Measuring and Improving Coproduction Using coopeRATE

Not Applicable

Terminated

• Conditions: Chronic Disease; Cystic Fibrosis
• Interventions: Behavioral: coopeRATE Prompt

• Registration Number: NCT04060329
• Lead Sponsor: Dartmouth-Hitchcock Medical Center

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.

Study Timeline

• Study First Submitted: 2019-08-15
• Study First Submitted QC: 2019-08-15
• Study First Posted: 2019-08-19
• Study Start: 2019-12-02
• Primary Completion: 2020-03-16
• Study Completion: 2020-03-16
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-07
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 280

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Phase 2	coopeRATE Prompt	Usual care + coopeRATE Prompt intervention
Clinicians	coopeRATE Prompt	After Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt intervention.

Primary Outcome Measures

Name	Time	Method
Collaborative goal setting	Immediately after the health care visit (Day 0)	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

Name	Time	Method
Shared decision-making	Immediately after the health care visit (Day 0)	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	Immediately after the health care visit (Day 0)	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	Immediately after the health care visit (Day 0)	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.

Trial Locations

Locations (9)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

University of Texas Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States

National Jewish Health; 🇺🇸 Denver, Colorado, United States

University of Nebraska Medical Center / Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

University of California San Diego; 🇺🇸 San Diego, California, United States

Dartmouth-Hitchcock Medical Center / Dartmouth-Hitchcock Manchester; 🇺🇸 Lebanon, New Hampshire, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States