Improving Veteran Access to Integrated Management of Back... | NCT04411420

NCT04411420

ID	Type	Description	Link
UH3AT009790	U.S. NIH Grant/Contract		View source

Status Module

Sponsor/Collaborators Module

Name	Class
Durham VA Medical Center	FED
University of North Carolina, Chapel Hill	OTHER
National Center for Complementary and Integrative Health (NCCIH)	NIH

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Integrated Care Pathway	Active Comparator	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.	Behavioral: Pain modulation with physical pain treatment Behavioral: Telephone delivered self-management counseling for increasing physical activity Behavioral: Telephone delivered behavioral treatment for participants with high risk for continued disability
Coordinated Care Management Pathway	Active Comparator	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.	Behavioral: Patient preference treatment protocol Behavioral: Nonpharmacological guideline adherent treatment protocol Behavioral: Facilitated referrals to existing VA or non-VA pain management resources

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Pain modulation with physical pain treatment	Behavioral	Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change in Pain Interference Measure	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.	Baseline, three months post baseline
Change in Physical Function Measure	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.	Baseline, three months post baseline

Secondary Outcomes

Measure	Description	Time Frame
Change in Sleep Disturbance	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.

Other Outcomes

Measure	Description	Time Frame
Change in Patient Reported Outcomes--Catastrophizing	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.

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Susan N Hastings, MD	Duke University / Durham VA	Principal Investigator
Steven Z George, PT, PhD	Duke University	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Durham VA		Durham	North Carolina	27705	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
33313728	Background	George SZ, Coffman CJ, Allen KD, Lentz TA, Choate A, Goode AP, Simon CB, Grubber JM, King H, Cook CE, Keefe FJ, Ballengee LA, Naylor J, Brothers JL, Stanwyck C, Alkon A, Hastings SN. Improving Veteran Access to Integrated Management of Back Pain (AIM-Back): Protocol for an Embedded Pragmatic Cluster-Randomized Trial. Pain Med. 2020 Dec 12;21(Suppl 2):S62-S72. doi: 10.1093/pm/pnaa348.
37756618	Background	Lentz TA, Coffman CJ, Cope T, Stearns Z, Simon CB, Choate A, Gladney M, France C, Hastings SN, George SZ. If You Build It, Will They Come? Patient and Provider Use of a Novel Hybrid Telehealth Care Pathway for Low Back Pain. Phys Ther. 2024 Feb 1;104(2):pzad127. doi: 10.1093/ptj/pzad127.

Label	URL
Updated Statistical Analysis Plan Preprint	View source

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	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.
FG001	Coordinated Care Management Pathway

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 25, 2019

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

Integrated Care Pathway

FG000811 subjects8 units
FG0011006 subjects9 units

Due to AIM-BACK being a cluster randomized trial design, there is some enrollment variability across clinics.

Arm/Group Information

ID	Title	Description
BG000	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.
BG001	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.
BG002	Total	Total of all reporting groups

Units	Counts
Participants	BG000811 BG0011006 BG0021817

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	OG000-2.67± 7.22 OG001-2.04± 6.73

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001		Mixed Models Analysis	Hierarchical linear model fit included random effects for clinic and clinic by time and pre-specified clinic- and patient-level covariates.	0.169	Threshold for significance is 0.025 due to dual primary outcomes.	Mean Difference (Final Values)	-0.59			2-Sided	97.5	-1.55	0.37			Difference is calculated as Integrated Sequenced Care Pathway 3-month change minus Coordinated Care Management Pathway 3-month change.		Superiority

Primary

Change in Physical Function Measure

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.

Participants with data collected at both timepoints.

Posted

Mean

Standard Deviation

T-score

Baseline, three months post baseline

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Sleep Disturbance

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.

Participants with data collected at both timepoints.

Posted

Mean

Standard Deviation

T-score

Baseline, three months post baseline

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Patient Reported Outcomes--PROMIS Sleep Disturbance

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.

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

Posted

Mean

Standard Deviation

T-score

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Number of Participants With Opioid Use--Chronic User

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).

Posted

Count of Participants

Participants

Baseline, twelve months post baseline

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants

Secondary

Change in Opioid Use - Morphine Dose

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.

Posted

Mean

Standard Deviation

MME

Baseline, twelve months post baseline

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts
Participants	OG000

Secondary

Change in Patient Reported Outcomes--PROMIS Pain Interference

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.

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

Posted

Mean

Standard Deviation

T-score

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Change in Patient Reported Outcomes--PROMIS Physical Function

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.

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

Posted

Mean

Standard Deviation

T-score

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Change in Patient Reported Outcomes--Catastrophizing

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Other Pre-specified

Change in Patient Reported Outcomes--Alcohol Use Disorders Identification Test Concise (AUDIT-C)

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Other Pre-specified

Change in Patient Reported Outcomes--Pain Intensity, Enjoyment of Life, General Activity (PEG) Screening Tool

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Change in Patient Reported Outcomes--Pain Self Efficacy Questionnaire (PSEQ-2)

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Units	Counts

Other Pre-specified

Change in Patient Reported Outcomes--Depressed Mood

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Other Pre-specified

Change in Patient Reported Outcomes--Quality of Life

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.

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

Posted

Mean

Standard Deviation

score on a scale

Baseline, three, six, and twelve months

ID	Title	Description
OG000	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.
OG001	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.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	1	516	18	516	12	516
EG001	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.	2	480	30	480	20	480

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Hospitalization	General disorders		Systematic Assessment		EG00018 events18 affected516 at risk EG00130 events30 affected480 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Important Medical Events	General disorders		Systematic Assessment		EG00012 events12 affected516 at risk EG00120 events20 affected480 at risk

ID	Term
D017116	Low Back Pain

Units	Counts
Participants	OG000415 OG001405

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms