Measuring and Improving Coproduction Using coopeRATE

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

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Disease; Cystic Fibrosis
• Intervention / Treatment: Behavioral: coopeRATE Prompt

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.

• Study Type: Interventional
• Enrollment (Actual): 280
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92103
      • University of California San Diego
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • University of Nebraska Medical Center / Nebraska Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15224
      • University of Pittsburgh Medical Center
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Phase 1; Usual care
Experimental: Phase 2; Usual care + coopeRATE Prompt 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.
Other: Clinicians; After Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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
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
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
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
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)
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)
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)
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)
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Boston Children's Hospital; Cystic Fibrosis Foundation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 2, 2019
• Primary Completion (Actual): March 16, 2020
• Study Completion (Actual): March 16, 2020

Study Registration Dates

• First Submitted: August 15, 2019
• First Submitted That Met QC Criteria: August 15, 2019
• First Posted (Actual): August 19, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2020
• Last Update Submitted That Met QC Criteria: July 7, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Chronic Disease; Cystic Fibrosis
• Other Study ID Numbers: SFD19152; ELWYN18QI0 (Other Grant/Funding Number: Cystic Fibrosis Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No