Feasibility of a Goal-based Agenda Setting Intervention

Study Overview
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Brief Summary
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This study aims to assess the feasibility of a new, brief intervention, the 'coopeRATE Prompt', for informing conversations between patients and physicians in routine tele-health and in-person adult Cystic Fibrosis (CF) care. The coopeRATE Prompt is two questions designed to elicit patients' concerns and goals to facilitate collaborative goal setting within the health care visit. This is a prospective single arm study that will be conducted at four CF care centers in the United States.

Detailed Description
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Participating patients will be asked to complete two online surveys. The first survey, which includes the coopeRATE Prompt intervention questions, is completed 1-4 days before their upcoming healthcare visit. After completing this survey and before their visit, patients' intervention responses are shared with their physician and, if requested, other members of their care team. The second patient survey is completed within 24 hours after their healthcare visit. Participating clinicians are asked to complete a single online survey within one month after completion of patient data collection.

Official Title
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Feasibility of a Goal-based Agenda Setting Intervention for Informing Conversations 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 CF are 18 years of age or older can read and write English have a scheduled in-person or tele-health routine CF care visit have access to internet and email Exclusion Criteria: does not have a diagnosis of CF is less than 18 years of age cannot read and write English does not have a scheduled in-person or tele-health routine CF care visit does have access to internet and email

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>coopeRATE Prompt | Behavioral: coopeRATE Prompt<br>* The coopeRATE Prompt intervention is a set of two questions delivered to patients before the clinical encounter that elicit their concerns and goals. The intervention is delivered to patients online, outside the clinic setting.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of intervention responses with physician (patient-reported) | Patient-reported discussion of intervention responses (concerns and goals) in the visit with physician, assessed using two items with multiple choice (single answer) format. The first item assesses how many of the patient concerns were discussed and the second item assesses how many of the patient goals were discussed. Item response options are 'None of them', 'Some of them', or 'All of them'. | Within 24 hours after completion of the healthcare visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention completion (patient-reported) | Presence of a response to each of the coopeRATE Prompt intervention questions. The coopeRATE Prompt includes two items with open-text response format. | 1-4 days before the healthcare visit | 
| Intervention acceptability (patient-reported) | Patient-reported intervention acceptability, assessed using an adapted version of the 4-item Acceptability of Intervention Measure (Weiner et al., 2017). Each item is rated on a 5-point scale ranging from 1 ('Completely disagree') to 5 ('Completely agree'). A respondent's total score is the mean of all item responses. | 1-4 days before the healthcare visit | 
| Utility of intervention (patient-reported) | Patient-reported utility (helpfulness) of intervention, 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'). | Within 24 hours after completion of the healthcare visit | 
| Way(s) in which intervention was helpful (patient-reported) | Patient-reported way(s) in which intervention was helpful, assessed using a single item with multiple choice (multiple answer) format. | Within 24 hours after completion of the healthcare visit | 
| Initiator of discussion (patient-reported) | Patient-reported initiator of discussion of intervention responses in the visit with physician, assessed using a single item with multiple choice (single answer) format. | Within 24 hours after completion of the healthcare visit | 
| Satisfaction with time spent (patient-reported) | Patient-reported satisfaction with amount of time spent discussing intervention responses in the visit with physician, assessed using a single item with multiple choice (single answer) format. | Within 24 hours after completion of the healthcare visit | 
| Preference for sharing intervention responses with other team members (patient-reported) | Patient-reported preference for sharing intervention responses with other members of the care team, assessed using a single item with multiple choice (multiple response) format. | 1-4 days before the healthcare visit | 
| Use of intervention responses with other team members (patient-reported) | Patient-reported discussion of intervention responses in the visit with other members of the care team, assessed using two items. The first item assesses whether intervention responses were discussed, with a multiple choice (single answer) format. The second item assesses the specific team members with whom discussions were had, with a multiple choice (multiple answer) format. | Within 24 hours after completion of the healthcare visit | 
| Satisfaction with intervention timing (patient-reported) | Patient-reported satisfaction with timing of intervention delivery, assessed using a single item with multiple choice (single answer) format. | Within 24 hours after completion of the healthcare visit | 
| Preferred intervention timing (patient-reported) | Patient-reported preferred timing of intervention delivery, assessed using a single item with open-text response format. | Within 24 hours after completion of the healthcare visit | 
| Future receipt of intervention (patient-reported) | Patient-reported preference for receiving the intervention again in the future, assessed using a single item with multiple choice (single answer) format. | Within 24 hours after completion of the healthcare visit | 
| Collaborative goal setting (patient-reported) | A new 3-item patient-reported measure under evaluation to assess collaborative goal setting between a patient and physician 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. | Within 24 hours after completion of the healthcare visit | 
| Shared decision-making (patient-reported) | Patient-reported shared decision-making with physician 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. | Within 24 hours after completion of the healthcare visit | 
| Frequency of intervention receipt (clinician-reported) | Clinician-reported frequency of receiving patient intervention responses, assessed using a single item with open-text response format. | Within 1 month following completion of patient data collection | 
| Use of intervention responses with patients (clinician-reported) | Clinician-reported frequency of use of intervention responses with patients in the visit, assessed using a single item with multiple choice (single answer) format. | Within 1 month following completion of patient data collection | 
| Utility of intervention (clinician-reported) | Clinician-reported utility (helpfulness) of intervention, 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'). | Within 1 month following completion of patient data collection | 
| Way(s) in which intervention was helpful (clinician-reported) | Clinician-reported way(s) in which intervention was helpful, assessed using a single item with multiple choice (multiple answer) format. | Within 1 month following completion of patient data collection | 
| Impact on time spent with patients (clinician-reported) | Clinician-reported impact on amount of time spent with patients, assessed using a single item with multiple choice (single answer) format. | Within 1 month following completion of patient data collection | 
| Reason(s) for not using intervention (never used) (clinician-reported) | Clinician-reported reason(s) for never discussing intervention responses with patients, assessed using a single item with multiple choice (multiple answer) format. | Within 1 month following completion of patient data collection | 
| Reason(s) for not using intervention (sometimes used) (clinician-reported) | Clinician-reported reason(s) for only sometimes discussing intervention responses with patients, assessed using a single item with multiple choice (multiple answer) format. | Within 1 month following completion of patient data collection | 
| Intervention acceptability (clinician-reported) | Clinician-reported intervention acceptability, assessed using an adapted version of the 4-item Acceptability of Intervention Measure (Weiner et al., 2017). Each item is rated on a 5-point scale ranging from 1 ('Completely disagree') to 5 ('Completely agree'). A respondent's total score is the mean of all item responses. | Within 1 month following completion of patient data collection | 
| Future use of intervention (clinician-reported) | Clinician-reported preference for using the intervention with patients in the future, assessed using a single item with multiple choice (single answer) format. | Within 1 month following completion of patient data collection |