Feasibility of a Goal-based Agenda Setting Intervention

Feasibility of a Goal-based Agenda Setting Intervention for Informing Conversations in Adult Cystic Fibrosis Care

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.

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.

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.

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'.

Presence of a response to each of the coopeRATE Prompt intervention questions. The coopeRATE Prompt includes two items with open-text response format.

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.

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').

Patient-reported way(s) in which intervention was helpful, assessed using a single item with multiple choice (multiple answer) format.

Patient-reported initiator of discussion of intervention responses in the visit with physician, assessed using a single item with multiple choice (single answer) format.

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.

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.

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.

Patient-reported satisfaction with timing of intervention delivery, assessed using a single item with multiple choice (single answer) format.

Patient-reported preferred timing of intervention delivery, assessed using a single item with open-text response format.

Patient-reported preference for receiving the intervention again in the future, assessed using a single item with multiple choice (single answer) format.

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.

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.

Clinician-reported frequency of receiving patient intervention responses, assessed using a single item with open-text response format.

Clinician-reported frequency of use of intervention responses with patients in the visit, assessed using a single item with multiple choice (single answer) format.

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').

Clinician-reported way(s) in which intervention was helpful, assessed using a single item with multiple choice (multiple answer) format.

Clinician-reported impact on amount of time spent with patients, assessed using a single item with multiple choice (single answer) format.

Clinician-reported reason(s) for never discussing intervention responses with patients, assessed using a single item with multiple choice (multiple answer) format.

Clinician-reported reason(s) for only sometimes discussing intervention responses with patients, assessed using a single item with multiple choice (multiple answer) format.

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.

Clinician-reported preference for using the intervention with patients in the future, assessed using a single item with multiple choice (single answer) format.

Patient-reported concerns and goals, assessed using the coopeRATE Prompt intervention. The coopeRATE Prompt includes two items with open-text response format. Item responses are assessed in terms of concern and goal frequency and type (categorizations to be determined).

Patient-reported additional intervention feedback, assessed using two items with open-text response format. Additional feedback is first assessed immediately after completing the intervention questions and again after the index healthcare visit.

Patient-reported type of routine CF care visit (e.g., in-person only, phone-only), assessed using a single item with multiple choice (single answer) format.

Patient-reported people seen (e.g., doctor, nurse) during the healthcare visit, assessed using a single item with multiple choice (multiple answer) format.

Patient-reported history with people seen during the healthcare visit, assessed using a single item with multiple choice (single answer) format.

Clinician-reported additional intervention feedback, assessed using a single item with open-text response format.

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

A de-identified copy of participant-level data and essential analytic code will be made available to others for research purposes, via data sharing.

The data and supporting information will be available after December 2021 and for an indefinite period of time.

Requests must include sufficient justification for the data which does not duplicate any current or planned data use. All requests will be subject to Investigator approval.

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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.

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