Contributions to the literature
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Our paper will determine the real-world barriers and facilitators to the sustained implementation of patient decision aids.
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We will provide insight on various processes to identify patients eligible to receive a patient decision aid and how and when to provide these tools to patients to minimize the burden on clinic workflow.
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Ultimately, we will delineate pathways that will enable clinics to determine how their workflow needs to change in order to achieve the sustained implementation of a patient decision aid.
Background
Methods
Design
Theoretical framework
Construct | Short description |
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I. Intervention characteristics | |
A. Intervention source: quality assurance. | EBSCO Systematic Literature Surveillance System (source of evidence for DynaMed Plus product) is best in class. |
B. Relative advantage: comparison opportunity | Very few clinicians have used patient decision aids designed to facilitate shared decision making. Our evidence so far indicates that clinical teams are positive about their utility. |
C. Adaptability: the degree to which an intervention can be adapted to local needs. | The availability of multiple formats: online and two printed versions (text and Picture Option Grid) allows maximum adaptability to local workflow variations. The online tool can be sent to patients ahead of visits, as well as after visits. The printed versions allow clinicians to tailor the content to local practice variation and to fit the tool into their style of communication with patients of varying literacy and computer literacy levels. We know that clinicians value the ability to add, edit, and make notes on these tools before they give them to patients to take home. The use of pictures maximizes the usability and accessibility of this approach across socioeconomic strata. |
D. Trialability: local test | The cost or complexity of using Option Grid is low, and so, we anticipate low resistance to trialability by the participating clinical teams. In other clinical contexts, we have experienced zero resistance to trialability. |
E. Complexity: as the number of steps, or the number of people or processes increases, so does the difficulty of implementation. | The Option Grid has been designed to be fast, frugal, and outwardly simple, so that it can fit into decision discussions that will benefit from accurate, accessible information. |
F. Design quality and packaging: instills confidence in the intervention. | The EBSCO Option Grid has achieved high quality design with professional user centered graphic design. |
G. Cost: investment, supply, and opportunity costs. | Investment will be related to the time taken to learn how to integrate the tool into the clinical workflow, a learning curve that has been observed to take a few interactions. The project will ensure adequate supply; future use will need to ensure online access for sustainability. We anticipate minimal disruption on opportunity costs—clinicians typically cover the type of information in Option Grids. The tool makes the exchange more efficient according to our evaluations. Evidence suggests that Option Grid decision aids do not typically increase consultation time as the content of the tool is information clinicians already provide to patients routinely. |
II. Inner setting | |
B. Networks and communication: The nature and quality of webs of social networks and the nature and quality of formal and informal communications within an organization. | Eligible patients will be identified using the site’s outpatient scheduling system in advance of their visit. Where possible, the eligible patients will be sent an Option Grid in advance of their appointment and will be instructed to bring the Option Grid to their appointment. |
C. Culture: Norms, values, and basic assumptions of a given organization. | We want to help implement a process where patients are engaged in their treatment decisions “upfront” by receiving an intervention that can facilitate a discussion with their clinician regarding their treatment options. |
D. Implementation climate: The absorptive capacity for change, shared receptivity of involved individuals to an intervention, and the extent to which use of that intervention will be rewarded, supported, and expected within their organization. | We will assess implementation climate by calculating the expected use of the intervention which is based on the volume of patients visiting each site who have been diagnosed with symptomatic uterine fibroids. |
E. Readiness for implementation: Tangible and immediate indicators of organizational commitment to its decision to implement an intervention. | We will determine readiness for implementation from the Measuring Organizational Readiness for patient Engagement (MORE) survey which will be administered prior to the commencement of the pre-implementation phase to 10 stakeholders at various levels of the service delivery team (i.e., clinicians, administrators, managers). |
III. Characteristics of individuals | |
A. Knowledge and beliefs about the intervention: Individuals’ attitudes toward and value placed on the intervention as well as familiarity with facts, truths, and principles related to the intervention. | ADOPT is a measure of patient attitudes to patient decision aids. Clinicians will be asked to select one or more words that best describes their attitudes to the potential use of patient decision aids from a pool of ten words. |
B. Self-efficacy: Individual belief in their own capabilities to execute courses of action to achieve implementation goals. | The words selected by the participating clinicians who complete the ADOPT measure will be indicative of their self-efficacy or the belief in their ability to execute the course of action and achieve implementation goals. |
C. Individual stage of change: Characterization of the phase an individual is in, as he or she progresses toward skilled, enthusiastic, and sustained use of the intervention. | We will compare collaboRATE scores (three-item patient-reported outcome measure) before and after the initiation phase to determine individual stage of change. |
D. Individual identification with organization: A broad construct related to how individuals perceive the organization, and their relationship and degree of commitment with that organization. | Ten stakeholders at various levels of the service delivery team (i.e., clinicians, administrators, managers) at each site will complete the Measuring Organizational Readiness for patient Engagement (MORE) survey. |
E. Other personal attributes: A broad construct to include other personal traits such as tolerance of ambiguity, intellectual ability, motivation, values, competence, capacity, and learning style. | Personal attributes will be determined via the ADOPT survey. Clinicians will circle up to 10 words that will be indicative of their personal traits. |
IV. Process | |
A. Planning: The degree to which a scheme or method of behavior and tasks for implementing an intervention are developed in advance and the quality of those schemes or methods. | We will be visiting each site multiple times throughout the study to provide support and assess the degree to which each site is willing to adopt our processes. |
B. Engaging: Attracting and involving appropriate individuals in the implementation and use of the intervention through a combined strategy of social marketing, education, role modeling, training, and other similar activities. | Our second site visit will aim to attract and involve appropriate individuals in the implementation and use of the intervention. In addition, we will be providing initiation to clinicians to teach them how to use the tools in practice. Each site will also have a “clinical champion”/site principal investigator that will support the implementation of the intervention. The strategy will also include feedback on study processes from the members of the Community Advisory Board. |
C. Executing: Carrying out or accomplishing the implementation according to plan. | The primary outcome measure is the number of eligible patients who receive the uterine fibroid Option Grid. |
D. Reflecting and evaluating: Quantitative and qualitative feedback about the progress and quality of implementation accompanied with regular personal and team debriefing about progress and experience. | A 23-item instrument—NoMAD Normalization Process Theory (NPT) survey—will be used to capture the perspective of professionals directly involved in the work of implementing the intervention. We will also conduct semi-structured interviews with a convenience sample of clinicians and staff at each of the five clinical sites to identify, monitor, and assess the progression and integration of the intervention and to determine the utility of the Option Grid patient decision aid and the barriers and facilitators to their integration in the clinic workflow. We will also be receiving feedback at our annual site visit to determine the process each site is using to facilitate implementation of the intervention. The outcomes we will be measuring include the extent to which tools are delivered, the extent to which patients are reporting use of Option Grid in appointments, and the collection of collaboRATE scores. |
Setting
Participants
Intervention
Translation procedure
Outcomes and data collection
Primary outcome measure
Secondary outcome measures
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Measuring Organizational Readiness for patient Engagement (MORE). MORE is designed to measure a healthcare organization’s willingness and ability to effectively implement patient engagement in healthcare [29]. The measure contains 25 items that are each scored on a four-point Likert-type scale (1 = avoid/not important; 4 = definitely involve/very important) [29]. Data from the measure will be analyzed to identify barriers and facilitators to implementation at each site and tailor the implementation strategy accordingly.Each site PI will be asked to nominate 20–30 MORE recipients within their department. Dartmouth study staff will then email the online survey link to nominees in the 2 months preceding the pre-implementation phase at each site.
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Attitudes toward Decision Aids fOr PatienTs (ADOPT). ADOPT is a measure of patient attitudes and perceptions toward PDAs. Clinicians are asked to select one or more words that best describe(s) their attitudes to the potential use of PDAs from a pool of 10 words. It can be completed by clinicians who have, or have not, used PDAs.ADOPT will be administered to all participating clinicians at three time points: (i) the start of the pre-implementation phase, (ii) the end of the active implementation phase, and (iii) the end of the sustainability phase. The surveys will be distributed via email to participating clinicians using a secure web link.
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Extent of shared decision making. Observer OPTION-5 is a validated, observational measure. It is a five-item scale, with each item rated from “0” to “4” where “0” represents the absence of a shared decision-making specific competency and “4” represents optimal performance [30].A research assistant employed at each site will audio-record five clinical encounters in both the pre- and active implementation phases for each participating clinician that consents to audio-recording. In each phase, we will establish a recruitment day(s) each week where a research assistant will approach as many eligible patients as possible to seek consent to audio-record their visit. This will be repeated each week until five encounter recordings per clinician per phase are obtained (10 per clinician in total). In the active implementation phase, we will begin the audio-recording recruitment process described above 2 months into the phase to allow clinicians time to get comfortable and confident with the intervention prior to recording. We will consult with sites to determine if we will audio-record encounters that take place between residents and patients. We anticipate a patient consent rate of 50 to 60% [31].
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Fidelity of intervention use. The fidelity assessment checklist enables us to determine if an Option Grid was used, how and when it was delivered to the patient, whether or not the clinician made a treatment recommendation or elicited patient preference, and the identification of the final treatment decision [32]. The checklist will help us understand if clinicians are using the tools as intended following initiation.The checklist will be completed independently by two Dartmouth-based project staff while listening to the audio-recorded clinic visits.
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NoMAD Normalization Process Theory (NPT) survey. A 23-item instrument used for capturing the perspective of professionals who will be involved in implementing and using Option Grid in practice [33]. The instrument contains four sections that ask questions on the various facets of implementing and using the intervention such as the effect that it has on workflow, the work and resources needed to drive implementation, and critical appraisal of the Option Grid.A convenience sample of 10 stakeholders at various levels of the service delivery team (i.e., clinicians, medical assistants, nurses, coordinators, managerial and reception staff) from each site will have the opportunity to complete the NoMAD survey at two time points: (i) at the end of the pre-implementation phase and (ii) at the end of the sustainability phase. Participants will be asked to provide their name each time they complete the survey. Stakeholders can complete the survey during a site visit, or they will have the opportunity to complete it online after the project team at Dartmouth sends a secure WebLink via email.
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Utility of Option Grid PDAs and clinician approach to implementation. Semi-structured interviews, guided by NPT, will be conducted with clinicians to assess the utility of the Option Grid tools and how they implemented the intervention in practice.A member of the project team at Dartmouth will conduct semi-structured interviews in-person or via phone with a convenience sample of clinicians at each of the five clinical sites to determine the utility of the uterine fibroid Option Grid PDA and the barriers and facilitators to its integration in the clinic workflow at two time points: (i) at the end of the active implementation phase and (ii) at the end of the sustainability phase.
Implementation phases | |||
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Pre | Active | Sustainability | |
Organizational readiness (Measuring Organizational Readiness for patient Engagement survey) | ✓ | ||
Clinician attitudes to PDAs (ADOPT: Attitudes toward Decision Aids fOr PatienTs survey) | ✓ | ✓ | ✓ |
Percentage of eligible patients receiving intervention (primary outcome measure) | ✓ | ✓ | ✓ |
Quality of shared decision-making process using Observer OPTION-5 | ✓ | ✓ | |
Utility of tools and approach (clinician interviews) | ✓ | ✓ | |
Normalization Process Theory: NOMAD Toolkit (interviews) | ✓ | ✓ | |
Intervention fidelity assessment using observer checklist | ✓ | ||
Patient outcomes | |||
Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) symptom severity subscale (8-items) | ✓ | ✓ | |
collaboRATE (three items) | ✓ | ✓ | |
The Comprehensive Score for financial Toxicity (COST)—one selected item | ✓ | ✓ | |
Resource utilization (ambulatory and hospital visits) | ✓ | ✓ | |
Intended and received treatment | ✓ | ✓ | |
Chew health literacy measure (one item) | ✓ | ✓ | |
Patient demographics (email address, health insurance status, age, race, gender, and spoken language) | ✓ | ✓ |
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collaboRATE. collaboRATE is a three-item, patient-reported experience measure of how patients perceive the effort that clinicians make to achieve three core aspects of shared decision making: informing patients, eliciting preferences, and integrating preferences into decisions made [27, 34]. Patients answer each question on a scale of 0 to 9. The measure is scored by using the percentage of patients who give the highest possible score of 9 for each item (top score) [27, 34].
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Uterine Fibroid Symptom and Health-Related Quality of Life Questionnaire (UFS-QOL) symptom severity subscale. We will ask patients to complete only the symptom severity subscale portion of the 37-item UFS-QOL questionnaire. The eight-item subscale asks patients how distressed their symptoms have made them feel over the past 3 months [35]. Each item is scored on a Likert-type scale from “1” (none of the time) to “5” (all of the time) [35].
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The Comprehensive Score for financial Toxicity (COST). COST is a patient-reported outcome measure to assess financial toxicity in patients with cancer [36, 37]. The measure contains 11 items. Study stakeholders, including patient partners, felt that the majority of the items were not applicable for this study and wanted to minimize respondents’ burden; therefore, we opted to only use one item. The question reads: “I worry about the financial problems I will have in the future as a result of my illness or treatment”, and the response scale is from “0” (not at all) to “4” (very much).
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Chew Health Literacy Measure. Three-item validated measure of health literacy. The items are the following: How confident are you filling out medical forms by yourself? How often do you have someone (like a family member, friend, hospital/clinic worker, or caregiver) help you read hospital materials? How often do you have problems learning about your medical condition because of difficulty understanding written information? Patients who circle “extremely” or “quite a bit” on the Likert-type scale are considered to have high health literacy [38].
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Resource utilization (ambulatory and hospital). The follow-up survey will query eligible patients to self-report the number of outpatients (or visit to primary care clinician), inpatient, or emergency visits during the 3-month follow-up period.
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Treatment choice. Patients will identify their intended treatment choice in the post-encounter survey. We will also ask patients in the 3-month follow-up survey whether they have seen another clinician about another treatment, whether an Option Grid tool was used in that encounter, and to identify the final treatment option they selected, or will select if they proceed with scheduling the treatment intervention.
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Patient demographics. We will collect the patient’s email address, health insurance status, age, race, gender, and spoken language via the survey they complete on the tablet computer post-encounter.