Measuring and Improving Coproduction Using coopeRATE

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cystic Fibrosis, Chronic Disease

Intervention / Treatment
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* Behavioral: coopeRATE Prompt


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional 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)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Phase 1<br>Usual care | |
| Experimental: Phase 2<br>Usual care + coopeRATE Prompt intervention | Behavioral: coopeRATE Prompt<br>* The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.<br>|
| Other: Clinicians<br>After Phase 2, clinicians will be asked about their experiences with, and views about, the coopeRATE Prompt intervention. | Behavioral: coopeRATE Prompt<br>* The coopeRATE Prompt intervention is a set of two questions delivered to patients immediately before the clinical encounter that elicit their concerns and goals.<br>|

What is the study measuring?
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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) |