Trial Outcomes & Findings for PROMIS Measures in Primary Care Practice (NCT NCT02383862)
NCT ID: NCT02383862
Last Updated: 2017-06-16
Results Overview
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.
COMPLETED
NA
300 participants
baseline and 3 month follow up
2017-06-16
Participant Flow
Recruitment occurred between March 2015 and April 2016 in primary care outpatient clinics.
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.
Participant milestones
| Measure |
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
|
Control Group
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Baseline
STARTED
|
151
|
149
|
|
Baseline
COMPLETED
|
151
|
149
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
3 Month Follow up
STARTED
|
151
|
149
|
|
3 Month Follow up
COMPLETED
|
128
|
128
|
|
3 Month Follow up
NOT COMPLETED
|
23
|
21
|
Reasons for withdrawal
| Measure |
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
|
Control Group
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
3 Month Follow up
Lost to Follow-up
|
23
|
21
|
Baseline Characteristics
PROMIS Measures in Primary Care Practice
Baseline characteristics by cohort
| Measure |
Feedback Group
n=151 Participants
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
|
Control Group
n=149 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50.5 years
STANDARD_DEVIATION 14.1 • n=99 Participants
|
48.2 years
STANDARD_DEVIATION 14.7 • n=107 Participants
|
49.4 years
STANDARD_DEVIATION 14.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
215 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
40 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
85 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
123 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
243 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
23 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
79 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
148 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
65 Participants
n=99 Participants
|
70 Participants
n=107 Participants
|
135 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
PROMIS Composite T-score
|
58.3 T-score
STANDARD_DEVIATION 7.6 • n=99 Participants
|
58.4 T-score
STANDARD_DEVIATION 6.4 • n=107 Participants
|
58.3 T-score
STANDARD_DEVIATION 7.0 • n=206 Participants
|
|
PROMIS Sleep T-score
|
58.3 T-score
STANDARD_DEVIATION 9.4 • n=99 Participants
|
58.1 T-score
STANDARD_DEVIATION 8.7 • n=107 Participants
|
58.2 T-score
STANDARD_DEVIATION 9.0 • n=206 Participants
|
|
PROMIS Pain T-score
|
61.5 T-score
STANDARD_DEVIATION 9.3 • n=99 Participants
|
61.4 T-score
STANDARD_DEVIATION 9.5 • n=107 Participants
|
61.5 T-score
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
PROMIS Anxiety T-score
|
59.0 T-score
STANDARD_DEVIATION 10.1 • n=99 Participants
|
59.2 T-score
STANDARD_DEVIATION 8.7 • n=107 Participants
|
59.1 T-score
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
PROMIS Depression T-score
|
55.8 T-score
STANDARD_DEVIATION 10.4 • n=99 Participants
|
56.0 T-score
STANDARD_DEVIATION 9.1 • n=107 Participants
|
55.9 T-score
STANDARD_DEVIATION 9.8 • n=206 Participants
|
|
PROMIS Fatigue T-score
|
56.8 T-score
STANDARD_DEVIATION 10.1 • n=99 Participants
|
57.2 T-score
STANDARD_DEVIATION 9.9 • n=107 Participants
|
57.0 T-score
STANDARD_DEVIATION 10.0 • n=206 Participants
|
PRIMARY outcome
Timeframe: baseline and 3 month follow upPopulation: Multiple imputation was used to determine follow-up scores for nonrespondents.
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.
Outcome measures
| Measure |
Feedback Group
n=151 Participants
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
|
Control Group
n=149 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up
|
3.48 T-score
Standard Error 0.54
|
2.38 T-score
Standard Error 0.55
|
SECONDARY outcome
Timeframe: baseline and 3 month follow upPopulation: Multiple imputation was used to determine follow-up scores for nonrespondents.
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.
Outcome measures
| Measure |
Feedback Group
n=151 Participants
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
|
Control Group
n=149 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up
|
4.88 T-score
Standard Error 0.76
|
4.04 T-score
Standard Error 0.76
|
SECONDARY outcome
Timeframe: baseline and 3 month follow upPopulation: Multiple imputation was used to determine follow-up scores for nonrespondents.
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.
Outcome measures
| Measure |
Feedback Group
n=151 Participants
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
|
Control Group
n=149 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Change From Baseline in PROMIS Pain T-score at 3-Month Follow up
|
2.77 T-score
Standard Error 0.68
|
2.12 T-score
Standard Error 0.78
|
SECONDARY outcome
Timeframe: baseline and 3 month follow upPopulation: Multiple imputation was used to determine follow-up scores for nonrespondents.
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.
Outcome measures
| Measure |
Feedback Group
n=151 Participants
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
|
Control Group
n=149 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up
|
2.96 T-score
Standard Error 0.77
|
2.13 T-score
Standard Error 0.84
|
SECONDARY outcome
Timeframe: baseline and 3 month follow upPopulation: Multiple imputation was used to determine follow-up scores for nonrespondents.
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.
Outcome measures
| Measure |
Feedback Group
n=151 Participants
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
|
Control Group
n=149 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Change From Baseline in PROMIS Depression T-score at 3-Month Follow up
|
3.08 T-score
Standard Error 0.77
|
1.59 T-score
Standard Error 0.77
|
SECONDARY outcome
Timeframe: baseline and 3 month follow upPopulation: Multiple imputation was used to determine follow-up scores for nonrespondents.
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.
Outcome measures
| Measure |
Feedback Group
n=151 Participants
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
|
Control Group
n=149 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up
|
3.68 T-score
Standard Error 0.87
|
2.01 T-score
Standard Error 0.99
|
SECONDARY outcome
Timeframe: 3 month follow-upPopulation: Participants who responded to the treatment satisfaction question 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.
Outcome measures
| Measure |
Feedback Group
n=128 Participants
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
|
Control Group
n=128 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Treatment Satisfaction at 3-Month Follow-up
Poor
|
14 Participants
|
6 Participants
|
|
Treatment Satisfaction at 3-Month Follow-up
Excellent
|
25 Participants
|
21 Participants
|
|
Treatment Satisfaction at 3-Month Follow-up
Very Good
|
28 Participants
|
33 Participants
|
|
Treatment Satisfaction at 3-Month Follow-up
Good
|
39 Participants
|
42 Participants
|
|
Treatment Satisfaction at 3-Month Follow-up
Fair
|
22 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 3-month follow-upPopulation: Participants who completed the PIRS-2 at 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.
Outcome measures
| Measure |
Feedback Group
n=255 Participants
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
|
Control Group
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)
|
3.46 units on a scale
Standard Deviation 1.80
|
—
|
SECONDARY outcome
Timeframe: 3 month follow upPopulation: Participants who completed the PEG at 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.
Outcome measures
| Measure |
Feedback Group
n=255 Participants
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
|
Control Group
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
Pain at 3 Month Follow up, as Measured by PEG
|
5.13 units on a scale
Standard Deviation 3.28
|
—
|
SECONDARY outcome
Timeframe: 3 month follow upPopulation: Participants who completed the GAD-2 at 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.
Outcome measures
| Measure |
Feedback Group
n=256 Participants
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
|
Control Group
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
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 outcome
Timeframe: 3 month follow upPopulation: Participants who completed the PHQ-2 at 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.
Outcome measures
| Measure |
Feedback Group
n=255 Participants
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
|
Control Group
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
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 outcome
Timeframe: 3 month follow upPopulation: Participants who completed the SF-36 vitality scale at 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.
Outcome measures
| Measure |
Feedback Group
n=256 Participants
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
|
Control Group
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
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 outcome
Timeframe: baselinePopulation: Participants whose electronic medical record of the baseline clinic visit was available for review
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.
Outcome measures
| Measure |
Feedback Group
n=147 Participants
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
|
Control Group
n=145 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
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
|
90.3 percentage of participants
|
|
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
|
9.7 percentage of participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Participants whose electronic medical record of the baseline clinic visit was available for review
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.
Outcome measures
| Measure |
Feedback Group
n=147 Participants
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
|
Control Group
n=145 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
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
|
84.1 percentage of participants
|
|
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
|
15.9 percentage of participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Participants whose electronic medical record of the baseline clinic visit was available for review
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.
Outcome measures
| Measure |
Feedback Group
n=147 Participants
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
|
Control Group
n=145 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
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
|
97.9 percentage of participants
|
|
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
|
2.1 percentage of participants
|
SECONDARY outcome
Timeframe: baselinePopulation: Participants whose electronic medical record of the baseline clinic visit was available for review
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.
Outcome measures
| Measure |
Feedback Group
n=147 Participants
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
|
Control Group
n=145 Participants
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit
|
|---|---|---|
|
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
|
30.3 percentage of participants
|
|
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
|
35.2 percentage of participants
|
|
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
|
23.5 percentage of participants
|
|
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
|
11.0 percentage of participants
|
Adverse Events
Feedback Group
Control Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place