Trial Outcomes & Findings for Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes (NCT NCT02792777)
NCT ID: NCT02792777
Last Updated: 2019-11-15
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
148 participants
Primary outcome timeframe
Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Results posted on
2019-11-15
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
96
|
52
|
|
Overall Study
COMPLETED
|
89
|
52
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
|
Overall Study
Recording malfunction
|
2
|
0
|
|
Overall Study
Later determined to be ineligible
|
2
|
0
|
|
Overall Study
Participant interviewed twice
|
1
|
0
|
Baseline Characteristics
1 participant declined to answer, did not collect data from 1 participant
Baseline characteristics by cohort
| Measure |
Interviews
n=89 Participants
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.
|
Concept Mapping
n=52 Participants
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.
|
Total
n=141 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
54.6 years
STANDARD_DEVIATION 13.8 • n=89 Participants
|
55.6 years
STANDARD_DEVIATION 14.7 • n=52 Participants
|
54.9 years
STANDARD_DEVIATION 14.1 • n=141 Participants
|
|
Sex: Female, Male
Female
|
49 Participants
n=89 Participants • 1 participant declined to answer, did not collect data from 1 participant
|
24 Participants
n=50 Participants • 1 participant declined to answer, did not collect data from 1 participant
|
73 Participants
n=139 Participants • 1 participant declined to answer, did not collect data from 1 participant
|
|
Sex: Female, Male
Male
|
40 Participants
n=89 Participants • 1 participant declined to answer, did not collect data from 1 participant
|
26 Participants
n=50 Participants • 1 participant declined to answer, did not collect data from 1 participant
|
66 Participants
n=139 Participants • 1 participant declined to answer, did not collect data from 1 participant
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=89 Participants
|
3 Participants
n=52 Participants
|
11 Participants
n=141 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
80 Participants
n=89 Participants
|
49 Participants
n=52 Participants
|
129 Participants
n=141 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=89 Participants
|
0 Participants
n=52 Participants
|
1 Participants
n=141 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
60 Participants
n=89 Participants
|
42 Participants
n=52 Participants
|
102 Participants
n=141 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian/White
|
24 Participants
n=89 Participants
|
5 Participants
n=52 Participants
|
29 Participants
n=141 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
4 Participants
n=89 Participants
|
4 Participants
n=52 Participants
|
8 Participants
n=141 Participants
|
|
Race/Ethnicity, Customized
Race · Unknown or not reported
|
1 Participants
n=89 Participants
|
1 Participants
n=52 Participants
|
2 Participants
n=141 Participants
|
|
Region of Enrollment
United States
|
89 participants
n=89 Participants
|
52 participants
n=52 Participants
|
141 participants
n=141 Participants
|
PRIMARY outcome
Timeframe: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 daysThe 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.
Outcome measures
| Measure |
Interviews
n=30 Participants
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.
|
Concept Mapping
n=24 Participants
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.
|
|---|---|---|
|
Comprehensiveness of Interviews as Compared to One Concept Mapping Group
Total number of outcomes
|
26 Reported patient-important outcomes
|
33 Reported patient-important outcomes
|
|
Comprehensiveness of Interviews as Compared to One Concept Mapping Group
Number of unique outcomes
|
6 Reported patient-important outcomes
|
13 Reported patient-important outcomes
|
PRIMARY outcome
Timeframe: Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 daysThe 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.
Outcome measures
| Measure |
Interviews
n=89 Participants
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.
|
Concept Mapping
n=52 Participants
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.
|
|---|---|---|
|
Comprehensiveness of Interviews Compared to Three Concept Mapping Groups
Unique Number of Outcomes
|
3 Reported patient-important outcomes
|
15 Reported patient-important outcomes
|
|
Comprehensiveness of Interviews Compared to Three Concept Mapping Groups
Total Number of Outcomes
|
26 Reported patient-important outcomes
|
38 Reported patient-important outcomes
|
PRIMARY outcome
Timeframe: 3 days for one concept mapping groupPopulation: This analysis is of the number of patient-important outcomes per concept mapping group.
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."
Outcome measures
| Measure |
Interviews
n=52 Participants
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.
|
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.
|
|---|---|---|
|
Comprehensiveness of Concept Mapping
Two Groups
|
36 Reported patient-important outcomes
|
—
|
|
Comprehensiveness of Concept Mapping
Three Groups
|
38 Reported patient-important outcomes
|
—
|
|
Comprehensiveness of Concept Mapping
One Group
|
33 Reported patient-important outcomes
|
—
|
SECONDARY outcome
Timeframe: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 daysThe 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.
Outcome measures
| Measure |
Interviews
n=30 Participants
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.
|
Concept Mapping
n=24 Participants
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.
|
|---|---|---|
|
Comparison of Method Efficiency in Terms of Time
Patient travel
|
0 Hours
|
2 Hours
|
|
Comparison of Method Efficiency in Terms of Time
Patient participation
|
1 Hours
|
6 Hours
|
|
Comparison of Method Efficiency in Terms of Time
Research team trainings
|
20 Hours
|
11 Hours
|
|
Comparison of Method Efficiency in Terms of Time
Research team participant recruitment
|
66 Hours
|
59 Hours
|
|
Comparison of Method Efficiency in Terms of Time
Research team travel
|
60 Hours
|
12 Hours
|
|
Comparison of Method Efficiency in Terms of Time
Research team conducting method
|
38 Hours
|
18 Hours
|
|
Comparison of Method Efficiency in Terms of Time
Research team data analysis
|
133 Hours
|
4 Hours
|
SECONDARY outcome
Timeframe: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 daysThe 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.
Outcome measures
| Measure |
Interviews
n=30 Participants
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.
|
Concept Mapping
n=24 Participants
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.
|
|---|---|---|
|
Comparison of Method Efficiency in Terms of Cost
Patient Incentives
|
750 Dollars
|
3,000 Dollars
|
|
Comparison of Method Efficiency in Terms of Cost
Transcription
|
1,000 Dollars
|
0 Dollars
|
|
Comparison of Method Efficiency in Terms of Cost
Data Analysis Software
|
1,380 Dollars
|
2,000 Dollars
|
Adverse Events
Interviews
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Concept Mapping
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place