Anxiety, Depression, Fatigue, Pain, Sleep
Conditions
Keywords
Sleep, Pain, Anxiety, Depression, Fatigue, PROMIS, primary care
Brief summary
The purpose of this study is to determine the effectiveness of providing PROMIS Profile Scale scores (e.g., sleep, pain, anxiety, depression, energy/fatigue) to physicians on patients' symptoms.
Detailed description
The SPADE symptoms (sleep, pain, anxiety, depression, and energy/fatigue) are the most common yet undertreated symptoms in clinical practice. Using the PROMIS (Patient-Reported Outcome Measurement Information System) Profile Scales as a measure of SPADE symptoms, this study will determine the effectiveness of providing patient symptom scores to clinicians, identify barriers and facilitators to the clinical use of such scores, and evaluate the psychometric properties of the PROMIS Profile Scales in a primary care population.
Interventions
OTHERFeedback Group
The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores
Sponsors
Patient-Centered Outcomes Research Institute
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients * Adults ≥ 18 years of age, * Receiving care from a participating primary care physician * Report a moderate level of severity ( ≥ 4 on a 0 to 10 scale) on at least one of 5 symptoms (sleep, pain, anxiety, depression, energy/fatigue) based on a 5-item screener. Physicians * Primary care physicians within the Indiana University Health and Eskenazi Health systems
Exclusion criteria
Patients * Patients less than 18 years of age * Patients who do not receive care from a participating primary care physician * Patients who have less than a moderate level of severity (less than 4 on a 0 to 10 item scale) on each of the 5 symptoms (sleep, pain, anxiety, depression, energy/fatigue) based on a 5-item screener. Physicians: * Primary care physicians who do not practice within the Indiana University Health or Eskenazi Health systems
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up | baseline and 3 month follow up | The 20-item PROMIS questionnaire (composed of 4-item scales for each of the 5 SPADE symptoms) was administered to participants at baseline and at 3 month follow up. PROMIS assesses the extent to which patients experience problems with SPADE symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater symptom severity. To assess the effects of feedback on SPADE symptom improvement, group differences in the change in PROMIS composite T-scores from baseline to 3 month follow up (baseline PROMIS T-score - 3 month PROMIS T-score) were calculated. Positive change scores are indicative of symptom improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up | baseline and 3 month follow up | The 4-item PROMIS subscale for sleep was administered to participants at baseline and at 3 month follow up. The sleep subscale measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale. Higher scores reflect more severe sleep problems. To assess the effects of feedback on sleep, group differences in the change in PROMIS sleep T-scores from baseline to 3 month follow up (baseline PROMIS sleep T-score - 3 month PROMIS sleep T-score) were calculated. Positive change scores are indicative of improvement in sleep. |
| Change From Baseline in PROMIS Pain T-score at 3-Month Follow up | baseline and 3 month follow up | The 4-item PROMIS subscale for pain was administered to participants at baseline and at 3 month follow up. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater pain. To assess the effects of feedback on pain, group differences in the change in PROMIS pain T-scores from baseline to 3-month follow up (baseline PROMIS pain T-score - 3 month PROMIS pain T-score) were calculated. Positive change scores are indicative of improvement in pain. |
| Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up | baseline and 3 month follow up | The 4-item PROMIS subscale for anxiety was administered to participants at baseline and at 3 month follow up. The anxiety subscale measures the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater anxiety. To assess the effects of feedback on anxiety, group differences in the change in PROMIS anxiety T-scores from baseline to 3-month follow up (baseline PROMIS anxiety T-score - 3 month PROMIS anxiety T-score) were calculated. Positive change scores are indicative of improvement in anxiety. |
| Change From Baseline in PROMIS Depression T-score at 3-Month Follow up | baseline and 3 month follow up | The 4-item PROMIS subscale for depression was administered to participants at baseline and at 3 month follow up. The depression subscale measures the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater depression. To assess the effects of feedback on depression, group differences in the change in PROMIS depression T-scores from baseline to 3-month follow up (baseline PROMIS depression T-score - 3 month PROMIS depression T-score) were calculated. Positive change scores are indicative of improvement in depression. |
| Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up | baseline and 3 month follow up | The 4-item PROMIS subscale for fatigue was administered to participants at baseline and at 3 month follow up. The fatigue subscale measures the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. To assess the effects of feedback on fatigue, group differences in the change in PROMIS fatigue T-scores from baseline to 3-month follow up (baseline PROMIS fatigue T-score - 3 month PROMIS fatigue T-score) were calculated. Positive change scores are indicative of improvement in fatigue. |
| Treatment Satisfaction at 3-Month Follow-up | 3 month follow-up | At 3-month follow-up, treatment satisfaction was assessed. This 1-item measure assesses patients' satisfaction with the care of their symptoms overall on a 5-point Likert scale ranging from excellent to poor. Higher scores indicate poorer satisfaction. |
| Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2) | 3-month follow-up | For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, sleep was assessed using the 2-item Pittsburgh Insomnia Rating Scale (PIRS-2). PIRS-2 measures quality and satisfaction with sleep over the past week. Possible scores range from 0 to 6, with higher scores reflecting poorer sleep. |
| Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit | baseline | Electronic medical records were reviewed to determine the number of tests ordered, other than radiologic or laboratory tests (e.g., sleep study), for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ tests ordered for SPADE symptoms at baseline was calculated. |
| Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2) | 3 month follow up | For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, anxiety was assessed using the 2-item Generalized Anxiety Disorder scale (GAD-2). GAD-2 measures the frequency of anxiety symptoms over the past 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe anxiety. |
| Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2) | 3 month follow up | For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, depression was assessed using the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the last 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe depression. |
| Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale | 3 month follow up | For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, fatigue was assessed using the 4-item SF-36 (Short Form-36 Healthy Survey) vitality scale. The SF-36 vitality scale measures fatigue and energy over the past week. Possible scores range from 0 to 100, with lower scores reflecting greater fatigue. |
| Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | baseline | Electronic medical records were reviewed to determine the number of laboratory tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ lab tests ordered for SPADE symptoms at baseline was calculated. |
| Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | baseline | Electronic medical records were reviewed to determine the number of radiologic (RAD) tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ RAD tests ordered for SPADE symptoms at baseline was calculated. |
| Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | baseline | Electronic medical records were reviewed to determine the number of medications ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0, 1, 2, or 3≤ medications ordered for SPADE symptoms at baseline was calculated. |
| Pain at 3 Month Follow up, as Measured by PEG | 3 month follow up | For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, pain was assessed using the 3-item PEG (Pain intensity, Enjoyment of life, and General activity). PEG measures pain intensity and interference in the past week. Possible scores range from 0 to 10, with higher scores reflecting more intense pain and interference. |
Countries
United States
Participant flow
Recruitment details
Recruitment occurred between March 2015 and April 2016 in primary care outpatient clinics.
Pre-assignment details
In clinic, patients who had 1≤ SPADE (sleep, pain, anxiety, depression low energy/fatigue) symptoms, consented and provided authorization, completed PROMIS (Patient-Reported Outcome Measurement Information System), and then were randomized to a feedback or control group. Patients unable to complete enrollment prior to the encounter were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Feedback Group Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Feedback Group: The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores | 151 |
| Control Group Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit | 149 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 3 Month Follow up | Lost to Follow-up | 23 | 21 |
Baseline characteristics
| Characteristic | Total | Feedback Group | Control Group |
|---|---|---|---|
| Age, Continuous | 49.4 years STANDARD_DEVIATION 14.4 | 50.5 years STANDARD_DEVIATION 14.1 | 48.2 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants | 5 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 243 Participants | 123 Participants | 120 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 45 Participants | 23 Participants | 22 Participants |
| PROMIS Anxiety T-score | 59.1 T-score STANDARD_DEVIATION 9.4 | 59.0 T-score STANDARD_DEVIATION 10.1 | 59.2 T-score STANDARD_DEVIATION 8.7 |
| PROMIS Composite T-score | 58.3 T-score STANDARD_DEVIATION 7 | 58.3 T-score STANDARD_DEVIATION 7.6 | 58.4 T-score STANDARD_DEVIATION 6.4 |
| PROMIS Depression T-score | 55.9 T-score STANDARD_DEVIATION 9.8 | 55.8 T-score STANDARD_DEVIATION 10.4 | 56.0 T-score STANDARD_DEVIATION 9.1 |
| PROMIS Fatigue T-score | 57.0 T-score STANDARD_DEVIATION 10 | 56.8 T-score STANDARD_DEVIATION 10.1 | 57.2 T-score STANDARD_DEVIATION 9.9 |
| PROMIS Pain T-score | 61.5 T-score STANDARD_DEVIATION 9.4 | 61.5 T-score STANDARD_DEVIATION 9.3 | 61.4 T-score STANDARD_DEVIATION 9.5 |
| PROMIS Sleep T-score | 58.2 T-score STANDARD_DEVIATION 9 | 58.3 T-score STANDARD_DEVIATION 9.4 | 58.1 T-score STANDARD_DEVIATION 8.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 148 Participants | 79 Participants | 69 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 7 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) White | 135 Participants | 65 Participants | 70 Participants |
| Sex: Female, Male Female | 215 Participants | 111 Participants | 104 Participants |
| Sex: Female, Male Male | 85 Participants | 40 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 151 | 0 / 149 |
| other Total, other adverse events | 0 / 151 | 0 / 149 |
| serious Total, serious adverse events | 0 / 151 | 0 / 149 |
Outcome results
Primary
Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up
The 20-item PROMIS questionnaire (composed of 4-item scales for each of the 5 SPADE symptoms) was administered to participants at baseline and at 3 month follow up. PROMIS assesses the extent to which patients experience problems with SPADE symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater symptom severity. To assess the effects of feedback on SPADE symptom improvement, group differences in the change in PROMIS composite T-scores from baseline to 3 month follow up (baseline PROMIS T-score - 3 month PROMIS T-score) were calculated. Positive change scores are indicative of symptom improvement.
Time frame: baseline and 3 month follow up
Population: Multiple imputation was used to determine follow-up scores for nonrespondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up | 3.48 T-score | Standard Error 0.54 |
| Control Group | Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up | 2.38 T-score | Standard Error 0.55 |
p-value: 0.16595% CI: [-0.45, 2.64]t-test, 2 sided
Secondary
Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, anxiety was assessed using the 2-item Generalized Anxiety Disorder scale (GAD-2). GAD-2 measures the frequency of anxiety symptoms over the past 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe anxiety.
Time frame: 3 month follow up
Population: Participants who completed the GAD-2 at 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2) | 2.14 units on a scale | Standard Deviation 2.08 |
Secondary
Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up
The 4-item PROMIS subscale for anxiety was administered to participants at baseline and at 3 month follow up. The anxiety subscale measures the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater anxiety. To assess the effects of feedback on anxiety, group differences in the change in PROMIS anxiety T-scores from baseline to 3-month follow up (baseline PROMIS anxiety T-score - 3 month PROMIS anxiety T-score) were calculated. Positive change scores are indicative of improvement in anxiety.
Time frame: baseline and 3 month follow up
Population: Multiple imputation was used to determine follow-up scores for nonrespondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up | 2.96 T-score | Standard Error 0.77 |
| Control Group | Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up | 2.13 T-score | Standard Error 0.84 |
p-value: 0.47195% CI: [-1.44, 3.11]t-test, 2 sided
Secondary
Change From Baseline in PROMIS Depression T-score at 3-Month Follow up
The 4-item PROMIS subscale for depression was administered to participants at baseline and at 3 month follow up. The depression subscale measures the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater depression. To assess the effects of feedback on depression, group differences in the change in PROMIS depression T-scores from baseline to 3-month follow up (baseline PROMIS depression T-score - 3 month PROMIS depression T-score) were calculated. Positive change scores are indicative of improvement in depression.
Time frame: baseline and 3 month follow up
Population: Multiple imputation was used to determine follow-up scores for nonrespondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Change From Baseline in PROMIS Depression T-score at 3-Month Follow up | 3.08 T-score | Standard Error 0.77 |
| Control Group | Change From Baseline in PROMIS Depression T-score at 3-Month Follow up | 1.59 T-score | Standard Error 0.77 |
p-value: 0.17495% CI: [-0.66, 3.65]t-test, 2 sided
Secondary
Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up
The 4-item PROMIS subscale for fatigue was administered to participants at baseline and at 3 month follow up. The fatigue subscale measures the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. To assess the effects of feedback on fatigue, group differences in the change in PROMIS fatigue T-scores from baseline to 3-month follow up (baseline PROMIS fatigue T-score - 3 month PROMIS fatigue T-score) were calculated. Positive change scores are indicative of improvement in fatigue.
Time frame: baseline and 3 month follow up
Population: Multiple imputation was used to determine follow-up scores for nonrespondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up | 3.68 T-score | Standard Error 0.87 |
| Control Group | Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up | 2.01 T-score | Standard Error 0.99 |
p-value: 0.22295% CI: [-1, 4.35]t-test, 2 sided
Secondary
Change From Baseline in PROMIS Pain T-score at 3-Month Follow up
The 4-item PROMIS subscale for pain was administered to participants at baseline and at 3 month follow up. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater pain. To assess the effects of feedback on pain, group differences in the change in PROMIS pain T-scores from baseline to 3-month follow up (baseline PROMIS pain T-score - 3 month PROMIS pain T-score) were calculated. Positive change scores are indicative of improvement in pain.
Time frame: baseline and 3 month follow up
Population: Multiple imputation was used to determine follow-up scores for nonrespondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Change From Baseline in PROMIS Pain T-score at 3-Month Follow up | 2.77 T-score | Standard Error 0.68 |
| Control Group | Change From Baseline in PROMIS Pain T-score at 3-Month Follow up | 2.12 T-score | Standard Error 0.78 |
p-value: 0.53995% CI: [-1.41, 2.7]t-test, 2 sided
Secondary
Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up
The 4-item PROMIS subscale for sleep was administered to participants at baseline and at 3 month follow up. The sleep subscale measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale. Higher scores reflect more severe sleep problems. To assess the effects of feedback on sleep, group differences in the change in PROMIS sleep T-scores from baseline to 3 month follow up (baseline PROMIS sleep T-score - 3 month PROMIS sleep T-score) were calculated. Positive change scores are indicative of improvement in sleep.
Time frame: baseline and 3 month follow up
Population: Multiple imputation was used to determine follow-up scores for nonrespondents.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up | 4.88 T-score | Standard Error 0.76 |
| Control Group | Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up | 4.04 T-score | Standard Error 0.76 |
p-value: 0.42595% CI: [-1.23, 2.91]t-test, 2 sided
Secondary
Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, depression was assessed using the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the last 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe depression.
Time frame: 3 month follow up
Population: Participants who completed the PHQ-2 at 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2) | 2.06 units on a scale | Standard Deviation 1.96 |
Secondary
Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, fatigue was assessed using the 4-item SF-36 (Short Form-36 Healthy Survey) vitality scale. The SF-36 vitality scale measures fatigue and energy over the past week. Possible scores range from 0 to 100, with lower scores reflecting greater fatigue.
Time frame: 3 month follow up
Population: Participants who completed the SF-36 vitality scale at 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale | 41.16 units on a scale | Standard Deviation 22.34 |
Secondary
Pain at 3 Month Follow up, as Measured by PEG
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, pain was assessed using the 3-item PEG (Pain intensity, Enjoyment of life, and General activity). PEG measures pain intensity and interference in the past week. Possible scores range from 0 to 10, with higher scores reflecting more intense pain and interference.
Time frame: 3 month follow up
Population: Participants who completed the PEG at 3 month follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Pain at 3 Month Follow up, as Measured by PEG | 5.13 units on a scale | Standard Deviation 3.28 |
Secondary
Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit
Electronic medical records were reviewed to determine the number of laboratory tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ lab tests ordered for SPADE symptoms at baseline was calculated.
Time frame: baseline
Population: Participants whose electronic medical record of the baseline clinic visit was available for review
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Feedback Group | Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 0 labs ordered | 91.8 percentage of participants |
| Feedback Group | Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 1≤ labs ordered | 8.2 percentage of participants |
| Control Group | Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 0 labs ordered | 90.3 percentage of participants |
| Control Group | Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 1≤ labs ordered | 9.7 percentage of participants |
Secondary
Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit
Electronic medical records were reviewed to determine the number of medications ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0, 1, 2, or 3≤ medications ordered for SPADE symptoms at baseline was calculated.
Time frame: baseline
Population: Participants whose electronic medical record of the baseline clinic visit was available for review
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Feedback Group | Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 0 meds ordered | 38.1 percentage of participants |
| Feedback Group | Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 1 med ordered | 27.2 percentage of participants |
| Feedback Group | Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 2 meds ordered | 19.1 percentage of participants |
| Feedback Group | Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 3≤ meds ordered | 15.6 percentage of participants |
| Control Group | Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 3≤ meds ordered | 11.0 percentage of participants |
| Control Group | Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 0 meds ordered | 30.3 percentage of participants |
| Control Group | Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 2 meds ordered | 23.5 percentage of participants |
| Control Group | Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 1 med ordered | 35.2 percentage of participants |
Secondary
Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit
Electronic medical records were reviewed to determine the number of radiologic (RAD) tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ RAD tests ordered for SPADE symptoms at baseline was calculated.
Time frame: baseline
Population: Participants whose electronic medical record of the baseline clinic visit was available for review
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Feedback Group | Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 0 RAD tests ordered | 86.4 percentage of participants |
| Feedback Group | Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 1≤ RAD tests ordered | 13.6 percentage of participants |
| Control Group | Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 0 RAD tests ordered | 84.1 percentage of participants |
| Control Group | Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 1≤ RAD tests ordered | 15.9 percentage of participants |
Secondary
Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit
Electronic medical records were reviewed to determine the number of tests ordered, other than radiologic or laboratory tests (e.g., sleep study), for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ tests ordered for SPADE symptoms at baseline was calculated.
Time frame: baseline
Population: Participants whose electronic medical record of the baseline clinic visit was available for review
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Feedback Group | Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 0 tests ordered | 91.2 percentage of participants |
| Feedback Group | Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 1≤ tests ordered | 8.8 percentage of participants |
| Control Group | Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 0 tests ordered | 97.9 percentage of participants |
| Control Group | Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit | Percentage of patients with 1≤ tests ordered | 2.1 percentage of participants |
Secondary
Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, sleep was assessed using the 2-item Pittsburgh Insomnia Rating Scale (PIRS-2). PIRS-2 measures quality and satisfaction with sleep over the past week. Possible scores range from 0 to 6, with higher scores reflecting poorer sleep.
Time frame: 3-month follow-up
Population: Participants who completed the PIRS-2 at 3 month follow up
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Feedback Group | Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2) | 3.46 units on a scale | Standard Deviation 1.8 |
Secondary
Treatment Satisfaction at 3-Month Follow-up
At 3-month follow-up, treatment satisfaction was assessed. This 1-item measure assesses patients' satisfaction with the care of their symptoms overall on a 5-point Likert scale ranging from excellent to poor. Higher scores indicate poorer satisfaction.
Time frame: 3 month follow-up
Population: Participants who responded to the treatment satisfaction question at 3 month follow up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Feedback Group | Treatment Satisfaction at 3-Month Follow-up | Very Good | 28 Participants |
| Feedback Group | Treatment Satisfaction at 3-Month Follow-up | Fair | 22 Participants |
| Feedback Group | Treatment Satisfaction at 3-Month Follow-up | Good | 39 Participants |
| Feedback Group | Treatment Satisfaction at 3-Month Follow-up | Poor | 14 Participants |
| Feedback Group | Treatment Satisfaction at 3-Month Follow-up | Excellent | 25 Participants |
| Control Group | Treatment Satisfaction at 3-Month Follow-up | Poor | 6 Participants |
| Control Group | Treatment Satisfaction at 3-Month Follow-up | Excellent | 21 Participants |
| Control Group | Treatment Satisfaction at 3-Month Follow-up | Very Good | 33 Participants |
| Control Group | Treatment Satisfaction at 3-Month Follow-up | Good | 42 Participants |
| Control Group | Treatment Satisfaction at 3-Month Follow-up | Fair | 26 Participants |