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

NCT02792777 | Completed Results

• 1 other identifier: 15G.667
• Study Type: observational
• Target: 148
• Locations: 1 country
• Sites: 1

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.

Conditions

Concept Mapping Versus Interviews

Keywords

Concept Mapping; VOICe; Interviews; Patient-Centered Research

Outcome Measures

Primary Outcomes (3)

• Comprehensiveness of Interviews as Compared to One Concept Mapping Group

  The investigators will use a qualitative content analysis approach to analyze interview transcripts from one healthcare setting, with one of the codes being "goals". All ideas coded to "goals" that are in any way relevant to patients' diabetes care will be extracted to create a list of patient-important outcomes. The investigators will then determine the proportion of patient-important outcomes identified in the interviews from one healthcare setting that are present in the list of patient-important outcomes generated from the initial concept mapping group during the brainstorming session. The investigators will also identify the presence of unique outcomes found in each method.

  Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days

• Comprehensiveness of Interviews Compared to Three Concept Mapping Groups

  The investigators will use a qualitative content analysis approach to analyze interview transcripts, with one of the codes being "goals". All ideas coded to "goals" that are in any way relevant to patients' diabetes care will be extracted to create a list of patient-important outcomes. The investigators will then determine the proportion of patient-important outcomes identified in interviews that are present in an aggregate list of patient-important outcomes generated from the brainstorming session of all three concept mapping groups. The investigators will also identify the presence of additional patient-important outcomes in three concept mapping groups that were not identified in interviews.

  Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 days

• Comprehensiveness of Concept Mapping

  The investigators will measure the comprehensiveness of outcomes elicited in one concept mapping group compared to multiple groups. The investigators will assess "concept mapping saturation," wherein we compare the patient-important outcomes that emerge from each CM group. The investigators will use the outcomes from our first group as the "baseline data," and will determine the amount of new data added from including a second/third group. This assessment will allow us to draw a basic "concept mapping saturation curve."

  3 days for one concept mapping group

Secondary Outcomes (2)

• Comparison of Method Efficiency in Terms of Time

  Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days

• Comparison of Method Efficiency in Terms of Cost

  Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days

Study Arms (2)

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.

Other: Interviews

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.

Other: Concept Mapping (CM)

Interventions

Interviews 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.

Interviews

Concept Mapping (CM) 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.

Concept Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

ThomasJeffersonU

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

• 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.

  PMID: 38166864 DERIVED

• 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.

  PMID: 30714080 DERIVED

• 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.

  PMID: 30621586 DERIVED

MeSH Terms

Interventions

Interviews as Topic

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Limitations and Caveats

Limited generalizability due to all enrollments in same health system; Potential selection bias to more engaged/motivated patients; Method efficiency may vary depending on size of research team, patient incentives, and analysis software needed.

Results Point of Contact

• Title: Kristin L Rising, MD MS
• Organization: Thomas Jefferson

kristin.rising@jefferson.edu

215-503-5507

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2016
• First Posted: June 8, 2016
• Study Start: January 1, 2016
• Primary Completion: January 29, 2018
• Study Completion: March 2, 2018
• Last Updated: November 15, 2019
• Results First Posted: October 21, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)