Depression, Opioid Use
Conditions
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.
Interventions
BEHAVIORALElectronic medical recorded clinical decision support [EMR CDS]
The opioid management tool has quick links to the Opioid Risk Tool (ORT), health maintenance reminders for risk mitigation tasks (pain management agreements; urine drug screening; prescribing naloxone); Pain Scale and depression/anxiety screen. The frequency with which providers are prompted to complete mitigation tasks is based on patients' level of risk for aberrant drug behavior defined by the ORT score. Additionally, the EMR CDS flags patients as high risk if one of the following criteria are met: (1) co-prescriptions for benzodiazepines; (2) active diagnosis of substance abuse in the last 12 months; or (3) MEDD \>=90 mg. The ORT score, morphine equivalent daily dose (MEDD), and hyperlinks to the Louisiana pharmacy drug monitoring program data are visible in the prescription writer. If MEDD \>=90 mg, the calculated MEDD is displayed in red font to alert the prescribing provider of high dosage. An Epic banner appears in charts to alert providers of existing pain management agreements.
BEHAVIORALStepped opioid collaborative care model [CCM]
The licensed clinical social worker (LCSW) will provide counseling services as indicated (behavioral activation, psychotherapy, crisis planning, facilitating connection to substance abuse counseling and treatment); meet weekly with the consulting psychiatrist for complex case review and care plan adjustments; and supervise the community health worker (CHW) case management and depression/anxiety care management activities. The CHW will update assets and barriers to recovery and self-management and help patients navigate community resources. The clinical pharmacist will review and reconcile active medication lists, assess medication side effects, drug interactions and adverse events; monitor analgesia; recommend algorithm based anti-depression medication titration as indicated. The consulting psychiatrist will directly co-manage patients with severe mental illness, substance abuse and complex medication regimens.
Sponsors
Ochsner Health System
Tulane University School of Public Health and Tropical Medicine
Harvard University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This proposal is a 4-year type 2 effectiveness-implementation hybrid stepped wedge cluster randomized control (cRCT) trial to evaluate a multi-component intervention to: electronic medical recorded (EMR)clinical decision support (CDS) guided care; and stepped opioid collaborative care model (CCM) to improve opioid management of primary care patients with chronic non-cancer pain. The stepped wedge cRCT design will allow us to examine the clinical impact of the intervention as the two components are implemented in a stepwise fashion across the health system. The EMR CDS guided care component went live in all primary care clinics as the health system's standard of practice in October 2017. The stepped opioid CCM component will require 15 months to scale up in 3-month intervals across five geographic regions of the health system in the state of Louisiana. We will randomize the order in which stepped opioid CCM becomes available in each region
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age 18 and older 2. Have a primary care provider at any of the study clinics 3. Receiving chronic opioid prescriptions (3 of the prior 4 months) for chronic non-cancer pain 4. Have a diagnosis of depression or anxiety
Exclusion criteria
1. Age less than 18 years 2. Active cancer or undergoing cancer treatment 3. Chronic cancer-related pain 4. Having a terminal illness 5. Receiving hospice care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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. |
| 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 |
| 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. |
| 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 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. |
| 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 |
Countries
United States
Participant flow
Recruitment details
Patient ENROLLMENT was CONTINUOUS following the go-live dates for each health system geographic region. Participants were referred for collaborative care management (CCM) between April 2019 and December 2021 for eligibility screening. All enrollment was completed by January 2022. A propensity matched control group (usual care) was identified among patients receiving care within the health system during the time of this study who were never exposed to the collaborative care intervention.
Pre-assignment details
Clinics within the same geographic region have the same operations management team and share resources. Using computer generated random numbers, each region (cluster) was randomized to the order of collaborative care intervention roll out in 5 steps occurring in 3 to 4-month intervals. Randomized sequence: (1) April 2019, Region 1; (2) July 2019, Region 2; (3) October 2019, Region 3; (4) January 2020, Region 4; (5) April 2020, Region 5.
Participants by arm
| Arm | Count |
|---|---|
| Electronic Medical Recorded Clinical Decision Support Electronic medical recorded clinical decision support (usual care) | 239 |
| Stepped Opioid Collaborative Care Model Usual care AND collaborative care with behavioral health integration | 239 |
| Total | 478 |
Baseline characteristics
| Characteristic | Electronic Medical Recorded Clinical Decision Support | Stepped Opioid Collaborative Care Model | Total |
|---|---|---|---|
| Age, Continuous | 56 years STANDARD_DEVIATION 14.8 | 57.3 years STANDARD_DEVIATION 11.9 | 56.6 years STANDARD_DEVIATION 13.4 |
| Anxiety | 208 Participants | 206 Participants | 414 Participants |
| Charlson Comorbidity Index | 4.0 Score on a scale STANDARD_DEVIATION 3.1 | 4.1 Score on a scale STANDARD_DEVIATION 3.4 | 4.1 Score on a scale STANDARD_DEVIATION 3.3 |
| Depression | 221 Participants | 224 Participants | 445 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 7 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 226 Participants | 231 Participants | 457 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Insurance Type Commercial | 107 Participants | 127 Participants | 234 Participants |
| Insurance Type Medicaid | 20 Participants | 16 Participants | 36 Participants |
| Insurance Type Medicare | 104 Participants | 93 Participants | 197 Participants |
| Insurance Type Self-Pay or Uninsured | 5 Participants | 3 Participants | 8 Participants |
| Insurance Type Unknown | 3 Participants | 0 Participants | 3 Participants |
| Morphine Equivalent Daily Dose | 40.3 mg per day STANDARD_DEVIATION 48.9 | 50.9 mg per day STANDARD_DEVIATION 73.2 | 45.5 mg per day STANDARD_DEVIATION 62.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 85 Participants | 89 Participants | 174 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 152 Participants | 148 Participants | 300 Participants |
| Region of Enrollment United States | 239 participants | 239 participants | 478 participants |
| Sex: Female, Male Female | 172 Participants | 169 Participants | 341 Participants |
| Sex: Female, Male Male | 67 Participants | 70 Participants | 137 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 239 | 3 / 239 |
| other Total, other adverse events | 24 / 239 | 17 / 239 |
| serious Total, serious adverse events | 39 / 239 | 35 / 239 |
Outcome results
Primary
Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg
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)
Time frame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)
Population: All participants who survived through end of study and had at least one documented opioid medication order, excluding buprenorphine and methadone, in the 12-month pre-index period are included in the analysis. Patients who died during the course of the study or were missing prescription data at baseline are not included in this analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg | Pre-Index | 0.209 odds of prescription high dose |
| Electronic Medical Recorded Clinical Decision Support | Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg | Post-Index | 0.185 odds of prescription high dose |
| Stepped Opioid Collaborative Care Model | Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg | Pre-Index | 0.417 odds of prescription high dose |
| Stepped Opioid Collaborative Care Model | Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg | Post-Index | 0.364 odds of prescription high dose |
p-value: 0.95695% CI: [-0.309, 0.292]Mixed Models Analysis
Secondary
Change in Patient Rating of Quality of Life
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.
Time frame: Baseline, 12-months following index event (post-index period)
Population: All Collaborative Care participants who completed at least two questionnaires and survived through end of study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Change in Patient Rating of Quality of Life | Baseline PROMIS-10 Global Mental Health Score | 34.001 units on a scale | Standard Deviation 7.191 |
| Electronic Medical Recorded Clinical Decision Support | Change in Patient Rating of Quality of Life | Change in PROMIS-10 Global Mental Health Score | 2.000 units on a scale | Standard Deviation 6.73 |
| Electronic Medical Recorded Clinical Decision Support | Change in Patient Rating of Quality of Life | Baseline PROMIS-10 Global Physical Health Score | 35.815 units on a scale | Standard Deviation 5.625 |
| Electronic Medical Recorded Clinical Decision Support | Change in Patient Rating of Quality of Life | Change in PROMIS-10 Global Physical Health Score | 0.929 units on a scale | Standard Deviation 5.275 |
Secondary
Change in Rate of Patient Report of Opioid Misuse
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.
Time frame: Baseline, 12 months following index event (post-index period)
Population: All collaborative care participants who completed at least two questionnaires and survived through end of study
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Change in Rate of Patient Report of Opioid Misuse | Baseline score | 4.8 units on a scale | Standard Deviation 2.9 |
| Electronic Medical Recorded Clinical Decision Support | Change in Rate of Patient Report of Opioid Misuse | Average change in score | -1.1 units on a scale | Standard Deviation 2.6 |
Secondary
Change in the Average Pain Score Among Participants Exposed to Collaborative Care
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.
Time frame: 12 months following index event (post-index period)
Population: All participants in the collaborative care study group who completed at least two questionnaires and survived through end of study were included in the analysis
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Change in the Average Pain Score Among Participants Exposed to Collaborative Care | Baseline score | 6.5 score on a scale | Standard Deviation 1.7 |
| Electronic Medical Recorded Clinical Decision Support | Change in the Average Pain Score Among Participants Exposed to Collaborative Care | Average change in score | -1.3 score on a scale | Standard Deviation 1.8 |
Secondary
Emergency Department Visits Per 1000 Participants
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
Time frame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)
Population: All participants who died during the course of the study are excluded from the analysis.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Emergency Department Visits Per 1000 Participants | Pre-Index | 1626 Visits per 1000 participants |
| Electronic Medical Recorded Clinical Decision Support | Emergency Department Visits Per 1000 Participants | Post-Index | 1526 Visits per 1000 participants |
| Stepped Opioid Collaborative Care Model | Emergency Department Visits Per 1000 Participants | Pre-Index | 1352 Visits per 1000 participants |
| Stepped Opioid Collaborative Care Model | Emergency Department Visits Per 1000 Participants | Post-Index | 1292 Visits per 1000 participants |
p-value: 0.90195% CI: [-0.272, 0.308]Mixed Models Analysis
Secondary
Inpatient Hospital Admission Per 1000 Participants
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
Time frame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)
Population: All participants who died during the course of the study are excluded from the analysis
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) |
|---|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Inpatient Hospital Admission Per 1000 Participants | Pre-Index | 528 Admissions per 1000 participants |
| Electronic Medical Recorded Clinical Decision Support | Inpatient Hospital Admission Per 1000 Participants | Post-Index | 413 Admissions per 1000 participants |
| Stepped Opioid Collaborative Care Model | Inpatient Hospital Admission Per 1000 Participants | Pre-Index | 309 Admissions per 1000 participants |
| Stepped Opioid Collaborative Care Model | Inpatient Hospital Admission Per 1000 Participants | Post-Index | 254 Admissions per 1000 participants |
p-value: 0.86495% CI: [-0.506, 0.603]Mixed Models Analysis
Secondary
New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service
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
Time frame: 12 months following index event (post-index period)
Population: All participants who survived through end of study and had no documented referrals to non-mental/behavioral health specialty services in the 12 months prior to enrollment in study were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service | 40 Participants |
| Stepped Opioid Collaborative Care Model | New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service | 45 Participants |
Secondary
New Post-index Documentation for Signed Pain Management Agreement (Pain Contract)
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
Time frame: 12 months following index event (post-index period)
Population: Participants who survived through end of study and had no documented pain contract in the 12 months prior to enrollment in study were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | New Post-index Documentation for Signed Pain Management Agreement (Pain Contract) | 21 Participants |
| Stepped Opioid Collaborative Care Model | New Post-index Documentation for Signed Pain Management Agreement (Pain Contract) | 23 Participants |
Secondary
New Post-index Naloxone Prescription Order
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
Time frame: 12 months following index event (post-index period)
Population: Participants who did not naloxone orders documented in their medical record in the 12 months prior to enrollment in study OR who survived to the end of the study were included from the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | New Post-index Naloxone Prescription Order | 10 Participants |
| Stepped Opioid Collaborative Care Model | New Post-index Naloxone Prescription Order | 23 Participants |
Secondary
New Post-index Order for Urine Drug Screen (UDS)
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
Time frame: 12 months following index event (post-index period)
Population: All participants who survived through end of study or loss to follow-up and had no documented UDS order in the 12 months prior to enrollment in study
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | New Post-index Order for Urine Drug Screen (UDS) | 23 Participants |
| Stepped Opioid Collaborative Care Model | New Post-index Order for Urine Drug Screen (UDS) | 33 Participants |
Secondary
New Post-index Orders for Antidepressant Medications
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
Time frame: 12 months following index event (post-index period)
Population: All participants who survived through end of study and had no orders for antidepressants in the 12 months prior to enrollment in study were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | New Post-index Orders for Antidepressant Medications | 37 Participants |
| Stepped Opioid Collaborative Care Model | New Post-index Orders for Antidepressant Medications | 49 Participants |
Secondary
Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety
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
Time frame: 12 months following index event (post-index period)
Population: All participants in the collaborative care study group with a baseline GAD-7 score ≥ 10 who completed at least two questionnaires and survived through end of study were included in the analysis
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety | 92 Participants |
Secondary
Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression
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.
Time frame: 12 months following index event (post-index period)
Population: All participants in the collaborative care arm of the study with a baseline PHQ-9 score ≥ 10 who completed at least two questionnaires and survived through end of study were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression | 129 Participants |
Secondary
Provider Experience With Managing Depression/Anxiety/Pain
Provider ratings of their experience with managing depression/anxiety/pain
Time frame: Baseline
Population: A cross-sectional survey was administered to primary care providers in December 2019 for baseline measure of provider confidence in managing depression, anxiety and chronic pain and use of defined care management protocols when prescribing medications. 93 out of 226 (41%) providers responded to the survey.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Use care management protocol when opioid medications prescribed | Neutral/Disagree/Strongly Disagree | 48 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Confident in ability to manage depression or anxiety | Strongly Agree or Agree | 83 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Confident in ability to manage depression or anxiety | Neutral/Disagree/Strongly Disagree | 10 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Confident in ability to manage depression or anxiety | Missing Data | 0 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Use care management protocol when depression or anxiety medication prescribed | Strongly Agree or Agree | 45 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Use care management protocol when depression or anxiety medication prescribed | Neutral/Disagree/Strongly Disagree | 47 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Use care management protocol when depression or anxiety medication prescribed | Missing Data | 1 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Confident in ability to manage chronic pain | Strongly Agree or Agree | 21 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Confident in ability to manage chronic pain | Neutral/Disagree/Strongly Disagree | 70 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Confident in ability to manage chronic pain | Missing Data | 2 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Use care management protocol when opioid medications prescribed | Strongly Agree or Agree | 44 Participants |
| Electronic Medical Recorded Clinical Decision Support | Provider Experience With Managing Depression/Anxiety/Pain | Use care management protocol when opioid medications prescribed | Missing Data | 1 Participants |
Secondary
Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods
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.
Time frame: 12 months prior to index event (pre-index period) and 12 months following index event (post-index period)
Population: All participants who survived through end of study and had at least one documented opioid medication order, excluding buprenorphine and methadone, in the 12-month pre-index period are included in the analysis. Patients who died during the course of the study or were missing prescription data at baseline are not included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Electronic Medical Recorded Clinical Decision Support | Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods | 0.957 Rate Ratio of average opioid dose |
| Stepped Opioid Collaborative Care Model | Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods | 0.863 Rate Ratio of average opioid dose |
p-value: 0.03995% CI: [-0.2, -0.005]Mixed Models Analysis