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

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ClinicalTrials.gov Identifier: NCT02792777
Recruitment Status : Completed
First Posted : June 8, 2016
Results First Posted : October 21, 2019
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
Thomas Jefferson University

Study Type Observational
Study Design Observational Model: Other;   Time Perspective: Prospective
Condition Concept Mapping Versus Interviews
Interventions Other: Interviews
Other: Concept Mapping (CM)
Enrollment 148
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Interviews Concept Mapping
Hide Arm/Group Description

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 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.

Period Title: Overall Study
Started 96 52
Completed 89 52
Not Completed 7 0
Reason Not Completed
Withdrawal by Subject             2             0
Recording malfunction             2             0
Later determined to be ineligible             2             0
Participant interviewed twice             1             0
Arm/Group Title Interviews Concept Mapping Total
Hide Arm/Group Description

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 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 of all reporting groups
Overall Number of Baseline Participants 89 52 141
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants 52 participants 141 participants
54.6  (13.8) 55.6  (14.7) 54.9  (14.1)
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 50 participants 139 participants
Female
49
  55.1%
24
  48.0%
73
  52.5%
Male
40
  44.9%
26
  52.0%
66
  47.5%
[1]
Measure Analysis Population Description: 1 participant declined to answer, did not collect data from 1 participant
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants 52 participants 141 participants
Hispanic or Latino
8
   9.0%
3
   5.8%
11
   7.8%
Not Hispanic or Latino
80
  89.9%
49
  94.2%
129
  91.5%
Unknown or Not Reported
1
   1.1%
0
   0.0%
1
   0.7%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 89 participants 52 participants 141 participants
Black or African American
60
  67.4%
42
  80.8%
102
  72.3%
Caucasian/White
24
  27.0%
5
   9.6%
29
  20.6%
Other
4
   4.5%
4
   7.7%
8
   5.7%
Unknown or not reported
1
   1.1%
1
   1.9%
2
   1.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 89 participants 52 participants 141 participants
89 52 141
1.Primary Outcome
Title Comprehensiveness of Interviews as Compared to One Concept Mapping Group
Hide Description 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.
Time Frame Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interviews Concept Mapping
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 30 24
Measure Type: Number
Unit of Measure: Reported patient-important outcomes
Total number of outcomes 26 33
Number of unique outcomes 6 13
2.Primary Outcome
Title Comprehensiveness of Interviews Compared to Three Concept Mapping Groups
Hide Description 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.
Time Frame Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interviews Concept Mapping
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 89 52
Measure Type: Number
Unit of Measure: Reported patient-important outcomes
Total Number of Outcomes 26 38
Unique Number of Outcomes 3 15
3.Primary Outcome
Title Comprehensiveness of Concept Mapping
Hide Description 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."
Time Frame 3 days for one concept mapping group
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis is of the number of patient-important outcomes per concept mapping group.
Arm/Group Title Concept Mapping
Hide Arm/Group Description:

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 Number of Participants Analyzed 52
Measure Type: Number
Unit of Measure: Reported patient-important outcomes
One Group Number Analyzed 24 participants
33
Two Groups Number Analyzed 14 participants
36
Three Groups Number Analyzed 14 participants
38
4.Secondary Outcome
Title Comparison of Method Efficiency in Terms of Time
Hide Description 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.
Time Frame Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interviews Concept Mapping
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 30 24
Measure Type: Number
Unit of Measure: Hours
Patient travel 0 2
Patient participation 1 6
Research team trainings 20 11
Research team participant recruitment 66 59
Research team travel 60 12
Research team conducting method 38 18
Research team data analysis 133 4
5.Secondary Outcome
Title Comparison of Method Efficiency in Terms of Cost
Hide Description 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.
Time Frame Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Interviews Concept Mapping
Hide Arm/Group Description:

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 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 Number of Participants Analyzed 30 24
Measure Type: Number
Unit of Measure: Dollars
Patient Incentives 750 3,000
Transcription 1,000 0
Data Analysis Software 1,380 2,000
Time Frame 1 year, 9 months
Adverse Event Reporting Description 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.
 
Arm/Group Title Interviews Concept Mapping
Hide Arm/Group Description

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 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.

All-Cause Mortality
Interviews Concept Mapping
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Serious Adverse Events
Interviews Concept Mapping
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Interviews Concept Mapping
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Kristin L Rising, MD MS
Organization: Thomas Jefferson
Phone: 215-503-5507
EMail: kristin.rising@jefferson.edu
Layout table for additonal information
Responsible Party: Thomas Jefferson University
ClinicalTrials.gov Identifier: NCT02792777    
Other Study ID Numbers: 15G.667
First Submitted: June 2, 2016
First Posted: June 8, 2016
Results First Submitted: May 8, 2019
Results First Posted: October 21, 2019
Last Update Posted: November 15, 2019