Feasibility of a Goal-based Agenda Setting Intervention

Cystic Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696484
• Other study ID #: Pro00047666
• Status: Completed
• Phase: N/A
• Start date: January 14, 2021
• Est. completion date: September 19, 2021

Study information

• Verified date: November 2021
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 219
• Est. completion date: September 19, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• coopeRATE Prompt
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.

Locations

Country	Name	City	State
United States	University of Virginia	Charlottesville	Virginia
United States	National Jewish Health	Denver	Colorado
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	Dartmouth-Hitchcock	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

Barr PJ, Thompson R, Walsh T, Grande SW, Ozanne EM, Elwyn G. The psychometric properties of CollaboRATE: a fast and frugal patient-reported measure of the shared decision-making process. J Med Internet Res. 2014 Jan 3;16(1):e2. doi: 10.2196/jmir.3085. Erratum in: J Med Internet Res. 2015;17(2):e32. J Med Internet Res. 2015;17(2):e32. — View Citation

Dalcin AT, Jerome GJ, Fitzpatrick SL, Louis TA, Wang NY, Bennett WL, Durkin N, Clark JM, Daumit GL, Appel LJ, Coughlin JW. Perceived helpfulness of the individual components of a behavioural weight loss program: results from the Hopkins POWER Trial. Obes Sci Pract. 2015 Oct;1(1):23-32. Epub 2015 Sep 9. — View Citation

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. — View Citation

Weiner BJ, Lewis CC, Stanick C, Powell BJ, Dorsey CN, Clary AS, Boynton MH, Halko H. Psychometric assessment of three newly developed implementation outcome measures. Implement Sci. 2017 Aug 29;12(1):108. doi: 10.1186/s13012-017-0635-3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concerns and goals (patient-reported)	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).	1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit
Other	Additional intervention feedback (patient-reported)	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.	1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit
Other	Type of routine healthcare visit (patient-reported)	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.	Within 1 month following completion of patient data collection
Other	People seen during the visit (patient-reported)	Patient-reported people seen (e.g., doctor, nurse) during the healthcare visit, assessed using a single item with multiple choice (multiple answer) format.	Within 24 hours after completion of the healthcare visit
Other	History with people seen during the visit (patient-reported)	Patient-reported history with people seen during the healthcare visit, assessed using a single item with multiple choice (single answer) format.	Within 24 hours after completion of the healthcare visit
Other	Additional intervention feedback (clinician-reported)	Clinician-reported additional intervention feedback, assessed using a single item with open-text response format.	Within 1 month following completion of patient data collection
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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