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Completed

NCT Number: NCT04696484

Feasibility of a Goal-based Agenda Setting Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Jewish Health, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

coopeRATE Prompt

Behavioral

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.

Primary outcomes

  1. Use of intervention responses with physician (patient-reported)

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

    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'.

Secondary outcomes

  1. Intervention completion (patient-reported)

    Time frame: 1-4 days before the healthcare visit

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

  2. Intervention acceptability (patient-reported)

    Time frame: 1-4 days before the healthcare visit

    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.

  3. Utility of intervention (patient-reported)

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

    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').

  4. Way(s) in which intervention was helpful (patient-reported)

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

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

  5. Initiator of discussion (patient-reported)

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

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

  6. Satisfaction with time spent (patient-reported)

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

    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.

  7. Preference for sharing intervention responses with other team members (patient-reported)

    Time frame: 1-4 days before the healthcare visit

    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.

  8. Use of intervention responses with other team members (patient-reported)

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

    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.

  9. Satisfaction with intervention timing (patient-reported)

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

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

  10. Preferred intervention timing (patient-reported)

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

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

  11. Future receipt of intervention (patient-reported)

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

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

  12. Collaborative goal setting (patient-reported)

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

    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.

  13. Shared decision-making (patient-reported)

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

    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.

  14. Frequency of intervention receipt (clinician-reported)

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

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

  15. Use of intervention responses with patients (clinician-reported)

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

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

  16. Utility of intervention (clinician-reported)

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

    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').

  17. Way(s) in which intervention was helpful (clinician-reported)

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

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

  18. Impact on time spent with patients (clinician-reported)

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

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

  19. Reason(s) for not using intervention (never used) (clinician-reported)

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

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

  20. Reason(s) for not using intervention (sometimes used) (clinician-reported)

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

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

  21. Intervention acceptability (clinician-reported)

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

    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.

  22. Future use of intervention (clinician-reported)

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

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

Other outcomes

  1. Concerns and goals (patient-reported)

    Time frame: 1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit

    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).

  2. Additional intervention feedback (patient-reported)

    Time frame: 1-4 days before the healthcare visit and within 24 hours after completion of the healthcare visit

    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.

  3. Type of routine healthcare visit (patient-reported)

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

    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.

  4. People seen during the visit (patient-reported)

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

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

  5. History with people seen during the visit (patient-reported)

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

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

  6. Additional intervention feedback (clinician-reported)

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

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

Sponsors and collaborators

Lead sponsor

Dartmouth-Hitchcock Medical Center

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 6, 2021
Registry last updated
Nov 24, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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