N/A
N=148
Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes
Concept Mapping Versus Interviews
Bottom Line
View on ClinicalTrials.gov: NCT02792777 ↗Enrolled (actual)
148
Serious AEs
—
Results posted
Oct 2019
Primary outcome: Primary: Comprehensiveness of Interviews as Compared to One Concept Mapping Group — 26; 33; 6; 13 Reported patient-important outcomes
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Interviews (Other); Concept Mapping (CM) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Thomas Jefferson University
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comprehensiveness of Interviews as Compared to One Concept Mapping Group |
26; 33; 6; 13 | — |
| PRIMARY Comprehensiveness of Interviews Compared to Three Concept Mapping Groups |
26; 38; 3; 15 | — |
| PRIMARY Comprehensiveness of Concept Mapping |
33; 36; 38 | — |
| SECONDARY Comparison of Method Efficiency in Terms of Time |
0; 2; 1; 6; 20; 11 | — |
| SECONDARY Comparison of Method Efficiency in Terms of Cost |
750; 3,000; 1,000; 0; 1,380; 2,000 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02792777). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.