Clinical trial NCT02792777: Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Concept Mapping Versus Interviews
Keywords: Concept Mapping
VOICe
Interviews
Patient-Centered Research
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
Collaborators: name: Patient-Centered Outcomes Research Institute
First posted: 2016-06-08
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The investigators aim to engage a discrete population of patients who have recently sought care at Thomas Jefferson University for treatment needs related to moderately to poorly controlled diabetes. Consistent with the overall population served by Jefferson, the investigators expect greater than 50% of enrolled patients to be African American and approximately 30% of them to be at the \<20% federal poverty line. All data will be collected prospectively. The investigators decided to engage patients with moderately to poorly controlled DM because these patients have a known high risk of severe complications related to poor diabetes control, and a significant proportion of patients remain poorly controlled despite available therapies. The investigators thus determined in discussion with the PAKSAB that this population is a good candidate for testing the method of concept mapping to identify patient-important outcomes.

Brief summary: The goal of this study is to improve the methods with which researchers identify patient centered outcomes for use in research. Specifically, the investigators will test the application of concept mapping as compared to one-on-one interviews as a comprehensive and efficient method of identifying patient-important outcomes for use in research.

Detailed description: This is an observational study comparing two methods - concept mapping and one-on-one interviews. The investigators will test the methods themselves by comparing the comprehensiveness of the lists of patient-important outcomes obtained through each method (primary outcome) as well as the efficiency, as measured by resource intensiveness, of the methods (secondary outcome). The aims of this study will be tested with adult patients with moderately to poorly controlled diabetes mellitus who receive care at a large, urban, academic health system. In order to allow comparisons of the comprehensiveness of the methods in producing patient-important outcomes regardless of the healthcare setting in which outcomes are elicited, the investigators will recruit patients for the interview group from 3 different care settings: an acute care visit (in the emergency department), a post-acute care visit (within 1 week of a hospital discharge), and a routine primary care visit. Target sample size within each healthcare setting is 30 patients, which is the anticipated number needed for thematic saturation. The investigators will then recruit patient-participants from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. In Aim 2, the investigators will test the hypothesis that concept mapping in a research setting produces outcomes consistent with those elicited from patients in the "real-world" settings. In Aim 3, the investigators will assess the overall resource utilization, assessed primarily by time required from patients, the research team, and the advisory board, of qualitative interviews conducted to thematic saturation within a single healthcare setting compared to resources used for a single iteration of concept mapping.

Findings from this work will improve patient-centered outcomes research methods by providing researchers with information about standardized scalable methods to identify patient-important outcomes for use in research studies, so that individual patients are able to select outcomes that are most useful to them. In addition to providing insight regarding methods for eliciting patient-centered outcomes, the study will also provide valuable information to stakeholders regarding how patients' priorities vary across the care continuum. The investigators will report how findings from concept mapping apply across healthcare settings, and the degree to which patient priorities (based on interviews) differ across healthcare settings. If concept mapping results (collected in the research setting) capture the priorities identified by patients across different healthcare settings, this finding would enhance researchers' ability to perform studies in different, or multiple, settings. If the findings do not generalize across settings, this will be a valuable finding demonstrating that patient priorities differ across interview settings and patient acuity and will validate researchers' needs to be specific about the setting in which they choose to perform research to ensure they are reaching their intended patient population.

The work is being performed in close collaboration with the Patient and Key Stakeholder Advisory Board (PAKSAB) - equal partners with the research team who have been involved with the proposal from inception. PAKSAB members will be part of the research team throughout conducting the aims and assisting with all analysis and data interpretation.

Eligibility criteria: Inclusion Criteria:

* Adult patient (age 18 and older)

  * English speaking
  * Provide informed consent
* Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for interview groups):

  * Acute care setting: patient in the Jefferson Emergency Department (ED) for a diabetes-related problem determined to require medical treatment
  * Post-acute care setting: patient was discharged from the Jefferson Family Medicine Associates (JFMA) hospital service within the past 7 days after admission for a diabetes-related problem
  * Primary care setting: patient currently attending a routine scheduled care visit (not urgent need) at the JFMA practice and has at least 2 measurements of HgbA1C \> 7.5 in the prior one year
* Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for concept mapping groups):

  * Acute care setting: patient within the Jefferson ED patient contact database (see below) who has had a visit to the Jefferson ED over the past 6 months (as determined on chart review) for a diabetes-related problem
  * Post-acute care setting: patient was discharged from the JFMA hospital service within the past 6 months after admission for a diabetes-related problem
  * Primary care setting: patient has had routine scheduled office visit within the past 6 months to the JFMA practice and has at least 2 measurements of HgbA1C \> 7.5 in the prior one year

Exclusion Criteria:

* Patient has had a significant permanent complication related to DM including:

  * End stage renal disease
  * History of amputation
  * Blindness related to diabetes complication
* Patient undergoing medical clearance for a detox center or any involuntary court or magistrate order
* Patient in police custody or currently incarcerated individual
* Patient who has, in their clinician's best judgment, major communication barriers such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent

Primary outcomes:
measure: Comprehensiveness of Interviews as Compared to One Concept Mapping Group
timeFrame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
measure: Comprehensiveness of Interviews Compared to Three Concept Mapping Groups
timeFrame: Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 days
measure: Comprehensiveness of Concept Mapping
timeFrame: 3 days for one concept mapping group
Secondary outcomes:
measure: Comparison of Method Efficiency in Terms of Time
timeFrame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
measure: Comparison of Method Efficiency in Terms of Cost
timeFrame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: ThomasJeffersonU
state: Pennsylvania
Study officials:
References:
citation: LaNoue M, Gentsch A, Cunningham A, Mills G, Doty AMB, Hollander JE, Carr BG, Loebell L, Weingarten G, Rising KL. Eliciting patient-important outcomes through group brainstorming: when is saturation reached? J Patient Rep Outcomes. 2019 Feb 4;3(1):9. doi: 10.1186/s41687-019-0097-2.
citation: Rising KL, LaNoue M, Gentsch AT, Doty AMB, Cunningham A, Carr BG, Hollander JE, Latimer L, Loebell L, Weingarten G, White N, Mills G. The power of the group: comparison of interviews and group concept mapping for identifying patient-important outcomes of care. BMC Med Res Methodol. 2019 Jan 8;19(1):7. doi: 10.1186/s12874-018-0656-x.