Abstract
Objective Delays in initiation of advanced therapies, which include biologics and targeted synthetic disease-modifying antirheumatic drugs, contribute to poor patient outcomes. The objective of this quality improvement project was to identify factors that lead to a delay in the initiation of advanced therapy and to perform plan-do-study-act cycles to decrease the time to start advanced therapy.
Methods A retrospective chart review identified factors involved in delay to start advanced therapy. The primary outcome of the study was the number of days to advanced therapy start as measured by the date of rheumatologist recommendation to the date advanced therapy was initiated by the patient. An Advanced Therapy Coordinator role was created to standardize the workflow, optimize communication, and ensure a safety checklist was instituted.
Results A total of 125 patients were reviewed for the study with 18 excluded. Preintervention median wait time was 82.0 (IQR 46.0-80.5) days. Median wait time during the intervention improved to 49.5 (IQR 34.0-69.5) days (April 2021 to January 2022), with nonrandom variation post intervention. Nonrandom variation was also noted in the latter baseline data (March 2020 to March 2021).
Conclusion This study demonstrates improved wait time to advanced therapy initiation through the role of an Advanced Therapy Coordinator to facilitate communication pathways.
Delays in initiation of advanced therapy, which includes biologics and targeted synthetic disease-modifying antirheumatic drugs (DMARDs), contribute to poor patient outcomes.1 Early initiation of treatment for inflammatory arthritis, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), and ankylosing spondylitis, has been shown to improve patient outcomes and delay disease progression.2-5 Based on this knowledge, a treat-to-target strategy has been used in the management of RA, with the Canadian Rheumatology Association (CRA) establishing benchmarks for time to DMARD initiation of 2 weeks from diagnosis.6 Time to start conventional and advanced DMARD therapy is a recognized system-level performance measure in RA.7 Factors that delay initiation of appropriate therapy include time to assessment by a rheumatologist, disease factors, comorbidities, safety concerns, patient preferences, and patient socioeconomic status.2,8 Shaw et al found that a delay in the adjustment of DMARD therapy of more than 90 days was common in patients with RA with moderately high disease activity.9 Interestingly, biologic DMARD initiation was found to be an associated factor in the delay to adjusting traditional DMARD therapy.9 The authors recommended streamlining the process of advanced therapy initiation at the payer and provider level to optimize patient outcomes.9 Current preadvanced therapy screening guidelines recommend routine blood work, screening for latent tuberculosis (TB), chest radiographs, hepatitis blood tests, and specific vaccinations.2,4 These recommendations involve collaborative communication with primary care physicians (PCPs), patients, and funding sources, to be collated by the rheumatologist prior to initiating advanced therapy. Further, administrative paperwork and approvals, which do not exist for conventional DMARDs, add to the delay in initiating advanced therapy. There is limited evidence of the barriers that delay the start of advanced therapy once it has been recommended by the rheumatologist. Thus, the objective of this quality improvement (QI) project was to identify factors that lead to a delay in the initiation of advanced therapy and to perform iterative plan-do-study-act (PDSA) cycles to decrease the time to start advanced therapy.
This project also describes patient demographics of those successful in completing the advanced therapy screening process.
METHODS
This project received Assessment Process for Quality Improvement Projects (APQIP) approval from the Women’s College Hospital Research Ethics Board (no. 2020-0074-E). As per the APQIP approval process, patient consent was waived for the QI initiative. Informed consent was obtained for the patient survey; however, due to insufficient response rate, this was not included in the publication. Diversity, equity, and inclusion data were retrospectively collected from administrative data due to lack of self-reported processes at the time of the study.
Context. The project was conducted in an urban, academic ambulatory care hospital in Ontario, Canada, comprising 6 rheumatologists with a focus on general rheumatology practice and specialty clinics for PsA and young adults with juvenile idiopathic arthritis (JIA) transitioning from pediatric care. Patients initiating advanced therapy require baseline bloodwork and a chest radiograph arranged by a rheumatologist, as well as updated vaccinations and TB testing facilitated through collaboration with PCPs. Patient support programs (PSPs) for advanced therapy require an enrollment form to connect patients to a community-based nurse to provide support in navigating the complex process to initiate treatment. PSPs, funded by the respective pharmaceutical companies, may provide the following: financial coverage navigation, access to investigations or vaccinations, flexible medication delivery services, and information and resources on medications or conditions. Within the Ontario healthcare system, physician visits, investigations, and vaccinations are publicly funded. Advanced therapy can be accessed through either private insurance or publicly funded resources, both requiring preapproval, contributing to delay in initiation compared to conventional DMARDs. Failure of conventional DMARD therapy for RA, PsA, inflammatory arthritis, JIA, seronegative arthritis, giant cell arteritis, and Still disease is typically required to qualify for privately or publicly funded advanced therapy.
Gap analysis. A retrospective chart review on a sample of convenience of 78 charts was completed from February 2015 to March 2021 on patients having completed the advanced therapy prescreening process. Patients who failed to complete the prescreening process were not included in the study. Inclusion criteria included a rheumatologic diagnosis and recommendation of advanced therapy during the study period (Table 1). Patients naïve to advanced therapy or those requiring repeat prescreening if > 5 years had passed since their last investigations were included.
Patient characteristics.
In an effort to understand the current state of advanced therapy initiation, multiple QI diagnostics were undertaken. Preintervention median wait time was 82.0 (IQR 46.0-80.5) days. The CRA recommends initiation of DMARD therapy within 14 days of diagnosis. Extending this standard to modification of therapy, patients in the baseline data waited 68 days longer than recommended.
Root cause analysis. A process map with time to complete each step was performed (Figure 1). Review of the process map data identified that the longest steps were completion of TB testing and vaccination, with a median wait time of 9.0 (IQR 0.0-24.5) days and 13.5 (IQR 0.0-63.5) days, respectively. The wait times identified by the process mapping failed to explain the prolonged wait to initiate advanced therapy.
Process for initiating advanced therapies in rheumatology. a PCP: primary care physician. b PSP: patient support program. c TB: tuberculosis.
During the chart review, missing documentation and/or missing dates on documentation were observed, which were grouped into missing documentation for the purposes of the project (Table 2). Notably, the following missing documentation was identified: enrollment form completion (12%), chest radiograph (10%), bloodwork (13%), TB test (23%), completion of vaccinations (72%), and PSP communication to rheumatology office (41%). None of the baseline charts identified PCP communication back to rheumatology office regarding TB tests and vaccinations in form of a communication letter.
Number of patients missing documentation.
Patients with a > 14-day wait time to start advanced therapy were reviewed for reasons for delay. Thirty-nine of 65 charts had documented reasons for delay; these were categorized and a Pareto diagram was used to further understand the problem (Figure 2). “According to the ‘Pareto Principle,’ in any group of things that contribute to a common effect, a relatively few contributors account for the majority of the effect,” whereby approximately 80% of the effect comes from 20% of the causes.10 Application of the Pareto principle identified the vital few root causes, with communication issues (41%) being the main reason for delay in starting advanced therapy. Contraindication to initiating advanced therapy was the second most common reason for delay at 26%. Contraindication was not targeted for change, as the purpose of prescreening is to identify contraindications or precautions warranting treatment prior to initiation of advanced therapy, necessitating a delay that is appropriate to protect patient safety. The remaining root causes, including patient factors (13%), funding (13%), vaccine issues (5%), and PCP access (3%), were beyond the scope of this study. Standardized communication between rheumatology, primary care, and patients was preexisting and stable from baseline to the end of the study.
Pareto diagram for delay in advanced therapies initiation (baseline data).
Change concept. The literature supports standardization to allow clinicians the ability to provide complex care, reduce error, and focus on process outliers.11 “Care coordination is the deliberate organization of patient care activities between two or more participants (including the patient) involved in a patient’s care to facilitate the appropriate delivery of health care services.”12 Thus, an Advanced Therapy Coordinator role was implemented to establish a standardized process and safety checklist, and to centralize accountability to address communication and documentation gaps.
The Advanced Therapy Coordinator position was filled by a 0.5 full-time equivalent (FTE) research assistant with a BSc. The Advanced Therapy Coordinator received training on use of the electronic medical record (EMR), steps in the advanced therapy prescreening process, orientation to PSPs, and hospital policies and procedures. The Advanced Therapy Coordinator had limited access to the EMR, to allow only for staff messaging, and was unable to address clinical queries from patients or staff.
The Advanced Therapy Coordinator intervention occurred from April 2021 to January 2022. Concurrent PDSA cycles were implemented due to the time-limited funding of the study. The PDSA cycles included the following:
1. Standardized EMR communication from the rheumatologist to the Advanced Therapy Coordinator to identify patients requiring monitoring of results and communications.
2. Completion of a safety checklist to ensure outstanding items were identified.
3. Centralized document collection and documentation of completed items.
4. Targeted reminder phone calls to patients.
5. Targeted follow-up with PCPs.
6. Targeted follow-up with PSPs.
Family of measures. The primary outcome of the study was the number of days to advanced therapy start as measured by the date of rheumatologist recommendation to the date advanced therapy was initiated by the patient. This was determined through communication received through the PSP, direct patient report, or documentation by the rheumatologist in the EMR.
Process measures included the number of communications between the Advanced Therapy Coordinator and staff and the percent of safety checklists provided; percent of dated/completed items documented; number of telephone reminder calls to patients, number of calls to PCP, number of calls to PSP, and number of days to complete the enrollment form; number of days to complete the release of information form; number of days to complete a chest radiograph; number of days to complete bloodwork; number of days to complete TB testing; and number of days to complete vaccinations.
Balancing measures included participant and provider satisfaction. Patients were surveyed through a telephone survey to determine patient experience. Providers were surveyed through an anonymous electronic survey to determine provider experience.
RESULTS
A total of 125 patients were reviewed for the study, comprising 78 in the preintervention baseline data and 47 patients in the intervention group. At completion of the study, 9 patients in each of the baseline and intervention groups were excluded for a total of 107 patients. The final study numbers included 69 at baseline, with 17 from February 2020 to February 2021, and 38 in the intervention group.
Preintervention median wait time was 82.0 (IQR 46.0-80.5) days. Data for the first year of the pandemic showed nonrandom variation prior to the intervention.
Median wait time during the intervention improved to 49.5 (IQR 34.0-69.5) days (Wilcoxon signed-rank test, P = 0.001; April 2021 to January 2022), with nonrandom variation post intervention (Figure 3). The time between recommendation and each step of the process was monitored at baseline and post intervention. The only improvement occurred in the time of recommendation to PSP contact improving from a median of 12.5 (IQR 1.0-48.5) days to 1.0 (IQR 1.0-3.5) days. There was no improvement in the time to TB testing over the course of the project and the intervention group used QuantiFERON (Gold Plus) testing in 3/38 (8%) of the intervention group.
Number of days to start advanced therapy. CL: confidence limit; UCL: upper confidence limit.
A total of 293 EMR staff messages were sent and received by the Advanced Therapy Coordinator in the intervention period. Usage of a standardized EMR communication from the rheumatologist to the Advanced Therapy Coordinator with provision of a safety checklist was 38/38 (100%) in the intervention group. Centralized document collection and documentation of completed items improved for the PSP enrollment form, chest radiograph, bloodwork, TB test, and vaccinations (Table 2).
The Advanced Therapy Coordinator made a median of 4.0 (IQR 3.0-6.0) targeted reminder phone calls to patients. Targeted follow-up with PCPs and PSPs had low usage.
Provider satisfaction was stable throughout the intervention. Patient satisfaction surveys had an insufficient response rate.
Patient characteristic information with an equity lens was extracted through retrospective chart review (Table 1). All patients were born in Canada or had lived in Canada for over 5 years and 5 were Indigenous. The majority of patients who were successful in completing the process were White (70%), English proficient (96%), and female (60.7%), had access to a PCP (77.6%), and had prior use of conventional DMARDs (93%).
DISCUSSION
This study demonstrates improved wait time to advanced therapy initiation through the role of an Advanced Therapy Coordinator to facilitate communication pathways. The baseline data demonstrated a prolonged wait of 82.0 days to initiate advanced therapy treatment with improvement to 49.5 days, demonstrating statistical and clinical significance. Participants successful in completing the preadvanced therapy screening in this study were mostly White, were English proficient, had access to a PCP, had prior conventional DMARD failure, and had not recently immigrated to Canada.
The use of care coordination to optimize the exchange of information to improve healthcare delivery is a recommended practice.12 Previous literature recommends a streamlined process of advanced therapy initiation at the payer and provider level to optimize patient access.9 Our current study supports care coordination and standardization through the effective implementation of standardized EMR communication from the rheumatologist to the Advanced Therapy Coordinator, use of a safety checklist, centralized document collection and documentation, and targeted patient reminder phone calls. Targeted follow-up with PCPs and PSPs had low usage, as these interactions required a clinician to address clinical concerns. Care coordination activities performed by a nurse and/or pharmacist may allow for increased interaction with PCPs and PSPs and warrant further investigation.
This study had several limitations, including the effect of coronavirus disease 2019 (COVID-19), limited focus on communication pathways, retrospective chart extraction, and the potential for bias. The present study included a secular factor demonstrating improvement in wait time prior to the intervention being implemented. This shift occurred with the onset of the COVID-19 pandemic in March 2020, a known disruptive period in health care globally. The effect of the COVID-19 pandemic persisted through the intervention period. In reviewing the data, there were fewer biologic starts (n = 17) during this time, which may have contributed to this finding. Further, the pandemic disrupted typical communication pathways. The use of asynchronous messaging through the EMR may have facilitated patient-to-provider communication. Asynchronous communication has been shown to improve communication efficiency of services given to patients by saving time.13 Additionally, the COVID-19 pandemic presented decreased access to in-person primary care.14 To support advanced therapy initiation, PSPs conducted TB testing using QuantiFERON laboratory testing rather than through in-person 2-step TB testing in primary care. Data in the intervention group showed use of QuantiFERON testing of only 8% and there was no improvement in time to TB testing over the course of the project. Therefore, it is unlikely that access to QuantiFERON improved access to advanced therapy in this project. Process measures specifically monitoring the role of the Advanced Therapy Coordinator (ie, number of electronic messages between the Advanced Therapy Coordinator and staff and percent of safety checklists provided, percent of dated/completed items documented, and number of telephone reminder calls to patients) suggest effective implementation of the role improved the primary outcome. The decreased variation on the statistical process chart also supports the effectiveness of the Advanced Therapy Coordinator in improving timely access to advanced therapy.
A limitation of this study is the focus on optimizing communication pathways to improve time to advanced therapy initiation. Root cause analysis revealed other delays, such as funding, access to a PCP, and access to vaccination. In this project, the majority had access to a PCP and had failed conventional DMARDs, limiting the effect of these delays in this study. Those experiencing health inequities are more likely to fall into the exclusion criteria of this study. Within the intervention period, 2 Indigenous people were unsuccessful in completing the prescreening process and were therefore not included in the final analysis of the study. In contrast, those successful in completing the preadvanced therapy screening were mostly White, were English proficient, and had not recently immigrated to Canada. There are previously reported health inequities in the Indigenous population, who experience increased prevalence, severity, and undertreatment of arthritis owing to the legacy of colonization, thereby negatively affecting health status.15,16 Patient factors, such as not consenting to treatment, poor health literacy, diagnosis disbelief or denial, and lack of trust contribute to nonadherence and may delay time to initiation of advanced therapy. Future studies evaluating those unsuccessful in completing the screening process are warranted to address equity and patient factors.
The retrospective data collection of this study limited a fulsome equity analysis, as factors such as gender and economic status were not available. Finally, bias may have influenced the results of this study. A sample of convenience for the baseline data was used and the Advanced Therapy Coordinator was not blinded to the intervention.
After presenting the results to hospital administration, we successfully implemented this project long term. A 0.5 FTE Advanced Therapy Coordinator role, performed by a registered nurse (RN), was filled within the rheumatology department. The RN is able to perform the tasks of the Advanced Therapy Coordinator and provide clinical support for patients, PCPs, and PSPs.
In conclusion, prolonged wait times to start advanced therapy for inflammatory arthritis improved through the establishment of an Advanced Therapy Coordinator role and standardized communication processes. The role of the Advanced Therapy Coordinator ensures that eligible patients can access effective advanced therapy in a timely manner, with improved documentation of process steps supporting enhanced patient safety. Equity factors require future study.
Footnotes
This research was funded through an unrestricted research grant from Pfizer Canada ULC.
CF has served as a consultant for AbbVie, Novartis, and UCB, and has received educational and research grants from Pfizer. LE has received educational and research grants from AbbVie, UCB, Pfizer, Janssen, Novartis, Eli Lilly, Sandoz, and Fresenius Kabi. NG has served on advisory boards and as consult for AbbVie, Pfizer, Janssen, Novartis, Eli Lilly, and UCB, and has received educational and research grants from AbbVie and Pfizer. DJ has served on advisory boards and provided consulting services for AbbVie, Pfizer, Janssen, Novartis, Eli Lilly, and Fresenius Kabi. ST declares no conflicts of interest relevant to this article.
- Accepted for publication September 29, 2023.
- Copyright © 2024 by the Journal of Rheumatology
