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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03433729
Other study ID # A092512
Secondary ID
Status Completed
Phase N/A
First received February 8, 2018
Last updated February 8, 2018
Start date March 2014
Est. completion date May 2014

Study information

Verified date February 2018
Source Cambridge University Hospitals NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of the study is to determine whether patients who use a prompt sheet to identify their important issues before they see a doctor are more likely to feel that their important issues have been discussed during their consultation. The study will be conducted in a respiratory outpatient clinic.


Description:

Evidence suggests that most patients come to a consultation with issues they wish to raise, but they may not actually raise them and clinicians may not elicit them. This can adversely affect the consultation outcome, e.g. through misunderstandings, unwanted prescriptions, non-adherence and unnecessary follow-ups. In a review of methods used before consultations to help patients address their information needs Kinnersely et al. (2009) found that there were small but statistically significant increases in patient satisfaction and the number of questions patients asked, and no effect on consultation length. However, they identified several gaps in the evidence including the need to assess a wider range of outcome measures, to identify the impact of the methods on the types of questions asked and the need to measure consultation length accurately.

This study aims to assess the impact of a written agenda form in a respiratory outpatient clinic. The form prompts the patient to identify their questions and issues, provides a list of frequently asked questions and invites the patient to write down the issues they wish to discuss with their doctor. We wish to identify whether use of the form increases the extent to which patients perceive that their important issues are discussed in the consultation. We will also assess whether patients feel more able to raise these issues and get the outcome they wanted, their confidence to manage their condition and consultation length.

The study is a randomised controlled trial (RCT) with a sample size of 158 patients. On arrival at the clinic patients will be randomly allocated to either the intervention group (who will receive an agenda form) or to standard practice. Patient reported outcomes will be collected after the patient has seen the doctor and consultation times will be recorded by an independent observer outside the consultation room.


Recruitment information / eligibility

Status Completed
Enrollment 165
Est. completion date May 2014
Est. primary completion date May 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- have an outpatient appointment at one of the designated clinics

- are able to understand the Patient Information Sheet and complete the agenda form and the feedback form, or are accompanied by a person who meets this criteria and who is willing to complete the form on the patient's behalf

- willing and able to give informed consent for participation in the study

Exclusion Criteria:

- No further criteria apply

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Patient agenda form
On arrival at the clinic patients are given an agenda form to prompt them to think about what issues they wished to discuss with their doctor. The form contains a prompt list of items they can tick, free space to write their own items, and a prompt to consider what is the most important issue for them and what they would like to happen before they leave their clinic appointment.

Locations

Country Name City State
United Kingdom Cambridge University Hospitals NHS Foundation Trust Cambridge Cambridgeshire

Sponsors (1)

Lead Sponsor Collaborator
Cambridge University Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary The proportion of patients who, on leaving their outpatient appointment, strongly agree with the statement "My doctor discussed the issues that were important to me" where options are strongly agree, agree, disagree, strongly disagree. Immediately after consultation with the doctor
Secondary The proportion of patients who strongly agree with the statement "I got the outcome I wanted from my consultation" where options are strongly agree, agree, disagree, strongly disagree. Immediately after consultation with the doctor
Secondary The proportion of patients who strongly agree with the statement "I felt able to raise issues that were important to me with my doctor" where options are strongly agree, agree, disagree, strongly disagree Immediately after consultation with the doctor
Secondary Patient confidence to manage their condition following the consultation, rated on a scale of 0-10 where 0 equals no confidence and 10 equals maximum confidence Immediately after consultation with the doctor
Secondary Length of consultation Immediately after consultation with the doctor
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