Conceptual Development Informing the Kidney Failure Patient Life Goals Survey

Abstract

Rationale & Objectives

To report on the qualitative study supporting concept elicitation and item development for a new survey assessing discussion of patient life goals (D-PaLS) for people with kidney failure (KF) on maintenance dialysis.

Study Design

Three-stage qualitative data collection using a semi-structured group discussion format with an expert panel (stage 1); 2 focus groups (stage 2); and cognitive debriefing interviews (stage 3).

Setting & Participants

All participants were recruited nationally in the United States to obtain a diverse convenience sample of KF patients with maintenance dialysis experience, nephrologists, and dialysis clinic staff.

Analytic Approach

Qualitative analysis of major themes to support life goals concept elicitation and survey item development and revision.

Results

There was strong consensus for the development of a patient life goals patient-reported outcome measure to support the alignment of patient life goals with treatment planning. Themes from stage 1 included “quality gap—life goals discussions are not happening,” “how life goals inform treatment planning,” and “starting the life goals conversation.” In stages 2 and 3, focus group feedback related to item interpretability; mix of item type; limiting survey burden; and preserving patient anonymity. The final survey contained 8 items (6 core items and 2 check-list items).

Limitations

People that volunteered for participation may reflect self-selection.

Conclusions

The new D-PaLS is a brief survey that was based on extensive input from patient and clinical provider stakeholders that supported elicitation of the measure concept and item development. The D-PaLS has the potential to support shared decision-making in treatment planning for people with KF. Stakeholder support is necessary throughout patient-reported outcome measure measure development to ensure content is meaningful and captures experiences and outcomes that are important to the patients.

Plain-language Summary

The discussion of patient life goals survey was developed based on conversations we had in 2017 with people with kidney failure and kidney doctors who felt it was important that discussing patient life goals should be happening as part of kidney replacement treatment planning. After the 2017 meeting, we developed initial survey questions that were reviewed by 2 focus groups, which provided feedback. Next, we conducted cognitive debriefing interviews to make sure survey questions were clear and easy to understand. The survey will fill a need for more patient-reported outcome measures for people being treated for kidney failure.

For people receiving long-term dialysis, discussion of patient life goals, or goals that an individual aspires to, with their dialysis facility care team can improve understanding of these goals at the facility-level, provider-level, and patient-level. These discussions can facilitate treatment planning and shared decision-making about modality selection, vascular access, and other treatment options for their dialysis and kidney failure care. As such, these discussions have the potential to improve patient-centered care, which is an outcome in its own right.¹

The Centers for Medicare and Medicaid Services (CMS) regulations for dialysis facilities require that discussions about kidney replacement modality and other aspects of treatment include consideration of how treatment can be planned to best support the patient’s personal values and life goals.² Reports of such patient and provider discussions about life goals, and other aspects of care are best captured directly from the patient, as a patient-reported outcome. A patient-reported outcome metric (PRO) is an important tool enabling patients to report their health condition, health behavior, or experience with health care that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else.^3,4 However, there is no established PRO that asks patients to report on their experiences discussing life goals with their dialysis facility care team.

The starting point of this study was to elicit concepts and survey content, asking kidney failure patients if their life goals are discussed by their care team and if treatment is aligned with those goals. This is the first step in developing a subsequent PRO-performance metric that assesses at the provider level whether patients feel their dialysis treatment plan is aligned with their life goals. The remainder of this paper describes the conceptual elicitation to establish the initial discussion of patient life goals (D-PaLS) PRO. Further information about the facility performance measure is described elsewhere.⁵

We collected stakeholder feedback to support the development of a new PRO for the long-term dialysis population (Exhibit 1). This 3-stage qualitative study, conducted from 2017 to 2019, was focused on establishing the concepts that warranted inclusion in the D-PaLS PRO and developing the specific item content that best represents these constructs. In the remainder of this paper, we describe our methods and results and conclude with a discussion about how the results were used to support construction of this new PRO.

Exhibit 1.

Patient life goals survey (Version 0.5).

Research Methods

Study population and setting

Data were collected in 3 stages using a combination of qualitative methods. We used semi-structured group discussions with content experts, such as kidney failure patients, nephrologists, and dialysis clinicians (stage 1) that served on a technical expert panel (TEP); and focus groups with kidney failure patients, care partners, and nephrologists and dialysis clinicians (stage 2). Stages 1 and 2 were co-led by a social scientist PhD and a clinical nephrologist MD (CD and JMM) (stages 2 and 3, see Boxes S1 and S2). Cognitive debriefings with kidney failure patients and nephrologists and dialysis clinicians (stage 3) were carried out by the first author (CD) (Box S1). Cognitive debriefing is an important tool that helps determine whether the target population finds the survey wording and format easy to understand and that the survey captures the intended concepts. Interview questions for the cognitive debriefings were developed by 2 PhD-level members of the study team (NEC and CD), and reviewed by a clinical nephrologist (JMM) to ensure applicability to the clinical setting.

Convenience sampling was used for all stages and included people with kidney failure who were currently receiving or had experience with chronic dialysis therapy or were current transplant recipients; nephrologists and dialysis clinicians (dialysis nurses, nurse practitioners, and social workers) who provide care to people on dialysis; PRO measure experts; and care partners of kidney failure patients. Participants were recruited via email through a stakeholder list that included national kidney patient organizations, nephrology professional organizations, and provider groups. Email recipients were invited to self-nominate or nominate other eligible individuals. Participation was voluntary, and recruitment was separate for each stage. We did not collect demographic data on patient or provider participants or nonresponders given the small sample sizes and the need for anonymity. Stage 1 participants were compensated for their travel, food, and accommodations. No compensation or incentives were provided to participants in the other stages.

In stage 1 (spring 2017), we convened a 2-day TEP on kidney failure patient-reported outcomes to discuss potential PRO measures and topic areas. The TEP members were provided a literature review and information gathering report on PRO measure topics specific to the kidney failure patient population (eg, health-related quality of life, patient experience, and dialysis recovery time). This material was used for an initial brainstorming session,⁶ which served as the starting point for further discussion to inform the final recommendations on PRO measure development. The TEP discussed several PRO topic areas, including the assessment of patient life goals, which is the focus of the current paper.⁶

In the second stage (spring 2018), we conducted 2 virtual 1-hour focus groups in an independent sample of patients and providers: one with kidney failure patients and a care partner and the other with nephrologists and other dialysis clinicians, in which feedback was elicited on draft survey items. In our last stage (stage 3; fall 2019), a PhD-level study team member (CD) carried out virtual semi-structured cognitive debriefing interviews with kidney failure patients and nephrologist and dialysis clinicians to ensure that the survey wording and format were easy to understand and captured the intended concepts (Box S3).

TEP and focus group participants, respectively, received a detailed summary of the discussion and recommendations and were asked to review and provide edits and corrections if needed.

Analysis methods

Qualitative methods based on grounded theory were used to analyze the data collected in each stage7, 8, 9 to identify an initial set of major themes and subthemes from each stage. Although review and extraction of themes were performed by a single study team member (CD), additional study team members reviewed the session notes, recordings, and transcripts and provided a review of these themes before finalizing the results sections (JMM for stages 1 and 2; JMM and NEC for stage 3).

For stage 1, iterative inductive methods^8,9 were used to produce themes related to patient life goals to inform item development for the D-PaLS. Illustrative quotes were identified to demonstrate participant descriptions of life goals and the relationship with multiple aspects of care delivery. For stages 2 and 3, consensus-based discussion methods were used by the study team to support additions, removals, or revisions to survey item content. All data were collected in accordance with the local institutional review board.

Results

Nineteen individuals participated in stage 1. Kidney failure patients comprised about half the TEP participants (n = 8); 1 member was a PRO measurement expert, and the remaining members were nephrologists and dialysis clinicians (n = 10) (6 nephrologists, 1 registered nurse [RN], 1 nurse practitioner, 1 social worker, and 1 pharmacist). Stage 2 included people with kidney failure (n = 9) and a care partner (n = 1). The provider focus group included nephrologists and dialysis clinicians (n = 9) (4 nephrologists, 2 RNs, 2 nurse practitioners, and 1 dietitian). In stage 3, we conducted individual cognitive debriefings (n = 22) (n = 12 people with kidney failure and n = 10 nephrology and dialysis clinicians, which included 3 nephrologists, 3 RNs, 2 nurse practitioners, 1 social worker, and 1 dietitian).

Stage 1: the importance of life goals discussions

Several themes emerged from the technical expert panel discussion of patient life goals. These are quality gap—life goals discussions are not happening, how life goals inform treatment planning, and starting the life goals conversation. Some overlap existed across these discussions, but resulting themes focused on a specific aspect of life goals and treatment planning. Box 1 includes quotations from the TEP members that illustrate these themes.

Box 1. Illustrative Quotes from the TEP About Life Goals.

TEP Member Quotes on Patient Aspirational Life Goals

Theme: The quality gap – life goals discussions are not happening “Right now the conversation is not even happening. So it needs to be documented . . . discussing what it is they (patient) want from their treatment (whether we call it goals or aspirations).” (Patient participant) “One of the things you just said, like going to college, my dialysis unit was just keeping me alive, I was very sick for a 22-year-old and one of the sickest patients at my unit. I could not go to college because I had to be there so long. My unit did not tell me about PD or anything else. I was able to go to graduate school because I learned about these things. If the unit does not educate on options, the person is stuck in one place.” (Patient participant) “ . . . for example I know a lady that cuts her treatment short so she can go see her grandchildren. Is she getting the best dialysis, no; is it improving her quality of life, yes.” (Patient participant) “ . . . what you would hope would happen is that instead of (the) facility letting you sign off early (is ask) how can we both meet our goals . . . (something) that allows you to do what it is that is important to you, whether it is switching modality. . .” (Provider participant) “A lot of people aren’t talking about what their life goals are. Having those conversations quarterly . . . or having specific questions about whatever is on our list…a lot of physicians are not having those conversations even with KDQOL . . . I got it once but they are not really asking about it (goals) . . .” (Patient participant) “(You) just need to have a process ‘did you have this conversation with your patient’, ‘are you having these conversations’ will help assess as many patients as possible. A lot of people are not talking about what their life goals are, a lot of physicians are not having those conversations. ‘Did someone ask you about your life goals?’ (It) needs to be a built-in process so there is follow-up (on the conversation).” (Patient participant) Theme: Life goals should inform treatment planning “If you want to take care of your grandchildren three times a week—tell the dialysis center that and they can help by changing your treatment.” (Patient participant) “ . . . The facility takes a look at my health and tailors my treatment to help me meet my goals . . . Patients then drive the measure (and makes it) visible to other people.” (Patient participant) “If life goals drive the care plan then patients are better engaged in all those other aspects (clinical aspects) . . . it is about their life goals not just arbitrary numbers.” (Patient participant) “Somebody is diagnosed with a disease, instead of being in service to treatment the treatment must be in service to the patient, tailored to the person. The question just needs to be asked. Right now education is that I talked to patient about transplant options, etc. . . . and I ‘checked the box’ . . . this is an opportunity to transform dialysis and how it is done using patient data. Potential there is to transform things, which can result in more engaged patients . . . As far as crafting a tool I think we are close in what we have. Life goals as defined by the patient. Actually think of it as aspirations . . . whether seeing grandchildren, or education or success in your career . . . it drives human nature.” (Patient participant) “If you have a symptom free treatment to give you the vitality to do the things you want to do . . . you need to have the right therapy to do what (what is important) . . . She [patient] does not get from us what she needs to have an aspirational life.” (Provider participant) “We all have wishes and dreams. We are tasked with once you have these PROs the system needs to enable recall of these conversations happening. Looking at the patients who may not be as eloquent. . . . I don’t think we are so different. We all have wishes and dreams, and goals, whatever we call them . . . they may be different . . . but they (goals) are there. And we can bring them and if they can determine how they [patients] undergo do dialysis. . . . That is a better world than we are in right now.” (Provider participant) “How do you optimize treatment, (symptom management) . . . 10% of our time is in interactions with the dialysis center which impacts the other 90% of our life, outside the clinic. Life goals . . . that is only the process, how do you measure if they’re being met…facility should not be held accountable to that. How do you know the process is working if don’t look at outcomes (symptoms) and if the patient is doing well or not.” (Patient participant) “(If) you want to go out and work, be aggressive in your career, then it may be home dialysis; if you feel sick a lot and want to feel better then it may be more dialysis. (I) want a modality that allows me to feel better. It all goes to putting patients and what their “fill in the blank” goals are . . . then how to address fatigue or other aspects of treatment. Focus on the bigger picture than just addressing one symptom.” (Patient participant) “I think you can ask a question—no matter what your individual goals are, it would not matter . . . are they addressing those things . . . We all have different goals but that is a question all of us can answer. You can get data on it, is a clinic doing well addressing desires and goals. Still see that yeah that clinic is doing a good job . . . see if clinics are trending up or down.” (Patient participant) Theme: Starting the life goals conversation “I want to work, be an advocate. The purpose of the life goals measure is it forces facilities to sit down and see what they can do to support goals, and what they focus on. Making patients feel like their goals are responded to.” (Provider participant) “The goal of this measure is to enable people . . . to get at some of these patients who do not stand up and raise their hand and say this is what I want to do. . . . Push the discussion of, ‘is your goal to feel better after treatment; be able to work?’ . . .” (Provider participant) “I’m not hearing a sentiment that the goals needs to be achieved, but (TEP) support for (providers) facilitating that the conversation happens.” (Provider participant)

Quality gap—life goals discussions are not happening

One theme that emerged repeatedly is that patients receiving dialysis often do not receive information about ways treatment can be delivered or individualized to facilitate pursuit of goals that are important to them, such as attending college, seeing and taking care of grandchildren, or getting or keeping a job. Several participants shared their and other patients’ experiences of how they had not received information about ways a specific treatment modality or other modification of their current modality could support their individual goals. For example, one participant said they were unaware a home modality was an option for them, but when they found out, they pushed for their facility to switch them to peritoneal dialysis:

“One of the things you just said, like going to college, my dialysis unit was just keeping me alive, I was very sick for a 22-year-old and one of the sickest patients at my unit. I could not go to college because I had to be there so long. My unit did not tell me about PD or anything else. I was able to go to graduate school because I learned about these things. If the unit does not educate on options, the person is stuck in one place.” (Patient participant)

Another participant said they felt most providers are not having these discussions with patients, or that it happens once but there is no follow-up to discuss how treatment can be changed and tailored to support the patient’s individual goals.

Life goals should inform treatment planning

Another distinct theme was that of placing dialysis treatment in a position to support a patient’s aspirations and life goals, as defined by that individual. Several reported that all too often patients subordinate their goals and lives to their dialysis treatment, whereby the treatment dictates their lives. Participants discussed the ideal state where the care team is aware of one’s life goals and in response, works with the patient to determine the best way to put treatment into service of supporting those goals.

One example described was of a patient receiving dialysis that often cut their treatment short so they could get home to take care of their grandchildren. Instead, the ideal is that the facility discusses with the patient how they can change their dialysis treatment schedule to support their caregiving role. Other participants emphasized that regardless of one’s individual goals, all facilities should be able to align treatment as much as possible to allow every person an opportunity to pursue their goals and aspirations:

“We are tasked with once you have these PROs the system needs to enable recall of these conversations happening…We all have wishes and dreams, and goals, whatever we call them…they may be different…but they [goals] are there. That is a better world than we are in right now.” (Provider participant)

Starting the life goals conversation

There was consensus that it is important for the facility care team to initiate the life goals discussion with patients:

“I want to work, be an advocate. The purpose of the life goals measure is it forces facilities to sit down and see what they can do to support goals, and what they focus on. Making patients feel like their goals are responded to.” (Provider participant)

Several participants felt this was important because not all patients will proactively initiate these discussions. Several also pointed out that just asking the question is important because it establishes context for patients engaging in their care planning; it also provides a tool for the care team to help guide treatment planning with patients. The intent is to have the discussion, not necessarily that all the goals must be achieved. Finally, asking about life goals at regular intervals is important.

The culmination of the TEP discussion around these themes resulted in identifying assessment of patient life goals as a high priority topic for new PRO development.

Stage 2: focus group feedback on the draft D-PaLS items

Four themes emerged from the focus groups: item interpretability, mix of item types, limiting survey burden, and preserving patient anonymity. The main category of feedback was item interpretability (Fig 1). Both patient and provider participants’ feedback related to wording and plain language understanding of survey items. One primary comment from patients and providers was to simplify wording and define terms. For example, they suggested defining the term dialysis care team and to avoid technical terms and use active voice in wording. Several providers on the focus group suggested including a question about who on the care team asks them about life goals (eg, kidney doctor, nurse, social worker, and no one).

Figure 1.

Themes for specific focus group and cognitive debriefing feedback. FG, focus groups; CD, cognitive debriefing.

Another suggestion from both patient and provider focus group participants was to use a mix of item types (eg, global questions and drill down/follow-up questions) and include free-text response options. The length of the survey was also discussed, and there was consensus that it should be as brief as possible to limit survey burden. Subsequently, 1 item was removed and 3 new ones were added.

Subsequent to the focus group, we conducted additional internal expert review that resulted in further item revisions and removal, resulting in a set of 9 items in the survey version used for cognitive debriefing (Box S1).

Stage 3: cognitive debriefing on the D-PaLS

In the cognitive debriefing stage, feedback was associated with the same 4 themes as the focus groups: item interpretability, mix of item type, limiting burden, and preserving patient anonymity (Fig 1). The main area of feedback from cognitive debriefing with patients was on item interpretability. Feedback from patients related to wording in the introduction, the list of life goals, and the 6 core items. For example, several patients felt the term dialysis patient was potentially off-putting because it suggests dialysis defines a patient’s whole identity. They suggested using a person treated with/receiving dialysis to reinforce the autonomy of the individual person as separate from their dialysis treatment. Several patient-care partners and provider participants felt one of the survey items was ambiguous.

Other feedback was specific to the items asking about whether the care team talks with you (the patient) about life goals. The patient participants said this should be re-worded to allow participants to respond based on their interaction with an individual member or some/all of their care team. For example, in some cases the social worker or the patient care technician may be the one who talks with the patients about life goals.

Suggestions from cognitive debriefing with providers (nephrologists and dialysis clinicians) focused on clarifying wording; for example, they suggested avoiding technical terms, such as treatment plan. Another suggestion was to let the patient-respondent define life goals in their own words. A few provider participants felt that more challenging or complex patients (based on health or limited personal or social resources) may not have really thought about life goals or what they mean or be reluctant to share them with their care team. Both patients and providers stressed the importance of survey brevity and anonymous administration.

Based on this feedback, 1 item was removed, resulting in the current D-PaLS survey that includes scorable items (n = 6) and check-list items with a free-text option (n = 2) (Fig 2).⁵

Figure 2.

Discussion of patient life goals item development by stage.

Discussion

The recommendations and feedback from each stage of our study provided strong support for the development of a PRO that can assess patient satisfaction with facility team-based discussions of life goals regarding kidney replacement treatment planning and maintenance. The themes from stage 1 provided the conceptual elicitation and initial item development work for the discussion of patient life goals survey (Exhibit 1). The initial survey was revised after stages 2 and 3 to reflect suggested changes in item content and wording from the focus group and cognitive debriefing sessions. These included removal and addition of items, wording changes to several life goals, adding a free-text option to the list of life goals and minimizing use of technical terms.

As a PRO-performance metric, the D-PaLS could be used to assess provider awareness of these goals and support patient decisions about kidney replacement modality (dialysis or transplant), vascular access type, and other aspects of treatment that could be tailored to align with the patient’s life goals. Provider discussions with patients about their aspirational goals facilitates patient decision-making and supports patient-centered care^1,10, 11, 12, 13 (Fig S1).

The intent of the D-PaLS is to provide information on patient satisfaction with their facility care team’s consideration of their life goals as part of the treatment planning process in order to facilitate better alignment between a patient’s life goals and their treatment. In addition, the first item of the D-PaLS measure also includes a list of potential life goals that provide something the patient can use as examples when thinking about life goals. Although the responses to this item will not be shared with the facility or evaluated, it is our hope that this may help guide patients’ discussions with their treatment team. It is also important to be clear that a patient’s individual life goals should not be judged, nor would the dialysis care team be evaluated on whether they incorporate each goal into the treatment plan, as we realize that may not be feasible depending on the goals.

This D-PaLS-PRO is consistent with CMS regulations² and clinical practice guidelines that place patient life goals as the cornerstone of kidney replacement treatment decision-making and care planning.^13,14 There is a structure in place to support these discussions, through the inter-disciplinary team plan of care meeting, mandated by the 2008 CMS conditions for coverage, and meeting at least annually.² Life goals are also addressed in the updated National Kidney Foundation’s Kidney Disease Outcomes Quality Initiative (NKF–KDOQI) guideline statements for vascular access: ‘The end-stage kidney disease [ESKD] life-plan is a strategy that should start in the predialysis period and encompasses a continuum-of-care model for CKD to ESKD. It aims to maximize ESKD modality choices and utilization for a specific patient’s foreseeable lifespan and specifically considers the patient’s current medical situation, current and future life goals, preferences, social support, functional status, and logistics, and other practical feasibilities’ (13).

The NKF–KDOQI’s exposition of these statements highlights the importance of life goal identification and ongoing discussions as an integral part of kidney failure treatment decisions.

Despite this emphasis on the importance of life goals discussions to inform kidney replacement modality and other treatment decisions,14, 15, 16 these conversations are not always happening.⁶ Even when they do, little is known about whether these discussions are associated with better patient outcomes. For example, the low uptake of home dialysis and access to transplant in the United States suggests the current approach to inform treatment decisions may be inadequate. Moreover, several studies show that on average about 30% of kidney failure patients have reported that their modality decision was not an informed choice or they did not feel like they were the ones that made the decision.^17,18 This has resulted in calls for a paradigm shift in the delivery of predialysis and dialysis care.^13,14

The conceptual underpinning of the life goals construct is based on empirical studies in the kidney failure population and other chronic disease populations like cancer, diabetes, chronic pain, and palliative care.16, 17, 18, 19, 20, 21, 22, 23 In each, the focus is on patient preference or values and life goal identification as part of shared decision-making among treatment options, or the impact of treatment on the ability to pursue one’s personal goals. While these were mainly smaller studies using qualitative or mixed methods, the results are consistent in that the identification of life goals is an important process of patient treatment planning.^22,24,25

More generally, systematic reviews26, 27, 28, 29 and perspective articles cite the importance of including life goals in decisions about treatment. In the kidney failure treatment setting, this includes the selection of dialysis modality and consideration of transplant and selection of vascular access type for delivery of hemodialysis treatment.^14,26,30,31 For example, Blake and Brown¹ outline how such decision-making should inform the selection of dialysis modality or other treatment options for people approaching kidney failure.

Although this study produced rich data across three stages, it also has several limitations. First, we did not collect data on demographics from TEP participants other than their designation that they were a person with kidney failure or a nephrology physician or dialysis provider. Although the TEP meetings were public, patients had the option to remain anonymous; therefore, we did not collect this information for any TEP members or for focus group or cognitive interview participants. A second limitation is a reflection of the convenience sampling approach, in that there may have been some self-selection of TEP members because they had to have the ability to travel to the meeting. Third, and similarly, all participants proactively volunteered by replying to an email recruitment message. This means that patient participants, in particular, were self-selected and all had computer literacy and a general comfort level sharing their experiences. Future studies on the validation of a facility-level D-PaLS could include a random sampling approach that reflects the characteristics of the target population.

This study describes the conceptual development of a novel patient-reported outcome survey about discussion of patient life goals for people with kidney failure on long-term dialysis. Following this qualitative study, we performed preliminary reliability and validity testing,⁵ and will be conducting facility-level testing to support suitability for future implementation as a facility-level PRO performance measure. Taken together this work will demonstrate the scientific soundness of the D-PaLS. Finally, the D-PaLS will help fill a gap in the available patient-reported outcome measures for people with kidney failure.

Supplementary Material

Supplementary File (PDF)

Figure S1; Boxes S1-S3.