SleepNCT02383862
PROMIS Measures in Primary Care Practice
A study testing Feedback Group in people with Sleep and Pain, run by Indiana University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Feedback Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Oct 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Incorporating PROMIS Symptom Measures Into Primary Care Practice
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.
Read the 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.
- Conditions
- Sleep, Pain, Anxiety, Depression, Fatigue
- Being tested
- Feedback Group
- Keywords
- Sleep, Pain, Anxiety, Depression, Fatigue, PROMIS, primary care
- Medical subject headings
- Pain, Anxiety Disorders, Depression, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Feedback GroupOther
The intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores
| Study group | Role | What they receive |
|---|---|---|
| Feedback Group | Experimental | Patients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit Receives: Other: Feedback Group |
| Control Group | No intervention | Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 3 month follow up
Secondary outcomes (15)
Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up
The 4-item PROMIS subscale for sleep was administered to participants at baseline and at 3 month follow up. The sleep subscale measures the extent to which patients experience problems with sleep over the past 7 days using a 5-point Likert scale. Higher scores reflect more severe sleep problems. To assess the effects of feedback on sleep, group differences in the change in PROMIS sleep T-scores from baseline to 3 month follow up (baseline PROMIS sleep T-score - 3 month PROMIS sleep T-score) were calculated. Positive change scores are indicative of improvement in sleep.
Measured: baseline and 3 month follow up
Change From Baseline in PROMIS Pain T-score at 3-Month Follow up
The 4-item PROMIS subscale for pain was administered to participants at baseline and at 3 month follow up. The pain subscale measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater pain. To assess the effects of feedback on pain, group differences in the change in PROMIS pain T-scores from baseline to 3-month follow up (baseline PROMIS pain T-score - 3 month PROMIS pain T-score) were calculated. Positive change scores are indicative of improvement in pain.
Measured: baseline and 3 month follow up
Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up
The 4-item PROMIS subscale for anxiety was administered to participants at baseline and at 3 month follow up. The anxiety subscale measures the extent to which patients experience anxiety symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater anxiety. To assess the effects of feedback on anxiety, group differences in the change in PROMIS anxiety T-scores from baseline to 3-month follow up (baseline PROMIS anxiety T-score - 3 month PROMIS anxiety T-score) were calculated. Positive change scores are indicative of improvement in anxiety.
Measured: baseline and 3 month follow up
Change From Baseline in PROMIS Depression T-score at 3-Month Follow up
The 4-item PROMIS subscale for depression was administered to participants at baseline and at 3 month follow up. The depression subscale measures the extent to which patients experience depressive symptoms over the past 7 days using a 5-point Likert scale. Higher scores reflect greater depression. To assess the effects of feedback on depression, group differences in the change in PROMIS depression T-scores from baseline to 3-month follow up (baseline PROMIS depression T-score - 3 month PROMIS depression T-score) were calculated. Positive change scores are indicative of improvement in depression.
Measured: baseline and 3 month follow up
Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up
The 4-item PROMIS subscale for fatigue was administered to participants at baseline and at 3 month follow up. The fatigue subscale measures the extent to which patients experience problems with fatigue over the past 7 days using a 5-point Likert scale. Higher scores reflect greater fatigue. To assess the effects of feedback on fatigue, group differences in the change in PROMIS fatigue T-scores from baseline to 3-month follow up (baseline PROMIS fatigue T-score - 3 month PROMIS fatigue T-score) were calculated. Positive change scores are indicative of improvement in fatigue.
Measured: baseline and 3 month follow up
Treatment Satisfaction at 3-Month Follow-up
At 3-month follow-up, treatment satisfaction was assessed. This 1-item measure assesses patients' satisfaction with the care of their symptoms overall on a 5-point Likert scale ranging from excellent to poor. Higher scores indicate poorer satisfaction.
Measured: 3 month follow-up
Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, sleep was assessed using the 2-item Pittsburgh Insomnia Rating Scale (PIRS-2). PIRS-2 measures quality and satisfaction with sleep over the past week. Possible scores range from 0 to 6, with higher scores reflecting poorer sleep.
Measured: 3-month follow-up
Pain at 3 Month Follow up, as Measured by PEG
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, pain was assessed using the 3-item PEG (Pain intensity, Enjoyment of life, and General activity). PEG measures pain intensity and interference in the past week. Possible scores range from 0 to 10, with higher scores reflecting more intense pain and interference.
Measured: 3 month follow up
Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, anxiety was assessed using the 2-item Generalized Anxiety Disorder scale (GAD-2). GAD-2 measures the frequency of anxiety symptoms over the past 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe anxiety.
Measured: 3 month follow up
Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, depression was assessed using the 2-item Patient Health Questionnaire (PHQ-2). The PHQ-2 measures the frequency of depressive symptoms over the last 2 weeks. Possible scores range from 0 to 6, with higher scores reflecting more severe depression.
Measured: 3 month follow up
Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale
For this secondary outcome, data were collected from the group as a whole without regard to randomization. Thus, data is analyzed for the group as a whole rather than separately for each arm. At 3-month follow up, fatigue was assessed using the 4-item SF-36 (Short Form-36 Healthy Survey) vitality scale. The SF-36 vitality scale measures fatigue and energy over the past week. Possible scores range from 0 to 100, with lower scores reflecting greater fatigue.
Measured: 3 month follow up
Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit
Electronic medical records were reviewed to determine the number of laboratory tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ lab tests ordered for SPADE symptoms at baseline was calculated.
Measured: baseline
Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit
Electronic medical records were reviewed to determine the number of radiologic (RAD) tests ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ RAD tests ordered for SPADE symptoms at baseline was calculated.
Measured: baseline
Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit
Electronic medical records were reviewed to determine the number of tests ordered, other than radiologic or laboratory tests (e.g., sleep study), for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0 or 1≤ tests ordered for SPADE symptoms at baseline was calculated.
Measured: baseline
Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit
Electronic medical records were reviewed to determine the number of medications ordered for SPADE symptoms at the baseline clinic visit. The percentage of participants in each group with 0, 1, 2, or 3≤ medications ordered for SPADE symptoms at baseline was calculated.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionAug 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Principal investigator, Kurt Kroenke, Indiana University
- Investigators
- Kurt Kroenke, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383862
- Sponsor's protocol ID
- 1410447721
- Status last verified
- Apr 2017
- First submitted
- 27 Feb 2015
- Last updated
- 16 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 31330252Talib 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.
PubMed 30109471Kroenke 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.
PubMed 29623512
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incorporating PROMIS Symptom Measures Into Primary Care Practice
- ClinicalTrials.gov ID
- NCT02383862
- Acronym / sponsor ID
- 1410447721
- Conditions
- Sleep, Pain, Anxiety, Depression, Fatigue
- Keywords
- Sleep, Pain, Anxiety, Depression, Fatigue, PROMIS, primary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- Mar 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Posted 16 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Feedback Group | Experimental | Other: Feedback GroupPatients whose clinician received baseline PROMIS symptom scores at the time of their clinic visit |
| Control Group | No intervention | –Patients whose clinician did not receive baseline PROMIS symptom scores at the time of their clinic visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
- Primary care physicians who do not practice within the Indiana University Health or Eskenazi Health systems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Feedback GroupThe intervention will consist of feedback provided to clinicians in the form of patients' baseline PROMIS scores | Other | Feedback Group |
Primary outcome
Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up
Time frame: baseline and 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.
15 secondary outcomes
Change From Baseline in PROMIS Sleep T-score at 3-Month Follow up
Time frame: baseline and 3 month follow up
Change From Baseline in PROMIS Pain T-score at 3-Month Follow up
Time frame: baseline and 3 month follow up
Change From Baseline in PROMIS Anxiety T-score at 3-Month Follow up
Time frame: baseline and 3 month follow up
Change From Baseline in PROMIS Depression T-score at 3-Month Follow up
Time frame: baseline and 3 month follow up
Change From Baseline in PROMIS Fatigue T-score at 3-Month Follow up
Time frame: baseline and 3 month follow up
Treatment Satisfaction at 3-Month Follow-up
Time frame: 3 month follow-up
Sleep at 3-month Follow up, as Measured by the Pittsburgh Insomnia Rating Scale (PIRS-2)
Time frame: 3-month follow-up
Pain at 3 Month Follow up, as Measured by PEG
Time frame: 3 month follow up
Anxiety at 3 Month Follow up, as Measured by the Generalized Anxiety Disorder Scale (GAD-2)
Time frame: 3 month follow up
Depression at 3-month Follow up, as Measured by the Patient Health Questionnaire (PHQ-2)
Time frame: 3 month follow up
Fatigue at 3-month Follow up, as Measured by the SF-36 Vitality Scale
Time frame: 3 month follow up
Percentage of Participants With Laboratory Tests Ordered for SPADE Symptoms at Baseline Clinic Visit
Time frame: baseline
Percentage of Participants With Radiologic (RAD) Tests Ordered for SPADE Symptoms at Baseline Clinic Visit
Time frame: baseline
Percentage of Participants With Tests Ordered (Other Than Radiologic and Laboratory Tests) for SPADE Symptoms at Baseline Clinic Visit
Time frame: baseline
Percentage of Participants With Medications Ordered for SPADE Symptoms at Baseline Clinic Visit
Time frame: baseline
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31330252Kroenke 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.
- Derived from this study: PubMed 30109471Talib 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.
- Derived from this study: PubMed 29623512Kroenke 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kurt Kroenke, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Feedback Group in people with Sleep and Pain, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in PROMIS Composite T-Score at 3-Month Follow-up (time frame: baseline and 3 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02383862, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2017.