Trial Outcomes & Findings for Opioid Treatment and Recovery Through a Safe Pain Management Program (NCT NCT03889418)

Last Updated: 2024-08-28

Results Overview

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)

Recruitment status

COMPLETED

Study phase

Target enrollment

490 participants

Primary outcome timeframe

12 months prior to index event (pre-index period) and 12 months following index event (post-index period)

Results posted on

2024-08-28

Participant Flow

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.

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.

Unit of analysis: Geographic region

Participant milestones

Participant milestones
Measure	Sequence 1: Electronic Medical Recorded Clinical Decision Support (EMR-CDS) Usual care group within Region 1 of the health system that was only exposed to EMR-CDS for chronic opioid management.	Sequence 1: Stepped Opioid Collaborative Care Management (EMR-CDS With CCM) Study group in Region 1 of the health system who received usual care (EMR-CDS) AND collaborative care management with behavioral health integration.	Sequence 2: EMR-CDS Study group in Region 2 of health system receiving usual care	Sequence 2: EMR-CDS With CCM Study group in Region 2 of the health system receiving EMR-CDS and CCM	Sequence 3: EMR-CDS Study group in Region 3 of health system receiving usual care	Sequence 3: EMR-CDS With CCM Study group in Region 3 of the health system receiving EMR-CDS and CCM	Sequence 4: EMR-CDS Study group in Region 4 of health system receiving usual care	Sequence 4: EMR With CCM Study group in Region 4 of the health system receiving EMR-CDS and CCM	Sequence 5: EMR-CDS Study group in Region 5 of health system receiving usual care	Sequence 5: EMR With CCM Study group in Region 5 of the health system receiving EMR-CDS and CCM
April-June 2019 (Months 0-3) STARTED	48 1	10 1	21 1	0 0	14 1	0 0	10 1	0 0	12 1	0 0
April-June 2019 (Months 0-3) COMPLETED	47 1	10 1	21 1	0 0	14 1	0 0	10 1	0 0	12 1	0 0
April-June 2019 (Months 0-3) NOT COMPLETED	1 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
July-September 2019 (Months 4-6) STARTED	54 1	20 1	23 1	2 1	16 1	1 0	10 1	0 0	13 1	0 0
July-September 2019 (Months 4-6) COMPLETED	54 1	19 1	22 1	2 1	16 1	1 0	10 1	0 0	13 1	0 0
July-September 2019 (Months 4-6) NOT COMPLETED	0 0	1 0	1 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0
October-December 2019 (Month 7-9) STARTED	60 1	36 1	28 1	11 1	16 1	1 1	12 1	0 0	16 1	1 0
October-December 2019 (Month 7-9) COMPLETED	60 1	36 1	28 1	11 1	16 1	1 1	12 1	0 0	15 1	1 0
October-December 2019 (Month 7-9) NOT COMPLETED	0 0	0 0	0 0	0 0	0 0	0 0	0 0	0 0	1 0	0 0
January - March 2020 (Month 10-12) STARTED	67 1	48 1	34 1	24 1	16 1	2 1	13 1	5 1	16 1	1 0
January - March 2020 (Month 10-12) COMPLETED	67 1	48 1	34 1	23 1	16 1	2 1	13 1	3 1	16 1	1 0
January - March 2020 (Month 10-12) NOT COMPLETED	0 0	0 0	0 0	1 0	0 0	0 0	0 0	2 0	0 0	0 0
April - June 2020 (Month 13-15) STARTED	75 1	60 1	38 1	27 1	19 1	2 1	16 1	3 1	19 1	4 1
April - June 2020 (Month 13-15) COMPLETED	75 1	59 1	38 1	26 1	19 1	2 1	16 1	3 1	19 1	4 1
April - June 2020 (Month 13-15) NOT COMPLETED	0 0	1 0	0 0	1 0	0 0	0 0	0 0	0 0	0 0	0 0
July 2020 - January 2022 (Month 16-28) STARTED	101 1	112 1	67 1	52 1	21 1	6 1	24 1	21 1	23 1	42 1
July 2020 - January 2022 (Month 16-28) COMPLETED	100 1	108 1	63 1	50 1	21 1	6 1	24 1	19 1	23 1	38 1
July 2020 - January 2022 (Month 16-28) NOT COMPLETED	1 0	4 0	4 0	2 0	0 0	0 0	0 0	2 0	0 0	4 0

Reasons for withdrawal

Reasons for withdrawal
Measure	Sequence 1: Electronic Medical Recorded Clinical Decision Support (EMR-CDS) Usual care group within Region 1 of the health system that was only exposed to EMR-CDS for chronic opioid management.	Sequence 1: Stepped Opioid Collaborative Care Management (EMR-CDS With CCM) Study group in Region 1 of the health system who received usual care (EMR-CDS) AND collaborative care management with behavioral health integration.	Sequence 2: EMR-CDS Study group in Region 2 of health system receiving usual care	Sequence 2: EMR-CDS With CCM Study group in Region 2 of the health system receiving EMR-CDS and CCM	Sequence 4: EMR With CCM Study group in Region 4 of the health system receiving EMR-CDS and CCM	Sequence 5: EMR-CDS Study group in Region 5 of health system receiving usual care	Sequence 5: EMR With CCM Study group in Region 5 of the health system receiving EMR-CDS and CCM
April-June 2019 (Months 0-3) Protocol Violation	1	0	0	0	0	0	0
July-September 2019 (Months 4-6) Protocol Violation	0	1	1	0	0	0	0
October-December 2019 (Month 7-9) Death	0	0	0	0	0	1	0
January - March 2020 (Month 10-12) Protocol Violation	0	0	0	1	2	0	0
April - June 2020 (Month 13-15) Death	0	1	0	0	0	0	0
April - June 2020 (Month 13-15) Protocol Violation	0	0	0	1	0	0	0
July 2020 - January 2022 (Month 16-28) Death	1	0	2	1	1	0	0
July 2020 - January 2022 (Month 16-28) Protocol Violation	0	4	2	1	1	0	4

Baseline Characteristics

Only patients who survived throughout the study time period and with data documented in the electronic medical record system 12-months before the index date are included in the analysis.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Electronic Medical Recorded Clinical Decision Support n=239 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=239 Participants Usual care AND collaborative care with behavioral health integration	Total n=478 Participants Total of all reporting groups
Age, Continuous	56 years STANDARD_DEVIATION 14.8 • n=239 Participants	57.3 years STANDARD_DEVIATION 11.9 • n=239 Participants	56.6 years STANDARD_DEVIATION 13.4 • n=478 Participants
Sex: Female, Male Female	172 Participants n=239 Participants	169 Participants n=239 Participants	341 Participants n=478 Participants
Sex: Female, Male Male	67 Participants n=239 Participants	70 Participants n=239 Participants	137 Participants n=478 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	12 Participants n=239 Participants	7 Participants n=239 Participants	19 Participants n=478 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	226 Participants n=239 Participants	231 Participants n=239 Participants	457 Participants n=478 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=239 Participants	1 Participants n=239 Participants	2 Participants n=478 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=239 Participants	1 Participants n=239 Participants	1 Participants n=478 Participants
Race (NIH/OMB) Asian	1 Participants n=239 Participants	0 Participants n=239 Participants	1 Participants n=478 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=239 Participants	0 Participants n=239 Participants	0 Participants n=478 Participants
Race (NIH/OMB) Black or African American	85 Participants n=239 Participants	89 Participants n=239 Participants	174 Participants n=478 Participants
Race (NIH/OMB) White	152 Participants n=239 Participants	148 Participants n=239 Participants	300 Participants n=478 Participants
Race (NIH/OMB) More than one race	0 Participants n=239 Participants	0 Participants n=239 Participants	0 Participants n=478 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=239 Participants	1 Participants n=239 Participants	2 Participants n=478 Participants
Region of Enrollment United States	239 participants n=239 Participants	239 participants n=239 Participants	478 participants n=478 Participants
Insurance Type Commercial	107 Participants n=239 Participants	127 Participants n=239 Participants	234 Participants n=478 Participants
Insurance Type Medicare	104 Participants n=239 Participants	93 Participants n=239 Participants	197 Participants n=478 Participants
Insurance Type Medicaid	20 Participants n=239 Participants	16 Participants n=239 Participants	36 Participants n=478 Participants
Insurance Type Self-Pay or Uninsured	5 Participants n=239 Participants	3 Participants n=239 Participants	8 Participants n=478 Participants
Insurance Type Unknown	3 Participants n=239 Participants	0 Participants n=239 Participants	3 Participants n=478 Participants
Charlson Comorbidity Index	4.0 Score on a scale STANDARD_DEVIATION 3.1 • n=239 Participants	4.1 Score on a scale STANDARD_DEVIATION 3.4 • n=239 Participants	4.1 Score on a scale STANDARD_DEVIATION 3.3 • n=478 Participants
Depression	221 Participants n=239 Participants	224 Participants n=239 Participants	445 Participants n=478 Participants
Anxiety	208 Participants n=239 Participants	206 Participants n=239 Participants	414 Participants n=478 Participants
Morphine Equivalent Daily Dose	40.3 mg per day STANDARD_DEVIATION 48.9 • n=231 Participants • Only patients who survived throughout the study time period and with data documented in the electronic medical record system 12-months before the index date are included in the analysis.	50.9 mg per day STANDARD_DEVIATION 73.2 • n=221 Participants • Only patients who survived throughout the study time period and with data documented in the electronic medical record system 12-months before the index date are included in the analysis.	45.5 mg per day STANDARD_DEVIATION 62.5 • n=452 Participants • Only patients who survived throughout the study time period and with data documented in the electronic medical record system 12-months before the index date are included in the analysis.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=231 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=221 Participants Usual care AND collaborative care with behavioral health integration
Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg Pre-Index	0.209 odds of prescription high dose Interval 0.149 to 0.295	0.417 odds of prescription high dose Interval 0.312 to 0.557
Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg Post-Index	0.185 odds of prescription high dose Interval 0.129 to 0.264	0.364 odds of prescription high dose Interval 0.27 to 0.491

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=231 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=221 Participants Usual care AND collaborative care with behavioral health integration
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 Interval 0.903 to 1.014	0.863 Rate Ratio of average opioid dose Interval 0.798 to 0.934

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=235 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=236 Participants Usual care AND collaborative care with behavioral health integration
Inpatient Hospital Admission Per 1000 Participants Pre-Index	528 Admissions per 1000 participants Interval 362.0 to 769.0	309 Admissions per 1000 participants Interval 213.0 to 450.0
Inpatient Hospital Admission Per 1000 Participants Post-Index	413 Admissions per 1000 participants Interval 276.0 to 616.0	254 Admissions per 1000 participants Interval 170.0 to 379.0

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=235 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=236 Participants Usual care AND collaborative care with behavioral health integration
Emergency Department Visits Per 1000 Participants Pre-Index	1626 Visits per 1000 participants Interval 1243.0 to 2127.0	1352 Visits per 1000 participants Interval 1034.0 to 1767.0
Emergency Department Visits Per 1000 Participants Post-Index	1526 Visits per 1000 participants Interval 1131.0 to 2059.0	1292 Visits per 1000 participants Interval 958.0 to 1742.0

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=209 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model Usual care AND collaborative care with behavioral health integration
Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression	129 Participants	—

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=161 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model Usual care AND collaborative care with behavioral health integration
Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety	92 Participants	—

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=217 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model Usual care AND collaborative care with behavioral health integration
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	—
Change in Patient Rating of Quality of Life Change in PROMIS-10 Global Mental Health Score	2.000 units on a scale Standard Deviation 6.730	—
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	—
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 outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=199 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model Usual care AND collaborative care with behavioral health integration
Change in the Average Pain Score Among Participants Exposed to Collaborative Care Baseline score	6.5 score on a scale Standard Deviation 1.7	—
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 outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=183 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=188 Participants Usual care AND collaborative care with behavioral health integration
New Post-index Documentation for Signed Pain Management Agreement (Pain Contract)	21 Participants	23 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=160 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=149 Participants Usual care AND collaborative care with behavioral health integration
New Post-index Order for Urine Drug Screen (UDS)	23 Participants	33 Participants

SECONDARY outcome

Timeframe: 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.

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

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=222 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=199 Participants Usual care AND collaborative care with behavioral health integration
New Post-index Naloxone Prescription Order	10 Participants	23 Participants

SECONDARY outcome

Timeframe: 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

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.

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=145 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model Usual care AND collaborative care with behavioral health integration
Change in Rate of Patient Report of Opioid Misuse Baseline score	4.8 units on a scale Standard Deviation 2.9	—
Change in Rate of Patient Report of Opioid Misuse Average change in score	-1.1 units on a scale Standard Deviation 2.6	—

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=115 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=85 Participants Usual care AND collaborative care with behavioral health integration
New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service	40 Participants	45 Participants

SECONDARY outcome

Timeframe: 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

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

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=117 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=98 Participants Usual care AND collaborative care with behavioral health integration
New Post-index Orders for Antidepressant Medications	37 Participants	49 Participants

SECONDARY outcome

Timeframe: 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.

Provider ratings of their experience with managing depression/anxiety/pain

Outcome measures

Outcome measures
Measure	Electronic Medical Recorded Clinical Decision Support n=93 Participants Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model Usual care AND collaborative care with behavioral health integration
Provider Experience With Managing Depression/Anxiety/Pain Confident in ability to manage depression or anxiety · Strongly Agree or Agree	83 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Confident in ability to manage depression or anxiety · Neutral/Disagree/Strongly Disagree	10 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Confident in ability to manage depression or anxiety · Missing Data	0 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Use care management protocol when depression or anxiety medication prescribed · Strongly Agree or Agree	45 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Use care management protocol when depression or anxiety medication prescribed · Neutral/Disagree/Strongly Disagree	47 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Use care management protocol when depression or anxiety medication prescribed · Missing Data	1 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Confident in ability to manage chronic pain · Strongly Agree or Agree	21 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Confident in ability to manage chronic pain · Neutral/Disagree/Strongly Disagree	70 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Confident in ability to manage chronic pain · Missing Data	2 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Use care management protocol when opioid medications prescribed · Strongly Agree or Agree	44 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Use care management protocol when opioid medications prescribed · Neutral/Disagree/Strongly Disagree	48 Participants	—
Provider Experience With Managing Depression/Anxiety/Pain Use care management protocol when opioid medications prescribed · Missing Data	1 Participants	—

Adverse Events

Electronic Medical Recorded Clinical Decision Support

Serious events: 39 serious events

Other events: 24 other events

Deaths: 4 deaths

Stepped Opioid Collaborative Care Model

Serious events: 35 serious events

Other events: 17 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Electronic Medical Recorded Clinical Decision Support n=239 participants at risk Electronic medical recorded clinical decision support (usual care)	Stepped Opioid Collaborative Care Model n=239 participants at risk Usual care AND collaborative care with behavioral health integration
Respiratory, thoracic and mediastinal disorders Chest pain	10.0% 24/239 • Number of events 33 • Using Diagnosis Related Group (DRG) codes, adverse events were assessed during 12 months following index event Serious Adverse Events include inpatient admissions with emergency or non-elective admission types with a length of stay \>1 day.	7.1% 17/239 • Number of events 32 • Using Diagnosis Related Group (DRG) codes, adverse events were assessed during 12 months following index event Serious Adverse Events include inpatient admissions with emergency or non-elective admission types with a length of stay \>1 day.

Additional Information

Principal Investigator

Ochsner Health

Phone: 504-842-8256

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place