PROMIS Measures in Primary Care Practice

NCT02383862 | Completed Results DMC

• 1 other identifier: 1410447721
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep; Pain; Anxiety; Depression; Fatigue

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in PROMIS Composite T-Score at 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.

  baseline and 3 month follow up

Secondary Outcomes (15)

• Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up

  baseline and 3 month follow up

• Change From Baseline in PROMIS Pain T-score at 3-Month Follow up

  baseline and 3 month follow up

• Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up

  baseline and 3 month follow up

• Change From Baseline in PROMIS Depression T-score at 3-Month Follow up

  baseline and 3 month follow up

• Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up

  baseline and 3 month follow up

Study Arms (2)

Feedback Group

EXPERIMENTAL

Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit

Other: Feedback Group

Control Group

NO INTERVENTION

Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit

Interventions

Feedback Group OTHER

The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores

Feedback Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Related Publications (3)

• 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.

  PMID: 31330252 DERIVED

• 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.

  PMID: 30109471 DERIVED

• 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.

  PMID: 29623512 DERIVED

MeSH Terms

Conditions

Pain; Anxiety Disorders; Depression; Fatigue

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Behavioral Symptoms; Behavior

Limitations and Caveats

A convenience sample was obtained from urban primary care clinics. Further studies in different primary care populations are needed.

Results Point of Contact

• Title: Research Coordintor
• Organization: Regenstrief Institute

tltalib@regenstrief.org

317-274-9288

Study Officials

• Kurt Kroenke, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 27, 2015
• First Posted: March 9, 2015
• Study Start: March 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: October 1, 2016
• Last Updated: June 16, 2017
• Results First Posted: June 16, 2017

Record last verified: 2017-04

Locations

US (1)