<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04501263</url>
  </required_header>
  <id_info>
    <org_study_id>18NI0074</org_study_id>
    <secondary_id>MCCC-RP-16-A20993</secondary_id>
    <nct_id>NCT04501263</nct_id>
  </id_info>
  <brief_title>Educational Intervention for Management of Constipation</brief_title>
  <acronym>DEMCON</acronym>
  <official_title>Developing an Testing an Educational Intervention for the Management of Constipation for People With Advanced Cancer: a Feasibility Intervention Study (DEMCON)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Ulster</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queen's University, Belfast</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Bristol</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Marie Curie Hospice, Belfast</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Ulster</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of the study is to develop and test the feasibility and acceptability of a&#xD;
      novel educational intervention for HCPs to help them manage constipation experienced by&#xD;
      people in the hospice setting. This stage aims to establish the feasibility of, and to pilot,&#xD;
      a novel educational intervention for HCPs. Additionally, it also originally aimed to test the&#xD;
      feasibility of the chosen measures of change in patient care, however this was not&#xD;
      undertaken. In order to achieve this aim, the objectives are to:&#xD;
&#xD;
        -  Implement the educational intervention across Marie Curie sites.&#xD;
&#xD;
        -  Evaluate the likely effectiveness of the educational intervention on the knowledge and&#xD;
           self-efficacy of HCPs.&#xD;
&#xD;
        -  Explore the feasibility and acceptability of the educational intervention with HCPs, and&#xD;
           identify factors associated with feasibility/acceptability&#xD;
&#xD;
        -  Explore the feasibility and acceptability of research procedures, and identify factors&#xD;
           associated with feasibility/acceptability&#xD;
&#xD;
        -  Examine the effect of contextual factors upon the implementation and sustainability of&#xD;
           the educational intervention in the hospice.&#xD;
&#xD;
        -  Examine the suitability of outcome measures for HCPs&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      An incremental, multi-method approach was adopted, in line with the MRC Framework for complex&#xD;
      interventions. Four prior data collection phases helped to inform the development of the&#xD;
      educational intervention (a review of guidelines and a systematic review of the existing&#xD;
      literature Muldrew et al 2018; a clinical case note review (McIlfatrick et al 2019) and&#xD;
      qualitative findings from patients, caregivers and health professionals (Hasson et al 2019).&#xD;
      The refinement of the intervention involved the project's fourth step (unpublished). This was&#xD;
      the use of the Nominal Group Technique (NGT) with 39 HCPs to help identify priorities in the&#xD;
      assessment and management of constipation. The findings from the NGT were further ratified by&#xD;
      an international review group (n=19) on constipation management and care.&#xD;
&#xD;
      A mixed methods approach was undertaken to inform the development of the intervention and&#xD;
      assess its impact. A small cohort, one-sample repeated measures design was used to assess the&#xD;
      impact of the intervention on the knowledge of participants (health care professionals). Data&#xD;
      collection was focused on three primary groups of HCPs; nurses, medics, and pharmacists.&#xD;
      Qualitative data were collected after the intervention to assess the appropriateness of the&#xD;
      intervention, the support in the specialist palliative care unit to complete it, the overall&#xD;
      processes surrounding its implementation, and any impact that participants felt it had on&#xD;
      practice. These data were gathered from focus groups (n=4) with 14 HCPs and nine telephone&#xD;
      interviews with managers and senior staff in the SPC units. The intervention was delivered,&#xD;
      and participants were recruited from five specialist palliative care inpatient units in the&#xD;
      UK (Northern Ireland, Scotland, and England).&#xD;
&#xD;
      HCPS (nurses, medics, pharmacists) were invited to participate if they met the following&#xD;
      inclusion criteria; (i) working in a clinical capacity in the SPC inpatient unit; (ii)&#xD;
      involvement in the management of patients with constipation; (iii) over 18 years of age; and&#xD;
      (iv) able to provide written consent in English. The educational intervention was advertised&#xD;
      across sites through Research Leads, flyers and the identification of a &quot;champion&quot;, in&#xD;
      conjunction with senior staff. HCPs who met the inclusion criteria and were willing to&#xD;
      participate could sign up via a webpage containing an information sheet, consent form, and&#xD;
      information on how to access the education programme.&#xD;
&#xD;
      Intervention development and implementation processes Based on the findings from the previous&#xD;
      stages, a 6-week, online, educational program was created with Syngery Learning an online&#xD;
      learning management company, on constipation assessment and management. Each week of the&#xD;
      program consisted of a short theoretical introduction to key aspects of constipation&#xD;
      (assessment, prevention, non-pharmacological management, pharmacological management, opioid&#xD;
      induced constipation, and bowel obstruction). This was supplemented with a quiz, link to&#xD;
      practice activity, and a group discussion in an online closed group. Participant's study was&#xD;
      largely self-directed and flexible. They could log in at any time during the 6-week data&#xD;
      collection period to complete the activities. Managers of the specialist palliative care&#xD;
      units were supportive of the educational program and assisted in the practical elements of&#xD;
      running the course, including releasing staff from their workload to complete the required&#xD;
      activities. Participants were encouraged to complete these activities during their work&#xD;
      hours.&#xD;
&#xD;
      Data collection Measures were completed online at baseline and after completion of the&#xD;
      educational intervention. Competency measures were the primary outcome of the study, linked&#xD;
      to the NiCan Framework for Generalist and Specialist Palliative and End of Life Care&#xD;
      Knowledge and Skills Framework. Participants completed a competency assessment tool extracted&#xD;
      from the Competency and End of Life Care Competency Tool and the Knowledge and Self-Efficacy&#xD;
      Survey. The intervention was implemented gradually, over two separate occasions, enabling&#xD;
      learning from the first phase to be incorporated into the second phase.&#xD;
&#xD;
      Qualitative Data Collection Qualitative data were collected after the intervention to assess&#xD;
      the appropriateness of the resource, the support within the SPC unit to complete it, the&#xD;
      overall processes surrounding its implementation, and any impact that participants felt it&#xD;
      had on practice. This used focus groups and telephone interviews with managers and senior&#xD;
      staff within the specialist palliative care units . Participants taking part in were invited&#xD;
      to participate if they met set inclusion criteria; (i) employed by hospice as HCP; (ii)&#xD;
      previous experience working with patients receiving palliative care who suffer from&#xD;
      constipation; (iii) over 18 years of age; and (iv) Willing to participant in the study and&#xD;
      have provided informed consent.&#xD;
&#xD;
      Cost analysis Information was collected on the time spent by staff on the training resource,&#xD;
      by staff type and by study centre. Staff time was valued using unit costs obtained from the&#xD;
      Personal Social Services Research Unit Costs of Health &amp; Social Care 2018.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2018</start_date>
  <completion_date type="Actual">March 31, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Study specific questionnaire</measure>
    <time_frame>October 2018- January 2019</time_frame>
    <description>To evaluate the feasibility of delivering an educational intervention in a specialist palliative care setting</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Study specific questionnaire</measure>
    <time_frame>October-2018-January 2019</time_frame>
    <description>To evaluate the acceptability of delivering an educational intervention in a specialist palliative care setting</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Knowledge and self-efficacy survey</measure>
    <time_frame>October 2018-January 2019</time_frame>
    <description>To evaluate the impact of the intervention on the knowledge of participants</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Focus group and telephone interviews</measure>
    <time_frame>October 2018- January 2019</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Personal Social Services Research Unit Costs of Health and Social Care</measure>
    <time_frame>October 2018-January 2019</time_frame>
    <description>To assess the resources used in the intervention on the knowledge of participants Assess the costs associated with providing the intervention</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Competency and end of life care competency tool</measure>
    <time_frame>October 2018-January 2019</time_frame>
    <description>To evaluate the impact of the intervention on the knowledge (competency) of participants</description>
  </secondary_outcome>
  <enrollment type="Actual">58</enrollment>
  <condition>Constipation</condition>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>DEMCoN Educational Intervention</intervention_name>
    <description>Educational programme on constipation for Health care professionals in this clinical specialist palliative care</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Health care professionals (nurses, medics, pharmacists)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Working in a clinical capacity in the SPC inpatient unit&#xD;
&#xD;
          -  Involvement in the management of patients with constipation.&#xD;
&#xD;
          -  Over 18 years of age;&#xD;
&#xD;
          -  Able to provide written consent in English.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Anyone who did not meet the above criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sonja McIlfatrick, PhD BA</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ulster University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ulster University</name>
      <address>
        <city>Newtownabbey</city>
        <state>Antrim</state>
        <zip>BT36 5DS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>29431016</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>31307441</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>31868574</PMID>
  </reference>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 28, 2020</study_first_submitted>
  <study_first_submitted_qc>August 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <last_update_submitted>August 1, 2020</last_update_submitted>
  <last_update_submitted_qc>August 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Constipation</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>July 2020-July 2025</ipd_time_frame>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04501263
org study id: 18NI0074
secondary id: MCCC-RP-16-A20993
nct id: NCT04501263
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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
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.
observational model: Other
time perspective: Retrospective
measure: Study specific questionnaire
time frame: October 2018- January 2019
description: To evaluate the feasibility of delivering an educational intervention in a specialist palliative care setting
measure: Study specific questionnaire
time frame: October-2018-January 2019
description: To evaluate the acceptability of delivering an educational intervention in a specialist palliative care setting
measure: Knowledge and self-efficacy survey
time frame: October 2018-January 2019
description: To evaluate the impact of the intervention on the knowledge of participants
measure: Focus group and telephone interviews
time frame: October 2018- January 2019
description: 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.
measure: Personal Social Services Research Unit Costs of Health and Social Care
time frame: October 2018-January 2019
description: To assess the resources used in the intervention on the knowledge of participants Assess the costs associated with providing the intervention
measure: Competency and end of life care competency tool
time frame: October 2018-January 2019
description: To evaluate the impact of the intervention on the knowledge (competency) of participants
intervention type: Behavioral
intervention name: DEMCoN Educational Intervention
description: Educational programme on constipation for Health care professionals in this clinical specialist palliative care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sonja McIlfatrick, PhD BA
role: Principal Investigator
affiliation: Ulster University
facility: 
country: United Kingdom
citation: 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: 29431016
citation: 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: 31307441
citation: 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: 31868574
responsible party type: Sponsor
mesh term: Constipation
sharing ipd: Yes
ipd description: The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.
ipd info type: Study Protocol
ipd time frame: July 2020-July 2025