Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Feedback Group | Experimental | Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit |
|
| Control Group | No Intervention | Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Feedback Group | Other | The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline and 3 month follow up |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Patients
Physicians
Exclusion Criteria:
Patients
Physicians:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Kurt Kroenke, MD | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31330252 | Derived | Kroenke K, Stump TE, Kean J, Talib TL, Haggstrom DA, Monahan PO. PROMIS 4-item measures and numeric rating scales efficiently assess SPADE symptoms compared with legacy measures. J Clin Epidemiol. 2019 Nov;115:116-124. doi: 10.1016/j.jclinepi.2019.06.018. Epub 2019 Jul 19. | |
| 30109471 | Derived | Talib TL, DeChant P, Kean J, Monahan PO, Haggstrom DA, Stout ME, Kroenke K. A qualitative study of patients' perceptions of the utility of patient-reported outcome measures of symptoms in primary care clinics. Qual Life Res. 2018 Dec;27(12):3157-3166. doi: 10.1007/s11136-018-1968-3. Epub 2018 Aug 14. |
Not provided
Not provided
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.
Recruitment occurred between March 2015 and April 2016 in primary care outpatient clinics.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Control Group | Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
| |||||||||||||
| 3 Month Follow up |
|
Patients with 1 or more SPADE symptoms who completed enrollment (e.g., consent, authorization, baseline questionnaire, randomization)
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Multiple imputation was used to determine follow-up scores for nonrespondents. | Posted | Mean | Standard Error | T-score | baseline and 3 month follow up |
|
Adverse event data was collected over a 20 month-period of time (March 2015 to October 2016).
The definitions do not differ.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
Not provided
Not provided
A convenience sample was obtained from urban primary care clinics. Further studies in different primary care populations are needed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Research Coordintor | Regenstrief Institute | 317-274-9288 | tltalib@regenstrief.org |
Not provided
| ID | Term |
|---|---|
| D010146 | Pain |
| D001008 | Anxiety Disorders |
| D003863 | Depression |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| baseline and 3 month follow up |
| 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. | baseline and 3 month follow up |
| 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. | baseline and 3 month follow up |
| 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. | baseline and 3 month follow up |
| 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. | baseline and 3 month follow up |
| 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. | 3 month follow-up |
| 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. | 3-month follow-up |
| 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. | 3 month follow up |
| 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. | 3 month follow up |
| 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. | 3 month follow up |
| 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. | 3 month follow up |
| 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. | baseline |
| 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. | baseline |
| 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. | baseline |
| 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. | baseline |
| 29623512 | Derived | Kroenke K, Talib TL, Stump TE, Kean J, Haggstrom DA, DeChant P, Lake KR, Stout M, Monahan PO. Incorporating PROMIS Symptom Measures into Primary Care Practice-a Randomized Clinical Trial. J Gen Intern Med. 2018 Aug;33(8):1245-1252. doi: 10.1007/s11606-018-4391-0. Epub 2018 Apr 5. |
| NOT COMPLETED |
|
|
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| PROMIS Composite T-score | The 20-item PROMIS questionnaire (composed of 4-item scales for each of the 5 SPADE symptoms) assesses the extent to which patients experience problems with SPADE symptoms over the past 7 days using a 5-point Likert scale. Each PROMIS scale provides a raw score, ranging from 4 to 20. Raw scores are converted to T-scores using the PROMIS conversion tables. The composite PROMIS T-score is the sum of the 5 symptom T-scores divided by 5. Higher scores reflect greater symptom severity. | Mean | Standard Deviation | T-score |
|
| PROMIS Sleep T-score | The 4-item PROMIS subscale for sleep assesses the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale. The sleep subscale provides a raw score, ranging from 4 to 20. Raw scores are converted to T-scores using the PROMIS conversion tables. Higher scores reflect more severe sleep problems. | Mean | Standard Deviation | T-score |
|
| PROMIS Pain T-score | The 4-item PROMIS subscale for pain assesses the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. The pain subscale provides a raw score, ranging from 4 to 20. Raw scores are converted to T-scores using the PROMIS conversion tables. Higher scores reflect greater pain. | Mean | Standard Deviation | T-score |
|
| PROMIS Anxiety T-score | The 4-item PROMIS subscale for anxiety assesses the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. The anxiety subscale provides a raw score, ranging from 4 to 20. Raw scores are converted to T-scores using the PROMIS conversion tables. Higher scores reflect greater anxiety. | Mean | Standard Deviation | T-score |
|
| PROMIS Depression T-score | The 4-item PROMIS subscale for depression assesses the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. The depression subscale provides a raw score, ranging from 4 to 20. Raw scores are converted to T-scores using the PROMIS conversion tables. Higher scores reflect greater depression. | Mean | Standard Deviation | T-score |
|
| PROMIS Fatigue T-score | The 4-item PROMIS subscale for fatigue assesses the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. The fatigue subscale provides a raw score, ranging from 4 to 20. Raw scores are converted to T-scores using the PROMIS conversion tables. Higher scores reflect greater fatigue. | Mean | Standard Deviation | T-score |
|
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
| OG001 | Control Group | Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit |
|
|
|
| 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. | Multiple imputation was used to determine follow-up scores for nonrespondents. | Posted | Mean | Standard Error | T-score | baseline and 3 month follow up |
|
|
|
|
| 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. | Multiple imputation was used to determine follow-up scores for nonrespondents. | Posted | Mean | Standard Error | T-score | baseline and 3 month follow up |
|
|
|
|
| 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. | Multiple imputation was used to determine follow-up scores for nonrespondents. | Posted | Mean | Standard Error | T-score | baseline and 3 month follow up |
|
|
|
|
| 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. | Multiple imputation was used to determine follow-up scores for nonrespondents. | Posted | Mean | Standard Error | T-score | baseline and 3 month follow up |
|
|
|
|
| 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. | Multiple imputation was used to determine follow-up scores for nonrespondents. | Posted | Mean | Standard Error | T-score | baseline and 3 month follow up |
|
|
|
|
| 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. | Participants who responded to the treatment satisfaction question at 3 month follow up | Posted | Count of Participants | Participants | 3 month follow-up |
|
|
|
| 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. | Participants who completed the PIRS-2 at 3 month follow up | Posted | Mean | Standard Deviation | units on a scale | 3-month follow-up |
|
|
|
| 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. | Participants who completed the PEG at 3 month follow up. | Posted | Mean | Standard Deviation | units on a scale | 3 month follow up |
|
|
|
| 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. | Participants who completed the GAD-2 at 3 month follow up | Posted | Mean | Standard Deviation | units on a scale | 3 month follow up |
|
|
|
| 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. | Participants who completed the PHQ-2 at 3 month follow up | Posted | Mean | Standard Deviation | units on a scale | 3 month follow up |
|
|
|
| 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. | Participants who completed the SF-36 vitality scale at 3 month follow up | Posted | Mean | Standard Deviation | units on a scale | 3 month follow up |
|
|
|
| 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. | Participants whose electronic medical record of the baseline clinic visit was available for review | Posted | Number | percentage of participants | baseline |
|
|
|
| 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. | Participants whose electronic medical record of the baseline clinic visit was available for review | Posted | Number | percentage of participants | baseline |
|
|
|
| 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. | Participants whose electronic medical record of the baseline clinic visit was available for review | Posted | Number | percentage of participants | baseline |
|
|
|
| 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. | Participants whose electronic medical record of the baseline clinic visit was available for review | Posted | Number | percentage of participants | baseline |
|
|
|
| 0 |
| 151 |
| 0 |
| 151 |
| 0 |
| 151 |
| EG001 | Control Group | Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit | 0 | 149 | 0 | 149 | 0 | 149 |
Not provided
Not provided
Not provided
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Good |
|
| Fair |
|
| Poor |
|
| Percentage of patients with 2 meds ordered |
|
| Percentage of patients with 3≤ meds ordered |
|