Clinical trial NCT04696484: Feasibility of a Goal-based Agenda Setting Intervention
Official title: Feasibility of a Goal-based Agenda Setting Intervention for Informing Conversations in Adult Cystic Fibrosis Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cystic Fibrosis
Chronic Disease
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
First posted: 2021-01-06
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Use of intervention responses with physician (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
Secondary outcomes:
measure: Intervention completion (patient-reported)
timeFrame: 1-4 days before the healthcare visit
measure: Intervention acceptability (patient-reported)
timeFrame: 1-4 days before the healthcare visit
measure: Utility of intervention (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Way(s) in which intervention was helpful (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Initiator of discussion (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Satisfaction with time spent (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Preference for sharing intervention responses with other team members (patient-reported)
timeFrame: 1-4 days before the healthcare visit
measure: Use of intervention responses with other team members (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Satisfaction with intervention timing (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Preferred intervention timing (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Future receipt of intervention (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Collaborative goal setting (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Shared decision-making (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Frequency of intervention receipt (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: Use of intervention responses with patients (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: Utility of intervention (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: Way(s) in which intervention was helpful (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: Impact on time spent with patients (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: Reason(s) for not using intervention (never used) (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: Reason(s) for not using intervention (sometimes used) (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: Intervention acceptability (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: Future use of intervention (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
Other outcomes:
measure: Concerns and goals (patient-reported)
timeFrame: 1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit
measure: Additional intervention feedback (patient-reported)
timeFrame: 1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit
measure: Type of routine healthcare visit (patient-reported)
timeFrame: Within 1 month following completion of patient data collection
measure: People seen during the visit (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: History with people seen during the visit (patient-reported)
timeFrame: Within 24 hours after completion of the healthcare visit
measure: Additional intervention feedback (clinician-reported)
timeFrame: Within 1 month following completion of patient data collection
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock
state: New Hampshire
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Dartmouth College
name: Glyn Elwyn
role: PRINCIPAL_INVESTIGATOR
References:
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.
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. doi: 10.1002/osp4.6. Epub 2015 Sep 9.
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.
citation: 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.