Hypothesis / aims of study
Female patients with interstitial cystitis/bladder pain syndrome (IC/BPS) report low satisfaction with prescribed treatments (1). For chronic pain conditions, self-management has been shown to improve self-efficacy (2). This is the first study to develop an evidence-based digital platform that remotely delivers treatments including self-management strategies to patients with IC/BPS.
Aims: (1) to develop a conceptual framework for the self-management of IC/BPS; (2) To develop a digital platform that remotely delivers first- and second-line American Urological Association (AUA) treatments of IC/BPS; (3) To conduct feasibility testing of the newly developed platform for the treatment of IC/BPS.
Study design, materials and methods
We used a process of contextual inquiry to develop a conceptual framework and digital platform for the self-management of IC/BPS. First, we conducted focus groups and detailed cognitive interviews of female patients with IC/BPS. Symptom data was collected using Interstitial Cystitis Symptom and Problem Index (ICSI and ICPI). Next, we integrated input from patients, providers (urogynecology and urology clinicians, psychologist, physical therapist) and health care innovation expert to develop a conceptual framework for the self-management of IC/BPS. We used this framework to inform the development of video modules that delivered self-management strategies to patients with IC/BPS. The video modules were designed to be delivered over a two-way texting platform that integrated with the electronic medical record and was compliant with regulations for protecting sensitive patient health information. Finally, we conducted a feasibility study in 10 women with IC/BPS eligible for first- and second-line treatments. Participants received video modules through the texting platform and participated in dialogue tree-based open-ended texting with a study coordinator for 6 weeks. Participants were instructed to 1) provide narrative feedback on the content; 2) request a call from a clinician as needed; and 3) assess ease of use of the platform (System Usability Scale, score range 0-100, higher score indicates easier use).
Results
The median age of participants of our focus groups and cognitive interviews was 42 years. Median score (range) for the ICSI was 12 (4,20) and for the ICPI 10 (3, 16) indicating moderate symptom burden.
The following treatment related themes emerged: (i) patients prefer the term interstitial cystitis to bladder pain syndrome (ii) Patients are highly motivated to learn self-management strategies for their symptoms (iii) Patients want an organized plan that minimizes the need to contact a provider between scheduled visits (iv) Patients feel isolated and unsupported, especially when initiating a new treatment (v) Patients are very concerned about the side-effect of medications (vi) Patients have a strong interest in integrative approaches such as diet, pelvic PT, mind-body interventions (vii) Patients prefer remote interventions that minimize barriers (e.g., transportation, childcare, work).
Based on the above findings, a biopsychosocial framework for the treatment of IC/BPS emerged. According to this framework, biological (neuropathic pain, pelvic floor dysfunction), psychological (symptom-related fear and anxiety) and social (barriers in access to care, limited patient-provider communication) domains modulate a patient’s biobehavioral response to pain (Figure 1). We used this model to develop video modules that deliver: 1) first- and second-line treatments and self-management strategies (Table 1) and 2) clinically validated messages offering support and guidance (Figure 1) using a structured dialogue tree.
Feasibility testing was performed in 10 participants (median age 40, median ICSI and ICPI were both 12). All patients received modules on patient education, bladder retraining and dietary triggers over two weeks. Each participant could then choose between cognitive behavioral therapy (CBT) for chronic pain, guided mindfulness practices, or pelvic floor physical therapy (PT) including myofascial trigger point release over four weeks. Four patients chose mindfulness, four chose PT, and two chose CBT. Median number of texts exchanged with each participant was 79 (range 49-120). Patient response rate was 89% indicating high engagement. In narrative feedback, patients expressed 1) appreciation for evidence-based treatments that they could access remotely on their own schedule and 2) confidence in implementing strategies for managing their symptoms. Qualitative comments included, “I felt like someone cared about me,” “I felt empowered,” and “I didn’t feel like I was alone in figuring this out All 10 patients completed the program. Mean SUS was 87.8 ± 6 denoting high usability of the platform. Suggestions for improvement included making the platform more personalized. No participant requested a call back from a clinician indicating low health care utilization.
Interpretation of results
A biopsychosocial framework is useful for developing patient-centered treatments that promote the self-management of IC/BPS symptoms. IC/BPS patients are highly motivated to self-manage their condition with support from health care providers. IC/BPS patients prefer organized treatment plans that allow them to choose treatments and which they can access remotely in their own time. Low-cost text-messaging allows delivery of treatments using platforms that integrate with electronic medical records while protecting sensitive health information. When supported through a digital platform, few patients called their health care providers.