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PROMIS Measures in Primary Care Practice

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Indiana University

Status

Completed

Conditions

Depression
Fatigue
Anxiety
Pain
Sleep

Treatments

Other: Feedback Group

Study type

Interventional

Funder types

Other

Identifiers

NCT02383862
1410447721

Details and patient eligibility

About

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.

Full 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.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Screening

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

300 participants in 2 patient groups

Feedback Group
Experimental group
Description:
Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit
Treatment:
Other: Feedback Group
Control Group
No Intervention group
Description:
Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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