N/A N=300 Randomized Single-blind Screening

PROMIS Measures in Primary Care Practice

Sleep · Pain · Anxiety · Depression · Fatigue

Bottom Line

View on ClinicalTrials.gov: NCT02383862 ↗

Enrolled (actual)

300

Serious AEs

0.0%

Results posted

Jun 2017

Primary outcome: Primary: Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up — 3.48; 2.38 T-score — p=0.165

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Feedback Group (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Aug 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up	3.48; 2.38	0.165
SECONDARY Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up	4.88; 4.04	0.425
SECONDARY Change From Baseline in PROMIS Pain T-score at 3-Month Follow up	2.77; 2.12	0.539
SECONDARY Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up	2.96; 2.13	0.471
SECONDARY Change From Baseline in PROMIS Depression T-score at 3-Month Follow up	3.08; 1.59	0.174
SECONDARY Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up	3.68; 2.01	0.222
SECONDARY Treatment Satisfaction at 3-Month Follow-up	25; 21; 28; 33; 39; 42	—
SECONDARY Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)	3.46	—
SECONDARY Pain at 3 Month Follow up, as Measured by PEG	5.13	—
SECONDARY Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)	2.14	—
SECONDARY Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)	2.06	—
SECONDARY Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale	41.16	—
SECONDARY Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit	91.8; 90.3; 8.2; 9.7	—
SECONDARY Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit	86.4; 84.1; 13.6; 15.9	—
SECONDARY Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit	91.2; 97.9; 8.8; 2.1	—
SECONDARY Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit	38.1; 30.3; 27.2; 35.2; 19.1; 23.5	—

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02383862). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.