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Open Access 15-10-2024

Pharmacist-facilitated Patient Reported Outcome Measure (PROM) monitoring: developing an EHR SmartForm© to monitor side effects of oral oncolytics during routine telehealth encounters

Auteurs: Angela M. Stover, Debbie Liang, Dana Mueller, Rachel Kurtzman, Christiana Ikemeh, Courtney Canter, Sonali Acharya, Jill Brese, Kaitlyn Buhlinger, Kevin Chen, Evan W. Colmenares, Aimee Faso, Benyam Muluneh, Bianka Patel, Jeffrey S. Reichard, Rushabh M. Shah, Michael Tilkens, John Valgus, Lorinda A. Coombs, Jennifer Elston Lafata, Jennifer L. Lund, Emily M. Ray, Gita Mody, Mary-Haston Vest

Gepubliceerd in: Quality of Life Research

Abstract

Purpose

Patient reported outcome measures (PROMs) are increasingly used in oncology care, but pharmacists providing direct patient care have been overlooked. We engaged pharmacists and adults receiving oral oncolytics (chemotherapy medication taken by mouth) to develop a SmartForm© in the electronic health record (EHR) for PROM monitoring. Pharmacists verbally ask the patient side effect questions during routine telehealth encounters and enter responses in real time.

Methods

Our development process was guided by the Knowledge to Action Framework. In phase 1 (Knowledge Inquiry), we prioritized side effects to assess in the EHR SmartForm© via interviews with patients and a Delphi panel with pharmacists. Adults receiving oral oncolytics for breast (n = 12), thoracic (n = 12), or hematological (n = 12) cancer were interviewed, with purposeful sampling for adults who were aged 65 + years or Black. Interviews were coded with content analysis. We conducted three Delphi rounds, with 11/19, 13/19, and 19/19 pharmacists, respectively. In phase 2 (Knowledge Synthesis), PROM items were selected and the EHR SmartForm© programmed. In phase 3 (Knowledge Tailoring), we conducted usability testing with pharmacists.

Results

Pharmacists and patients were consistent in prioritizing side effects of oral oncolytics and 10 were retained. Patients advocated asking whether they can do their usual activities, while pharmacists added medication adherence. Usability testing yielded suggestions to simplify the SmartForm©.

Conclusion

By presenting screenshots of our SmartForm©, our findings are useful to other healthcare systems looking for a PROM solution integrated in the EHR, with a reasonable pharmacist/clinician workload, and no requirement for patients to have internet access/comfort.

Supplementary file1 (DOCX 20 KB)

Supplementary Information

The online version contains supplementary material available at https://doi.org/10.1007/s11136-024-03789-8.

Portions of this work were presented at the Cancer and Aging Research Group (CARG) annual conference in February 2023, the International Society for Quality of Life research (ISOQOL) in October 2023, and the Hematology/Oncology Pharmacy Association (HOPA) conference in April 2024. The views and opinions expressed in this article are those of the authors and do not reflect the views of sponsors.

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Plain English Summary

Why is this study needed?

Health systems typically monitor side effects of chemotherapy taken by mouth via nurses and physicians. However, pharmacists who provide direct patient care also have the skills and medical training to monitor side effects, and need symptom questionnaires that are relevant to the essential care they provide.

What is the key problem/issue/question this manuscript addresses?

Implementing side effect monitoring in clinics is challenging due to barriers at the patient, physician, and system-levels. The main challenges are that side effect monitoring needs to be part of usual workflow for pharmacists and not burdensome, and some patients do not have access to (or comfort with) the internet.

What is the main point of your study?

By engaging pharmacists and patients, we were able to design a side effect monitoring system in the electronic health record that addressed known barriers and meets their needs.

What are your main results and what do they mean?

Pharmacists and patients were consistent in prioritizing side effects to ask all patients (nausea, diarrhea, constipation, appetite, pain, mouth/throat sores, fatigue, neuropathy, dyspnea, rash). Patients advocated asking whether they can do their usual activities, while pharmacists added medication adherence and focused on the need for form simplicity.

Introduction

Patient reported outcome measures (PROMs) are a proven way to enhance side effect detection during cancer treatment [1‐3], but multi-level barriers make effective implementation challenging [4‐8]. Increasingly, PROMs are used in oncology care by nurses and physicians [9‐11], but additional care team members have been overlooked. Pharmacists who provide direct patient care are well positioned to lead clinic-based PROM initiatives because they complete a rigorous 4 year pharmacy school training, with options to pursue specialized residencies, fellowships, board certification, and prescribing privileges [12, 13]. Most academic health centers have integrated clinic-based pharmacists on oncology teams who collaboratively manage patients receiving oral oncolytics (chemotherapy medication taken by mouth) that must be dispensed through accredited specialty pharmacies [13]. This presents opportunities for pharmacist-led PROM implementation.

For PROM implementation to be successful, it needs to be integrated within routine patient care and clinical work streams [4, 8, 14, 15] and have a reasonable workload for the pharmacist. One way to do this has been to use patient portals embedded within the electronic health record (EHR) to collect PROMs. Yet, there is increasing evidence of patient disparities with access and comfort with electronic PROMs [16‐18] and EHR portal use [19‐21]. Given these disparities, we developed an EHR SmartForm© where specialty pharmacists verbally ask the PROM items during their routine outreach telephone calls for education and medication refills. Verbal administration ensures that a patient's needs become the focus of the encounter and avoids potential disparities due to broadband or device access or other factors that impede patient use of online portals.

Similar to the barriers for nurse or physician PROM implementation [4‐6], pharmacist workload is also a concern [22, 23]. In Hough et al. [22], completing remote PROMs for one week after infusion with alerts to pharmacists for concerning symptoms decreased 14-day unplanned healthcare use, but the initiative was discontinued due to pharmacist workload strain [22]. Saadeh et al. [23] conducted a feasibility study in a community cancer center and encountered several EHR barriers and increases in pharmacist workload when patients did not respond to their electronic PROM as this required additional calls to patients. Given the potential for pharmacist burden and patient disparities with internet access/comfort, this paper describes how we engaged clinic-based and specialty pharmacists in oncology and patients to develop an EHR SmartForm© for PROM monitoring during routine telepharmacy calls. Our development process was guided by the Knowledge to Action framework [24, 25]. We provide screen shots of the EHR product for dissemination to other healthcare systems implementing PROMs.

Methods

Institutional review board (IRB)

The IRB at the University of North Carolina at Chapel Hill approved the study. Patients gave verbal informed consent for telephone interviews (IRB# 22-0745) and the remainder of activities were exempt from oversight (IRB# 22-1466).

Study setting

UNC Health and its affiliates are the largest public healthcare system in North Carolina. UNC Health's pharmacist-led oral oncolytic management program has been established since 2014 as an integrated, closed-loop care model for managing oncology patients across the medication use process, including prescribing, verifying, dispensing, administering, and patient monitoring [26]. At UNC's main campus, the program includes 19 board-certified clinical and specialty pharmacists treating a variety of cancer types. Specialty pharmacy services include prior authorization and copayment assistance support, clinical assessments and monitoring, free home delivery of medications, and 24/7 on-call support for clinical concerns or questions. Clinic-based pharmacists on oncology teams provide direct patient care and oversee the prescribing and monitoring of oral oncolytics.

Planned process: Knowledge to Action framework

We followed a planned process to develop and test the EHR SmartForm© and clinical note-writing shortcut that was informed by the Knowledge to Action framework (KTA) [24] and PROM and EHR implementation best practices [4, 8, 14, 15, 27]. KTA is a widely used implementation science framework that includes key steps for iterative knowledge creation and action [25]. The KTA knowledge creation steps are Knowledge Inquiry (we interviewed patients and conducted a Delphi panel with pharmacists), Knowledge Synthesis (selecting PROM items and programming EHR SmartForm©), and Knowledge Tailoring (usability testing with pharmacists).

Study participants

Patients and pharmacists from three oncology clinics (breast, thoracic, and hematological cancers) were eligible for study participation. In the thoracic clinic, patients with sarcoma were also eligible. Adults prescribed oral oncolytics have a high symptom burden with > 60% experiencing moderate to severe side effects [28, 29]. They also risk disease progression and mortality if medication adherence is poor [30‐32].

For patients, inclusion criteria were adults (aged 18 +) receiving oral oncolytics at a participating clinic who had at least one in-person or telephone encounter with a clinical or specialty pharmacist in the past 12 months. We excluded patients who could not participate in an English language interview and those not receiving pharmacist care for their cancer between October 2021 and September 2022. Eligible patients were identified by querying an EHR data warehouse. Purposive sampling was used to achieve a minimum of 50% of patients aged ≥ 65 and 20% of Black patients for each clinic to reflect the catchment area demographics. Thoracic and hematology patients included a minimum of 50% women (the breast clinic had mostly women).

The study coordinator contacted patients via telephone to determine interest and obtain verbal agreement to participate. Three trained interviewers conducted telephone interviews using a semi-structured interview guide. Interviews lasted a mean of 22.5 min (range of 9 to 42 min), and participants were given a $40 gift card. Interviews were audio-recorded and transcribed prior to analyses. Interviews with patients occurred before the Delphi panel with pharmacists.

For the Delphi panel, a total of 19 pharmacists who provide direct patient oncology care were eligible and sent email invitations to participate via the pharmacy leadership team. The exclusion criterion was not providing care in a participating clinic between October 2021 and September 2022.

KTA knowledge creation steps

Figure 1 shows our conceptual model with our research methods mapped to the KTA knowledge creation steps [24]. Future work will address the action cycle.

Phase 1: Knowledge Inquiry

Interviews with patients

The sample size was determined by a systematic review suggesting saturation of interview themes occurs at 9–12 interviews when the objective is narrowly defined and groups are relatively homogenous [33]. Patients may have differing side effect profiles based on their cancer type and oral oncolytic family, and thus we chose 12 patients per clinic to start. If necessary, we had planned additional interviews if thematic saturation was not reached when reviewed at 12 interviews.

Interview data analysis

Transcripts from adults receiving oral oncolytics were coded to identify key side effects to include in the EHR SmartForm©. Transcripts were double-coded by two trained coders using content analysis [34]. An initial codebook was based on the interview guide and notes taken during interviews and was purposively flexible to allow for new themes. The codebook was pilot tested and decision rules were fine-tuned. The final codebook was then applied to the remaining transcripts. Standard consensus coding guidelines were followed [34], where emerging themes and discrepancies were captured and reconciled through discussion. Code reports were generated for each clinic, and narrative summaries were written with illustrative quotes to highlight themes. Results were compared across clinics (breast, thoracic, or hematological cancer).

Delphi panel with pharmacists

We also conducted a modified Delphi panel [35, 36] with pharmacists who provide direct patient care in oncology to prioritize side effects to include in the EHR SmartForm©. Two rounds of electronic surveys and a live consensus meeting were completed (three rounds total). Participants were informed that their responses would be retained if they did not complete other rounds.

Delphi panel data analysis

Side effect domains (e.g., respiratory, gastrointestinal, etc.) included in the initial Delphi round were based on best practices for pharmacist management of oral oncolytic therapy [37] and published quality initiatives by US oncolytics programs [11, 17, 38, 39]. The Delphi survey used a five-point Likert scale (strongly disagree to strongly agree to include on EHR SmartForm©). In round 2 of the Delphi panel, pharmacists received a list of side effects within each domain from round 1. In other words, round 1 was higher-level categories like “gastrointestinal,” and round 2 was specific side effects like “nausea.” Symptom domains in the bottom 25th percentile for agreement were excluded in subsequent Delphi rounds. In all rounds, Delphi participants had the option to provide feedback on the suitability of side effects and propose additional items. Responses were anonymous, and ratings were shared with the Delphi participants prior to voting in rounds 2 and 3. At the live consensus meeting (round 3), side effects that achieved consensus at ≥ 75% agreement (agree or strongly agree to include in the EHR SmartForm©) were reviewed and ratified. Side effects with 25–74% agreement were discussed, and those with 24% or less endorsement were excluded.

Phase 2: Knowledge Synthesis

Key side effects to prioritize were then compared across pharmacists and patients. Side effects were selected if pharmacists and at least two patient groups (by clinic) endorsed the side effect as important. An exception is medication adherence because patient interviews were conducted before the Delphi panel, and thus patients could not be asked about it directly.

Selecting PROM items

The research team matched the side effects selected to individual items on PROMs with desired characteristics (developed with patient and clinician input, calibrated with modern psychometric methods, and validity and reliability evidence in multiple cancer types) [40‐42].

Programming EHR SmartForm©

An Epic analyst at the health system programmed the selected PROM items into the EHR SmartForm© (Fig. 2). A second analyst also created a shortcut for clinical note-writing called a “smartphrase©,” which is a single word input (e.g., “.oralchemo”) to efficiently import EHR SmartForm© PROM responses directly into clinical notes.

Phase 3: Knowledge Tailoring

Usability testing rounds

Usability of the EHR SmartForm© and clinical note-writing shortcut was assessed with health-system clinical and specialty pharmacists who provide direct patient care in breast, thoracic, or hematologic clinics and would be the end users. Consistent with best practices for usability testing of PROM systems [43], pharmacists reviewed draft versions of the EHR SmartForm© to make improvement recommendations. Two experienced interviewers conducted usability testing in the health system’s EHR platform test environment, and notes were taken using a standardized template. Pharmacists were given a $50 gift card for participation.

Usability testing data analysis

Pharmacists’ recommendations were summarized, and potential changes were reviewed with the health system’s pharmacy leadership and EHR analysts. Subsequent rounds were planned if major revisions were requested.

Results

Phase 1: Knowledge Inquiry

Interviews with patients

We interviewed 36 adults receiving oral oncolytics (12 breast, 12 thoracic, 12 hematology oncology). Demographic characteristics are in Table 1. Our target percentages were met or exceeded. Patients with thoracic and hematologic malignancies were 50% women, and patients with breast cancer were 83% women. Across the 3 clinics, patients identifying as Black ranged from 25% (thoracic) to 42% (hematology), and those aged 65 + ranged from 50% (hematology) to 75% (thoracic). At 12 interviews in each clinic, thematic saturation was reviewed and met.

Table 1

Patient demographic characteristics for interviews (Phase 1)

Characteristic	Breast (n=12) n (%)	Thoracic (n=12) n (%)	Hematology (n=12) n (%)
Women	10 (83)	6 (50)	6 (50)
Men	2 (17)	6 (50)	6 (50)
Non-Hispanic White	4 (33)	8 (75)	6 (50)
Non-Hispanic Black	4 (33)	3 (25)	5 (42)
Non-Hispanic other race	4 (33)	1 (8)	1 (8)
Age 65 and older	7 (58)	8 (75)	6 (50)
Completed interview by video call	5 (42)	7 (58)	2 (17)
Completed interview by phone	7 (58)	5 (42)	10 (83)

Table 2 shows the themes and supporting quotes from the patient interviews. Almost all patients reported that they wanted their pharmacist to ask them about side effects on a regular basis instead of the burden falling to them to mention a side effect. One patient said, “I would like for them to ask that. What's wrong? What side effects are you having pertaining to your medicine and stuff? If they didn't ask, you would never know. I think they should ask.” Another said, “Unless I report a side effect, nobody asks me about it.” Patients also emphasized that an important marker of health for them is whether they can continue to do their usual activities, such as working or taking care of children, and thus they recommended asking all patients about it.

Table 2

Themes and interview quotes from patients

Theme	Patients with breast cancer	Patients with thoracic cancers	Patients with hematology cancers
Which symptoms should be prioritized in the EHR SmartForm© PROM	Mouth sores: “I would say.. the mouth sores… I think they should ask other people if they’re having the same”	Flushing, appetite, bloating, fatigue: “Then the comfortability of the flushing and sweating, and then the appetite and bloating and feeling tired because those are all the things I’ve been feeling”	Dyspnea: “If I were a patient and didn’t know what I know, I would want somebody to tell me, “If you have trouble breathing, you need to seek help”
	Diarrhea: “I would say hot flashes and loose stool diarrhea”	Nausea, vomiting, diarrhea, losing weight: “I’m continuing to have nausea and diarrhea. I’ve lost 30 pounds, so I can’t make myself take this stuff [medication]. I got so neurotic about it. When it came time to take it, I would throw it up. This is really neurotic… What we decided to do was I’d take two days off a week, and I did that for a while”	Mucositis: “Yeah. The mucositis is number one. Boy, it’s a bad actor. [Laughter] I would want to know that that was a potential side effect”
	Neuropathy: "Okay, …is this severe, or making sure—especially with the neuropathy in your hands and feet, that's very important … because you don't want to get to the point that if you don't sit here and tell 'em in time that it get to the point where it'll be just untreated. Because the neuropathy is very serious, and you don't want it to sit here and actually get to the point where it can't be treated. That's real big; the neuropathy”		Nausea, indigestion: “I guess, you might say, like nausea, aches, or whatever, indigestion…”
	Fatigue: “I would want them to ask people what the fatigue and maybe being uncomfortable like your joint pains. I wish they would ask more detail about that… like I said, I'm retired, so there's not like a scale from 1 to 10 if my joints are hurting or if it's 1 to 10 if my fatigue is there. Maybe if there was more of a sliding scale type of thing where people can respond in that way. Maybe they can get a better, I don't know, a better thought on how this is affecting people, I guess”		Nausea, bowel movements, sleep: “Well, if they have nausea, if they have with the bowel movements, if there’s any change. If they have nausea, if they have stomach pains, if they have—how are they sleeping”
			Weight gain: “Weight gain”
			Diarrhea: “The diarrhea. That fluttering in the stomach”
			Diarrhea, rash, loss of appetite: “Well, the three main ones I was concerned about was diarrhea, rash, and loss of appetite…”
Prioritize mental health symptoms	“Ask patients about their initial mental state. I also had headaches, confusion and forgetting things and wasn’t sure if it was because of my medication or my cancer”	“I think that the mental health aspect is probably an important thing just to check in on”	“Cause I tell you, it affected my mental state. My ability to do anything was no. It wasn't gonna happen 'cause in my head I was on a ledge. I was on a ledge one time and I almost didn't get off. You know, come down. It was really, really hard for me”
Prioritize mental health symptoms		“Hey, I’m feeling kind of down because of this drug side effect or because now I know I have cancer”	“Oh, my advantages, he encouraged me just keep doing what I'm doing. I like the things they say. They keep my morale up, keep me from going to depression. I don't want to fall back into that mode”
Prioritize whether patients can do their usual activities	“Then, the joint pain, it’s definitely affecting [my activities] me going up and down the stairs in my house. It’s not to the point where I can say, “Oh, I need crutches” or “Oh, I need a cane.” It’s tolerable for the moment. It’s just uncomfortable”	“The doctor was concerned because it [diarrhea] was something that like changin' my lifestyle. Whether I had to take something else to fight it”	“Yeah, they should discuss if they’re havin’, like you just said, which side effect interferes with their daily routine the most and what they wanna—if there’s anything they can do with it”
	“My stomach issues do interfere with some of my activities. I sometimes I have a sense of urgency to go to the bathroom, and then sometimes it happens repeatedly and then that’s when I'll take some medicine to stop it”	“For speaking specifically of [drug name], the fatigue was enough that doing some of the simple physical activities of just working in the yard or some of those types of things—it’s been significant enough that—before, I could go out there and work for hours. Now it would be you work for 5 or 10 min; you gotta sit down and rest. A lot more frequency of resting time and just gettin’ worn out a lot quicker. That’s changed things. It’s such that maybe things that we would’ve done before—more physical like a—I don’t know—don’t go to a concert or something”	“How their daily routine has changed”
	“I wasn't able to work any during my [oral] chemo. It was just too much going on. I had to get my body back, to be in my strength and everything”	“I initially started out with the full dose, then six, and immediately had terrible nausea and vomiting, awful fatigue, and amazing diarrhea, and thought, if this is my life, it's not worth fighting for. [Laughter] under normal circumstances, I vomit about once every ten years. It's just not somethin' that I'm used to. When I was troubled with that [nausea and vomiting], it was really disruptive. I could compensate for the diarrhea. I could wear the adult diapers and never be more than ten paces from a toilet. I got one of those waterproof things for under my seat, so I didn't have to wash the whole mattress pad and all that. I could compensate for that, but the nausea's just put me down”	“Diarrhea, I was taking the medicine in the morning time, but I was trying to teach school, and it was causing diarrhea. I didn't ever know when it was going to hit, so I started taking the medicine at night and that worked out better, 'cause if it reacted on me then, then it'd be through the night, and I wouldn't have to worry about trying to get out of class and all that”
		“Like I said, this has been a tough year because the weight loss is what caused the problems. Slowly but surely, I stopped driving a car because I didn’t trust myself. I’m allowed to, but I just felt that I might hurt myself or other people on the road. I’m working on getting myself back upstairs to my own bedroom ‘cause I’ve been sleeping in the downstairs guestroom, and it’s not set up properly. It's one thing for a guest. It’s another thing to live in it. I’m working with physical therapy on that, to get up and down the stairs safely. I went through a period of time where I was falling a lot”	“Well, at this point in my life I really don’t have any responsibilities, and I don’t have many activities, but yes, it has. I don’t have the strength and the stamina to do a lot”
			“It is hard. That’s the one a the hardest things that I really struggle with is the fatigue. Some days, I don’t even leave the house’cause I’m just tired”
Recommendations for how to ask patients how they are feeling and functioning	"How are you coming along with your new meds? What can I do to better assist you?"	“It's just having them ask you general questions. Are you having any difficulties with anything or problems with anything. I think having a pharmacist there, that can say, "Oh, this is something that's common or something that this medication can cause. Why don't you try or do this or let me research this and get back to you." I think that's what's important”	“That right there, I would like for them to ask that. What's wrong? What side-effects are you having pertaining to your medicine and stuff? You know what I mean? If they didn't ask, you would never know. I think they should ask”
		“She…this is what she—this is our whole meeting—went down every one the graph with me, every lab with me, and told me what they look at. She was really, really nice. Very detailed. This is what I needed to know from my pharmacist..”	“Unless I report a side-effect, nobody asks me about it”
		“Now, I did see some things that were errors that I was gonna let her know. I was reading over her report, and it said that I said that I didn't—that she [patient] denies missing any doses. I never told anybody that. That's a lie. I mean, that's a—she misheard me. I have missed doses. Remember, I—and the doctor—every doctor knows this, that I don't take my medicine correctly. I don't want that on here because that's not fair and that's not right”
Advantages of meeting with a pharmacist	“I guess the only thing I would say is it’s very helpful when you start a new medication to have somebody go over with you what’s a possible side effect could be”	“I guess warning people what to look out for, and I know that’s largely the oncologist’s job. That’s always been really helpful to me to have somebody [pharmacist] tell me before I start taking it what things I should be concerned about”	“I really don't know 'cause the advantage is that she helped me take the medicine and tell you how to take it and make sure you're taking it the right way, eating the proper food and stuff. I didn't see no disadvantage”
	“Well, after having talked to the oncologist and telling him some things I was feeling, and then she [pharmacist] called me, that's the advantage. I think she seems to have a little bit—this is just me speculating—she seems to have more insight into what might really be a side effect. Yeah, you might have a headache, but could it be related to sinuses? Is it constant? Does it feel like this, or does it feel like that? You might be forgetful about somethings, but we all are. Are you losing your balance? Things like that, she just seems to have a little bit more, I don't know, experience or information or whatever with what might be going on”	“That they may be able to pass that information on to the oncologist, and if required to make some changes in dosage or, I don’t know, whatever is needed”	“I think it's very important in the beginning [to talk with a pharmacist. For many of us who have had cancer previous to this, we have expectations when we go in. Those expectations include knowing that things are gonna crop up that we don't expect or don't think, oh, well, that's not gonna bother me very much, and it does. It can be scary for some people. I'm a lucky person”
	“My pharmacist explains things clearer when—'cause she asks me questions that my doctor doesn't sometimes, and she also, when I talk to her, if I tell her something, my pharmacist always goes back and talks with my doctor. With other pharmacy and she's told me about some of my symptoms, and then she comes back with answers for me. I feel very comfortable talking with [name]”	“I feel like he's [pharmacist]—can make those decisions without having to go back and forth with Dr. [oncologist name] and anybody else. I kind of like that part of it. I guess a negative aspect is there are sometimes where we’ve had conversations or decisions where I’m kind of questioning goin’ “Hmm. Is this the same thing [oncologist name] would say? Are you guys on the same page?” That kind of thing. I definitely see good parts and bad parts”	“I think that’s a good advantage. Because especially for me since I’m not too close to UNC, to get a phone call and be able to discuss the side effects and what I could be doin’ for them, it’s very helpful”

Delphi panel

Nineteen invitations were sent for each round and n = 11/19 (58%), n = 13/19 (68%), and n = 19/19 (100%) pharmacists participated, respectively, in rounds 1, 2, and 3. In round 1, most (11/16) of the original side effect domains were endorsed by at least 75% of pharmacists (Online Appendix A). The domains with 25–74% endorsement were sexual health (45%), breast tenderness or swelling (45%), genitourinary (64%), visual/perceptual (64%), and attention/memory (73%). No domains had fewer than 25% endorsement, and thus none were excluded in this round. Pharmacists requested adding items assessing medication adherence to future rounds.

In round 2, 53 specific side effects, 1 item on usual activities, and medication adherence items were listed. Of the 53 side effects, 34/53 (64%) were endorsed by at least 75% of pharmacists (Online Appendix B). Decreased sweating, hiccups, and stretch marks had fewer than 25% endorsement and were excluded. The new items on ability to do usual activities and medication adherence were endorsed at 100% and retained.

At the live consensus meeting (round 3), an additional 42 side effects were discussed but ultimately excluded because they are not applicable to many oral oncolytics, can be captured in the “other symptom” item, and a major insurance payer in our state does not require reporting on them (Online Appendix C). Notably, pharmacists also discussed that they would not be able to independently manage mental health conditions such as anxiety and depression without proper referral to the psycho-oncology team, and thus were removed from the EHR SmartForm©. Instead, if a patient endorsed anxiety or depression as a side effect, the pharmacist recorded it in the text box for “other” side effects and started the referral process.

Phase 2: Knowledge Synthesis

Comparison of Delphi panel and patient interviews

Table 3 shows that patients and pharmacists agreed on most side effects to prioritize, including gastrointestinal (nausea, diarrhea, constipation, appetite, mouth/throat sores), pain, fatigue, neuropathy, dyspnea, rash, anxiety, and depression. The domains for usual activities and medication adherence were also retained.

Table 3

Combined results for delphi and patient interviews

Domain	Pharmacists	Breast patients	Thoracic patients	Hematology patients	Included in final EHR SmartForm© ?
Nausea	X	X	X	X	Yes
Constipation	X	X	X	X	Yes
Diarrhea	X	X	X	X	Yes
Fatigue	X	X	X	X	Yes
Pain	X	X	X	X	Yes
Mouth or throat sores	X	X	X	X	Yes
Rash	X	X	X	X	Yes
Appetite	X	X	X	X	Yes
Mental Health	X	X	X	X	No *
Neuropathy	X	X	X		Yes
Dyspnea	X		X	X	Yes
Other side effects with a text box	X	X	X	X	Yes
Trouble doing usual activities	X	X	X	X	Yes
Medication adherence	X				Yes **

^*Reasons for exclusion: Side effects may be unrelated to oral oncolytics, not required for state payer reporting, and pharmacists reported they did not have training in independent management of these medications

^**Patients were not asked directly about medication adherence during interviews

Selecting PROM items

The research team matched the retained side effects, usual activities, and medication adherence to individual items on PROMs. PRO-CTCAE [44, 45] is an item bank of 124 items representing 78 symptomatic toxicities that met our PROM criteria of being developed with patient and clinician input, calibrated with modern psychometric methods, and has validity and reliability evidence in cancer [40, 44, 45]. To meet patients’ recommendation about assessing whether they can do their usual activities, we added an item from the National Institutes of Health’s PROMIS (PRO Measurement Information System) global health scale [46]. We also added Wilson’s medication adherence items [47].

Programming the EHR SmartForm©

Two Epic analysts at the health system programmed the PROM items into the EHR SmartForm© and created a shortcut for clinical note-writing called a “smartphrase”© (pharmacist types a single word to automatically pull PROM responses into their clinical note).

Phase 3: Knowledge Tailoring

Two rounds of usability testing were needed for the EHR SmartForm© and clinical note-writing shortcut. In the first round, there was consensus among the pharmacists that the side effect items from standardized questionnaires [44, 46, 47] were too scripted to use in routine patient encounters because they preferred more of a discussion with patients. Instead, pharmacists asked for just the side effect name to be listed in patient-friendly terms (e.g., “felt sick to your stomach”) with severity response options (none, mild, moderate, severe).

The original item for usual activities was changed to, “How many days over the past month did your cancer medication or cancer keep you from doing your usual activities?” The medication adherence questions were replaced with two items assessing the number of missed doses in the last 30 days and barriers to taking medication and moved to the end of the EHR SmartForm© to align with pharmacist workflow. The original output from the clinical note-writing shortcut was perceived to be unusable because there was no formatting. As a solution, the discrete fields from the EHR SmartForm© were formatted into a table summarizing the patient’s responses that could be pulled into a clinical note (Fig. 3).

The second round of usability testing was done via a conference call with all participating pharmacists. The changes requested from the prior round were perceived by the pharmacists to be satisfactory and fit with their workflow. One more change was requested to add a radio button for “not applicable to drug” beside the severity options. This was judged by the pharmacists to be a minor change, and the usability testing concluded.

Discussion

PROMs are increasingly used in oncology care by nurses and physicians, but implementation has proven to be challenging in part because of staff burden. As such, pharmacists represent an overlooked group to further spread the workload associated with this relatively new process. Pharmacists who provide direct patient care to patients with chronic health conditions are well positioned to monitor PROMs and mitigate concerning side effects, given their rigorous training and expertise in the intricate interplay between a drug's pharmacokinetic and pharmacodynamic properties within the human body. They are key members of care teams and should be considered to lead PROM initiatives in healthcare settings. Yet, to leverage their expertise, monitoring needs to be easily supported within existing workflows and tailored to symptoms relevant to patients and pharmacists. We used engagement with patients and pharmacists, the Knowledge to Action framework [48], and PROM and EHR implementation best practices [4, 8, 14, 15, 27, 49] to develop an EHR SmartForm© and clinical note-writing shortcut for pharmacists to monitor side effects of oral oncolytics during routine telehealth encounters. Through this process, we created an intervention approach that addresses known patient barriers to completing PROMs (disparities in access to/comfort with internet and electronic PROMs). Results also suggest the importance of streamlining pharmacist-led PROM implementation (workflow fit and burden), for the most relevant and actionable symptoms, and clinic/infrastructure (insurance payer reporting) changes [4, 8, 22, 23, 50].

At the patient level, we addressed the barrier of some patients’ inequitable access to (or discomfort with) the internet [50] via specialty pharmacists verbally asking patients the PROM items during routine outreach calls (telehealth) and recording patient responses in the EHR SmartForm© in real-time. Verbal administration of a PROM has a negligible impact on patient responses and increases providers' ability to engage patients with low literacy [51, 52] and potentially those who use translators during clinical encounters. Asking patients standardized questions about side effects on routine telehealth calls also has the advantage of direct and immediate contact between the pharmacist and patient. This is in contrast to RCTs led by nurses and physicians, where patients typically complete PROMs at home on a web-enabled device, and nurses receive automated alerts for concerning symptoms and call the patient back [9, 10].

At the pharmacist level, we addressed the barrier of a PROM increasing workload [22, 23] in several ways. We added a verbal PROM to calls already being made by specialty pharmacists for education and medication refill outreach. Clinical pharmacy practitioners with prescribing privileges then managed severe side effects reported by patients, which matched the previous workflow if a patient spontaneously mentioned a side effect when the specialty pharmacist called them. Adding 12 side effects, activity, and medication adherence questions was perceived by specialty pharmacists to fit with their typical telehealth workflow reasonably. To address the time-consuming process of documenting patient information, a clinical note-writing shortcut was created that captured patient responses within an aesthetic table customizable to each pharmacist's progress note template and was perceived to be efficient.

To address the barrier of the PROM items being perceived as too scripted for a typical pharmacist encounter with a patient, the EHR SmartForm© was revised to include the side effect name in lay language (e.g., “felt tired even after resting” instead of “fatigue”). Future PROM training for pharmacists will emphasize that the SmartForm© should align with the pharmacists' natural patient interview process, and items can be asked in any order.

In the KTA Knowledge Inquiry and Synthesis phases, pharmacists and patients were consistent in their priorities for which oral oncolytic side effects to include in an EHR SmartForm© (nausea, diarrhea, constipation, appetite, pain, mouth/throat sores, fatigue, neuropathy, dyspnea, rash). These side effects are similar to those recommended by the Hematology/Oncology Pharmacy Association [53] and symptoms assessed by other US oncolytics programs, although those programs include both infusional and oral oncolytics [11, 17, 38, 39]. The side effect list is also consistent with 9/14 of PRO-CTCAE’s “core” item set [45], except for five items ultimately excluded (vomiting, insomnia, anxiety, sadness, and nothing could cheer you up); these differences may reflect different training foci between pharmacists, nurses, and physicians and drug-related vs. overall patient symptoms. Vomiting was excluded because nausea is more common, possibly as a result of pharmacist and clinician adherence to evidence-based guidelines for anti-emetic prescribing [37]. Insomnia, anxiety, and sadness were excluded because they may be unrelated to oral oncolytics, are not be required for payer reporting at this time, and pharmacists reported they did not have training in independent management of these symptoms.

At the clinical and infrastructure level, the EHR SmartForm’s discrete data fields address the barrier of onerous chart reviews to report side effect trends to insurance payers. The EHR SmartForm© automates the process and enables real-time tracking at the patient or clinic levels, in structured data fields. This model may be scalable to cancer centers with SmartForm© capability (from any EHR vendor). For example, some cancer centers may not be able to participate in CMS’ value-based payment model for 2023–2028 (Enhancing Oncology model) [54] because their EHR cannot administer electronic PROMs and monitor alerts for PROMs completed by patients at home. An infrastructure change to a verbal SmartForm(©) may help sustain PROMs in oncology pharmacy care delivery.

Limitations

First, the EHR SmartForm© and clinical note-writing shortcut were developed with input from patients and pharmacists affiliated with a single US cancer health system, which potentially limits generalizability. However, nationwide, > 3800 board-certified oncology pharmacists could be tapped to lead PROM initiatives. Different workflows will be needed in states that do not extend prescribing privileges to pharmacists. For example, concerning SmartForm© responses could be collected by a specialty pharmacist and sent to an oncologist. Pragmatic trials of pharmacist-facilitated PROM monitoring and verbal administration during telehealth are needed to supplement existing trials led by physicians and nurses to give health systems more choices in implementing PROMs.

Second, interviews with patients occurred before the Delphi panel, and thus, we could not add medication adherence to the patient interviews. However, some patients did mention it spontaneously as a question their pharmacist typically asks them.

Third, we had planned to use items from questionnaires with validity and reliability evidence. Still, concerns were raised that the items were too scripted to be verbally administered during usual care. Instead, pharmacists wanted just the name of the side effect listed in patient-friendly language (e.g., “felt tired even after you rest” instead of “fatigue”). Thus, we can say that these questionnaires informed the items in the EHR SmartForm© but may not be directly comparable. Future work should examine the SmartForm’s effectiveness in accurately identifying patients with side effects from oral oncolytics and how these items perform psychometrically.

In addition, we do not know if the EHR SmartForm© works as planned during routine telehealth encounters. A feasibility/pilot study is underway.

Despite these limitations, the strengths of this study included attention to equity, key partner engagement, and diverse patient participants (including those who do not have access/comfort with the internet), which may improve program acceptability and sustainability. Calvert and colleagues [50] provide recommendations for ensuring PROM systems are equitable and inclusive so more groups benefit from healthcare innovations. For example, some recommendations are to allow for resource allocation for different individuals to reach the same outcomes and to address when health data are not representative of the diversity in a patient population [50]. Their paper is available as part of an excellent compilation of PROM implementation best practices called “Patient-Reported Outcomes Tools: Engaging Users and Stakeholders” (PROTEUS-Practice) [8].

Conclusion

With iterative input from pharmacists and diverse patients, we developed a PROM monitoring system in the EHR that supports specialty pharmacists, during routine patient outreach calls, verbally collecting and monitoring a key set of symptoms that are important to both patients and pharmacists. By using an implementation science framework and presenting screenshots of our work, our findings are useful to other healthcare systems and researchers looking for a PROM solution for usual care integrated in the EHR, with a reasonable pharmacist/clinician workload, and no requirement for patients to have internet access/comfort.

Acknowledgements

We would like to acknowledge three patient advocates who contributed to this study: Kang Sung, Ronald Taylor, and Anne Wilson. We would also to acknowledge Dan Giang, PharmD, MBA for programming work on the EHR SmartForm© and Kerry Parrish for analyst work. We also thank Epic Systems Corporation for allowing us to publish screenshots.

Declarations

Conflict of interest

AMS: unrelated funding in the past two years from Sivan Innovation, UroGen Pharma Ltd., and the American Society of Clinical Oncology (all awarded to institution). Dr. Stover received a honorarium for serving on the steering committee for PROTEUS. LAC: serves on the Board of Directors for APSHO. GM: Unrelated research funding from Sivan Innovation. KC: Unrelated consulting fees or speaking honoraria in the last 24 months from: Pfizer, Blueprint Medicines, G1 Therapeutics. JLL: In the last 24 months, Dr. Lund’s spouse was employed by GSK and owned stock in the company. Dr. Lund is also a member of one of the sponsors funding this work, the Cancer and Aging Research Group (CARG). MHV and DL: unrelated Pfizer funding. EMR: unrelated research funding from Pfizer, OptumHealth, and the American Society of Clinical Oncology (awarded to institution). RS: consultant for the American Society of Health-System Pharmacists on an unrelated project. JEL: unrelated funding from Genentech (awarded to institution). DM, RK, CI, CC, SA, JB, KB, EWC, AF, BM, BP, JSR: none.ma Ltd., and the American Society of Clinical Oncology (all awarded to institution). Dr. Stover received a honorarium for serving on the steering committee for PROTEUS. LAC: serves on the Board of Directors for APSHO. GM: Unrelated research funding from Sivan Innovation. KC: Unrelated consulting fees or speaking honoraria in the last 24 months from: Pfizer, Blueprint Medicines, G1 Therapeutics. JLL: In the last 24 months, Dr. Lund’s spouse was employed by GSK and owned stock in the company. Dr. Lund is also a member of one of the sponsors funding this work, the Cancer and Aging Research Group (CARG). MHV and DL: unrelated Pfizer funding. EMR: unrelated research funding from Pfizer, OptumHealth, and the American Society of Clinical Oncology (awarded to institution). RS: consultant for the American Society of Health-System Pharmacists on an unrelated project. JEL: unrelated funding from Genentech (awarded to institution). DM, RK, CI, CC, SA, JB, KB, EWC, AF, BM, BP, JSR: none.

Patients gave verbal informed consent for telephone interviews (IRB# 22-0745) and the remainder of activities were exempt from oversight (IRB# 22-1466).

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Titel: Pharmacist-facilitated Patient Reported Outcome Measure (PROM) monitoring: developing an EHR SmartForm© to monitor side effects of oral oncolytics during routine telehealth encounters
Auteurs: Angela M. Stover
Debbie Liang
Dana Mueller
Rachel Kurtzman
Christiana Ikemeh
Courtney Canter
Sonali Acharya
Jill Brese
Kaitlyn Buhlinger
Kevin Chen
Evan W. Colmenares
Aimee Faso
Benyam Muluneh
Bianka Patel
Jeffrey S. Reichard
Rushabh M. Shah
Michael Tilkens
John Valgus
Lorinda A. Coombs
Jennifer Elston Lafata
Jennifer L. Lund
Emily M. Ray
Gita Mody
Mary-Haston Vest
Publicatiedatum: 15-10-2024
Uitgeverij: Springer International Publishing
Gepubliceerd in: Quality of Life Research
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI: https://doi.org/10.1007/s11136-024-03789-8

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Abstract

Purpose

Methods

Results

Conclusion

Supplementary Information

Publisher's Note

Plain English Summary

Introduction

Methods

Institutional review board (IRB)

Study setting

Planned process: Knowledge to Action framework

Study participants

KTA knowledge creation steps

Phase 1: Knowledge Inquiry

Interviews with patients

Interview data analysis

Delphi panel with pharmacists

Delphi panel data analysis

Phase 2: Knowledge Synthesis

Selecting PROM items

Programming EHR SmartForm©

Phase 3: Knowledge Tailoring

Usability testing rounds

Usability testing data analysis

Results

Phase 1: Knowledge Inquiry

Interviews with patients

Delphi panel

Phase 2: Knowledge Synthesis

Comparison of Delphi panel and patient interviews

Selecting PROM items

Programming the EHR SmartForm©

Phase 3: Knowledge Tailoring

Discussion

Limitations

Conclusion

Acknowledgements

Declarations

Conflict of interest

Consent to Participate

Publisher's Note

Deel dit onderdeel of sectie (kopieer de link)

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Supplementary Information