Respiratory Tract DiseasesNCT03433729
Patient Agenda Setting and Clinic Efficiency in Outpatients
A study testing Patient agenda form in people with Respiratory Tract Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Tract Diseases
- What is being tested?
- Patient agenda form
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 165 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2014to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No further criteria apply
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: A Randomized Controlled Trial to Assess the Impact of an Agenda Setting Form in a Respiratory Outpatient Clinic: Are Patients More Likely to Perceive That Their Important Issues Are Discussed and Does the Form Improve Clinic Efficiency?
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.
Read the detailed 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.
- Conditions
- Respiratory Tract Diseases
- Being tested
- Patient agenda form
- Keywords
- Outpatient Clinics, Hospital, Humans, Outcome Assessment (Health Care), Patient Outcome Assessment, Patient satisfaction, Hospitalists, Secondary care
- Medical subject headings
- Respiratory Tract Diseases, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient agenda formOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Patient Agenda Form | Experimental | Patient Agenda form: Patients receive an agenda form to use before their consultation. Receives: Other: Patient agenda form |
| Usual care | No intervention | Patients' appointment continues as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Immediately after consultation with the doctor
Secondary outcomes (4)
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.
Measured: Immediately after consultation with the doctor
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
Measured: Immediately after consultation with the doctor
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
Measured: Immediately after consultation with the doctor
Length of consultation
Measured: Immediately after consultation with the doctor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study startMar 2014
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 165 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jonathan Fuld, Cambridge University Hospitals NHS Foundation Trust
- Investigators
- Jonathan P Fuld, MD ChB, PhD, Principal investigator, Cambridge University Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03433729
- Sponsor's protocol ID
- A092512
- Status last verified
- Feb 2018
- First submitted
- 8 Feb 2018
- Last updated
- 15 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial to Assess the Impact of an Agenda Setting Form in a Respiratory Outpatient Clinic: Are Patients More Likely to Perceive That Their Important Issues Are Discussed and Does the Form Improve Clinic Efficiency?
- ClinicalTrials.gov ID
- NCT03433729
- Acronym / sponsor ID
- A092512
- Conditions
- Respiratory Tract Diseases
- Keywords
- Outpatient Clinics, Hospital, Humans, Outcome Assessment (Health Care), Patient Outcome Assessment, Patient satisfaction, Hospitalists, Secondary care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 165 participants (actual)
- Lead sponsor
- Cambridge University Hospitals NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient Agenda Form | Experimental | Other: Patient agenda formPatient Agenda form: Patients receive an agenda form to use before their consultation. |
| Usual care | No intervention | –Patients' appointment continues as usual. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- No further criteria apply
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient agenda formOn 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. | Other | Patient Agenda Form |
Primary outcome
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.
Time frame: Immediately after consultation with the doctor
4 secondary outcomes
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.
Time frame: Immediately after consultation with the doctor
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
Time frame: Immediately after consultation with the doctor
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
Time frame: Immediately after consultation with the doctor
Length of consultation
Time frame: Immediately after consultation with the doctor
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan P Fuld, MD ChB, PhD principal investigator
Cambridge University Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient agenda form in people with Respiratory Tract Diseases, run by Cambridge University Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: Immediately after consultation with the doctor). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.