Back to resultsMeasuring and Improving Coproduction Using coopeRATE
Primary Purpose
Cystic Fibrosis, Chronic Disease
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
coopeRATE Prompt
Sponsored by
About this trial
This is an interventional health services research trial for Cystic Fibrosis
Eligibility Criteria
Inclusion Criteria:
- Have a diagnosis of cystic fibrosis
- Are 18 years of age or older
- Can read and write in English
- Are attending a participating site for a routine cystic fibrosis care visit
- Have already consented to participate in the Cystic Fibrosis Foundation Patient Registry
- Allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
- Have not previously participated in the study
Exclusion Criteria:
- Do not have a diagnosis of cystic fibrosis
- Are less than 18 years of age
- Cannot read and write in English
- Are not attending a participating site for a routine cystic fibrosis care visit
- Have not already consented to participate in the Cystic Fibrosis Foundation Patient Registry
- Do not allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
- Have previously participated in the study
Sites / Locations
- University of California San Diego
- National Jewish Health
- University of Kansas Medical Center
- Boston Children's Hospital
- University of Nebraska Medical Center / Nebraska Medical Center
- Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester
- University of Pittsburgh Medical Center
- University of Texas Southwestern Medical Center
- University of Virginia
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Other
Arm Label
Phase 1
Phase 2
Clinicians
Arm Description
Usual care
Usual care + coopeRATE Prompt intervention
After Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt intervention.
Outcomes
Primary Outcome Measures
Collaborative goal setting
A new 3-item patient-reported measure under evaluation to assess collaborative goal setting between a patient and their clinician during the health care visit. Each item is rated on a 4-point scale ranging from 0 ('Strongly disagree') to 3 ('Strongly agree'), with an additional 'Not sure' option. Scoring method is to be determined.
Secondary Outcome Measures
Shared decision-making
Patient-reported shared decision-making during the health care visit, assessed using the 3-item collaboRATE measure (Elwyn et al., 2013; Barr et al., 2014). Each item is rated on a 10-point scale ranging from 0 ('No effort was made') to 9 ('Every effort was made'). Respondent's are assigned a score of 1 if every item is rated 'Every effort was made' and a score of 0 for all other response combinations.
Interpersonal and communication skills
Patient-reported interpersonal and communication skills of their clinician during the health care visit, assessed using a 14-item version of the Communication Assessment Tool (CAT) (Makoul, Krupat, & Chang, 2007). Each item is rated on a 5-point scale ranging from 1 ('Poor') to 5 ('Excellent'). A respondent's total scale score is the percentage of items rated as 'Excellent'.
Self-efficacy to manage chronic disease
Patient-reported self-efficacy for managing their chronic disease immediately following the health care visit, assessed using an adapted version of the 6-item Self-Efficacy to Manage Chronic Disease Scale (Ritter & Lorig, 2014). Each item is rated on a 10-point scale ranging from 1 ('Not at all confident') to 10 ('Totally confident'). A respondent's total score is the mean of all item responses.
Full Information
NCT ID
NCT04060329
First Posted
August 15, 2019
Last Updated
July 7, 2020
Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Cystic Fibrosis Foundation, Boston Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04060329
Brief Title
Measuring and Improving Coproduction Using coopeRATE
Official Title
Measuring and Improving Coproduction Using coopeRATE: A Before-and-after Study in Adult Cystic Fibrosis Care
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Terminated
Why Stopped
Reasons associated with COVID-19 pandemic led to cancellation of Phase 2
Study Start Date
December 2, 2019 (Actual)
Primary Completion Date
March 16, 2020 (Actual)
Study Completion Date
March 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dartmouth-Hitchcock Medical Center
Collaborators
Cystic Fibrosis Foundation, Boston Children's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to identify new methods of measuring and improving collaborative goal setting between patients and clinicians in adult cystic fibrosis care.
Detailed Description
This study has 3 specific aims: Aim 1 will assess the construct validity of the coopeRATE Measure in the before phase of a before-and-after study in adult cystic fibrosis care settings. The coopeRATE Measure is a generic, patient-reported experience measure of collaborative goal setting that was recently developed in consultation with patients and other key stakeholders. Aim 2 will assess the impact of the coopeRATE Prompt intervention on collaborative goal setting and other outcomes in a before-and-after study in adult cystic fibrosis care settings. The coopeRATE Prompt intervention is a set of questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals. Aim 3 will evaluate the feasibility and acceptability of implementing the coopeRATE Prompt and Measure in routine adult cystic fibrosis care.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis, Chronic Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
In Phase 1, participants receive usual care only. In Phase 2, a different group of participants receive the coopeRATE Prompt intervention in addition to usual care.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Phase 1
Arm Type
No Intervention
Arm Description
Usual care
Arm Title
Phase 2
Arm Type
Experimental
Arm Description
Usual care + coopeRATE Prompt intervention
Arm Title
Clinicians
Arm Type
Other
Arm Description
After Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt intervention.
Intervention Type
Behavioral
Intervention Name(s)
coopeRATE Prompt
Intervention Description
The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.
Primary Outcome Measure Information:
Title
Collaborative goal setting
Description
A new 3-item patient-reported measure under evaluation to assess collaborative goal setting between a patient and their clinician during the health care visit. Each item is rated on a 4-point scale ranging from 0 ('Strongly disagree') to 3 ('Strongly agree'), with an additional 'Not sure' option. Scoring method is to be determined.
Time Frame
Immediately after the health care visit (Day 0)
Secondary Outcome Measure Information:
Title
Shared decision-making
Description
Patient-reported shared decision-making during the health care visit, assessed using the 3-item collaboRATE measure (Elwyn et al., 2013; Barr et al., 2014). Each item is rated on a 10-point scale ranging from 0 ('No effort was made') to 9 ('Every effort was made'). Respondent's are assigned a score of 1 if every item is rated 'Every effort was made' and a score of 0 for all other response combinations.
Time Frame
Immediately after the health care visit (Day 0)
Title
Interpersonal and communication skills
Description
Patient-reported interpersonal and communication skills of their clinician during the health care visit, assessed using a 14-item version of the Communication Assessment Tool (CAT) (Makoul, Krupat, & Chang, 2007). Each item is rated on a 5-point scale ranging from 1 ('Poor') to 5 ('Excellent'). A respondent's total scale score is the percentage of items rated as 'Excellent'.
Time Frame
Immediately after the health care visit (Day 0)
Title
Self-efficacy to manage chronic disease
Description
Patient-reported self-efficacy for managing their chronic disease immediately following the health care visit, assessed using an adapted version of the 6-item Self-Efficacy to Manage Chronic Disease Scale (Ritter & Lorig, 2014). Each item is rated on a 10-point scale ranging from 1 ('Not at all confident') to 10 ('Totally confident'). A respondent's total score is the mean of all item responses.
Time Frame
Immediately after the health care visit (Day 0)
Other Pre-specified Outcome Measures:
Title
Description of goals discussed during the visit
Description
Patient-reported goals discussed during the health care visit (if goals were discussed), assessed using a single item with open-text response format.
Time Frame
Immediately after the health care visit (Day 0)
Title
Preference for discussing goals
Description
Patient-reported preference for discussing goals with their clinician during the health care visit, assessed using a single item with multiple choice (single answer) format.
Time Frame
Immediately after the health care visit (Day 0)
Title
Use of coopeRATE Prompt
Description
Patient-reported use of the coopeRATE Prompt intervention during the health care visit, assessed using a single item with multiple choice (single answer) format.
Time Frame
Immediately after the health care visit (Day 0) - Phase 2 only
Title
Reason(s) for not using coopeRATE Prompt (patient)
Description
Patient-reported reason(s) for not using the coopeRATE Prompt intervention during the health care visit (if intervention was not used), assessed using a single item with multiple choice (multiple answer) format.
Time Frame
Immediately after the health care visit (Day 0) - Phase 2 only
Title
Perceived helpfulness of coopeRATE Prompt
Description
Patient-reported perceived helpfulness of the coopeRATE Prompt intervention (if intervention was used), assessed using a single adapted item (Dalcin et al., 2015). The item is rated on a 5-point scale ranging from 0 ('Not at all helpful') to 4 ('Extremely helpful').
Time Frame
Immediately after the health care visit (Day 0) - Phase 2 only
Title
Way(s) in which coopeRATE Prompt helpful
Description
Patient-reported way(s) in which the coopeRATE Prompt intervention was helpful (if intervention was perceived to be at least slightly helpful), assessed using a single item with multiple choice (multiple answer) format.
Time Frame
Immediately after the health care visit (Day 0) - Phase 2 only
Title
People seen during health care visit
Description
Patient-reported people seen (e.g., doctor, nurse) during the health care visit, assessed using a single item with multiple choice (multiple answer) format.
Time Frame
Immediately after the health care visit (Day 0)
Title
History with people seen during health care visit
Description
Patient-reported history with people seen during the health care visit, assessed using a single item with multiple choice (single answer) format.
Time Frame
Immediately after the health care visit (Day 0)
Title
Type of health care visit
Description
Patient-reported type of health care visit, assessed using a single item with multiple choice (multiple answer) format.
Time Frame
Immediately after the health care visit (Day 0)
Title
Participation in other research
Description
Patient-reported participation in other research studies during the health care visit, assessed using two single items with multiple choice (single answer) format.
Time Frame
Immediately after the health care visit (Day 0)
Title
Receipt of coopeRATE Prompt
Description
Clinician-reported receipt of the coopeRATE Prompt intervention, assessed using a single item with multiple choice (single answer) format.
Time Frame
Within one month after completion of Phase 2 patient data collection
Title
Frequency of use of coopeRATE Prompt
Description
Clinician-reported frequency of using the coopeRATE Prompt intervention to guide conversations with patients (if intervention was ever received), assessed using a single item with multiple choice (single answer) format.
Time Frame
Within one month after completion of Phase 2 patient data collection
Title
Reason(s) for not using coopeRATE Prompt (clinician)
Description
Clinician-reported reason(s) for not using the coopeRATE Prompt intervention to guide conversations with patients (if intervention was not always used), assessed using two single items with multiple choice (multiple answer) format.
Time Frame
Within one month after completion of Phase 2 patient data collection
Title
Frequency of coopeRATE Prompt improving conversations
Description
Clinician-reported frequency of the coopeRATE Prompt intervention improving the quality of conversations with patients (if intervention was ever used), assessed using a single item with multiple choice (single answer) format.
Time Frame
Within one month after completion of Phase 2 patient data collection
Title
Frequency of coopeRATE Prompt increasing consultation time
Description
Clinician-reported frequency of the coopeRATE Prompt intervention increasing consultation time with patients (if intervention was ever used), assessed using a single item with multiple choice (single answer) format.
Time Frame
Within one month after completion of Phase 2 patient data collection
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Have a diagnosis of cystic fibrosis
Are 18 years of age or older
Can read and write in English
Are attending a participating site for a routine cystic fibrosis care visit
Have already consented to participate in the Cystic Fibrosis Foundation Patient Registry
Allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
Have not previously participated in the study
Exclusion Criteria:
Do not have a diagnosis of cystic fibrosis
Are less than 18 years of age
Cannot read and write in English
Are not attending a participating site for a routine cystic fibrosis care visit
Have not already consented to participate in the Cystic Fibrosis Foundation Patient Registry
Do not allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data
Have previously participated in the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glyn Elwyn
Organizational Affiliation
Dartmouth College
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
University of Nebraska Medical Center / Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States
Facility Name
Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
University of Texas Southwestern Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
23768763
Citation
Elwyn G, Barr PJ, Grande SW, Thompson R, Walsh T, Ozanne EM. Developing CollaboRATE: a fast and frugal patient-reported measure of shared decision making in clinical encounters. Patient Educ Couns. 2013 Oct;93(1):102-7. doi: 10.1016/j.pec.2013.05.009. Epub 2013 Jun 12.
Results Reference
background
PubMed Identifier
24389354
Citation
Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085. Erratum In: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32.
Results Reference
background
PubMed Identifier
17574367
Citation
Makoul G, Krupat E, Chang CH. Measuring patient views of physician communication skills: development and testing of the Communication Assessment Tool. Patient Educ Couns. 2007 Aug;67(3):333-42. doi: 10.1016/j.pec.2007.05.005. Epub 2007 Jun 18.
Results Reference
background
PubMed Identifier
25091546
Citation
Ritter PL, Lorig K. The English and Spanish Self-Efficacy to Manage Chronic Disease Scale measures were validated using multiple studies. J Clin Epidemiol. 2014 Nov;67(11):1265-73. doi: 10.1016/j.jclinepi.2014.06.009. Epub 2014 Aug 3.
Results Reference
background
PubMed Identifier
27668085
Citation
Dalcin AT, Jerome GJ, Fitzpatrick SL, Louis TA, Wang NY, Bennett WL, Durkin N, Clark JM, Daumit GL, Appel LJ, Coughlin JW. Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Obes Sci Pract. 2015 Oct;1(1):23-32. doi: 10.1002/osp4.6. Epub 2015 Sep 9.
Results Reference
background
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Measuring and Improving Coproduction Using coopeRATE
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