Core Outcome Set for Pharmacist-led Interventions in CKD

NCT05987280 | Unknown

• 1 other identifier: 40350
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Chronic Kidney Diseases

Keywords

Pharmacy; Pharmacist; Kidney disease; Core outcome set

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  4 weeks

Study Arms (2)

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.

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.

Other: eDelphi method

Interventions

eDelphi method OTHER

eDelphi method

Phase 1; Phase 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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

You may qualify if:

• 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

You may not qualify if:

• Any participants not self-defined as one of the above five groups.

Sponsors & Collaborators

• University of Leicester: lead

Study Sites (1)

Thomas Wilkinson

Leicester, Leicestershire, LE1 7RH, United Kingdom

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Kidney Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Thomas Wilkinson, PhD

CONTACT

07538494193; tjw26@le.ac.uk

Ashkon Ardavani

CONTACT

07927307013; aa1305@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2023
• First Posted: August 14, 2023
• Study Start: July 20, 2023
• Primary Completion: December 31, 2023
• Study Completion: October 31, 2024
• Last Updated: August 14, 2023

Record last verified: 2023-07

Locations

GB (1)