Clinical trial NCT02383862: PROMIS Measures in Primary Care Practice
Official title: Incorporating PROMIS Symptom Measures Into Primary Care Practice
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sleep
Pain
Anxiety
Depression
Fatigue
Keywords: Sleep
Pain
Anxiety
Depression
Fatigue
PROMIS
primary care
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2015-03-09
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.

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

Primary outcomes:
measure: Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up
timeFrame: baseline and 3 month follow up
Secondary outcomes:
measure: Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up
timeFrame: baseline and 3 month follow up
measure: Change From Baseline in PROMIS Pain T-score at 3-Month Follow up
timeFrame: baseline and 3 month follow up
measure: Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up
timeFrame: baseline and 3 month follow up
measure: Change From Baseline in PROMIS Depression T-score at 3-Month Follow up
timeFrame: baseline and 3 month follow up
measure: Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up
timeFrame: baseline and 3 month follow up
measure: Treatment Satisfaction at 3-Month Follow-up
timeFrame: 3 month follow-up
measure: Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)
timeFrame: 3-month follow-up
measure: Pain at 3 Month Follow up, as Measured by PEG
timeFrame: 3 month follow up
measure: Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)
timeFrame: 3 month follow up
measure: Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)
timeFrame: 3 month follow up
measure: Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale
timeFrame: 3 month follow up
measure: Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit
timeFrame: baseline
measure: Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit
timeFrame: baseline
measure: Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit
timeFrame: baseline
measure: Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit
timeFrame: baseline
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
Study officials:
affiliation: Indiana University
name: Kurt Kroenke, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.