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.

Study Overview

• Status: Completed
• Conditions: Chronic Disease; Cystic Fibrosis
• Intervention / Treatment: Behavioral: coopeRATE Prompt

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.

• Study Type: Interventional
• Enrollment (Actual): 219
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention; coopeRATE Prompt	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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Cystic Fibrosis Foundation

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 14, 2021
• Primary Completion (ACTUAL): September 3, 2021
• Study Completion (ACTUAL): September 19, 2021

Study Registration Dates

• First Submitted: January 4, 2021
• First Submitted That Met QC Criteria: January 5, 2021
• First Posted (ACTUAL): January 6, 2021

Study Record Updates

• Last Update Posted (ACTUAL): November 24, 2021
• Last Update Submitted That Met QC Criteria: November 23, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Disease Attributes; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Pancreatic Diseases; Fibrosis; Chronic Disease; Cystic Fibrosis
• Other Study ID Numbers: Pro00047666 (Other Identifier: DUHS IRB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: A de-identified copy of participant-level data and essential analytic code will be made available to others for research purposes, via data sharing.
• IPD Sharing Time Frame: The data and supporting information will be available after December 2021 and for an indefinite period of time.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No