PROMIS Measures in Primary Care Practice

• ClinicalTrials.gov Identifier: NCT02383862
• Recruitment Status: Completed
• First Posted: March 9, 2015
• Results First Posted: June 16, 2017
• Last Update Posted: June 16, 2017
• Sponsor: Indiana University
• Collaborator: Patient-Centered Outcomes Research Institute
• Information provided by (Responsible Party): Kurt Kroenke, Indiana University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Sleep; Pain; Anxiety; Depression; Fatigue	Other: Feedback Group	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Screening
• Official Title: Incorporating PROMIS Symptom Measures Into Primary Care Practice
• Study Start Date: March 2015
• Actual Primary Completion Date: August 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up [ Time Frame: 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 Outcome Measures :

1. Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up [ Time Frame: 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.
2. Change From Baseline in PROMIS Pain T-score at 3-Month Follow up [ Time Frame: 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.
3. Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up [ Time Frame: 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.
4. Change From Baseline in PROMIS Depression T-score at 3-Month Follow up [ Time Frame: 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.
5. Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up [ Time Frame: 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.
6. Treatment Satisfaction at 3-Month Follow-up [ Time Frame: 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.
7. Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2) [ Time Frame: 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.
8. Pain at 3 Month Follow up, as Measured by PEG [ Time Frame: 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.
9. Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2) [ Time Frame: 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.
10. Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2) [ Time Frame: 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.
11. Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale [ Time Frame: 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.
12. Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit [ Time Frame: 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.
13. Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit [ Time Frame: 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.
14. Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit [ Time Frame: 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.
15. Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit [ Time Frame: 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

Sponsors and Collaborators

Indiana University

Patient-Centered Outcomes Research Institute

Investigators

• Principal Investigator: Kurt Kroenke, MD; Indiana University

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

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.

• Responsible Party: Kurt Kroenke, Professor of Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT02383862
• Other Study ID Numbers: 1410447721
• First Posted: March 9, 2015
• Results First Posted: June 16, 2017
• Last Update Posted: June 16, 2017
• Last Verified: April 2017

Keywords provided by Kurt Kroenke, Indiana University:

Sleep; Pain; Anxiety; Depression; Fatigue; PROMIS; primary care

Additional relevant MeSH terms:

Fatigue; Depression; Behavioral Symptoms