Care Outcomes for Chiropractic Outpatient Veterans

Acceptability will be assessed by conducting structured, qualitative exit interviews with participants and providers.

Time frame: At Week 10 of the study

Population: Acceptability of chiropractic service delivery as viewed by those veterans who were interviewed.

As part of the recruitment plan, investigators are trying to target female and minority veterans. Historically these groups have been underrepresented in veteran research. The investigators will review EHR data for participant demographics.

Time frame: Screening through baseline

As part of the feasibility assessment, the investigators will monitor the amount of time it takes to complete study recruitment and enrollment, and data collection. The investigators will monitor this through a data capture program.

Time frame: From date of first participant enrolled to date last participant is enrolled, up to 8 months.

As part of the feasibility assessment, investigators will monitor the number of study participants who enroll in and have at least one communication with MyHealthEVet. MyHealthEVet is an online communication tool designed to partner veterans and the veteran's health care team. It provides information on the veteran's health record and health topics as well as allows messaging communication between veterans and health care providers. Usage reports generated by MyHealthEVet will be analyzed to determine number of study participants engaged.

Time frame: 10 weeks from Baseline

Safety for this study will be assessed by the number of adverse events counted and recorded.

Time frame: 10 weeks from Baseline

As part of the feasibility assessment and ability to calculate a sample size for a full scale trial with subgroup analysis, investigators will monitor the percentage of missing data. This will include the percentage of participants who did not attend the initial chiropractic visit and withdraw or are lost to follow-up.

Time frame: 10 weeks from Baseline

Developed by the World Health Organization (WHO), this 10-item screening questionnaire determines harmful or hazardous consumption of alcohol, correctly classifying 95% of people as having a clinical diagnosis of an alcohol abuse disorder (0-12, 0=No Alcohol Use).

Time frame: Baseline visit and week 10

This instrument is self-reported with seven items and will be used to assess generalized anxiety disorder. At a cut off score of 10 (0-21, 0=No Anxiety Disorder, 21=Severe Anxiety Disorder), it has a sensitivity of 0.89 and specificity of 0.82 for identifying patients with GAD in primary care settings.

Time frame: Baseline visit and week 10

HEAL is a validated item-bank comprised of 6 domains developed through the Patient Reported Outcomes Measurement Information System (PROMIS) methodology. Investigators will use HEAL to assess nonspecific factors known to influence patient outcomes, including perceptions of the patient-provider connection, healthcare environment, treatment expectancy, spirituality, positive or negative outlook, and attitudes toward complementary and alternative medicine (CAM). A higher T-score represents more of the concept being measured. A T-score of 50 is equal to the mean and is considered normal. Lower numbers indicate values lower than the mean and higher numbers indicate values higher than the mean. Higher values are indicative of more positive perception. For example, a T-score of 55 on Patient-Provider Connection indicates that the respondent has a more positive perception toward the patient-provider connection than the general chronic condition population (half a standard deviation higher).

Time frame: After the initial chiropractic visit

PASTOR is an on-line data collection tool based on the NIH Patient Reported Outcomes Measurement Information System (PROMIS) and adopted by the DoD/VA Pain Management Task Force. Specific measures include the Defense & Veterans Pain Rating Scale (DVPRS), an enhanced 11-item (total range 0-10, 0=no pain, 10=worst pain) numeric rating scale (NRS) that improves on standard pain NRS by including a Faces Rating Scale component; 'traffic light' color-coding system to delineate mild, moderate and severe pain; and word descriptors, paired with 4, 0-10 NRS items to quantify the impact of pain on general activity, sleep, mood, and stress. PASTOR incorporates PROMIS measures for mental health conditions (PTSD, depression, anxiety, anger, and alcohol use), physical and social function, fatigue, and pain interference with daily activities to provide graphical representation of improvements or declines in patient status that are compared to matched US samples on age, race/ethnicity and sex.

Time frame: Baseline visit and weeks 5 and 10

Population: There are missing data when a participant was lost to follow-up or chose not to complete an item.

The PEG is a 3-item tool to improve assessment and monitoring of chronic pain. The overall PEG-3 score ranges from 0-10 with 10 indicating more pain, more interference with enjoyment of life, and more interference with general activity. Questions assess average pain intensity (P) (AVERAGE pain in past week: 0-10, 0= No Pain, 10=Pain as bad as you can imagine), interference with enjoyment of life (E), and interference with general activity (G) (In past week, how pain interfered with...(0-10, 0=Does not interfere, 10=Completely interferes).

Time frame: Week 3 and Week 7

This instrument is self-reported with nine items and will be used to assess depressive disorder. Total scores range from 0 to 27 with a score of 10-14 considered to be in the moderate range (0-27, 0=No Depression, 27=Severe Depression). It has been tested in primary care settings and has a test-retest reliability of 0.81 to 0.96.

Time frame: Baseline visit and week 10

This 17-item, self-reported instrument will assess PTSD. A total severity score is determined by summing scores from each of 17 items. A change of 5-10 points represents the minimum threshold for determining treatment response; a 10-20 point change represents a clinically significant change in PTSD symptom severity (17-85, 17=Not at all Severe PTSD Symptoms, 85=Extremely Severe PTSD Symptoms).

Time frame: Baseline visit and week 10

The RMDQ is a widely used health status measure for low back pain. Scoring of the RMDQ ranges from 0-24, with a higher score indicating an increase in low back pain disability. (0-24, 0=No Disability, 24=Severe Disability)

Time frame: Baseline visit and weeks 5 and 10

Developed by the Patient-Reported Outcomes Measurement Information System (PROMIS), this 8-item, self-reported tool will assess a person's level of confidence to manage/control symptoms, to manage their symptoms in different settings and to keep symptoms from interfering with work, sleep, relationships or recreational activities. Each question usually has five response options ranging in value from 1 to 5. The total raw score for a measure is converted to into a T-score for each participant. The T-score rescales the raw score into a standardized score with a mean of 50 and a standard deviation (SD) of 10. Therefore a person with a T-score of 40 is one SD below the mean. A higher PROMIS T-score represents more of the concept being measured. For example, a T-score of 55 on the PROMIS Self-Efficacy for Managing Symptoms indicates that the respondent has greater self-efficacy for managing their symptoms than the general chronic condition population (half a standard deviation higher).

Time frame: Baseline visit and week 10

Population: PROMIS - Self-Efficacy for Managing Symptoms - T score at Baseline and Week 10 follow-up.

This is a 9-item, validated tool developed by Keele University to be used as a screening tool for patients with low back pain. It stratifies patients based on their prognosis of persistent disabling symptoms and allows practitioners to group patients into 3 categories (low, medium, or high risk of poor outcome).

Time frame: Baseline visit and week 10