Rheumatic Diseases
Conditions
Keywords
Health-related quality of life, PROMIS
Brief summary
This study will examine the impact of providing patient-reported outcomes measurement information system (PROMIS) scores to patients before appointments with their healthcare provider.
Interventions
BEHAVIORALPRO Integration into Clinical Practice
HCPs will document their discussion and recommendations/referrals in MiChart (Epic EMR)
Sponsors
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Intervention model description
There will be two arms (1: 1 randomization) of the trial to assess PRO integration into care
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for patients: * New and established patients seeking care at Michigan Medicine rheumatology clinics * Patients should have access to the patient portal in MiChart patient portal * Patients should have access to the internet at home to be able to complete the PROMIS PRO measures and study surveys online * Patients should have completed PROMIS pain, physical function, and sleep disturbance measures at least one day before their baseline appointment * At least one of the PROMIS PRO scores should be in the concerning zone (pain intensity ≥ 5, physical function ≤ 40, or sleep disturbance ≥ 60).
Exclusion criteria
* Non-English speakers * under 18 years of age Inclusion Criteria for providers: * Rheumatology health care providers, including clinicians and advanced practice providers at Michigan Medicine who are currently treating rheumatology patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) | Up to 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP | Up to 3 months | 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. |
| Quality of Patient-provider Communication | Up to 2 weeks | 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. |
| Change in Score of the Most Bothersome PROMIS Domain | Baseline, 3 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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) | 55 |
| Usual Care Patients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual. | 55 |
| Total | 110 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Cancelled appointment | 1 | 0 |
| Overall Study | Did not complete 12-week survey | 16 | 16 |
| Overall Study | Excluded due to technical difficulties with generating scorecard | 8 | 0 |
Baseline characteristics
| Characteristic | PRO Integration Into Clinical Practice | Total | Usual Care |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 24 Participants | 16 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 86 Participants | 39 Participants |
| Age, Continuous | 51.7 years STANDARD_DEVIATION 14.9 | 53.5 years STANDARD_DEVIATION 14.6 | 55.2 years STANDARD_DEVIATION 14.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 13 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants | 95 Participants | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| PROMIS Domain Scores Pain Intensity, 0-10 scale, where 0 is no pain and 10 is worst possible pain | 5.2 score STANDARD_DEVIATION 1.8 | 5.3 score STANDARD_DEVIATION 1.9 | 5.5 score STANDARD_DEVIATION 2.1 |
| PROMIS Domain Scores Physical Function, T-score. A higher score indicates greater function. | 38.2 score STANDARD_DEVIATION 7 | 37.9 score STANDARD_DEVIATION 6.6 | 37.7 score STANDARD_DEVIATION 6.3 |
| PROMIS Domain Scores Sleep Disturbance, T-score. A lower score indicates less disturbance. | 58.2 score STANDARD_DEVIATION 7.4 | 57.6 score STANDARD_DEVIATION 8.4 | 57.1 score STANDARD_DEVIATION 9.2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 53 Participants | 104 Participants | 51 Participants |
| Region of Enrollment United States | 55 Participants | 110 Participants | 55 Participants |
| Sex: Female, Male Female | 47 Participants | 88 Participants | 41 Participants |
| Sex: Female, Male Male | 8 Participants | 22 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
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.
Time frame: Up to 3 months
Population: 1 appointment was cancelled and 8 were unable to receive score card due to technical difficulties.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO Integration Into Clinical Practice | 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) | 23 Participants |
| Usual Care | 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) | 7 Participants |
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.
Time frame: Baseline, 3 months
Population: The most concerning domain for subjects in each arm was analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO Integration Into Clinical Practice | Change in Score of the Most Bothersome PROMIS Domain | Pain Intensity, 0-10 scale | -1.1 score | Standard Deviation 2.5 |
| PRO Integration Into Clinical Practice | Change in Score of the Most Bothersome PROMIS Domain | Physical Function, T-score. A higher score indicates higher function. | -0.5 score | Standard Deviation 2.6 |
| PRO Integration Into Clinical Practice | Change in Score of the Most Bothersome PROMIS Domain | Sleep Disturbance, T-score. A lower score indicates less disturbance. | -2.8 score | Standard Deviation 6.6 |
| Usual Care | Change in Score of the Most Bothersome PROMIS Domain | Pain Intensity, 0-10 scale | -0.9 score | Standard Deviation 2.4 |
| Usual Care | Change in Score of the Most Bothersome PROMIS Domain | Physical Function, T-score. A higher score indicates higher function. | 1.1 score | Standard Deviation 4.8 |
| Usual Care | Change in Score of the Most Bothersome PROMIS Domain | Sleep Disturbance, T-score. A lower score indicates less disturbance. | -3.3 score | Standard Deviation 6.4 |
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.
Time frame: Up to 3 months
Population: 1 appointment was cancelled and 8 were unable to receive score card due to technical difficulties.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| PRO Integration Into Clinical Practice | Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP | 17 Participants |
| Usual Care | Percent of Appointments at Which Referrals/Recommendations Related to PROMIS Scores Are Documented in the EMR Note by the Participating HCP | 6 Participants |
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.
Time frame: Up to 2 weeks
Population: Not all subjects completed every question. Some subjects skipped questions. In the usual care arm, no question was answered by more than 43 people.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| PRO Integration Into Clinical Practice | Quality of Patient-provider Communication | Communication: Explained results, medications (+) | 4.0 score on a scale | Standard Deviation 1.2 |
| PRO Integration Into Clinical Practice | Quality of Patient-provider Communication | Interpersonal style: Compassionate, respectful (+) | 4.4 score on a scale | Standard Deviation 1 |
| PRO Integration Into Clinical Practice | Quality of Patient-provider Communication | Communication: Elicited concerns, responded (+) | 4.1 score on a scale | Standard Deviation 1.3 |
| PRO Integration Into Clinical Practice | Quality of Patient-provider Communication | Interpersonal style: Discrimination (-) | 1.1 score on a scale | Standard Deviation 0.4 |
| PRO Integration Into Clinical Practice | Quality of Patient-provider Communication | Decision making: Patient-centered decision (+) | 4.0 score on a scale | Standard Deviation 1.3 |
| PRO Integration Into Clinical Practice | Quality of Patient-provider Communication | Interpersonal style: Disrespectful office staff (-) | 1.0 score on a scale | Standard Deviation 0 |
| PRO Integration Into Clinical Practice | Quality of Patient-provider Communication | Communication: Hurried communication (-) | 1.3 score on a scale | Standard Deviation 0.5 |
| Usual Care | Quality of Patient-provider Communication | Interpersonal style: Disrespectful office staff (-) | 1.0 score on a scale | Standard Deviation 0.2 |
| Usual Care | Quality of Patient-provider Communication | Communication: Hurried communication (-) | 1.2 score on a scale | Standard Deviation 0.5 |
| Usual Care | Quality of Patient-provider Communication | Communication: Elicited concerns, responded (+) | 4.5 score on a scale | Standard Deviation 1 |
| Usual Care | Quality of Patient-provider Communication | Communication: Explained results, medications (+) | 4.0 score on a scale | Standard Deviation 1.1 |
| Usual Care | Quality of Patient-provider Communication | Decision making: Patient-centered decision (+) | 4.0 score on a scale | Standard Deviation 1.3 |
| Usual Care | Quality of Patient-provider Communication | Interpersonal style: Compassionate, respectful (+) | 4.5 score on a scale | Standard Deviation 0.9 |
| Usual Care | Quality of Patient-provider Communication | Interpersonal style: Discrimination (-) | 1.0 score on a scale | Standard Deviation 0.2 |