Despite a national focus on improving patient centeredness, most research continues to measure things that are thought to be important to patients rather than directly engaging patients to identify important outcomes.
One-on-one interviews and focus groups are two well-known methods used to engage patients. Both methods can be technically challenging, time consuming, resource intensive, and rely heavily on investigator’s interpretations of the results. Our study will explore whether there is a more efficient and effective way to learn about patient-important outcomes.
Overview of Our Study
In this study, we are testing and comparing methods to identify patient-important outcomes. Specifically, we will determine the efficacy and efficiency of using concept mapping, a structured brainstorming process, as compared to one-on-one interviews for identifying patient-important outcomes.
To perform this work, we will engage patient with diabetes to ask them about their priorities for their diabetes treatment. We will engage one group of patients with one-on-one interviews, and another group of patients with concept mapping. While the primary goal of this research is to compare two research methods, we will also develop an extensive list of patient-important outcomes for managing diabetes in the course of our work.
We have designed this project through collaboration with our Patient Advocates and Key Stakeholders Advisory Board (PAKSAB). We will continue to work closely with our PAKSAB through the end of this project, and we have a few members of the group serving as active members of our research team.
The Patient-Centered Outcomes Research Institute (PCORI) Award ME-1503-28476 is funding this study. Thomas Jefferson University’s Institutional Review Board has approved the study protocol (15G.667). The study’s clinicaltrials.gov identifier is NCT02792777.
This illustration depicts a model we have developed to describe the cyclical nature of chronic disease management experienced by individuals, regardless of their specific diagnoses or needs. This model explicitly incorporates the inevitable reality of acute exacerbations of chronic conditions, spanning the period from feeling well (baseline – at 6:00 on the wheel) through the progression of symptoms and eventually back to a baseline health state (whether it be the old or a new baseline). We seek to recruit and enroll patients across the care continuum by recruiting patients at three distinct care periods around this care continuum pathway: 1) during an acute care seeking episode, 2) during a period of post-acute care (within one week after hospital discharge), and 3) during a routine primary care visit. We have chosen to enroll patients within each of these three distinct health settings to enable us to capture any variation in patient priorities and preferences that exist related to current health status.
The study has three aims:
Aim 1: To engage patients to identify their own patient-important outcomes for managing their chronic conditions through 1) one-on-one interviews and 2) concept mapping groups.
Interviews are semi-structured and last about 30 minutes. The research team worked closely with our Patient and Key Stakeholder Advisory Board (PAKSAB) to create an interview guide. We anticipate performing 90-120 interviews (30-40 interviews with patients from each care period).
The research team and PAKSAB members will also facilitate three concept mapping groups. We will aim to recruit 25 patients for each concept mapping group. Patients from all three care periods will be recruited into these groups to ensure representation of perspectives from around the care continuum. See the concept mapping FAQ for details on the method.
Aim 2: To compare the comprehensiveness of concept mapping to one-on-one interviews for identifying patient-important outcomes for managing their chronic conditions.
We will compare the themes from concept mapping and interviews to see the comprehensiveness of each method, in generating themes. We will also compare the similarities and differences between the themes that emerge from concept mapping and interviews. We will also see whether responses vary by care period or patient characteristics.
Aim 3: To compare the efficiency of concept mapping to one-on-one interviews for identifying patient-important outcomes for managing their chronic conditions.
We will examine the financial cost and efficiency of concept mapping and interviews by comparing the time that researchers, PAKSAB members, and participants devote to the project to complete concept mapping and interviews, as well as the expenses incurred for each method
This project period is January 1, 2016-December 31, 2018. Our timeline is below
Year 1: All interview training; conduct 75% of interviews; begin interview analysis
Year 2: Complete interviews and interview analysis; conduct concept mapping sessions
Year 3: Complete comparative analysis of the two methods; dissemination of results