Feasibility of a Goal-based Agenda Setting Intervention

Dartmouth-Hitchcock Medical Center219 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

219

Conditions

Cystic Fibrosis Chronic Disease

Interventions

coopeRATE PromptBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (4)

National Jewish Health

Denver, Colorado, United States

University of Kansas Medical Center

Kansas City, Kansas, United States

Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

University of Virginia

Charlottesville, Virginia, United States

Outcomes

Primary Outcomes

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'.

Time frame: Within 24 hours after completion of the healthcare visit

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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').

Time frame: 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.

Time frame: Within 24 hours after completion of the healthcare visit

Data from ClinicalTrials.gov

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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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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').

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Within 1 month following completion of patient data collection