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Opioid Treatment and Recovery Through a Safe Pain Management Program

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ClinicalTrials.gov Identifier: NCT03889418
Recruitment Status : Completed
First Posted : March 26, 2019
Results First Posted : December 12, 2023
Last Update Posted : December 12, 2023
Sponsor:
Collaborators:
Tulane University School of Public Health and Tropical Medicine
Harvard University
Information provided by (Responsible Party):
Eboni Price-Haywood, Ochsner Health System

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Crossover Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Health Services Research
Conditions Depression
Opioid Use
Chronic Pain
Anxiety
Interventions Behavioral: Electronic medical recorded clinical decision support [EMR CDS]
Behavioral: Stepped opioid collaborative care model [CCM]
Enrollment 490
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.
Arm/Group Title Sequence 1: Electronic Medical Recorded Clinical Decision Support (EMR-CDS) Sequence 1: Stepped Opioid Collaborative Care Management (EMR-CDS With CCM) Sequence 2: EMR-CDS Sequence 2: EMR-CDS With CCM Sequence 3: EMR-CDS Sequence 3: EMR-CDS With CCM Sequence 4: EMR-CDS Sequence 4: EMR With CCM Sequence 5: EMR-CDS Sequence 5: EMR With CCM
Hide Arm/Group Description Usual care group within Region 1 of the health system that was only exposed to EMR-CDS for chronic opioid management. Study group in Region 1 of the health system who received usual care (EMR-CDS) AND collaborative care management with behavioral health integration. Study group in Region 2 of health system receiving usual care Study group in Region 2 of the health system receiving EMR-CDS and CCM Study group in Region 3 of health system receiving usual care Study group in Region 3 of the health system receiving EMR-CDS and CCM Study group in Region 4 of health system receiving usual care Study group in Region 4 of the health system receiving EMR-CDS and CCM Study group in Region 5 of health system receiving usual care Study group in Region 5 of the health system receiving EMR-CDS and CCM
Period Title: April-June 2019 (Months 0-3)
Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region)
Started [1] 48 1 10 1 21 1 0 0 14 1 0 0 10 1 0 0 12 1 0 0
Completed 47 1 10 1 21 1 0 0 14 1 0 0 10 1 0 0 12 1 0 0
Not Completed 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Protocol Violation             1                         0                         0                         0                         0                         0                         0                         0                         0                         0            
[1]
[EMR-CDS with CCM] participants started enrollment in region 1 in period 1. In Region 2, 3, 4 & 5, only EMR-CDS (usual care) matched controls were identified. Note: Number of participants to start a period includes number that completed the previous period and newly enrolled participants.
Period Title: July-September 2019 (Months 4-6)
Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region)
Started [1] 54 1 20 1 23 1 2 1 16 1 1 0 10 1 0 0 13 1 0 0
Completed 54 1 19 1 22 1 2 1 16 1 1 0 10 1 0 0 13 1 0 0
Not Completed 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Protocol Violation             0                         1                         1                         0                         0                         0                         0                         0                         0                         0            
[1]
[EMR-CDS with CCM] participants started enrollment in region 2 in period 2. In Region 3, 4 & 5, only EMR-CDS (usual care) matched controls were identified. Note: Number of participants to start a period includes number that completed the previous period and newly enrolled participants.
Period Title: October-December 2019 (Month 7-9)
Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region)
Started [1] 60 1 36 1 28 1 11 1 16 1 1 1 12 1 0 0 16 1 1 [2] 0
Completed 60 1 36 1 28 1 11 1 16 1 1 1 12 1 0 0 15 1 1 0
Not Completed 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0
Reason Not Completed
Death             0                         0                         0                         0                         0                         0                         0                         0                         1                         0            
[1]
[EMR-CDS with CCM] participants started enrollment in region 3 in period 3. In Regions 4 & 5, EMR-CDS (usual care) matched controls were identified. Note: Number of participants to start a period includes number that completed the previous period and newly enrolled participants.
[2]
Patient recruited out of sequence but retained in study.
Period Title: January - March 2020 (Month 10-12)
Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region)
Started [1] 67 1 48 1 34 1 24 1 16 1 2 1 13 1 5 1 16 1 1 0
Completed 67 1 48 1 34 1 23 1 16 1 2 1 13 1 3 1 16 1 1 0
Not Completed 0 0 0 0 0 0 1 0 0 0 0 0 0 0 2 0 0 0 0 0
Reason Not Completed
Protocol Violation             0                         0                         0                         1                         0                         0                         0                         2                         0                         0            
[1]
[EMR-CDS with CCM] participants started enrollment in region 4 in period 4. In Region 5, only EMR-CDS (usual care) matched controls were identified. Note: Number of participants to start a period includes number that completed the previous period and newly enrolled participants.
Period Title: April - June 2020 (Month 13-15)
Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region)
Started [1] 75 1 60 1 38 1 27 1 19 1 2 1 16 1 3 1 19 1 4 1
Completed 75 1 59 1 38 1 26 1 19 1 2 1 16 1 3 1 19 1 4 1
Not Completed 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0
Reason Not Completed
Death             0                         1                         0                         0                         0                         0                         0                         0                         0                         0            
Protocol Violation             0                         0                         0                         1                         0                         0                         0                         0                         0                         0            
[1]
[EMR-CDS with CCM] participants started enrollment in region 5 in period 5. Note: Number of participants to start a period includes number that completed the previous period and newly enrolled participants.
Period Title: July 2020 - January 2022 (Month 16-28)
Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region) Number of participants Number of units (Geographic region)
Started 101 1 112 1 67 1 52 1 21 1 6 1 24 1 21 1 23 1 42 1
Completed 100 1 108 1 63 1 50 1 21 1 6 1 24 1 19 1 23 1 38 1
Not Completed 1 0 4 0 4 0 2 0 0 0 0 0 0 0 2 0 0 0 4 0
Reason Not Completed
Death             1                         0                         2                         1                         0                         0                         0                         1                         0                         0            
Protocol Violation             0                         4                         2                         1                         0                         0                         0                         1                         0                         4            
Arm/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model Total
Hide Arm/Group Description Electronic medical recorded clinical decision support (usual care) Usual care AND collaborative care with behavioral health integration Total of all reporting groups
Overall Number of Baseline Participants 239 239 478
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 239 participants 239 participants 478 participants
56  (14.8) 57.3  (11.9) 56.6  (13.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
Female
172
  72.0%
169
  70.7%
341
  71.3%
Male
67
  28.0%
70
  29.3%
137
  28.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
Hispanic or Latino
12
   5.0%
7
   2.9%
19
   4.0%
Not Hispanic or Latino
226
  94.6%
231
  96.7%
457
  95.6%
Unknown or Not Reported
1
   0.4%
1
   0.4%
2
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
American Indian or Alaska Native
0
   0.0%
1
   0.4%
1
   0.2%
Asian
1
   0.4%
0
   0.0%
1
   0.2%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
85
  35.6%
89
  37.2%
174
  36.4%
White
152
  63.6%
148
  61.9%
300
  62.8%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
1
   0.4%
1
   0.4%
2
   0.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 239 participants 239 participants 478 participants
239 239 478
Insurance Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
Commercial
107
  44.8%
127
  53.1%
234
  49.0%
Medicare
104
  43.5%
93
  38.9%
197
  41.2%
Medicaid
20
   8.4%
16
   6.7%
36
   7.5%
Self-Pay or Uninsured
5
   2.1%
3
   1.3%
8
   1.7%
Unknown
3
   1.3%
0
   0.0%
3
   0.6%
Charlson Comorbidity Index   [1] 
Mean (Standard Deviation)
Unit of measure:  Score on a scale
Number Analyzed 239 participants 239 participants 478 participants
4.0  (3.1) 4.1  (3.4) 4.1  (3.3)
[1]
Measure Description: Charlson Comorbidity Index is a validated method of estimating the 10-year risk of death from concurrent disease. The higher the score, the higher the predicted risk of mortality. The index score is based on 17 different medical conditions categories defined by the International Classification of Disease. Each comorbidity category has an associated weight (from 1 to 6). The condition-specific scores are summed for the overall score (range 0 to 29). Refer to online calculators to predict mortality risk for a given score.
Depression   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
221
  92.5%
224
  93.7%
445
  93.1%
[1]
Measure Description: International Classification Disease diagnose code for Major Depression Disorder documented in patient medical record
Anxiety   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 239 participants 239 participants 478 participants
208
  87.0%
206
  86.2%
414
  86.6%
[1]
Measure Description: International Classification Disease diagnosis code for anxiety disorders documented in patient medical record
Morphine Equivalent Daily Dose   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Mg per day
Number Analyzed 231 participants 221 participants 452 participants
40.3  (48.9) 50.9  (73.2) 45.5  (62.5)
[1]
Measure Description: Morphine Equivalent Daily Dose (MEDD) is calculated by determining the total daily amount of a prescribed opioid, multiplying the dose of the opioid by a conversion factor to ascertain morphine milligram equivalents and then adding up the dosage.
[2]
Measure Analysis Population Description: 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.
1.Primary Outcome
Title Odds of Morphine Equivalent Daily Dose (MEDD) of Opioid Prescription >=50 mg
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 231 221
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: odds of prescription high dose
Pre-Index
0.209
(0.149 to 0.295)
0.417
(0.312 to 0.557)
Post-Index
0.185
(0.129 to 0.264)
0.364
(0.270 to 0.491)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Medical Recorded Clinical Decision Support, Stepped Opioid Collaborative Care Model
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.956
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio, log
Estimated Value -0.009
Confidence Interval (2-Sided) 95%
-0.309 to 0.292
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.153
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Rate Ratios for Average Morphine Equivalent Daily Dose (MEDD) of Opioid Prescriptions in the Post-index Versus Pre-index Periods
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 231 221
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Rate Ratio of average opioid dose
0.957
(0.903 to 1.014)
0.863
(0.798 to 0.934)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Medical Recorded Clinical Decision Support, Stepped Opioid Collaborative Care Model
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.039
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Ratio, log
Estimated Value -0.103
Confidence Interval (2-Sided) 95%
-0.200 to -.005
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.050
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Inpatient Hospital Admission Per 1000 Participants
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who died during the course of the study are excluded from the analysis
Arm/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 235 236
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Admissions per 1000 participants
Pre-Index
528
(362 to 769)
309
(213 to 450)
Post-Index
413
(276 to 616)
254
(170 to 379)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Medical Recorded Clinical Decision Support, Stepped Opioid Collaborative Care Model
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.864
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter Rate Ratio, log
Estimated Value 0.049
Confidence Interval (2-Sided) 95%
-0.506 to 0.603
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.282
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Emergency Department Visits Per 1000 Participants
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants who died during the course of the study are excluded from the analysis.
Arm/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 235 236
Least Squares Mean (95% Confidence Interval)
Unit of Measure: Visits per 1000 participants
Pre-Index
1626
(1243 to 2127)
1352
(1034 to 1767)
Post-Index
1526
(1131 to 2059)
1292
(958 to 1742)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Electronic Medical Recorded Clinical Decision Support, Stepped Opioid Collaborative Care Model
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.901
Comments [Not Specified]
Method Mixed Models Analysis
Comments [Not Specified]
Method of Estimation Estimation Parameter rate ratio, log
Estimated Value 0.018
Confidence Interval (2-Sided) 95%
-0.272 to 0.308
Parameter Dispersion
Type: Standard Error of the Mean
Value: 0.148
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Depression
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 209
Measure Type: Count of Participants
Unit of Measure: Participants
129
  61.7%
6.Secondary Outcome
Title Proportion of Patients Exposed to Collaborative Care With Improvement in Symptoms of Anxiety
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 161
Measure Type: Count of Participants
Unit of Measure: Participants
92
  57.1%
7.Secondary Outcome
Title Change in Patient Rating of Quality of Life
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
All Collaborative Care participants who completed at least two questionnaires and survived through end of study
Arm/Group Title Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 217
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline PROMIS-10 Global Mental Health Score 34.001  (7.191)
Change in PROMIS-10 Global Mental Health Score 2.000  (6.730)
Baseline PROMIS-10 Global Physical Health Score 35.815  (5.625)
Change in PROMIS-10 Global Physical Health Score 0.929  (5.275)
8.Secondary Outcome
Title Change in the Average Pain Score Among Participants Exposed to Collaborative Care
Hide Description 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)
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Hide Analysis Population Description
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/Group Title Stepped Opioid Collaborative Care Model
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Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 199
Mean (Standard Deviation)
Unit of Measure: score on a scale
Baseline score 6.5  (1.7)
Average change in score -1.3  (1.8)
9.Secondary Outcome
Title New Post-index Documentation for Signed Pain Management Agreement (Pain Contract)
Hide Description 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)
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Hide Analysis Population Description
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/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
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Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 183 188
Measure Type: Count of Participants
Unit of Measure: Participants
21
  11.5%
23
  12.2%
10.Secondary Outcome
Title New Post-index Order for Urine Drug Screen (UDS)
Hide Description 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)
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Hide Analysis Population Description
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/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 160 149
Measure Type: Count of Participants
Unit of Measure: Participants
23
  14.4%
33
  22.1%
11.Secondary Outcome
Title New Post-index Naloxone Prescription Order
Hide Description 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)
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Hide Analysis Population Description
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/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 222 199
Measure Type: Count of Participants
Unit of Measure: Participants
10
   4.5%
23
  11.6%
12.Secondary Outcome
Title Change in Rate of Patient Report of Opioid Misuse
Hide Description 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)
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Hide Analysis Population Description
All collaborative care participants who completed at least two questionnaires and survived through end of study
Arm/Group Title Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 145
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline score 4.8  (2.9)
Average change in score -1.1  (2.6)
13.Secondary Outcome
Title New Post-index Documentation for Referral to Any Non-mental/Behavioral Health Specialty Service
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 115 85
Measure Type: Count of Participants
Unit of Measure: Participants
40
  34.8%
45
  52.9%
14.Secondary Outcome
Title New Post-index Orders for Antidepressant Medications
Hide Description 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)
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description:
Electronic medical recorded clinical decision support (usual care)
Usual care AND collaborative care with behavioral health integration
Overall Number of Participants Analyzed 117 98
Measure Type: Count of Participants
Unit of Measure: Participants
37
  31.6%
49
  50.0%
15.Secondary Outcome
Title Provider Experience With Managing Depression/Anxiety/Pain
Hide Description Provider ratings of their experience with managing depression/anxiety/pain
Time Frame Baseline
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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/Group Title Primary Care Providers
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Physicians and Advanced Practice Practitioners who provide primary care within the health system
Overall Number of Participants Analyzed 93
Measure Type: Count of Participants
Unit of Measure: Participants
Confident in ability to manage depression or anxiety Strongly Agree or Agree
83
  89.2%
Neutral/Disagree/Strongly Disagree
10
  10.8%
Missing Data
0
   0.0%
Use care management protocol when depression or anxiety medication prescribed Strongly Agree or Agree
45
  48.4%
Neutral/Disagree/Strongly Disagree
47
  50.5%
Missing Data
1
   1.1%
Confident in ability to manage chronic pain Strongly Agree or Agree
21
  22.6%
Neutral/Disagree/Strongly Disagree
70
  75.3%
Missing Data
2
   2.2%
Use care management protocol when opioid medications prescribed Strongly Agree or Agree
44
  47.3%
Neutral/Disagree/Strongly Disagree
48
  51.6%
Missing Data
1
   1.1%
Time Frame Using Diagnosis Related Group (DRG) codes, adverse events were assessed during 12 months following index event
Adverse Event Reporting Description Serious Adverse Events include inpatient admissions with emergency or non-elective admission types with a length of stay >1 day.
 
Arm/Group Title Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Hide Arm/Group Description Electronic medical recorded clinical decision support (usual care) Usual care AND collaborative care with behavioral health integration
All-Cause Mortality
Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Affected / at Risk (%) Affected / at Risk (%)
Total   4/239 (1.67%)      3/239 (1.26%)    
Hide Serious Adverse Events
Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   39/239 (16.32%)      35/239 (14.64%)    
Blood and lymphatic system disorders     
Major hematological and immunological diagnoses * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Red blood cell disorder * 1  4/239 (1.67%)  20 3/239 (1.26%)  10
Cardiac disorders     
Myocardial Infarction * 1  1/239 (0.42%)  1 1/239 (0.42%)  1
Atherosclerosis * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Heart failure * 1  5/239 (2.09%)  10 5/239 (2.09%)  5
Hypertension * 1  1/239 (0.42%)  6 0/239 (0.00%)  0
Endocrine disorders     
Diabetes * 1  4/239 (1.67%)  4 0/239 (0.00%)  0
Disorders of nutrition, metabolism, fluids and electrolytes * 1  3/239 (1.26%)  4 1/239 (0.42%)  1
Gastrointestinal disorders     
Disorders of pancreas except malignancy * 1  1/239 (0.42%)  1 1/239 (0.42%)  1
Esophagitis, Gastroenteritis and Misc Digestive Disorders * 1  1/239 (0.42%)  1 2/239 (0.84%)  2
Gastrointestinal hemorrhage * 1  1/239 (0.42%)  2 0/239 (0.00%)  0
Gastrointestinal obstruction * 1  0/239 (0.00%)  0 1/239 (0.42%)  1
Major gastrointestinal disorders and peritoneal infections * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Major small and large bowel procedures * 1  0/239 (0.00%)  0 1/239 (0.42%)  1
General disorders     
Epistaxis * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Infections and infestations     
Infectious and parasitic diseases * 1  2/239 (0.84%)  2 0/239 (0.00%)  0
Post-operative and post-traumatic infections * 1  0/239 (0.00%)  0 2/239 (0.84%)  2
Septicemia or severe sepsis * 1  1/239 (0.42%)  1 8/239 (3.35%)  9
Injury, poisoning and procedural complications     
Complications of treatment * 1  0/239 (0.00%)  0 1/239 (0.42%)  1
Musculoskeletal and connective tissue disorders     
Medical back problems * 1  0/239 (0.00%)  0 1/239 (0.42%)  1
Nervous system disorders     
Intracranial hemorrhage or cerebral infarction * 1  1/239 (0.42%)  1 2/239 (0.84%)  2
Seizures * 1  1/239 (0.42%)  1 1/239 (0.42%)  1
Syncope and collapse * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Traumatic stupor and coma * 1  1/239 (0.42%)  2 0/239 (0.00%)  0
Renal and urinary disorders     
Kidney and urinary tract infections * 1  0/239 (0.00%)  0 1/239 (0.42%)  1
Other kidney and urinary tract diagnoses * 1  2/239 (0.84%)  3 0/239 (0.00%)  0
Renal failure * 1  4/239 (1.67%)  4 1/239 (0.42%)  1
Respiratory, thoracic and mediastinal disorders     
Major chest trauma * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Pulmonary edema and respiratory failure * 1  3/239 (1.26%)  3 0/239 (0.00%)  0
Respiratory infections and inflammations * 1  2/239 (0.84%)  2 4/239 (1.67%)  4
Respiratory system diagnosis with ventilator support * 1  2/239 (0.84%)  2 0/239 (0.00%)  0
Simple pneumonia and pleurisy * 1  2/239 (0.84%)  2 0/239 (0.00%)  0
Skin and subcutaneous tissue disorders     
Cellulitis * 1  1/239 (0.42%)  2 1/239 (0.42%)  1
Minor skin disorders * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Skin graft * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Surgical and medical procedures     
Amputation * 1  2/239 (0.84%)  2 1/239 (0.42%)  1
Operating Room Procedure * 1  3/239 (1.26%)  4 1/239 (0.42%)  1
Hip and femur procedure * 1  1/239 (0.42%)  1 1/239 (0.42%)  1
Other skin, subcutaneous tissue and breast procedures * 1  2/239 (0.84%)  2 1/239 (0.42%)  1
Other vascular procedure * 1  0/239 (0.00%)  0 1/239 (0.42%)  1
Peritoneal adhesiolysis * 1  1/239 (0.42%)  1 0/239 (0.00%)  0
Spinal procedures or spinal neurostimulators * 1  0/239 (0.00%)  0 1/239 (0.42%)  1
Tracheostomy * 1  0/239 (0.00%)  0 1/239 (0.42%)  1
1
Term from vocabulary, DRG
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Electronic Medical Recorded Clinical Decision Support Stepped Opioid Collaborative Care Model
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/239 (10.04%)      17/239 (7.11%)    
Respiratory, thoracic and mediastinal disorders     
Chest pain * 1  24/239 (10.04%)  33 17/239 (7.11%)  32
1
Term from vocabulary, DRG
*
Indicates events were collected by non-systematic assessment
All data collected for the study were extracted from the health system electronic medical system.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
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Name/Title: Principal Investigator
Organization: Ochsner Health
Phone: 504-842-8256
EMail: eboni.pricehaywood@ochsner.org
Publications:
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Responsible Party: Eboni Price-Haywood, Ochsner Health System
ClinicalTrials.gov Identifier: NCT03889418    
Other Study ID Numbers: 1R01DA045029-01 ( U.S. NIH Grant/Contract )
First Submitted: March 20, 2019
First Posted: March 26, 2019
Results First Submitted: August 22, 2023
Results First Posted: December 12, 2023
Last Update Posted: December 12, 2023