Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes

NCT ID: NCT02792777

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 148 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-03-02

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.

Conditions

Concept Mapping Versus Interviews

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Interviews

Interview participants will be recruited 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 total recruitment goal for this cohort is 90-120 participants.

Interviews

Intervention Type: OTHER

Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis.

Concept Mapping

Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target of 20 patients. The total recruitment goal for this cohort is 60 people.

Concept Mapping (CM)

Intervention Type: OTHER

The CM process consists of 3 steps that take place over 3 sessions:

Step 1: Generation of Ideas- Participants brainstorm and generate responses to the focus statement. Once the group agrees that no new statements are being generated, the list of statements is reviewed within the group.

Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance. Research staff enters this information into the CM software.

Concept Systems Global Software generates point maps using a technique that detects underlying similarities/differences between statements. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.

Step 3: Interpretation- The CM group revises the concept map. Participants review the cluster names suggested by the software and decide upon final naming of each cluster as a group.

Interventions

Interviews

Patients will be engaged in open-ended, semi-structured qualitative interviews, which will be performed one-on-one either in person or over the phone (depending on the healthcare setting that they are recruited from). Qualitative interviews will be audio recorded, with the patient's permission, transcribed, de-identified and entered into NVivo software for coding and analysis.

Intervention Type: OTHER

Concept Mapping (CM)

The CM process consists of 3 steps that take place over 3 sessions:

Step 1: Generation of Ideas- Participants brainstorm and generate responses to the focus statement. Once the group agrees that no new statements are being generated, the list of statements is reviewed within the group.

Step 2: Structuring of Statements- Each participant is given a set of sort cards and asked to sort the statements into piles. Participants then rate each idea regarding importance. Research staff enters this information into the CM software.

Concept Systems Global Software generates point maps using a technique that detects underlying similarities/differences between statements. The CM software then uses hierarchical cluster analysis to draw boundaries around the point map to create conceptual clusters.

Step 3: Interpretation- The CM group revises the concept map. Participants review the cluster names suggested by the software and decide upon final naming of each cluster as a group.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

Thomas Jefferson University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

ThomasJeffersonU

Philadelphia, Pennsylvania, United States

Countries

United States

References

Gentsch AT, Reed MK, Cunningham A, Chang AM, Kahn S, Kovalsky D, Doty AMB, Mills G, Hollander JE, Rising KL. "Once I take that one bite": the consideration of harm reduction as a strategy to support dietary change for patients with diabetes. BMC Endocr Disord. 2024 Jan 2;24(1):3. doi: 10.1186/s12902-023-01529-6.

Reference Type: DERIVED

PMID: 38166864 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30714080 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 30621586 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15G.667

Identifier Type: -

Identifier Source: org_study_id