Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date June 2, 2016
First Posted Date June 8, 2016
Results First Submitted Date May 8, 2019
Results First Posted Date October 21, 2019
Last Update Posted Date November 15, 2019
Study Start Date January 2016
Actual Primary Completion Date January 29, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2019)
  • Comprehensiveness of Interviews as Compared to One Concept Mapping Group [ Time Frame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days ]
    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.
  • Comprehensiveness of Interviews Compared to Three Concept Mapping Groups [ Time Frame: Interviewed patients participated for 1 day; One group of concept mapping patients participated for 3 days ]
    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.
  • Comprehensiveness of Concept Mapping [ Time Frame: 3 days for one 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."
Original Primary Outcome Measures
 (submitted: June 6, 2016)
Comparison of methods in terms of comprehensiveness [ Time Frame: 01/2018-01/2019 ]
First, we will determine the proportion of outcome themes identified in each interview settings that are present in 1) the list of outcome clusters generated from the initial concept mapping session and 2) an aggregate list of outcome clusters from all three concept mapping sessions. We will also identify the presence of additional outcomes clusters in the concept mapping groups that were not identified in interviews. Then we will measure the comprehensiveness of outcomes as elicited in one concept mapping session compared to multiple sessions. We will assess "concept mapping saturation," wherein we compare the cluster themes that emerge from each CM group. We 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."
Change History
Current Secondary Outcome Measures
 (submitted: September 27, 2019)
  • Comparison of Method Efficiency in Terms of Time [ Time Frame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days ]
    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.
  • Comparison of Method Efficiency in Terms of Cost [ Time Frame: Interviewed patients participated for 1 day; Concept mapping patients participated for 3 days ]
    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.
Original Secondary Outcome Measures
 (submitted: June 6, 2016)
Comparison of methods in terms of efficiency [ Time Frame: 01/2018-01/2019 ]
We will assess the efficiency of implementation of the two methods, with efficiency including primarily measures of overall time of researchers, patient-partners, and patient-participants required for method completion. We will compare the efficiency of conducting one concept mapping iteration to the efficiency of performing one set of interviews done to theme saturation. The efficiency of each method will be assessed by measuring overall resource utilization for conducting that method. We will determine the resource intensiveness for completion of a single concept mapping iteration through to completion, and for one set of interviews performed to saturation. Collection of the data points will be performed during the design and implementation of Aim 1. This efficiency analysis is structured for what would need to be budgeted for in a grant application, and will provide useful information for general planning needs for method implementation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Concept Mapping as a Scalable Method for Identifying Patient-Important Outcomes
Official Title Not Provided
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.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Concept Mapping Versus Interviews
Intervention
  • Other: 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.
  • Other: Concept Mapping (CM)

    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.

Study Groups/Cohorts
  • 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.
    Intervention: 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.
    Intervention: Other: Concept Mapping (CM)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 27, 2019)
148
Original Estimated Enrollment
 (submitted: June 6, 2016)
195
Actual Study Completion Date March 2, 2018
Actual Primary Completion Date January 29, 2018   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02792777
Other Study ID Numbers 15G.667
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Thomas Jefferson University
Study Sponsor Thomas Jefferson University
Collaborators Patient-Centered Outcomes Research Institute
Investigators Not Provided
PRS Account Thomas Jefferson University
Verification Date October 2019