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NCT Number: NCT03657121

Mortality and Symptom Burden Post Hospitalisation With COPD

Chronic Obstructive Pulmonary Disease (COPD) is a common progressive lung disease which causes breathlessness and frequent exacerbations, with patients often requiring hospitalisation. Patients with severe COPD commonly become housebound and lose their independence. They have a higher symptom burden than those with incurable lung cancer, yet are less likely to receive specialist palliative care, or to have been engaged in advance care planning (where patients discuss and often document their wishes regarding their future care). Hospital admissions become increasingly common towards the end-of-life; therefore, hospitalisation is a good opportunity to identify patients at risk of poor outcome. Such patients may wish to consider alternatives to admission and avoid intrusive treatments. Unfortunately, predicting which patients are likely to die in the near future is challenging thus far.

The first step required to improve provision of palliative care services, and ensure patients are given the opportunity to make truly informed decisions about their future care, is accurate identification of those most likely to benefit.

Well-designed clinical (prognostic) tools outperform clinician judgement in most settings. The investigators will compare the accuracy of one year mortality prediction of several clinical tools in patients who survive a COPD exacerbation requiring admission. This will initially be performed using existing data collected during previous research (the 1,593 patient validation study for the PEARL score - Previous admissions, extended Medical Research Council Dyspnoea score, Age, Right and Left heart failure), then confirmed in at least 310 patients admitted uniquely and consecutively with an exacerbation of COPD. The latter group of patients will be invited to participate in a longitudinal follow-up study, assessing symptom burden, quality of life, and readmissions over one year.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Bronchitis Chronic Bronchitis With Acute Exacerbation Chronic Bronchitis With Airways Obstruction Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

35 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, Tyne and Wear, United Kingdom

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About this study

The PEARL (Previous admissions, Extended Medical Research Council Dyspnoea Score, Age, Right-sided heart failure and Left-sided heart failure) score predicts readmission or death within 90 days of discharge following an exacerbation of Chronic Obstructive Pulmonary Disease (ECOPD), and was developed by the lead supervisor's research team. Within the PEARL derivation cohort (2 hospitals, 824 patients), they have developed a novel tool to predict one year survival. The performance of this novel tool and existing Chronic Obstructive Pulmonary Disease (COPD) prognostic tools will be compared in the PEARL validation cohort (6 hospitals, 1,593 patients). The existing tools are the Body Mass Index, Airflow Obstruction, Dyspnoea and Exacerbations (BODEX) index (score range 0-9); PEARL score (score range 0-9); COPD Gold Standards Framework Prognostic Indicator Guidance (COPD PIG); Comorbidity, Obstruction, Dyspnoea and Exacerbations (CODEX) index (score range 0-10); Age, Dyspnoea and Obstruction (ADO) index (score range 0-14); Dyspnoea, Obstruction, Smoking, Exacerbation (DOSE) index (score range 0-8), the Supportive and Palliative Care Indicators Tool (SPICT) and another tool recently developed by another centre (PubMed reference not yet available). COPD-PIG and SPICT are not scored in the same manner and therefore do not have a range.

Performance of all tools will also be further prospectively assessed in a minimum of 310 patients. The COPD-PIG is intended to only be scored in patients who the clinician "would not be surprised" if they died within one year; the performance of this tool cannot be fully assessed retrospectively. Prospective validation will also allow an assessment of the ease of data collection; this is not available for the existing PEARL cohort but is a key consideration in selection of the final tool to ensure it is appropriate for widespread use on hospital wards. Consecutive, unique patients admitted to Northumbria Healthcare NHS Foundation Trust and Newcastle Upon Tyne Hospitals NHS Foundation Trust with ECOPD will be identified. Demographic and clinical indices, including the components of the nine prognostic tools, will be collected. Caldicott and ethics committee approval are in place (REC:18/NE/0226). Hospital readmissions, utilisation of other healthcare services such as the local palliative care teams and Hospice and survival will be assessed over one year. In common with similar studies, this validation study will be non-consenting.

Patients identified as high-risk by the selected tool who survive beyond one year may still warrant palliative care input if their symptom burden is high. The patients enrolled in the validation study will be invited to participate in a consenting longitudinal outcomes study, aiming for at least 50% participation. Symptom burden and functional status will be assessed using the St George's Respiratory Questionnaire (SGRQ), Hospital Anxiety and Depression Score (HADS), Australian modified Karnofsky Score (AKPS), Extended Medical Research Council Dyspnoea (eMRCD) score, and modified Borg scale at baseline, and 1, 3, 6 and 12 months. The baseline and 3 month assessments will be conducted via face to face meetings. The additional 1, 6 and 12 month assessments will be conducted over the phone. This data will be used both to calculate the relationship between symptom burden and death, and to identify the characteristics of patients who are especially symptomatic.

The characteristics of the cohort will be summarised using standard descriptive statistics appropriate to the level and distribution of the data. Groups will be compared (including by mortality outcome) using standard tests of statistical inference (e.g. t-test, Mann-Whitney U test, Fishers exact test). The performance of candidate prognostic tools will be compared by 1) assessing the positive and negative predictive value within the high-risk and low risk groups respectively; and 2) Area Under the curve of the Receiver Operating Characteristic (AUROC) analysis, with performance compared using the method of DeLong et al. Where data imputation is required, this will be done using multiple imputation methods. Statistical significance will be set at 5% throughout. The statistical analysis plan will be finalised prior to end of recruitment to avoid potential bias.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 35 years or older.
  • Smoking history greater than or equal to 10 pack years.
  • Obstructive spirometry (FEV1/FVC < 0.7).
  • ECOPD primary diagnosis.
  • Survival to discharge.

Exclusion criteria

  • Previous inclusion in the study.
  • Malignant neoplasm or other pathology likely to limit survival to less than 1 year.
  • For the longitudinal study only, inability to give informed consent.

Treatment and study plan

Primary outcomes

  1. Positive predictive value of the prognostic tools listed for prediction of one year mortality.

    Time frame: 12 months

    This is an exploratory study. The optimal tool to identify patients for advance care planning needs to offer high PPV (i.e. the substantial majority of those identified at high risk of dying should not survive beyond one year) and reasonably high sensitivity (i.e. most deaths within one year should be identified). Ease of completion must also be considered as this will strongly influence engagement.

  2. Sensitivity of the prognostic tools listed for prediction of one year mortality.

    Time frame: 12 months

    As above

Secondary outcomes

  1. Ease of completion of prognostic tools assessed by Likert scale

    Time frame: 12 months

    Commonly used psychometric scale, which will be utilised by the principal investigator to score the practical ease of completion of the prognostic tools for individual patients. A 10 point scale (score range 1-10) will be utilised with higher numbers conferring greater ease.

  2. Ease of completion of prognostic tools assessed by missing data.

    Time frame: 12 months

  3. For each prognostic tool, the area under the receiver operating characteristic curve.

    Time frame: 12 months

  4. Negative predictive value of the prognostic tools for prediction of one year mortality.

    Time frame: 12 months

  5. Hospital readmission rates at 30, 90 and 365 days.

    Time frame: 12 months

  6. Proportion of patients on the palliative care register and relation to mortality.

    Time frame: 12 months

  7. Utilisation of palliative care services: hospice; community palliative care team.

    Time frame: 12 months

    Rates of usage of these services will be identified at 12 months

  8. Inter-observer agreement on scoring of the prognostic tools

    Time frame: 12 months

    A random sample of patients will be selected and the prognostic tools re-scored by a different member of the research team to identify disagreements.

  9. Determine baseline St George's Respiratory Questionnaire score

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools.

    SGRQ is a validated questionnaire which measures the health status of patients with COPD, with a score ranging from 0 (no impairment) to 100 (worst possible health). Patients in a high mortality risk group identified for advance care planning who do not die are not "false positives" if they have a high symptom burden. The proportion of patients with high symptom burden not identified is also clinically relevant. This and the subsequent secondary outcomes are therefore important in this regard.

  10. Determine baseline Hospital Anxiety and Depression Score

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components.

  11. Determine baseline modified Borg score

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. The modified Borg scale is validated to assess breathlessness and is scored from 0 (not breathless) to 10 (maximal breathlessness).

  12. Assess baseline Australia-modified Karnofsky Performance Status

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. AKPS is a validated 10 point scale measuring performance status with 0 being normal health and 100 being dead.

  13. Mean change in SGRQ compared to MCID.

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. MCID is the minimal clinically important difference for the validated tool. SGRQ is a validated questionnaire which measures the health status of patients with COPD, with a score ranging from 0 (no impairment) to 100 (worst possible health).

  14. Mean change in HADS compared to MCID.

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. MCID is the minimal clinically important difference for the validated tool. HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components.

  15. Mean change in modified BORG score compared to MCID.

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. MCID is the minimal clinically important difference for the validated tool. The modified Borg scale is validated to assess breathlessness and is scored from 0 (not breathless) to 10 (maximal breathlessness).

  16. Mean change in AKPS compared to MCID.

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. MCID is the minimal clinically important difference for the validated tool. AKPS is a validated 10 point scale measuring performance status with 0 being normal health and 100 being dead.

  17. Duration SGRQ score maintained above baseline.

    Time frame: 12 months

    To be measured in days. Within the whole longitudinal cohort and individual risk groups within the prognostic tools. SGRQ is a validated questionnaire which measures the health status of patients with COPD, with a score ranging from 0 (no impairment) to 100 (worst possible health).

  18. Duration HADS score maintained above baseline.

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. To be measured in days. HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components.

  19. Duration modified BORG score maintained above baseline.

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. To be measured in days. The modified Borg scale is validated to assess breathlessness and is scored from 0 (not breathless) to 10 (maximal breathlessness).

  20. Duration AKPS maintained above baseline.

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools. To be measured in days. AKPS is a validated 10 point scale measuring performance status with 0 being normal health and 100 being dead.

  21. Relation between clinically significant anxiety on discharge and survival.

    Time frame: 12 months

    As per the anxiety component of the HADS tool - HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components.

  22. Relation between clinically significant depression on discharge and survival.

    Time frame: 12 months

    As per the depression component of the HADS tool - HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components.

  23. Relation between clinically significant anxiety on discharge and quality of life.

    Time frame: 12 months

    As per the anxiety component of the HADS tool - HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components. Quality of life as measured by the SGRQ, modified Borg and AKPS scores, with details of these scores described above.

  24. Relation between clinically significant depression on discharge and quality of life.

    Time frame: 12 months

    As per the depression component of the HADS tool - HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components. Quality of life as measured by the SGRQ, modified Borg and AKPS scores, with details of these scores described above.

  25. Relation between clinically significant anxiety on discharge and functional status.

    Time frame: 12 months

    As per the anxiety component of the HADS tool - HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components. Functional status as per the AKPS and SGRQ scores described above.

  26. Relation between clinically significant depression on discharge and functional status.

    Time frame: 12 months

    As per the depression component of the HADS tool - HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components. Functional status as per the AKPS and SGRQ scores described above.

  27. Relation between clinically significant anxiety on discharge and readmissions.

    Time frame: 12 months

    As per the anxiety component of the HADS tool - HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components.

  28. Relation between clinically significant depression on discharge and readmissions.

    Time frame: 12 months

    As per the depression component of the HADS tool - HADS is a validated questionnaire with a score range of 0 (healthy) to maximum 21 (abnormal) for both anxiety and depression components.

  29. Best prognostic tool to predict poor QoL and/or death within one year, as per positive predictive value and sensitivity.

    Time frame: 12 months

    Within the whole longitudinal cohort and individual risk groups within the prognostic tools.

Sponsors and collaborators

Lead sponsor

Northumbria Healthcare NHS Foundation Trust

Other

Collaborators

  • Hospice UK
  • National Institute for Health Research, United Kingdom
  • Newcastle-upon-Tyne Hospitals NHS Trust

Registry information

Official study title

COPD: Comparison of Existing Prognostic Tools for 1 Year Mortality and Assessment of Symptom Burden to Facilitate Advance Care Planning

Acronym: MoSHCOPD

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 4, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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