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| Name | Class |
|---|---|
| Patient-Centered Outcomes Research Institute | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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." |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Method Efficiency in Terms of Time | The investigators will assess the efficiency of implementation of the two methods, with efficiency including time required by researchers (team of 3) and patient-participants to complete each method. The investigators will compare the efficiency of conducting one concept mapping iteration (24 participants) to the efficiency of performing one set of interviews done to theme saturation (30 interviews). This efficiency analysis is structured for what would need to be budgeted in a grant application, and will provide useful information for general planning needs for method implementation. |
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Inclusion Criteria:
Adult patient (age 18 and older)
Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for interview groups):
Diagnosis of moderately to poorly controlled diabetes mellitus (DM) defined as follows (for concept mapping groups):
Exclusion Criteria:
Patient has had a significant permanent complication related to DM including:
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
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ThomasJeffersonU | Philadelphia | Pennsylvania | 19107 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38166864 | Derived | 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. | |
| 30714080 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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: 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. |
| FG001 | Concept Mapping | Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people. Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions: Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement. 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. CM Software detects underlying similarities/differences between statements to generate point maps. 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 cluster names suggested by the software and decide upon final naming of each cluster. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Reported patient-important outcomes | Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days |
|
1 year, 9 months
All-Cause Mortality, Serious, and Other [not including Serious] Adverse Events were not monitored or assessed because patients were not at risk for adverse events aside from discomfort during interviews and concept mapping sessions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristin L Rising, MD MS | Thomas Jefferson | 215-503-5507 | kristin.rising@jefferson.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 6, 2019 | Sep 13, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007407 | Interviews as Topic |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| 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. |
|
| 3 days for one concept mapping group |
| Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days |
| Comparison of Method Efficiency in Terms of Cost | The investigators will assess the efficiency of implementation of the two methods, with efficiency assessed by cost to complete a single concept mapping iteration (24 participants) and cost to complete one set of interviews performed to saturation (30 interviews). This efficiency analysis is structured for what would need to be budgeted in a grant application, and will provide useful information for general planning needs for method implementation. | Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days |
| 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. |
| 30621586 | 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. |
| Later determined to be ineligible |
|
| Participant interviewed twice |
|
| BG001 | Concept Mapping | Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people. Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions: Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement. 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. CM Software detects underlying similarities/differences between statements to generate point maps. 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 cluster names suggested by the software and decide upon final naming of each cluster. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | 1 participant declined to answer, did not collect data from 1 participant | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Concept Mapping | Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people. Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions: Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement. 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. CM Software detects underlying similarities/differences between statements to generate point maps. 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 cluster names suggested by the software and decide upon final naming of each cluster. |
|
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| Primary | 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. | Posted | Number | Reported patient-important outcomes | Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 days |
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| Primary | 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." | This analysis is of the number of patient-important outcomes per concept mapping group. | Posted | Number | Reported patient-important outcomes | 3 days for one concept mapping group |
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| Secondary | Comparison of Method Efficiency in Terms of Time | The investigators will assess the efficiency of implementation of the two methods, with efficiency including time required by researchers (team of 3) and patient-participants to complete each method. The investigators will compare the efficiency of conducting one concept mapping iteration (24 participants) to the efficiency of performing one set of interviews done to theme saturation (30 interviews). This efficiency analysis is structured for what would need to be budgeted in a grant application, and will provide useful information for general planning needs for method implementation. | Posted | Number | Hours | Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days |
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| Secondary | Comparison of Method Efficiency in Terms of Cost | The investigators will assess the efficiency of implementation of the two methods, with efficiency assessed by cost to complete a single concept mapping iteration (24 participants) and cost to complete one set of interviews performed to saturation (30 interviews). This efficiency analysis is structured for what would need to be budgeted in a grant application, and will provide useful information for general planning needs for method implementation. | Posted | Number | Dollars | Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Concept Mapping | Concept mapping participants will be recruited from existing clinical and research databases for 3 separate concept mapping groups, each with a target recruitment of 20 patients. The total recruitment goal for this cohort is 60 people. Concept Mapping (CM): The CM process consists of 3 steps that take place over 3 sessions: Step 1: Generation of Ideas- Participants brainstorm responses to a focus statement. 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. CM Software detects underlying similarities/differences between statements to generate point maps. 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 cluster names suggested by the software and decide upon final naming of each cluster. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| Unknown or Not Reported |
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| Other |
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| Unknown or not reported |
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| Three Groups |
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| Research team trainings |
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| Research team participant recruitment |
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| Research team travel |
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| Research team conducting method |
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| Research team data analysis |
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| Data Analysis Software |
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