NCT04501263

Brief Summary

The overall aim of the study is to develop and test the feasibility and acceptability of a novel educational intervention for HCPs to help them manage constipation experienced by people in the hospice setting. This stage aims to establish the feasibility of, and to pilot, a novel educational intervention for HCPs. Additionally, it also originally aimed to test the feasibility of the chosen measures of change in patient care, however this was not undertaken. In order to achieve this aim, the objectives are to:

  • Implement the educational intervention across Marie Curie sites.
  • Evaluate the likely effectiveness of the educational intervention on the knowledge and self-efficacy of HCPs.
  • Explore the feasibility and acceptability of the educational intervention with HCPs, and identify factors associated with feasibility/acceptability
  • Explore the feasibility and acceptability of research procedures, and identify factors associated with feasibility/acceptability
  • Examine the effect of contextual factors upon the implementation and sustainability of the educational intervention in the hospice.
  • Examine the suitability of outcome measures for HCPs

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 6, 2020

Completed
Last Updated

August 6, 2020

Status Verified

August 1, 2020

Enrollment Period

8 months

First QC Date

July 28, 2020

Last Update Submit

August 1, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • Study specific questionnaire

    To evaluate the feasibility of delivering an educational intervention in a specialist palliative care setting

    October 2018- January 2019

  • Study specific questionnaire

    To evaluate the acceptability of delivering an educational intervention in a specialist palliative care setting

    October-2018-January 2019

Secondary Outcomes (4)

  • Knowledge and self-efficacy survey

    October 2018-January 2019

  • Focus group and telephone interviews

    October 2018- January 2019

  • Personal Social Services Research Unit Costs of Health and Social Care

    October 2018-January 2019

  • Competency and end of life care competency tool

    October 2018-January 2019

Interventions

Educational programme on constipation for Health care professionals in this clinical specialist palliative care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Health care professionals (nurses, medics, pharmacists)

You may qualify if:

  • Working in a clinical capacity in the SPC inpatient unit
  • Involvement in the management of patients with constipation.
  • Over 18 years of age;
  • Able to provide written consent in English.

You may not qualify if:

  • Anyone who did not meet the above criteria.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ulster University

Newtownabbey, Antrim, BT36 5DS, United Kingdom

Location

Related Publications (3)

  • Muldrew DHL, Hasson F, Carduff E, Clarke M, Coast J, Finucane A, Graham L, Larkin P, McCorry NK, Slater P, Watson M, Wright E, McIlfatrick S. Assessment and management of constipation for patients receiving palliative care in specialist palliative care settings: A systematic review of the literature. Palliat Med. 2018 May;32(5):930-938. doi: 10.1177/0269216317752515. Epub 2018 Feb 12.

    PMID: 29431016BACKGROUND
  • McIlfatrick S, Muldrew DHL, Beck E, Carduff E, Clarke M, Finucane A, Graham-Wisener L, Larkin P, McCorry NK, Slater P, Hasson F. Examining constipation assessment and management of patients with advanced cancer receiving specialist palliative care: a multi-site retrospective case note review of clinical practice. BMC Palliat Care. 2019 Jul 15;18(1):57. doi: 10.1186/s12904-019-0436-3.

    PMID: 31307441BACKGROUND
  • Hasson F, Muldrew D, Carduff E, Finucane A, Graham-Wisener L, Larkin P, Mccorry N, Slater P, McIlfatrick S. 'Take more laxatives was their answer to everything': A qualitative exploration of the patient, carer and healthcare professional experience of constipation in specialist palliative care. Palliat Med. 2020 Sep;34(8):1057-1066. doi: 10.1177/0269216319891584. Epub 2019 Dec 23.

    PMID: 31868574BACKGROUND

MeSH Terms

Conditions

Constipation

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sonja McIlfatrick, PhD BA

    Ulster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 6, 2020

Study Start

October 1, 2018

Primary Completion

May 31, 2019

Study Completion

March 31, 2020

Last Updated

August 6, 2020

Record last verified: 2020-08

Data Sharing

IPD Sharing
Will share

The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.

Shared Documents
STUDY PROTOCOL
Time Frame
July 2020-July 2025

Locations