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

Abstract

OBJECTIVE 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 (VA) and three university-affiliated specialty clinics. Adults with GI symptoms were eligible. Intervention patients completed GI PROMIS symptom questionnaires on an e-portal one week before their visit; PROs were available for review by patients and their providers prior to 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 & Systems (CAHPS) 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>.05). Intervention patients had similar assessments of their providers’ interpersonal skills (DISQ 89.4±11.7 vs. 89.8±16.0, p=.79) and shared decision-making (SDM-Q-9 79.3±12.4 vs. 79.0±22.0, p=.85) vs. controls. 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.

Meaningful shared decision‐making: complex process demanding cognitive and emotional skills

“…A variety of decision aids has been developed and proposed to help patients understand diagnostic or treatment options . The assumption that technical information, provided in the friendly format of a decision aid, is all what is needed for people to make decisions, dismisses the value of the conversation and the essential bidirectional dimension of SDM.…”

“… Sources: Hargraves et al, Nicolai et al, Brezis et al, Tsulukidze et al, Barr et al, Almario et al, Little et al, and Krupat et al …”

“…A variety of decision aids has been developed and proposed to help patients understand diagnostic or treatment options. 55,58,[75][76][77][78][79][80] The assumption that technical information, provided in the friendly for- An additional advisable step to help clinicians might be the design of a structured tool for assessing and improving the process of SDM, as suggested in Table 1.…”

“…Sources: Hargraves et al, 55 Nicolai et al, 58 Brezis et al, 75 Tsulukidze et al, 76 Barr et al, 77 Almario et al, 78 Little et al, 79 and Krupat et al 80 is useful for teamwork and communication skills, 83 can elicit authentic physician behaviours, 84 and is effective to teach and evaluate clinicians' competence for difficult conversations. 85,86 Simulation exercises demonstrate clinicians' variability for identical cases in the process of relationship building 87 and allow exploring strategies for collaboration and counseling-what physicians say, how they say it and why.…”

Systematic review: Disease‐specific instruments to assess gastrointestinal symptoms in functional dyspepsia

“…Short outcome measures for 8 gastrointestinal symptom complexes were developed with good reliability and validity . Although the use of these domain‐specific PROMs was hypothesized to improve patient satisfaction, a recently performed trial compared the use of PROMIS with regular care and found no difference in patient satisfaction and shared decision making . However, several limitations should be considered including the poor response rate, lack of information about influence on clinic visit efficiency and frequency, cost‐effectiveness, and long‐term effects, which demonstrates the need for additional research …”