Patient-centred Integrated Palliative Care Pathways in Advanced Cancer and Chronic Disease

NCT02175147 | Unknown

• 1 other identifier: 305555
• Study Type: observational
• Target: 576
• Locations: 5 countries
• Sites: 5

Brief Summary

Rationale: Palliative care integration in treatment pathways, palliative care networks and institutional collaborations in health services delivery seems a promising approach reducing fragmentation and discontinuity. Integrated Palliative Care (IPC) approaches in Europe are largely unknown and under-investigated. The investigators aim is to explore experiences of patients with advanced cancer, Chronic Obstructive Pulmonary Disease (COPD) and Chronic Heart Failure (CHF), family and professional caregivers within with IPC. This includes perceived quality of life, quality of care, burden/rewards of care giving, symptoms and collaboration between caregivers in the patient's care network. Objectives: To investigate how patients with advanced cancer, COPD and CHF, their family and professional caregivers within a selection of IPC initiatives in Belgium, Germany, Hungary, The Netherlands and United Kingdom experience care delivery in the last phase of disease.

• To investigate what opinions patients and family caregivers have on the (continuity and) quality of care delivered
• To investigate how patients rate their symptoms and quality of life
• To investigate how family caregivers rate their burden / rewards of care giving
• To investigate how the care network of the patient is organised with respect to the type, properties and quality of relationships between patients and family / professional caregivers Study design: Longitudinal multiple embedded case study. Study population: Adult patients with advanced cancer, COPD, and CHF under the care of IPC initiatives in five participating countries, their family and professional caregivers. The investigators aim to enroll up to 288 patients, 288 family caregivers and 192 professional caregivers in total. Study parameters: Experiences with IPC initiatives, quality of care, quality of life, perceived symptoms, perceived collaboration between professional caregivers, burden and rewards of care giving. Methods: Semi-structured interviews, patient diary, Social Network Analysis and the following questionnaires: Palliative care Outcome Scale; Canhelp Lite, Caregiver Reaction Assessment. Patients and family caregivers will be followed over 3 months at 4 consecutive contact points. The diary (containing two questions) will be kept weekly by patients. There will be group or individual interviews with professional caregivers. Analysis: The overall analysis will involve a synthesis of the qualitative and quantitative data. For more information see Detailed Description.

Conditions

COPD; Cancer; Heart Failure

Outcome Measures

Primary Outcomes (6)

• Change from baseline Experiences with IPC initiatives at 3 months

  The semi-structured interviews will be used to explore views of patients and family caregivers about their experiences with the integrated palliative care initiative. Topics include: * An exploration of problems and needs of the patient * An exploration of the contacts and relationships of patients and family caregivers with professional caregivers * An exploration of satisfaction and perceived deficits in service provision from the perspective of patients and family caregivers * An exploration of the views of patients and family caregivers on collaboration between professional care providers in the care network of the patient.

  Baseline and Month 3

• Change from baseline Quality of care at 1, 2 and 3 months

  Quality of care/satisfaction will be measured using the Canhelp Lite and the Social Network Analysis (SNA) method. Outcomes will be explored in the interviews, see also "Experiences with IPC initiatives"

  Baseline, Month 1, Month 2, Month 3

• Change from baseline Quality of life at 1, 2, and 3 months

  Quality of Life will be measured using the Palliative Care Outcome Scale (POS) version 1. Outcomes will be explored in the interviews, see also "Experiences with IPC initiatives"

  Baseline, Month 1, Month 2, Month 3

• Change from baseline Perceived symptoms at 1, 2, and 3 months

  Quality of Life will be measured using the Palliative Care Outcome Scale (POS) version 1. Outcomes will be explored in the interviews, see also "Experiences with IPC initiatives".

  Baseline, Month 1, Month 2, Month 3

• Change from Perceived collaboration between professional caregivers at 3 months

  Quality of Life will be measured using Social Network Analysis method (SNA). Outcomes will be explored in the interviews, see also "Experiences with IPC initiatives"

  Baseline, Month 3

• Change from baseline Burden and rewards of care giving at 1, 2, and 3 months

  Burden and rewards of care giving will be measured using the Caregiver Reaction Assessment.

  Baseline, Month 1, Month 2, Month 3

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In Belgium, Germany, Hungary, The Netherlands and United Kingdom 3-5 'model initiatives' of palliative care were selected. From each initiative, patients with advanced cancer, COPD and CHF, their family and professional caregivers are recruited. Patients (and if presented the family caregiver) are recruited by their main responsible doctor or (research) nurse involved in the initiative under examination. Participants need to meet the inclusion and exclusion criteria in order to be eligible for the study. A family caregiver is defined as the person who takes care and supports the patient for most of the time. Family caregivers are not necessarily a family member. Professional caregivers involved in the IPC initiatives under examination are invited for the group interviews.

You may qualify if:

• Aged 18 year or above
• Able to communicate in the national language (Dutch, English, German, Hungarian)
• Cognitively able to complete questionnaires and to participate in interviews.
• Surprise question "Would the patient's attending doctor be surprised if the patient died within 1 year?" is answered "No" by the patient's attending doctor
• Patients need to meet on of the following clinical criteria:
• Malignant disease: Advanced cancer (cancer with local progression and / or distant metastasis at presentation).
• Chronic Heart Failure: Severe heart failure (in accordance with New York Heart Association (NYHA) classification stage III-IV)
• COPD: Gold stage IV classification

You may not qualify if:

• \. People who lack mental capacity to give interviews and fill in questionnaires

Sponsors & Collaborators

• Radboud University Medical Center: lead
• European Union: collaborator
• Medical University of Pecs: collaborator
• Lancaster General Hospital: collaborator
• University Hospital, Bonn: collaborator
• KU Leuven: collaborator
• World Health Organization: collaborator
• European Association for Palliative Care: collaborator
• University of Rotterdam, The Netherlands: collaborator
• University of Navarra: collaborator
• University of Sheffield: collaborator
• Icahn School of Medicine at Mount Sinai: collaborator

Study Sites (5)

Katholieke Universiteit Leuven

Leuven, Belgium

NOT YET RECRUITING

University Hospital Bonn

Bonn, Germany

RECRUITING

Medical University of Pecs

Pécs, Hungary

RECRUITING

Radboud University Medical Centre Palliative consultation team

Nijmegen, Gelderland, Netherlands

RECRUITING

Lancaster General Hospital

Lancaster, United Kingdom

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Neoplasms; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases

Study Officials

• Marieke Groot, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Marlieke van der Eerden, MSc.

CONTACT

+31243655606; Marlieke.vanderEerden@radboudumc.nl

Marieke Groot, Dr.

CONTACT

+31243666252; Marieke.Groot@radboudumc.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2014
• First Posted: June 26, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: June 26, 2014

Record last verified: 2014-06

Locations

GB (1); BE (1); DE (1); HU (1); NL (1)