Durham VA
Durham, North Carolina, 27705, United States
NCT Number: NCT04411420
The purpose and objective of this pragmatic trial is to examine the effectiveness of two different quality improvement care pathways for low back pain (LBP); a sequenced, integrated care pathway (ICP) and 2) a coordinated, care management pathway (CCP). We will test the central hypothesis that the ICP will reduce pain interference with normal activities and improve physical function, as measured by Patient Reported Outcomes Measurement Information System (PROMIS) Short Form scores when compared to the CCP.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Durham, North Carolina, 27705, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Clinic eligibility:
Participant Survey Eligibility Criteria:
Inclusion criteria
Exclusion criteria
Examples of pain modulation with physical pain treatment include spinal manipulation, massage, or transcutaneous electrical nerve stimulation
Centrally located physical therapy assistants will provide six weeks of telehealth consults to increase physical activity for the patient
Patients with a higher risk of developing chronic or persistent back pain will be identified using the nine question risk stratification start back screening tool (SBST) and will receive six additional weeks of physical activity instructions and additional pain modulation treatments as needed.
the pain navigator will work through a shared decision making process with the patient to determine the preferred treatment protocol
the pain navigator will select only nonpharmacological guideline adherent treatment options for the patient
the pain navigator will work with the referring physician to select only existing VA or non-VA pain management resources for the patient.
Time frame: Baseline, three months post baseline
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.
Time frame: Baseline, three months post baseline
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.
Time frame: Baseline, three months post baseline
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.
Time frame: Baseline, three, six, and twelve months
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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, three, six, and twelve months
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.
Time frame: Baseline, three, six, and twelve months
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.
Time frame: Baseline, three, six, and twelve months
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.
Time frame: Baseline, three, six, and twelve months
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.
Time frame: Baseline, three, six, and twelve months
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.
Time frame: Baseline, three, six, and twelve months
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.
Time frame: Baseline, three, six, and twelve months
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.
Time frame: Baseline, three, six, and twelve months
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.
Duke University
Other
Improving Veteran Access to Integrated Management of Back Pain: A Pragmatic, Cluster Randomized Trial
Acronym: AIM-BACK
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