Trial Outcomes & Findings for Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study (NCT NCT03026790)

NCT ID: NCT03026790

Last Updated: 2023-06-05

Results Overview

Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 820 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-06-05

Participant Flow

Participant milestones

Measure	Active Comparator: Telecare Collaborative Management (TCM) Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Overall Study STARTED	411	409
Overall Study COMPLETED	358	363
Overall Study NOT COMPLETED	53	46

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Veterans' Pain Care Organizational Improvement Comparative Effectiveness Study

Baseline characteristics by cohort

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=411 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=409 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.	Total n=820 Participants Total of all reporting groups
Age, Continuous	62.1 years STANDARD_DEVIATION 10.8 • n=5 Participants	62.2 years STANDARD_DEVIATION 10.4 • n=7 Participants	62.2 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	51 Participants n=7 Participants	111 Participants n=5 Participants
Sex: Female, Male Male	351 Participants n=5 Participants	358 Participants n=7 Participants	709 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	63 Participants n=5 Participants	67 Participants n=7 Participants	130 Participants n=5 Participants
Race (NIH/OMB) White	312 Participants n=5 Participants	297 Participants n=7 Participants	609 Participants n=5 Participants
Race (NIH/OMB) More than one race	22 Participants n=5 Participants	22 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	12 Participants n=7 Participants	16 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Binary response variable defined by reduction of at least 30% in Brief Pain Inventory (BPI) total score from baseline

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=350 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=362 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Pain Response	58 Participants	54 Participants

SECONDARY outcome

Timeframe: 12 months

Population: All participants who were alive at 12 months

Binary response variable defined by reduction of at least 50% in opioid daily dose (morphine-equivalent mg) from baseline

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=403 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=399 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
50% Reduction in Opioid Daily Dose	102 Participants	98 Participants

SECONDARY outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Binary composite response variable defined by achieving at least a 30% reduction in BPI total score and at least 50% reduction in opioid daily dose from baseline.

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=350 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=362 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Composite Response	17 Participants	17 Participants

SECONDARY outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Brief Pain Inventory (BPI) total score calculated as average of 11 items (range 0-10; higher is worse)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=351 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=362 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Brief Pain Inventory (BPI) Total Score	6.07 units on a scale Standard Deviation 1.81	6.01 units on a scale Standard Deviation 1.91

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Veterans RAND 12-item health survey (VR-12) Physical Component Score (range 0-100; higher is better)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=357 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=363 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
VR-12 Physical Component Score	41.9 units on a scale Standard Deviation 12.9	42.5 units on a scale Standard Deviation 13.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Medication-related adverse symptoms count (0-19; higher is worse)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=270 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=278 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Symptom Checklist	4 symptom count Standard Deviation 3.7	3.5 symptom count Standard Deviation 3.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Prescribed Opioids Difficulty Scale (PODS) Problems score (range 0-32; higher is worse)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=234 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=245 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
PODS Problems	3.4 units on a scale Standard Deviation 6.2	2.5 units on a scale Standard Deviation 5.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Patient Health Questionnaire 8-item (PHQ-8) depression scale score (range 0-24; higher is worse)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=320 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=327 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
PHQ-8	8.79 units on a scale Standard Deviation 5.84	5.2 units on a scale Standard Deviation 5.85

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

General Anxiety Disorders 7-item questionnaire (GAD-7) score (range 0-21; higher is worse)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=319 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=326 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
GAD-7	6.01 units on a scale Standard Deviation 5.61	5.55 units on a scale Standard Deviation 5.61

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Patient Reported Outcomes Measurement Information System (PROMIS) sleep disturbance short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=310 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=322 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
PROMIS Sleep Disturbance	57.2 T-score Standard Deviation 9.1	55.5 T-score Standard Deviation 9.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Patient Reported Outcomes Measurement Information System (PROMIS) fatigue short-form 4a T-score (higher is worse). Raw scores were rescaled into standardized T-scores with a mean of 50 representing the average for the US population and a standard deviation (SD) of 10. A person with a T-score of 40 is one SD below the mean.

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=310 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=321 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
PROMIS Fatigue	57.1 T-score Standard Deviation 10.9	55.7 T-score Standard Deviation 11.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Headache Impact Test score (range 36-78; higher is worse)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=289 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=303 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
Headache Impact Test	50.77 units on a scale Standard Deviation 12.26	49.84 units on a scale Standard Deviation 11.54

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Veterans RAND 12-item health survey (VR-12) Mental Component Score (range 0-100; higher is better)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=356 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=363 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
VR-12 Mental Component Score	41.9 units on a scale Standard Deviation 12.9	42.5 units on a scale Standard Deviation 13.2

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Population: All participants who completed the measure at 12 months

Prescribed Opioids Difficulty Scale (PODS) Concerns score (range 0-28; higher is worse)

Outcome measures

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=244 Participants Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=254 Participants Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
PODS Concerns	3.8 units on a scale Standard Deviation 4.7	4 units on a scale Standard Deviation 4.8

Adverse Events

Active Comparator: Telecare Collaborative Management (TCM)

Serious events: 109 serious events

Other events: 207 other events

Deaths: 7 deaths

Active Comparator: Integrated Pain Team (IPT)

Serious events: 109 serious events

Other events: 178 other events

Deaths: 9 deaths

Serious adverse events

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=358 participants at risk Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=363 participants at risk Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
General disorders Hospitalization	30.4% 109/358 • 12 months	30.0% 109/363 • 12 months

Other adverse events

Measure	Active Comparator: Telecare Collaborative Management (TCM) n=358 participants at risk Uses medication management approach delivered by a clinical pharmacist care manager with a collaborating physician to address common barriers to effective pain medication management in primary care.	Active Comparator: Integrated Pain Team (IPT) n=363 participants at risk Uses a biopsychosocial management approach delivered by a multidisciplinary team that emphasizes non-pharmacological pain management options.
General disorders Emergency department visit	57.8% 207/358 • 12 months	49.0% 178/363 • 12 months

Additional Information

Erin Krebs

University of Minnesota

Phone: 612-629-7558

Email: Erin.Krebs@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place