Impact of National Institutes of Health Gastrointestinal PROMIS Measures in Clinical Practice: Results of a Multicenter Controlled Trial

Abstract

Objectives: The National Institutes of Health (NIH) created the Patient Reported Outcomes Measurement Information System (PROMIS) to allow efficient, online measurement of patient-reported outcomes (PROs), but it remains untested whether PROMIS improves outcomes. Here, we aimed to compare the impact of gastrointestinal (GI) PROMIS measures vs. usual care on patient outcomes.

Methods: We performed a pragmatic clinical trial with an off-on study design alternating weekly between intervention (GI PROMIS) and control arms at one Veterans Affairs and three university-affiliated specialty clinics. Adults with GI symptoms were eligible. Intervention patients completed GI PROMIS symptom questionnaires on an e-portal 1 week before their visit; PROs were available for review by patients and their providers before and during the clinic visit. Usual care patients were managed according to customary practices. Our primary outcome was patient satisfaction as determined by the Consumer Assessment of Healthcare Providers and Systems questionnaire. Secondary outcomes included provider interpersonal skills (Doctors' Interpersonal Skills Questionnaire (DISQ)) and shared decision-making (9-item Shared Decision Making Questionnaire (SDM-Q-9)).

Results: There were 217 and 154 patients in the GI PROMIS and control arms, respectively. Patient satisfaction was similar between groups (P>0.05). Intervention patients had similar assessments of their providers' interpersonal skills (DISQ 89.4±11.7 vs. 89.8±16.0, P=0.79) and shared decision-making (SDM-Q-9 79.3±12.4 vs. 79.0±22.0, P=0.85) vs.

Conclusions: This is the first controlled trial examining the impact of NIH PROMIS in clinical practice. One-time use of GI PROMIS did not improve patient satisfaction or assessment of provider interpersonal skills and shared decision-making. Future studies examining how to optimize PROs in clinical practice are encouraged before widespread adoption.

FIGURE 1

Sample “heat map” report of GI PROMIS scores and history of present illness (HPI). Patients complete PROMIS items on the e-portal, and the results are converted into a GI PROMIS symptom heat map and HPI. Patients’ PROMIS scores are compared to the general U.S. population with benchmarks to add interpretability to the scores, similar to a lab test. Both the heat map and HPI are viewable on the e-portal for both the patient and healthcare provider prior to the clinic visit.

FIGURE 2

Flow diagram of enrolled patients. For the control group, intention-to-treat and per-protocol analyses included those who returned the post-visit outcome questionnaires. For the GI PROMIS arm, the intention-to-treat analyses included those who completed GI PROMIS and who showed for their visit; missing outcome data was imputed to the corresponding mean value calculated from controls for each item. Per-protocol analyses for the GI PROMIS arm only included those who completed GI PROMIS and the post-visit outcome questionnaires.