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Feasibility of a Goal-based Agenda Setting Intervention

NCT ID: NCT04696484

Last Updated: 2021-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

219 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-14

Study Completion Date

2021-09-19

Brief Summary

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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

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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.

Conditions

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Cystic Fibrosis Chronic Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Intervention

coopeRATE Prompt

Group Type EXPERIMENTAL

coopeRATE Prompt

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cystic Fibrosis Foundation

OTHER

Sponsor Role collaborator

Dartmouth-Hitchcock Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Glyn Jones-Elwyn

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Glyn Elwyn

Role: PRINCIPAL_INVESTIGATOR

Dartmouth College

Locations

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National Jewish Health

Denver, Colorado, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Dartmouth-Hitchcock

Lebanon, New Hampshire, United States

Site Status

University of Virginia

Charlottesville, Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 28851459 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27668085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23768763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24389354 (View on PubMed)

Other Identifiers

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Pro00047666

Identifier Type: -

Identifier Source: org_study_id