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| ID | Type | Description | Link |
|---|---|---|---|
| K24AR063120 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | NIH |
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This study will examine the impact of providing patient-reported outcomes measurement information system (PROMIS) scores to patients before appointments with their healthcare provider.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRO Integration into Clinical Practice | Experimental | PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card |
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| Usual Care | No Intervention | Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRO Integration into Clinical Practice | Behavioral | HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Appointments at Which Patient-Reported Outcomes Measurement Information System (PROMIS) Scores Are Documented in the Electronic Medical Record (EMR) Note by the Participating Health Care Provider (HCP) | Documentation in EMR notes will be categorized as either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom PROMIS scores were documented in the EMR for their appointment. | Up to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP | Documentation in EMR notes will be either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom referrals were documented in the EMR. | Up to 3 months |
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Inclusion Criteria for patients:
Exclusion Criteria:
Inclusion Criteria for providers:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dinesh Khanna, MD, MSc | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39480493 | Derived | Gedert R, Ochocki D, Kortam N, Huang S, Nagaraja V, Chakrabarti K, Ford J, Garber M, Lee J, Ognenovski V, Roofeh D, Cella D, Khanna D. A pilot trial of integrating the Patient-Reported Outcome Measurement Information System (PROMIS(R)) into rheumatology care. Clin Exp Rheumatol. 2025 Jan;43(1):112-118. doi: 10.55563/clinexprheumatol/fp914f. Epub 2024 Oct 25. |
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| ID | Title | Description |
|---|---|---|
| FG000 | PRO Integration Into Clinical Practice | PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR) |
| FG001 | Usual Care | Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | PRO Integration Into Clinical Practice | PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR) |
| BG001 | Usual Care |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percent of Appointments at Which Patient-Reported Outcomes Measurement Information System (PROMIS) Scores Are Documented in the Electronic Medical Record (EMR) Note by the Participating Health Care Provider (HCP) | Documentation in EMR notes will be categorized as either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom PROMIS scores were documented in the EMR for their appointment. | 1 appointment was cancelled and 8 were unable to receive score card due to technical difficulties. | Posted | Count of Participants | Participants | Up to 3 months |
|
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | PRO Integration Into Clinical Practice | PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card PRO Integration into Clinical Practice: HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Dinesh Khanna | University of Michigan | 734-763-7182 | khannad@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2021 | Feb 20, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012216 | Rheumatic Diseases |
| ID | Term |
|---|---|
| D009140 | Musculoskeletal Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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There will be two arms (1: 1 randomization) of the trial to assess PRO integration into care
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| Quality of Patient-provider Communication | Patient-provider communication is measured using the Interpersonal Processes of Care (IPC) Survey (29 items), which measures 7 subscales. For the subscales "elicited concerns/responded", "explained results/medications", "patient-centered decision making", and "compassionate, respectful" a higher score is better. For the subscales "hurried communication", "discrimination", and "disrespectful office staff" a lower score is better. (score for each subscale ranges from 1-5; + indicates a higher score is better, - indicates a lower score is better). Questions were not mandatory. | Up to 2 weeks |
| Change in Score of the Most Bothersome PROMIS Domain | Change in score of PROMIS domain deemed most bothersome by each subject at baseline. Pain intensity is reported as a scaled score of 0-10, where 0 is no pain and 10 is the worst pain possible. Physical function and sleep disturbance are reported as T-scores. The scores in PROMIS measures are computed to a T-score metric, where 50 represents the mean for US general population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measured, except physical function where a lower T-score indicates increased impairment. With physical function, a higher score indicates greater function and with sleep disturbance, a lower score indicates less disturbance. | Baseline, 3 months |
| Did not complete 12-week survey |
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Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| PROMIS Domain Scores | Pain intensity is reported as a scaled score of 0-10, where 0 indicates no pain and 10 indicates worst possible pain. The scores in PROMIS measures are computed to a T-score metric, where 50 represents the mean for US general population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measured, except physical function where a lower T-score indicates increased impairment. With physical function, a higher score indicates greater function and with sleep disturbance, a lower score indicates less disturbance. | Mean | Standard Deviation | score |
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| OG001 | Usual Care | Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual. |
|
|
| Secondary | Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP | Documentation in EMR notes will be either 'yes' or 'no' and identified through EMR data pulls. Percent of appointments is shown by the count (and percentage) of participants for whom referrals were documented in the EMR. | 1 appointment was cancelled and 8 were unable to receive score card due to technical difficulties. | Posted | Count of Participants | Participants | Up to 3 months |
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|
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| Secondary | Quality of Patient-provider Communication | Patient-provider communication is measured using the Interpersonal Processes of Care (IPC) Survey (29 items), which measures 7 subscales. For the subscales "elicited concerns/responded", "explained results/medications", "patient-centered decision making", and "compassionate, respectful" a higher score is better. For the subscales "hurried communication", "discrimination", and "disrespectful office staff" a lower score is better. (score for each subscale ranges from 1-5; + indicates a higher score is better, - indicates a lower score is better). Questions were not mandatory. | Not all subjects completed every question. Some subjects skipped questions. In the usual care arm, no question was answered by more than 43 people. | Posted | Mean | Standard Deviation | score on a scale | Up to 2 weeks |
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|
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| Secondary | Change in Score of the Most Bothersome PROMIS Domain | Change in score of PROMIS domain deemed most bothersome by each subject at baseline. Pain intensity is reported as a scaled score of 0-10, where 0 is no pain and 10 is the worst pain possible. Physical function and sleep disturbance are reported as T-scores. The scores in PROMIS measures are computed to a T-score metric, where 50 represents the mean for US general population, and 10 is the standard deviation. A higher PROMIS T-score represents more of the concept being measured, except physical function where a lower T-score indicates increased impairment. With physical function, a higher score indicates greater function and with sleep disturbance, a lower score indicates less disturbance. | The most concerning domain for subjects in each arm was analyzed. | Posted | Mean | Standard Deviation | score | Baseline, 3 months |
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| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
| EG001 | Usual Care | Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual. | 0 | 55 | 0 | 55 | 0 | 55 |
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| Communication: Elicited concerns, responded (+) |
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| Communication: Explained results, medications (+) |
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| Decision making: Patient-centered decision (+) |
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| Interpersonal style: Compassionate, respectful (+) |
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| Interpersonal style: Discrimination (-) |
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| Interpersonal style: Disrespectful office staff (-) |
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| Physical Function, T-score. A higher score indicates higher function. |
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| Sleep Disturbance, T-score. A lower score indicates less disturbance. |
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