Hypothesis / aims of study
The objective of this feasibility study is to evaluate a new diagnostic and treatment paradigm for patients with lower urinary tract symptoms (LUTS). The paradigm utilizes patient reported questionnaires and diaries accessed through a mobile app* to enable joint decision-making amongst patients and providers about the need for remote versus office visits. This study is the first step towards the validation of the paradigm which intends to:
1. Quantitate symptom severity and suggest preliminary diagnoses remotely in order to triage patients and substitute office visits with remote visits when appropriate.
2. Optimize the quality, accuracy, and efficiency of office visits.
3. Identify patients with remediable symptoms where the initial clinical approach and management conveyed through a remote encounter would be identical to the exchange that would occur in an in-person visit.
4. Utilize the data to refine lower urinary tract phenotypes previously described for overactive bladder and nocturia and for phenotypes being developed for urinary incontinence and voiding dysfunction.
5.Utilize the phenotypes to develop unique clinical pathways for the entire spectrum of LUTS.
Study design, materials and methods
Consecutive patients referred for urologic consult at a single large institution (KP) were asked a series of questions to determine their suitability and willingness to use a mobile app* prior to their first office visit. Inclusion criteria were men and women over the age of 18 who had a registered email address in their Electronic Medical Record (EMR), had ownership of a smart phone, and were able and willing to download and complete the app prior to the first visit. Once completed, the data was reviewed by a nurse, and after discussion with a urologist, a decision was made whether or not the patient needed an urgent or routine office visit or could be offered a remote visit. Patients who were offered the option to have a remote healthcare visit via telephone either began on treatment or began further diagnostic evaluation. Clinical data collected included age, sex and working diagnoses, based on the Lower Urinary Tract Symptom Score Questionnaire (LUTSS) and bladder diary. In addition, the following data regarding the remote paradigm pathway was recorded—total number of: new urology consults, patients invited to use the app, patients excluded and lost to follow-up, patients registered, patients that completed the app, and patients that chose a remote visit over an office visit. In addition, we recorded the time from 1) urology referral to email invitation to participate and 2) initiation of diagnostic/treatment plan. Patient satisfaction surveys were also completed.
There were 500 urology referrals during the catchment period of whom 226 met the entry criteria. A total of 201 patients were invited to download the app of whom 71 (63 men and 8 women) completed it. Fifty-seven patients completed a bladder diary and LUTSS questionnaire. Of these, 16/57 (28%) had office visits and 41/57 (72%) had remote visits. Overall, remote, instead of in-office visits was achieved in 8% of the entire cohort, and 72% of those who completed the clinical pathway. This data is summarized in Figure 1. The satisfaction questionnaire was completed in 34/57 (60%) of the patients who completed this clinical pathway. Of these, 80% found the mobile app to be an effective way of sharing information with their physician, and 74% found the app to be easy to use.
Interpretation of results
We find these preliminary results very encouraging. The mean and median age were 61 and 64 years, respectively, and 72/201 (36%) patients were over the age of 70. Nearly half of the patients had email addresses and a smart phone. Further, of the patients who completed the data entry, nearly three-quarters elected to have remote visits. For patients who are in urgent need of an office visit, wait times for appointments can be minimized. For those patients whom office visits are deemed not necessary, the hassle and expense of making a trip to the doctor can also be mitigated. If these data are corroborated by larger and more diverse studies, utilization of this paradigm could result in a major change in the way healthcare is practiced. The Lower Urinary Tract Symptoms Score Questionnaire (LUTSS), the American Urological Association Symptoms Score (AUASS), the Patient Global Impression of Improvement (PGI-I) and the bladder diary, instruments that have been incorporated into the mobile app, provide a more nuanced approach wherein each serves as a check against the other. The net result, we believe, will lead to much more accurate diagnoses and better treatment outcomes. Of course, all of this needs to be verified by good clinical studies. This feasibility study is just the first step.
A new paradigm for outpatient diagnosis and treatment of LUTS was developed using software comprised of a mobile app, validated PRO questionnaires, bladder diaries, and remote patient monitoring. Patients were triaged according to symptom severity, and 72% of those who completed the app elected to have their initial evaluation performed remotely (8% of total new urology consults). Patient and physician satisfaction were high. Of course, It is necessary to determine the extent to which healthcare quality and economic benefit are improved by this paradigm, and further studies extending and applying it to a larger and more diverse group of patients are underway.
*weShare URO is a mobile app and software platform developed by Symptelligence Medical Informatics, LLC (Symptelligence.com)