ConstipationDEMCONNCT04501263
Educational Intervention for Management of Constipation
An observational study of Constipation, run by University of Ulster at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Constipation
- What is being tested?
- DEMCoN Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 58 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 31 Mar 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Health care professionals (nurses, medics, pharmacists)
Who may be able to join
- 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.
Who cannot join
- Anyone who did not meet the above criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Developing an Testing an Educational Intervention for the Management of Constipation for People With Advanced Cancer: a Feasibility Intervention Study (DEMCON)
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
Read the detailed description
An incremental, multi-method approach was adopted, in line with the MRC Framework for complex interventions. Four prior data collection phases helped to inform the development of the educational intervention (a review of guidelines and a systematic review of the existing literature Muldrew et al 2018; a clinical case note review (McIlfatrick et al 2019) and qualitative findings from patients, caregivers and health professionals (Hasson et al 2019). The refinement of the intervention involved the project's fourth step (unpublished). This was the use of the Nominal Group Technique (NGT) with 39 HCPs to help identify priorities in the assessment and management of constipation. The findings from the NGT were further ratified by an international review group (n=19) on constipation management and care.
A mixed methods approach was undertaken to inform the development of the intervention and assess its impact. A small cohort, one-sample repeated measures design was used to assess the impact of the intervention on the knowledge of participants (health care professionals). Data collection was focused on three primary groups of HCPs; nurses, medics, and pharmacists. Qualitative data were collected after the intervention to assess the appropriateness of the intervention, the support in the specialist palliative care unit to complete it, the overall processes surrounding its implementation, and any impact that participants felt it had on practice. These data were gathered from focus groups (n=4) with 14 HCPs and nine telephone interviews with managers and senior staff in the SPC units. The intervention was delivered, and participants were recruited from five specialist palliative care inpatient units in the UK (Northern Ireland, Scotland, and England).
HCPS (nurses, medics, pharmacists) were invited to participate if they met the following inclusion criteria; (i) working in a clinical capacity in the SPC inpatient unit; (ii) involvement in the management of patients with constipation; (iii) over 18 years of age; and (iv) able to provide written consent in English. The educational intervention was advertised across sites through Research Leads, flyers and the identification of a "champion", in conjunction with senior staff. HCPs who met the inclusion criteria and were willing to participate could sign up via a webpage containing an information sheet, consent form, and information on how to access the education programme.
Intervention development and implementation processes Based on the findings from the previous stages, a 6-week, online, educational program was created with Syngery Learning an online learning management company, on constipation assessment and management. Each week of the program consisted of a short theoretical introduction to key aspects of constipation (assessment, prevention, non-pharmacological management, pharmacological management, opioid induced constipation, and bowel obstruction). This was supplemented with a quiz, link to practice activity, and a group discussion in an online closed group. Participant's study was largely self-directed and flexible. They could log in at any time during the 6-week data collection period to complete the activities. Managers of the specialist palliative care units were supportive of the educational program and assisted in the practical elements of running the course, including releasing staff from their workload to complete the required activities. Participants were encouraged to complete these activities during their work hours.
Data collection Measures were completed online at baseline and after completion of the educational intervention. Competency measures were the primary outcome of the study, linked to the NiCan Framework for Generalist and Specialist Palliative and End of Life Care Knowledge and Skills Framework. Participants completed a competency assessment tool extracted from the Competency and End of Life Care Competency Tool and the Knowledge and Self-Efficacy Survey. The intervention was implemented gradually, over two separate occasions, enabling learning from the first phase to be incorporated into the second phase.
Qualitative Data Collection Qualitative data were collected after the intervention to assess the appropriateness of the resource, the support within the SPC unit to complete it, the overall processes surrounding its implementation, and any impact that participants felt it had on practice. This used focus groups and telephone interviews with managers and senior staff within the specialist palliative care units . Participants taking part in were invited to participate if they met set inclusion criteria; (i) employed by hospice as HCP; (ii) previous experience working with patients receiving palliative care who suffer from constipation; (iii) over 18 years of age; and (iv) Willing to participant in the study and have provided informed consent.
Cost analysis Information was collected on the time spent by staff on the training resource, by staff type and by study centre. Staff time was valued using unit costs obtained from the Personal Social Services Research Unit Costs of Health \& Social Care 2018.
- Conditions
- Constipation
- Being tested
- DEMCoN Educational Intervention
- Medical subject headings
- Constipation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DEMCoN Educational InterventionBehavioural
Educational programme on constipation for Health care professionals in this clinical specialist palliative care
What is being measured
The primary outcome is the main question the study is designed to answer.
Study specific questionnaire
To evaluate the feasibility of delivering an educational intervention in a specialist palliative care setting
Measured: October 2018- January 2019
Study specific questionnaire
To evaluate the acceptability of delivering an educational intervention in a specialist palliative care setting
Measured: October-2018-January 2019
Secondary outcomes (4)
Knowledge and self-efficacy survey
To evaluate the impact of the intervention on the knowledge of participants
Measured: October 2018-January 2019
Focus group and telephone interviews
To explore managers and staffs views on the appropriateness of the resource, the support to complete it and process surrounding implementation and any perceived impact on practice.
Measured: October 2018- January 2019
Personal Social Services Research Unit Costs of Health and Social Care
To assess the resources used in the intervention on the knowledge of participants Assess the costs associated with providing the intervention
Measured: October 2018-January 2019
Competency and end of life care competency tool
To evaluate the impact of the intervention on the knowledge (competency) of participants
Measured: October 2018-January 2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start1 Oct 2018
- Primary completion31 May 2019
- Study completion31 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ConstipationStudies 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
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Queen's University, Belfast, University of Bristol, Marie Curie Hospice, Belfast
- Responsible party
- Sponsor
- Investigators
- Sonja McIlfatrick, PhD BA, Principal investigator, Ulster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04501263
- Sponsor's protocol ID
- 18NI0074
- Other IDs
- MCCC-RP-16-A20993
- Acronym
- DEMCON
- Status last verified
- Aug 2020
- First submitted
- 28 Jul 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
Publications
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.
PubMed 29431016McIlfatrick 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.
PubMed 31307441Hasson 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.
PubMed 31868574
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing an Testing an Educational Intervention for the Management of Constipation for People With Advanced Cancer: a Feasibility Intervention Study (DEMCON)
- ClinicalTrials.gov ID
- NCT04501263
- Acronym / sponsor ID
- DEMCON / 18NI0074
- Conditions
- Constipation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Queen's University, Belfast, University of Bristol, Marie Curie Hospice, Belfast
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Mar 2020 (actual)
- First posted
- 6 Aug 2020 (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 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
Detailed description
An incremental, multi-method approach was adopted, in line with the MRC Framework for complex interventions. Four prior data collection phases helped to inform the development of the educational intervention (a review of guidelines and a systematic review of the existing literature Muldrew et al 2018; a clinical case note review (McIlfatrick et al 2019) and qualitative findings from patients, caregivers and health professionals (Hasson et al 2019). The refinement of the intervention involved the project's fourth step (unpublished). This was the use of the Nominal Group Technique (NGT) with 39 HCPs to help identify priorities in the assessment and management of constipation. The findings from the NGT were further ratified by an international review group (n=19) on constipation management and care.
A mixed methods approach was undertaken to inform the development of the intervention and assess its impact. A small cohort, one-sample repeated measures design was used to assess the impact of the intervention on the knowledge of participants (health care professionals). Data collection was focused on three primary groups of HCPs; nurses, medics, and pharmacists. Qualitative data were collected after the intervention to assess the appropriateness of the intervention, the support in the specialist palliative care unit to complete it, the overall processes surrounding its implementation, and any impact that participants felt it had on practice. These data were gathered from focus groups (n=4) with 14 HCPs and nine telephone interviews with managers and senior staff in the SPC units. The intervention was delivered, and participants were recruited from five specialist palliative care inpatient units in the UK (Northern Ireland, Scotland, and England).
HCPS (nurses, medics, pharmacists) were invited to participate if they met the following inclusion criteria; (i) working in a clinical capacity in the SPC inpatient unit; (ii) involvement in the management of patients with constipation; (iii) over 18 years of age; and (iv) able to provide written consent in English. The educational intervention was advertised across sites through Research Leads, flyers and the identification of a "champion", in conjunction with senior staff. HCPs who met the inclusion criteria and were willing to participate could sign up via a webpage containing an information sheet, consent form, and information on how to access the education programme.
Intervention development and implementation processes Based on the findings from the previous stages, a 6-week, online, educational program was created with Syngery Learning an online learning management company, on constipation assessment and management. Each week of the program consisted of a short theoretical introduction to key aspects of constipation (assessment, prevention, non-pharmacological management, pharmacological management, opioid induced constipation, and bowel obstruction). This was supplemented with a quiz, link to practice activity, and a group discussion in an online closed group. Participant's study was largely self-directed and flexible. They could log in at any time during the 6-week data collection period to complete the activities. Managers of the specialist palliative care units were supportive of the educational program and assisted in the practical elements of running the course, including releasing staff from their workload to complete the required activities. Participants were encouraged to complete these activities during their work hours.
Data collection Measures were completed online at baseline and after completion of the educational intervention. Competency measures were the primary outcome of the study, linked to the NiCan Framework for Generalist and Specialist Palliative and End of Life Care Knowledge and Skills Framework. Participants completed a competency assessment tool extracted from the Competency and End of Life Care Competency Tool and the Knowledge and Self-Efficacy Survey. The intervention was implemented gradually, over two separate occasions, enabling learning from the first phase to be incorporated into the second phase.
Qualitative Data Collection Qualitative data were collected after the intervention to assess the appropriateness of the resource, the support within the SPC unit to complete it, the overall processes surrounding its implementation, and any impact that participants felt it had on practice. This used focus groups and telephone interviews with managers and senior staff within the specialist palliative care units . Participants taking part in were invited to participate if they met set inclusion criteria; (i) employed by hospice as HCP; (ii) previous experience working with patients receiving palliative care who suffer from constipation; (iii) over 18 years of age; and (iv) Willing to participant in the study and have provided informed consent.
Cost analysis Information was collected on the time spent by staff on the training resource, by staff type and by study centre. Staff time was valued using unit costs obtained from the Personal Social Services Research Unit Costs of Health \& Social Care 2018.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Health care professionals (nurses, medics, pharmacists)
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Anyone who did not meet the above criteria.
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 |
|---|---|---|
| DEMCoN Educational InterventionEducational programme on constipation for Health care professionals in this clinical specialist palliative care | Behavioural | – |
Primary outcome
Study specific questionnaire
Time frame: October 2018- January 2019
To evaluate the feasibility of delivering an educational intervention in a specialist palliative care setting
Study specific questionnaire
Time frame: October-2018-January 2019
To evaluate the acceptability of delivering an educational intervention in a specialist palliative care setting
4 secondary outcomes
Knowledge and self-efficacy survey
Time frame: October 2018-January 2019
Focus group and telephone interviews
Time frame: October 2018- January 2019
Personal Social Services Research Unit Costs of Health and Social Care
Time frame: October 2018-January 2019
Competency and end of life care competency tool
Time frame: October 2018-January 2019
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 6 Aug 2020.
- Background: PubMed 29431016Muldrew 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.
- Background: PubMed 31307441McIlfatrick 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.
- Background: PubMed 31868574Hasson 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.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
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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.
Sonja McIlfatrick, PhD BA principal investigator
Ulster University
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 Constipation, run by University of Ulster 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 4 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 6 Aug 2020. 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?
Study specific questionnaire (time frame: October 2018- January 2019). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04501263, which also lists 3 linked publications.
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 6 Aug 2020.