Trial Outcomes & Findings for Improving Veteran Access to Integrated Management of Back Pain (NCT NCT04411420)

NCT ID: NCT04411420

Last Updated: 2025-06-27

Results Overview

The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1817 participants
• Primary outcome timeframe: Baseline, three months post baseline
• Results posted on: 2025-06-27

Participant Flow

A subset of the overall population was recruited to participate in a series of telephone surveys.

Unit of analysis: Primary Care Clinics

Participant milestones

Measure	Integrated Care Pathway The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Overall Study (All Participants) STARTED	811 8	1006 9
Overall Study (All Participants) COMPLETED	461 8	537 9
Overall Study (All Participants) NOT COMPLETED	350 0	469 0
Survey Subset STARTED	516 8	480 9
Survey Subset COMPLETED	382 8	360 9
Survey Subset NOT COMPLETED	134 0	120 0

Reasons for withdrawal

Measure	Integrated Care Pathway The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Overall Study (All Participants) Lost to Follow-up	350	469
Survey Subset Lost to Follow-up	134	120

Baseline Characteristics

A subset of the overall participants was recruited to participate in a series of telephone surveys.

Baseline characteristics by cohort

Measure	Integrated Care Pathway n=811 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=1006 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.	Total n=1817 Participants Total of all reporting groups
Age, Continuous	51.4 years STANDARD_DEVIATION 15.1 • n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	52.0 years STANDARD_DEVIATION 15.6 • n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	51.7 years STANDARD_DEVIATION 15.3 • n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Sex: Female, Male Female	65 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	44 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	109 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Sex: Female, Male Male	451 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	436 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	887 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Ethnicity (NIH/OMB) Hispanic or Latino	37 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	48 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	85 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Ethnicity (NIH/OMB) Not Hispanic or Latino	476 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	429 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	905 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	3 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	6 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Race (NIH/OMB) American Indian or Alaska Native	5 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	7 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	12 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Race (NIH/OMB) Asian	5 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	6 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	11 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	1 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	1 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Race (NIH/OMB) Black or African American	166 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	83 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	249 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Race (NIH/OMB) White	300 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	326 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	626 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Race (NIH/OMB) More than one race	13 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	24 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	37 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Race (NIH/OMB) Unknown or Not Reported	27 Participants n=516 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	33 Participants n=480 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.	60 Participants n=996 Participants • A subset of the overall participants was recruited to participate in a series of telephone surveys.
Region of Enrollment United States	811 Participants n=811 Participants	1006 Participants n=1006 Participants	1817 Participants n=1817 Participants

PRIMARY outcome

Timeframe: Baseline, three months post baseline

Population: Participants with data collected at both timepoints.

The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater pain interference.

Outcome measures

Measure	Integrated Care Pathway n=454 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=527 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Pain Interference Measure	-2.67 T-score Standard Deviation 7.22	-2.04 T-score Standard Deviation 6.73

PRIMARY outcome

Timeframe: Baseline, three months post baseline

Population: Participants with data collected at both timepoints.

The PROMIS Short form scores will be collected by the clinical providers within the medical record at baseline and three months to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates better physical function.

Outcome measures

Measure	Integrated Care Pathway n=458 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=531 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Physical Function Measure	1.87 T-score Standard Deviation 5.70	1.44 T-score Standard Deviation 5.14

SECONDARY outcome

Timeframe: Baseline, three months post baseline

Population: Participants with data collected at both timepoints.

The PROMIS Short form scores will be collected in the medical record by the provider at baseline, and three months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. With the revised statistical analysis plan, the patient reported outcomes survey data were used to supplement missing three month follow up data from the medical record, when possible. A higher score indicates greater sleep disturbance.

Outcome measures

Measure	Integrated Care Pathway n=456 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=529 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Sleep Disturbance	-2.56 T-score Standard Deviation 7.35	-2.06 T-score Standard Deviation 8.01

SECONDARY outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure sleep disturbance. The sleep disturbance form asks the participant to rate a series of sleep related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater sleep disturbance.

Outcome measures

Measure	Integrated Care Pathway n=425 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=414 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--PROMIS Sleep Disturbance Baseline to 3 months	-1.35 T-score Standard Deviation 6.92	-1.07 T-score Standard Deviation 6.60
Change in Patient Reported Outcomes--PROMIS Sleep Disturbance Baseline to 6 months	-1.50 T-score Standard Deviation 6.65	-1.66 T-score Standard Deviation 6.89
Change in Patient Reported Outcomes--PROMIS Sleep Disturbance Baseline to 12 months	-1.25 T-score Standard Deviation 7.14	-1.26 T-score Standard Deviation 7.26

SECONDARY outcome

Timeframe: Baseline, twelve months post baseline

Opioid use will be defined at baseline and 12 months post baseline as a binary variable based on whether a chronic opioid user or not at baseline and at twelve months. Opioid use is chronic if participant had at least one prescription with a total day supply of at least 120 days or if there were at least 10 prescription fills in the 12 months prior to the specified timepoint (baseline, 12 months post baseline).

Outcome measures

Measure	Integrated Care Pathway n=811 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=1006 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Number of Participants With Opioid Use--Chronic User Baseline	28 Participants	36 Participants
Number of Participants With Opioid Use--Chronic User 12 months	22 Participants	26 Participants

SECONDARY outcome

Timeframe: Baseline, twelve months post baseline

Opioid use--morphine dose will be defined at baseline and 12 months post baseline as a continuous variable measuring morphine equivalents for opioid dose at baseline and twelve months. Change in total milligrams of morphine equivalents (MME) use is reported.

Outcome measures

Measure	Integrated Care Pathway n=811 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=1006 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Opioid Use - Morphine Dose	-2.62 MME Standard Deviation 36.3	-2.69 MME Standard Deviation 52.3

SECONDARY outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain interference. The pain interference form asks the participant to rate a series of pain related questions on a scale of 1-5 within the past seven days with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates greater pain interference.

Outcome measures

Measure	Integrated Care Pathway n=424 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=410 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--PROMIS Pain Interference Baseline to 3 months	-1.44 T-score Standard Deviation 6.19	-1.10 T-score Standard Deviation 6.08
Change in Patient Reported Outcomes--PROMIS Pain Interference Baseline to 6 months	-1.64 T-score Standard Deviation 6.29	-1.22 T-score Standard Deviation 6.69
Change in Patient Reported Outcomes--PROMIS Pain Interference Baseline to 12 months	-1.77 T-score Standard Deviation 6.50	-1.31 T-score Standard Deviation 6.65

SECONDARY outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

The PROMIS Short form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure physical function. The physical function form asks the participant to rate a series of physical function related questions on a scale of 1-5 with 1 representing a better outcome. Ratings are summed across the four questions and converted to a standardized T-score (mean 50, standard deviation 10) according to PROMIS Scoring tables. Observations with 1 missing rating (of 4) were scored using the auto-scoring template in REDCap; observations with more than 1 missing rating were not scored and so were coded as missing. A higher score indicates better physical function.

Outcome measures

Measure	Integrated Care Pathway n=424 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=414 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--PROMIS Physical Function Baseline to 3 months	-0.20 T-score Standard Deviation 4.55	-0.15 T-score Standard Deviation 4.62
Change in Patient Reported Outcomes--PROMIS Physical Function Baseline to 6 months	0.24 T-score Standard Deviation 5.07	0.14 T-score Standard Deviation 4.83
Change in Patient Reported Outcomes--PROMIS Physical Function Baseline to 12 months	-0.09 T-score Standard Deviation 5.02	0.08 T-score Standard Deviation 5.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

Catastrophizing questions from the NIH recommended minimum data set will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate catastrophizing with two agree (1) / disagree (0) questions. Responses marked as DK/Ref/Missing are coded as missing. Responses are then summed across the two questions; possible outcome values are 0, 1, 2. A higher score indicates greater catastrophizing.

Outcome measures

Measure	Integrated Care Pathway n=352 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=303 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--Catastrophizing Baseline to 3 months	0.08 score on a scale Standard Deviation 0.66	0.08 score on a scale Standard Deviation 0.71
Change in Patient Reported Outcomes--Catastrophizing Baseline to 6 months	0.11 score on a scale Standard Deviation 0.62	0.07 score on a scale Standard Deviation 0.76
Change in Patient Reported Outcomes--Catastrophizing Baseline to 12 months	0.05 score on a scale Standard Deviation 0.72	0.09 score on a scale Standard Deviation 0.77

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

The AUDIT-C form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure alcohol use. The AUDIT-C form asks the participant to rate three alcohol use questions on a scale of 0-4 with zero representing a better outcome. The total score is the sum of the non-missing responses to the three questions, with range of possible values 0-12.

Outcome measures

Measure	Integrated Care Pathway n=425 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=414 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) Baseline to 3 months	-0.17 score on a scale Standard Deviation 1.11	-0.14 score on a scale Standard Deviation 1.36
Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) Baseline to 6 months	-0.17 score on a scale Standard Deviation 1.35	-0.19 score on a scale Standard Deviation 1.37
Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C) Baseline to 12 months	-0.25 score on a scale Standard Deviation 1.46	-0.18 score on a scale Standard Deviation 1.49

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

The PEG screening tool scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure pain intensity. The PEG form asks the participant to rate a series of pain intensity related questions on a scale of 0-10 with 0 representing a better outcome. The total score is the sum of responses to the three questions and is missing if any of the three questions is missing. The range of possible values is 0-30.

Outcome measures

Measure	Integrated Care Pathway n=422 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=411 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool Baseline to 12 months	-0.38 score on a scale Standard Deviation 2.09	-0.38 score on a scale Standard Deviation 2.15
Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool Baseline to 3 months	-0.35 score on a scale Standard Deviation 1.89	-0.42 score on a scale Standard Deviation 1.94
Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool Baseline to 6 months	-0.44 score on a scale Standard Deviation 1.94	-0.42 score on a scale Standard Deviation 2.05

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

Pain Self-Efficacy Questionnaire from the PSEQ-2 form will be collected by the interviewers at baseline, three, six, and twelve months post baseline and will evaluate self-efficacy on a scale of 0-6 with zero representing a worse outcome. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-12.

Outcome measures

Measure	Integrated Care Pathway n=409 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=391 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) Baseline to 3 months	-0.13 score on a scale Standard Deviation 2.82	-0.38 score on a scale Standard Deviation 3.02
Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) Baseline to 6 months	-0.08 score on a scale Standard Deviation 2.73	-0.46 score on a scale Standard Deviation 2.98
Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2) Baseline to 12 months	-0.22 score on a scale Standard Deviation 2.88	-0.39 score on a scale Standard Deviation 2.90

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

The Patient Health Questionnaire-2 (PHQ2) form scores will be collected by the interviewers at baseline, three, six, and twelve months post baseline to measure depressed mood. The PHQ2 form asks the participant to answer two questions about potential depressed mood within the past week with ratings between 0 and 3. The total score is the sum of responses to the two questions and is missing if either of the two questions is missing. The range of possible values is 0-6. A higher score indicates greater depressed mood.

Outcome measures

Measure	Integrated Care Pathway n=416 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=404 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--Depressed Mood Baseline to 3 months	0.02 score on a scale Standard Deviation 1.44	0.04 score on a scale Standard Deviation 1.60
Change in Patient Reported Outcomes--Depressed Mood Baseline to 6 months	0.09 score on a scale Standard Deviation 1.58	0.02 score on a scale Standard Deviation 1.58
Change in Patient Reported Outcomes--Depressed Mood Baseline to 12 months	-0.01 score on a scale Standard Deviation 1.57	0.02 score on a scale Standard Deviation 1.60

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, three, six, and twelve months

Population: Participants with data collected collected at both timepoints needed to calculate a change.

The EuroQoL five-item quality of life questionnaire, EQ-5D-5L, will be administered by interviewers at baseline, three, six, and twelve months post baseline to measure quality of life. The EQ-5D-5L asks the participant five questions related to quality of life on a scale of 1-5. If all questions are answered, the responses are concatenated to form a 5-digit state in the order mobility, self care, usual activities, pain discomfort, anxiety/depression. This 5-digit state is then converted to an index between 0 and 1. A higher score indicates greater quality of life.

Outcome measures

Measure	Integrated Care Pathway n=415 Participants The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=405 Participants The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
Change in Patient Reported Outcomes--Quality of Life Baseline to 3 months	-0.04 score on a scale Standard Deviation 0.26	-0.03 score on a scale Standard Deviation 0.25
Change in Patient Reported Outcomes--Quality of Life Baseline to 6 months	0.04 score on a scale Standard Deviation 0.26	-0.04 score on a scale Standard Deviation 0.25
Change in Patient Reported Outcomes--Quality of Life Baseline to 12 months	-0.04 score on a scale Standard Deviation 0.26	-0.02 score on a scale Standard Deviation 0.26

Adverse Events

Integrated Care Pathway

Serious events: 18 serious events

Other events: 12 other events

Deaths: 1 deaths

Coordinated Care Management Pathway

Serious events: 30 serious events

Other events: 20 other events

Deaths: 2 deaths

Serious adverse events

Measure	Integrated Care Pathway n=516 participants at risk The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=480 participants at risk The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
General disorders Hospitalization	3.5% 18/516 • Number of events 18 • Up to 12 months Adverse Events were collected on survey participants only. A non-systematic method was implemented. Adverse events were collected via unsolicited participant self-report during follow-up study surveys. Study staff attempted to verify reported adverse events via medical record review. All hospitalizations were considered serious and Emergency Department visits were considered important medical events. All events were assessed for study relatedness. All events were reviewed by the Durham VA IRB.	6.2% 30/480 • Number of events 30 • Up to 12 months Adverse Events were collected on survey participants only. A non-systematic method was implemented. Adverse events were collected via unsolicited participant self-report during follow-up study surveys. Study staff attempted to verify reported adverse events via medical record review. All hospitalizations were considered serious and Emergency Department visits were considered important medical events. All events were assessed for study relatedness. All events were reviewed by the Durham VA IRB.

Other adverse events

Measure	Integrated Care Pathway n=516 participants at risk The integrated care pathway provides both on-site physical therapy services and centrally-delivered services via telephone or video from study providers at the Durham VA.	Coordinated Care Management Pathway n=480 participants at risk The care management pathway involves a referral of patients from a physician to a pain navigator on site at the local VA who is knowledgeable in current recommended treatment guidelines for low back pain.
General disorders Important Medical Events	2.3% 12/516 • Number of events 12 • Up to 12 months Adverse Events were collected on survey participants only. A non-systematic method was implemented. Adverse events were collected via unsolicited participant self-report during follow-up study surveys. Study staff attempted to verify reported adverse events via medical record review. All hospitalizations were considered serious and Emergency Department visits were considered important medical events. All events were assessed for study relatedness. All events were reviewed by the Durham VA IRB.	4.2% 20/480 • Number of events 20 • Up to 12 months Adverse Events were collected on survey participants only. A non-systematic method was implemented. Adverse events were collected via unsolicited participant self-report during follow-up study surveys. Study staff attempted to verify reported adverse events via medical record review. All hospitalizations were considered serious and Emergency Department visits were considered important medical events. All events were assessed for study relatedness. All events were reviewed by the Durham VA IRB.

Additional Information

Leo Brothers

Duke University

Phone: 919-668-8322

Email: joseph.l.brothers@duke.edu

Results disclosure agreements

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