Measuring and Improving Coproduction Using coopeRATE

Cystic Fibrosis Clinical Trial

Official title:

Measuring and Improving Coproduction Using coopeRATE: A Before-and-after Study in Adult Cystic Fibrosis Care

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04060329
• Other study ID #: SFD19152
• Secondary ID: ELWYN18QI0
• Status: Terminated
• Phase: N/A
• Start date: December 2, 2019
• Est. completion date: March 16, 2020

Study information

• Verified date: July 2020
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 280
• Est. completion date: March 16, 2020
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Have a diagnosis of cystic fibrosis

2. Are 18 years of age or older

3. Can read and write in English

4. Are attending a participating site for a routine cystic fibrosis care visit

5. Have already consented to participate in the Cystic Fibrosis Foundation Patient Registry

6. Allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data

7. Have not previously participated in the study

Exclusion Criteria:

1. Do not have a diagnosis of cystic fibrosis

2. Are less than 18 years of age

3. Cannot read and write in English

4. Are not attending a participating site for a routine cystic fibrosis care visit

5. Have not already consented to participate in the Cystic Fibrosis Foundation Patient Registry

6. Do not allow study researchers to access their Cystic Fibrosis Foundation Patient Registry information and link it to their study data

7. Have previously participated in the study

Related Conditions & MeSH terms

• Chronic Disease
• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• coopeRATE Prompt
The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	University of Virginia	Charlottesville	Virginia
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	National Jewish Health	Denver	Colorado
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester	Lebanon	New Hampshire
United States	University of Nebraska Medical Center / Nebraska Medical Center	Omaha	Nebraska
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	University of California San Diego	San Diego	California

Sponsors (3)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Boston Children’s Hospital, Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. Epub 2015 Sep 9. — View 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. — View 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. Epub 2007 Jun 18. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Description of goals discussed during the visit	Patient-reported goals discussed during the health care visit (if goals were discussed), assessed using a single item with open-text response format.	Immediately after the health care visit (Day 0)
Other	Preference for discussing goals	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.	Immediately after the health care visit (Day 0)
Other	Use of coopeRATE Prompt	Patient-reported use of the coopeRATE Prompt intervention during the health care visit, assessed using a single item with multiple choice (single answer) format.	Immediately after the health care visit (Day 0) - Phase 2 only
Other	Reason(s) for not using coopeRATE Prompt (patient)	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.	Immediately after the health care visit (Day 0) - Phase 2 only
Other	Perceived helpfulness of coopeRATE Prompt	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').	Immediately after the health care visit (Day 0) - Phase 2 only
Other	Way(s) in which coopeRATE Prompt helpful	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.	Immediately after the health care visit (Day 0) - Phase 2 only
Other	People seen during health care visit	Patient-reported people seen (e.g., doctor, nurse) during the health care visit, assessed using a single item with multiple choice (multiple answer) format.	Immediately after the health care visit (Day 0)
Other	History with people seen during health care visit	Patient-reported history with people seen during the health care visit, assessed using a single item with multiple choice (single answer) format.	Immediately after the health care visit (Day 0)
Other	Type of health care visit	Patient-reported type of health care visit, assessed using a single item with multiple choice (multiple answer) format.	Immediately after the health care visit (Day 0)
Other	Participation in other research	Patient-reported participation in other research studies during the health care visit, assessed using two single items with multiple choice (single answer) format.	Immediately after the health care visit (Day 0)
Other	Receipt of coopeRATE Prompt	Clinician-reported receipt of the coopeRATE Prompt intervention, assessed using a single item with multiple choice (single answer) format.	Within one month after completion of Phase 2 patient data collection
Other	Frequency of use of coopeRATE Prompt	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.	Within one month after completion of Phase 2 patient data collection
Other	Reason(s) for not using coopeRATE Prompt (clinician)	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.	Within one month after completion of Phase 2 patient data collection
Other	Frequency of coopeRATE Prompt improving conversations	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.	Within one month after completion of Phase 2 patient data collection
Other	Frequency of coopeRATE Prompt increasing consultation time	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.	Within one month after completion of Phase 2 patient data collection
Primary	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.	Immediately after the health care visit (Day 0)
Secondary	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.	Immediately after the health care visit (Day 0)
Secondary	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'.	Immediately after the health care visit (Day 0)
Secondary	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.	Immediately after the health care visit (Day 0)