Chronic Kidney DiseasesCOSP-KDNCT05987280
Core Outcome Set for Pharmacist-led Interventions in CKD
An observational study of Chronic Kidney Diseases, run by University of Leicester at 1 site in United Kingdom.
Trial summary
Background Chronic kidney disease (CKD) is a progressive condition characterised by a gradual reduction in kidney function and structure over time. CKD is a risk factor for other morbidity, where it not only increases the likelihood of all-cause and cardiovascular mortality, but also can have a detrimental impact on… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Diseases
- What is being tested?
- eDelphi method
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Jul 2023to 31 Oct 2024
- Phase
- Observational
- 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
- Adult, Older adult
Study population: The stakeholders that will be invited to participate in this survey include: 1) pharmacists involved in the care of kidney patients and non-renal pharmacists; 2) researchers involved in CKD and pharmacy research; 3) nurses and physicians involved in CKD management; 4) people living with kidney disease; and 5) their carers and/or family members. It is likely that participants will not fit into distinct homogeneous groups; for example, researchers may also be registered pharmacists. Participants will answer questions relevant to their group. All participants over the age of 18 will be invited to take part in the survey
Who may be able to join
- The stakeholders that will be invited to participate in this survey include: 1) self-defined pharmacists involved in the care of kidney patients and non-renal pharmacists; 2) self-defined researchers involved in CKD and pharmacy research; 3) self-defined nurses and physicians involved in CKD management; 4) self-defined people living with kidney disease; and 5) their carers and/or family members.
- It is likely that participants will not fit into distinct homogeneous groups; for example, researchers may also be registered pharmacists. Participants will answer questions relevant to their group. All participants over the age of 18 will be invited to take part in the survey
Who cannot join
- Any participants not self-defined as one of the above five groups.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Thomas Wilkinson
Leicester, Leicestershire, LE1 7RH
Thomas Wilkinson, 07538494193, tjw26@leicester.ac.uk
tjw26@leicester.ac.uk
About this study
Official title: Development of a Core Outcome Set for Pharmacist-led Interventions in Chronic Kidney Disease: a Protocol for a Survey and e-Delphi Consensus Study
Background Chronic kidney disease (CKD) is a progressive condition characterised by a gradual reduction in kidney function and structure over time. CKD is a risk factor for other morbidity, where it not only increases the likelihood of all-cause and cardiovascular mortality, but also can have a detrimental impact on quality of life. Whilst several systematic reviews have demonstrated the benefits of interventions delivered by pharmacists, there is significant variability in terms of the outcomes reported and an inconsistency with the measures used (e.g., medication adherence is often assessed using different outcome measures). The large heterogeneity of outcomes reported and the measures used in randomised controlled trials investigating the impact interventions involving pharmacists have on CKD patients makes it difficult to interpret findings and make comparisons between interventions have. This ultimately affects the quality of research and limits the ability to synthesize evidence, particularly in meta-analyses. Issues around inconsistent outcome reporting could be addressed with the development and application of agreed standardised sets of outcomes. Indeed, the significant range of outcomes in the CKD pharmacy literature led the authors in Raiisi et al., to state that further research is required to establish a core outcome set (COS) in CKD, in relation to pharmacy practice. COS are a collection of outcomes that are standardised and agreed upon, in which as a minimum, they should be measured and reported in all trials for a particular clinical topic. They are of importance as input is provided from a variety of stakeholders such as patients, researchers, family members, carers, and healthcare professionals, in which relevant outcomes are more likely to be identified, as well as helping reduce reporting bias and heterogeneity in the research literature. Currently no pharmacy-specific COS exists for interventions conducted in CKD.
Aims The overall objective is to develop a COS for clinical trials evaluating the efficacy or effectiveness of pharmacist-led interventions (i.e., interventions provided to patients are either pharmacist-led or involve their input) in people with CKD. The aim of Phase 1 is to conduct an online survey to explore outcomes of importance to stakeholders. The outcomes identified in Phase 1 will lead into a subsequent Delphi process to develop a COS (Phase 2).
Read more
Methods
Phase 1
The investigators aim to use an online survey to collect data from participants. The questions in this survey can be found in the attached documentation. It is estimated that this survey will take 10 minutes to complete. The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease.
Phase 2 The outcomes generated in this survey will be supplemented by outcomes identified in an ongoing systematic review performed by the research group. The investigators will take this long-list of outcomes and aim to reach a consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds.
This will also take place using surveys online and the investigators will submit an ethical amendment for each round with the questions and outcomes we will be seeking consensus on. In each Delphi round, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Between each round, excluded outcomes will be removed.
Included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS.
Following the Delphi survey, the investigators will conduct a consensus day. A sample of participants will be invited to discuss the findings and reach a consensus on the final COS.
- Conditions
- Chronic Kidney Diseases
- Being tested
- eDelphi method
- Keywords
- Pharmacy, Pharmacist, Kidney disease, Core outcome set
- Medical subject headings
- Renal Insufficiency, Chronic, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eDelphi methodOther
eDelphi method
| Study group | Role | What they receive |
|---|---|---|
| Phase 1 | We aim to use an online survey to collect data from participants. It is estimated that this survey will take 10 minutes to complete. The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease. Receives: Other: eDelphi method | |
| Phase 2 | The outcomes generated in this survey will be supplemented by outcomes identified in an ongoing systematic review being performed by our group. We will take this long list of outcomes and aim to reach consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds.
This will also take place using surveys online and we will submit an ethical amendment for each round with the questions and outcomes we will be seeking consensus on. In each Delphi round, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Between each round, excluded outcomes will be removed. Included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS. Receives: Other: eDelphi method |
What is being measured
The primary outcome is the main question the study is designed to answer.
Generation of longlist of outcomes
The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease. Outcomes suggested by the participants will be entered into a 'longlist' of outcomes for Phase 2.
Measured: 8 weeks
Delphi Round 1
We will take this long list of outcomes and aim to reach consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds.
In Delphi round 1, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Participants will score outcomes on a 7-point Likert scale.
Measured: 4 weeks
Delphi Round 2
Between Rounds 1 and 2, excluded outcomes will be removed. Included outcomes are defined as those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree
In Delphi round 2, participants will be asked to rate the importance of remaining outcomes for inclusion or exclusion. Participants will score outcomes on a 7-point Likert scale.
Final included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start20 Jul 2023
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05987280
- Sponsor's protocol ID
- 40350
- Acronym
- COSP-KD
- Status last verified
- Jul 2023
- First submitted
- 20 Jul 2023
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Core Outcome Set for Pharmacist-led Interventions in Chronic Kidney Disease: a Protocol for a Survey and e-Delphi Consensus Study
- ClinicalTrials.gov ID
- NCT05987280
- Acronym / sponsor ID
- COSP-KD / 40350
- Conditions
- Chronic Kidney Diseases
- Keywords
- Pharmacy, Pharmacist, Kidney disease, Core outcome set
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Study start
- 20 Jul 2023 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Oct 2024 (estimated)
- First posted
- 14 Aug 2023 (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.
Background Chronic kidney disease (CKD) is a progressive condition characterised by a gradual reduction in kidney function and structure over time. CKD is a risk factor for other morbidity, where it not only increases the likelihood of all-cause and cardiovascular mortality, but also can have a detrimental impact on quality of life. Whilst several systematic reviews have demonstrated the benefits of interventions delivered by pharmacists, there is significant variability in terms of the outcomes reported and an inconsistency with the measures used (e.g., medication adherence is often assessed using different outcome measures). The large heterogeneity of outcomes reported and the measures used in randomised controlled trials investigating the impact interventions involving pharmacists have on CKD patients makes it difficult to interpret findings and make comparisons between interventions have. This ultimately affects the quality of research and limits the ability to synthesize evidence, particularly in meta-analyses. Issues around inconsistent outcome reporting could be addressed with the development and application of agreed standardised sets of outcomes. Indeed, the significant range of outcomes in the CKD pharmacy literature led the authors in Raiisi et al., to state that further research is required to establish a core outcome set (COS) in CKD, in relation to pharmacy practice. COS are a collection of outcomes that are standardised and agreed upon, in which as a minimum, they should be measured and reported in all trials for a particular clinical topic. They are of importance as input is provided from a variety of stakeholders such as patients, researchers, family members, carers, and healthcare professionals, in which relevant outcomes are more likely to be identified, as well as helping reduce reporting bias and heterogeneity in the research literature. Currently no pharmacy-specific COS exists for interventions conducted in CKD.
Aims The overall objective is to develop a COS for clinical trials evaluating the efficacy or effectiveness of pharmacist-led interventions (i.e., interventions provided to patients are either pharmacist-led or involve their input) in people with CKD. The aim of Phase 1 is to conduct an online survey to explore outcomes of importance to stakeholders. The outcomes identified in Phase 1 will lead into a subsequent Delphi process to develop a COS (Phase 2).
Methods
Phase 1
The investigators aim to use an online survey to collect data from participants. The questions in this survey can be found in the attached documentation. It is estimated that this survey will take 10 minutes to complete. The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease.
Phase 2 The outcomes generated in this survey will be supplemented by outcomes identified in an ongoing systematic review performed by the research group. The investigators will take this long-list of outcomes and aim to reach a consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds.
This will also take place using surveys online and the investigators will submit an ethical amendment for each round with the questions and outcomes we will be seeking consensus on. In each Delphi round, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Between each round, excluded outcomes will be removed.
Included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS.
Following the Delphi survey, the investigators will conduct a consensus day. A sample of participants will be invited to discuss the findings and reach a consensus on the final COS.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Phase 1 | – | Other: eDelphi methodWe aim to use an online survey to collect data from participants. It is estimated that this survey will take 10 minutes to complete. The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease. |
| Phase 2 | – | Other: eDelphi methodThe outcomes generated in this survey will be supplemented by outcomes identified in an ongoing systematic review being performed by our group. We will take this long list of outcomes and aim to reach consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds. This will also take place using surveys online and we will submit an ethical amendment for each round with the questions and outcomes we will be seeking consensus on. In each Delphi round, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Between each round, excluded outcomes will be removed. Included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- The stakeholders that will be invited to participate in this survey include: 1) pharmacists involved in the care of kidney patients and non-renal pharmacists; 2) researchers involved in CKD and pharmacy research; 3) nurses and physicians involved in CKD management; 4) people living with kidney disease; and 5) their carers and/or family members. It is likely that participants will not fit into distinct homogeneous groups; for example, researchers may also be registered pharmacists. Participants will answer questions relevant to their group. All participants over the age of 18 will be invited to take part in the survey
Key inclusion criteria (2 listed)
- The stakeholders that will be invited to participate in this survey include: 1) self-defined pharmacists involved in the care of kidney patients and non-renal pharmacists; 2) self-defined researchers involved in CKD and pharmacy research; 3) self-defined nurses and physicians involved in CKD management; 4) self-defined people living with kidney disease; and 5) their carers and/or family members.
- It is likely that participants will not fit into distinct homogeneous groups; for example, researchers may also be registered pharmacists. Participants will answer questions relevant to their group. All participants over the age of 18 will be invited to take part in the survey
Key exclusion criteria (1 listed)
- Any participants not self-defined as one of the above five groups.
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 |
|---|---|---|
| eDelphi methodeDelphi method | Other | Phase 1, Phase 2 |
Primary outcome
Generation of longlist of outcomes
Time frame: 8 weeks
The first part of the survey asks questions about the participant including what stakeholder group best describes them. The second part asks them about what outcomes are important in pharmacy research and in the management of kidney disease. Outcomes suggested by the participants will be entered into a 'longlist' of outcomes for Phase 2.
Delphi Round 1
Time frame: 4 weeks
We will take this long list of outcomes and aim to reach consensus on a COS using a 2-round Delphi process. The Delphi process is a structured process used for forming a consensus, where stakeholder groups provide their opinions in an iterative approach for answering questions over several rounds. In Delphi round 1, participants will be asked to rate the importance of outcomes for inclusion or exclusion. Participants will score outcomes on a 7-point Likert scale.
Delphi Round 2
Time frame: 4 weeks
Between Rounds 1 and 2, excluded outcomes will be removed. Included outcomes are defined as those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree In Delphi round 2, participants will be asked to rate the importance of remaining outcomes for inclusion or exclusion. Participants will score outcomes on a 7-point Likert scale. Final included outcomes (those reaching consensus, defined as a minimum of 75% of participants who scored outcomes as agree or strongly agree or disagree or strongly disagree) will go into the COS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Diseases, run by University of Leicester 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 2 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: status not confirmed, as of the sponsor's last update on 14 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Wilkinson, PhD (07538494193, tjw26@le.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Generation of longlist of outcomes (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 14 Aug 2023.