PROMIS Measures in Primary Care Practice

Depression Clinical Trial

Official title:

Incorporating PROMIS Symptom Measures Into Primary Care Practice

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02383862
• Other study ID #: 1410447721
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: November 2, 2016
• Start date: March 2015
• Est. completion date: October 2016

Study information

• Verified date: November 2016
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

The SPADE symptoms (sleep, pain, anxiety, depression, and energy/fatigue) are the most common yet undertreated symptoms in clinical practice. Using the PROMIS 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: October 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Anxiety
• Depression
• Fatigue
• Pain
• Sleep

Intervention

Other:
• Feedback Group
The intervention will consist of physicians receiving PROMIS scores, reflecting patients SPADE symptoms, at the time of their patients' visits.

Locations

Country	Name	City	State
United States	Indiana University	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Patient-Centered Outcomes Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline in PROMIS Composite Score at 3-Month Follow-up	PROMIS symptom measures will be administered at baseline and at 3 month follow-up. To assess the effects of feedback on sleep, pain, anxiety, depression and energy/fatigue, group differences in the change in PROMIS composite scores from baseline to 3 month follow up will be calculated.	PROMIS Composite Scores of the 5 SPADE symptoms (sleep, pain, anxiety, depression, and energy/fatigue) will be computed at baseline and at 3 month follow up.	No
Secondary	Treatment Satisfaction at 3-Month Follow-up	At 3-month follow-up, treatment satisfaction will be assessed for any symptom that was at a moderate level (PROMIS T-score greater than or equal to 55) at baseline using a 3-item symptom specific treatment satisfaction scale.	Patients' satisfaction with treatment will be assessed at 3 month follow-up.	No
Secondary	Patient Health Questionnaire 4-item composite depression and anxiety measure (PHQ-4)	Secondary composite measure of depression and anxiety	3-month follow-up	No
Secondary	PEG 3-item pain scale	Secondary measure of pain	3-month follow-up	No
Secondary	SF-36 vitality scale	Secondary measure of fatigue	3-month follow-up	No
Secondary	Pittsburgh Insomnia Rating Scale	Secondary measure of insomnia	3-month follow-up	No
Secondary	Number of symptom-specific tests ordered at the baseline visit	Number of symptom specific tests documented in electronic medical records	Baseline visit	No
Secondary	Number of symptom-specific medications ordered at baseline visit	Number of symptom-specific medications prescribed in electronic medical records	Baseline visit	No