PRO Integration into Clinical Practice for Rheumatic Diseases

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
The University of Michigan, Ann Arbor, MI
Rheumatic Diseases+1 More
PRO Integration into Clinical Practice - Behavioral
Eligibility
18+
All Sexes
Eligible conditions
Select

Study Summary

This study is evaluating whether providing PROMIS scores to patients before appointments with their healthcare provider can improve patient satisfaction.

See full description

Eligible Conditions

  • Rheumatic Diseases

Treatment Effectiveness

Study Objectives

This trial is evaluating whether PRO Integration into Clinical Practice will improve 1 primary outcome and 3 secondary outcomes in patients with Rheumatic Diseases. Measurement will happen over the course of Up to 2 weeks.

Baseline, 3 months
Change in score of the most bothersome PROMIS domain
Up to 2 weeks
Quality of patient-provider communication
Up to 3 months
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)
Percent of appointments at which referrals/recommendations related to PROMIS scores are documented in the EMR note by the participating HCP

Trial Safety

Trial Design

2 Treatment Groups

Usual Care
1 of 2
PRO Integration into Clinical Practice
1 of 2
Active Control
Experimental Treatment

This trial requires 500 total participants across 2 different treatment groups

This trial involves 2 different treatments. PRO Integration Into Clinical Practice is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

PRO Integration into Clinical Practice
Behavioral
PRO scores will be shared with patients and healthcare providers (HCPs) via an emailed report card
Usual CarePatients and HCPs will not receive an emailed PROMIS score report. PROMIS scores, however, will be available in the EMR as usual.

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 3 months
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly up to 3 months for reporting.

Who is running the study

Principal Investigator
D. K.
Prof. Dinesh Khanna,, MD
University of Michigan

Closest Location

The University of Michigan - Ann Arbor, MI

Eligibility Criteria

This trial is for patients born any sex aged 18 and older. There are 5 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
At least one of the PROMIS PRO scores should be in the range that suggests the person is having problems with pain, physical function, or sleep. show original
Patients should have access to the internet in order to be able to complete the PROMIS PRO measures and study surveys online. show original
may find their wait time has increased, due to a recent change in the clinic’s scheduling system show original
, which includes their laboratory results, medication list and other important health information show original
Patients should have completed PROMIS pain, physical function, and sleep disturbance measures at least one day before their baseline appointment

Patient Q&A Section

What is rheumatic diseases?

"In the USA, rheumatic diseases affect all ethnic groups in equal measure. Rheumatic diseases include rheumatoid arthritis, lupus, SLE, Sjögren syndrome, ankylosing spondylitis, gout, scleroderma, Hashimoto's thyroiditis and celiac disease, and others. Rheumatic disease is a chronic disorder, and usually manifests gradually over time, but symptoms can appear suddenly in individuals with rheumatic disease." - Anonymous Online Contributor

Unverified Answer

What causes rheumatic diseases?

"Rheumatic diseases like rheumatoid arthritis, lupus, scleroderma, and Sjögren's syndrome are not genetically determined but result from a predisposition to develop autoimmune disorders. These disorders are generally associated with immune-system abnormalities and often involve the brain. The most common symptom is joint pain, although there are many other findings and symptoms." - Anonymous Online Contributor

Unverified Answer

How many people get rheumatic diseases a year in the United States?

"Around 10 million Americans have at least one of the following rheumatic diseases, of which 725,000 get a new diagnosis each year. Rheumatic diseases are frequently disabling, but many people with these diseases may not come for treatment." - Anonymous Online Contributor

Unverified Answer

Can rheumatic diseases be cured?

"While good treatment can lead to resolution of many systemic autoimmune rheumatic diseases, their etiology remains undefined. Many autoimmune rheumatic diseases can be cured. If some sort of etiologic relationship remains for any particular autoimmune rheumatic disease, its remission may be achievable." - Anonymous Online Contributor

Unverified Answer

What are common treatments for rheumatic diseases?

"It is crucial to consider both the disease manifestation and patient's own preferences in a clinical decision-making process. To reach desired outcomes, treatment should be based on disease burden. Most commonly, patients are prescribed DMARDs for the treatment of their RA disease." - Anonymous Online Contributor

Unverified Answer

What are the signs of rheumatic diseases?

"Rheumatic diseases present themselves by a range of symptoms like fevers, erythrocytosis, enlargement of lymph nodes, enlargement of the spleen, and enlargement of the liver, and can present at any stage of life." - Anonymous Online Contributor

Unverified Answer

How serious can rheumatic diseases be?

"Results from a recent paper does not support previous suggestions that individuals with rheumatic disease symptoms will suffer from severe pain, fatigue and an inability to work or other daily routines resulting in prolonged sickness absence. It also does not support previous findings of increased social or mental distress during sick leave. The data presented here indicates that in a group of patients with established rheumatic disease, little evidence of significant impact of sickness absence on health-related quality of life is found. On the contrary, other findings suggest that significant and sustained fatigue can be a consequence of rheumatic disease and sickness absence can negatively affect work capacity and psychosocial wellbeing regardless of the duration of illness and disease activity." - Anonymous Online Contributor

Unverified Answer

What does pro integration into clinical practice usually treat?

"the value of pro integration into clinical practice is recognised. These data indicate that integrated care will improve the quality of care, reduce the costs, provide an improvement in the patient's quality of life, and are therefore likely to facilitate a more cost-efficient use of health care resources." - Anonymous Online Contributor

Unverified Answer

Have there been other clinical trials involving pro integration into clinical practice?

"Results from a recent clinical trial of this study have confirmed that it is feasible to involve nurses in rheumatology clinics. They are not only an alternative source of professional information but also as a means of educating the majority of patients. Finally, the high overall acceptability and low level of satisfaction of the nurses has demonstrated the value of this approach." - Anonymous Online Contributor

Unverified Answer

Is pro integration into clinical practice safe for people?

"Results from a recent clinical trial suggest that the evidence of the safety of pro integration into clinical practice is limited. In the absence of safety data, integrating these new technologies into clinical practice is a risk. The benefits of pro integration into clinical practice should be considered before implementing innovative technology within healthcare." - Anonymous Online Contributor

Unverified Answer

What is the primary cause of rheumatic diseases?

"In our population, the common cause for rheumatic diseases is infection by infectious organisms. Furthermore, rheumatic diseases may be genetically associated with a combination of bacterial infections. This could depend on genetic factors, such as MICA allele, which was not studied in our population, and/or epigenetic factors, such as HLA genes (i.e., DRB1 genes)." - Anonymous Online Contributor

Unverified Answer

Does pro integration into clinical practice improve quality of life for those with rheumatic diseases?

"The majority of patients reported a significant improvement in their HRQoL scores after the completion of the integrated rheumatic service. Patients felt most appreciably better and were able to maintain or improve their level of activity in the week following service completion. This evidence supports the implementation of integrated clinical practice with a multidisciplinary rheumatic disease team. It has measurable benefits on HRQoL over time." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
See if you qualify for this trial
Get access to this novel treatment for Rheumatic Diseases by sharing your contact details with the study coordinator.