PROMIS Measures in Primary Care Practice

Study Overview
=================
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.

Official Title
-----------------
Incorporating PROMIS Symptom Measures Into Primary Care Practice

Conditions
-----------------
Sleep, Pain, Anxiety, Depression, Fatigue

Intervention / Treatment
-----------------
* Other: Feedback Group


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feedback Group<br>Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit | Other: Feedback Group<br>* The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores<br>|
| No Intervention: Control Group<br>Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep, Pain, Anxiety, Depression, Fatigue, PROMIS, primary care