AzTrials
AzTrials

Pulmonary Disease, Chronic ObstructiveMoSHCOPDNCT03657121

Mortality and Symptom Burden Post Hospitalisation With COPD

An observational study of Pulmonary Disease, Chronic Obstructive and Pulmonary Disease, Obstructive, run by Northumbria Healthcare NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 35 years and older
How many people
447 participants
Where
2 sitesUnited Kingdom
Study dates
16 Jan 2019to 18 Dec 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 35 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Consecutive, unique patients admitted to Northumbria Healthcare NHS Foundation Trust or Newcastle Upon Tyne Hospitals NHS Foundation Trust with an exacerbation of Chronic Obstructive Pulmonary Disease (ECOPD) will be identified and included in the non consenting prognostic study. All eligible patients within this group will be approached to participate in the longitudinal study and will only be included if they consent to do so.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites

  • Northumbria Healthcare NHS Foundation Trust

    Cramlington, NE23 6NZ

  • Newcastle Upon Tyne Hospitals NHS Foundation Trust

    Newcastle upon Tyne, Tyne and Wear, NE1 4LP

Other trials in United Kingdom

About this study

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

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.

Read the detailed description

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.

Keywords
Prognosis, Palliative Care, End Stage, Mortality, Palliative, Advance Care Planning, Symptom, Exacerbation
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Lung Diseases, Obstructive, Emphysema, Bronchitis, Chronic

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: 12 months

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

    As above

    Measured: 12 months

Secondary outcomes (29)

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

    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.

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

    Measured: 12 months

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

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

    Measured: 12 months

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

    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.

    Measured: 12 months

  9. Determine baseline St George's Respiratory Questionnaire score

    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.

    Measured: 12 months

  10. Determine baseline Hospital Anxiety and Depression Score

    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.

    Measured: 12 months

  11. Determine baseline modified Borg score

    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).

    Measured: 12 months

  12. Assess baseline Australia-modified Karnofsky Performance Status

    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.

    Measured: 12 months

  13. Mean change in SGRQ compared to MCID.

    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).

    Measured: 12 months

  14. Mean change in HADS compared to MCID.

    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.

    Measured: 12 months

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

    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).

    Measured: 12 months

  16. Mean change in AKPS compared to MCID.

    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.

    Measured: 12 months

  17. Duration SGRQ score maintained above baseline.

    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).

    Measured: 12 months

  18. Duration HADS score maintained above baseline.

    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.

    Measured: 12 months

  19. Duration modified BORG score maintained above baseline.

    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).

    Measured: 12 months

  20. Duration AKPS maintained above baseline.

    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.

    Measured: 12 months

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

    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.

    Measured: 12 months

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

    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.

    Measured: 12 months

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

    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.

    Measured: 12 months

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

    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.

    Measured: 12 months

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

    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.

    Measured: 12 months

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

    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.

    Measured: 12 months

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

    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.

    Measured: 12 months

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

    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.

    Measured: 12 months

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

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Sep 2018
  2. Study start16 Jan 2019
  3. Primary completion18 Dec 2020
  4. Study completion18 Dec 2020

Resources

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
Cohort
Time perspective
Prospective
Enrolment
447 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03657121
Sponsor's protocol ID
244285
Acronym
MoSHCOPD
Status last verified
Mar 2021
First submitted
2 Aug 2018
Last updated
3 Mar 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Echevarria C, Steer J, Heslop-Marshall K, Stenton SC, Hickey PM, Hughes R, Wijesinghe M, Harrison RN, Steen N, Simpson AJ, Gibson GJ, Bourke SC. The PEARL score predicts 90-day readmission or death after hospitalisation for acute exacerbation of COPD. Thorax. 2017 Aug;72(8):686-693. doi: 10.1136/thoraxjnl-2016-209298. Epub 2017 Feb 24.

    PubMed 28235886

  • Soler-Cataluna JJ, Martinez-Garcia MA, Sanchez LS, Tordera MP, Sanchez PR. Severe exacerbations and BODE index: two independent risk factors for death in male COPD patients. Respir Med. 2009 May;103(5):692-9. doi: 10.1016/j.rmed.2008.12.005. Epub 2009 Jan 7.

    PubMed 19131231

  • Thomas K et al. The GSF Prognostic Indicator Guidance. The Gold Standards Framework Centre in End of Life Care CIC; October 2011

  • Almagro P, Soriano JB, Cabrera FJ, Boixeda R, Alonso-Ortiz MB, Barreiro B, Diez-Manglano J, Murio C, Heredia JL; Working Group on COPD, SpanishSociety of Internal Medicine*. Short- and medium-term prognosis in patients hospitalized for COPD exacerbation: the CODEX index. Chest. 2014 May;145(5):972-980. doi: 10.1378/chest.13-1328.

    PubMed 24077342

  • Puhan MA, Hansel NN, Sobradillo P, Enright P, Lange P, Hickson D, Menezes AM, ter Riet G, Held U, Domingo-Salvany A, Mosenifar Z, Anto JM, Moons KG, Kessels A, Garcia-Aymerich J; International COPD Cohorts Collaboration Working Group. Large-scale international validation of the ADO index in subjects with COPD: an individual subject data analysis of 10 cohorts. BMJ Open. 2012 Dec 12;2(6):e002152. doi: 10.1136/bmjopen-2012-002152. Print 2012.

    PubMed 23242246

  • Sundh J, Janson C, Lisspers K, Stallberg B, Montgomery S. The Dyspnoea, Obstruction, Smoking, Exacerbation (DOSE) index is predictive of mortality in COPD. Prim Care Respir J. 2012 Sep;21(3):295-301. doi: 10.4104/pcrj.2012.00054.

    PubMed 22786813

  • Highet G, Crawford D, Murray SA, Boyd K. Development and evaluation of the Supportive and Palliative Care Indicators Tool (SPICT): a mixed-methods study. BMJ Support Palliat Care. 2014 Sep;4(3):285-90. doi: 10.1136/bmjspcare-2013-000488. Epub 2013 Jul 25.

    PubMed 24644193

  • Steer J, Gibson J, Bourke SC. The DECAF Score: predicting hospital mortality in exacerbations of chronic obstructive pulmonary disease. Thorax. 2012 Nov;67(11):970-6. doi: 10.1136/thoraxjnl-2012-202103. Epub 2012 Aug 15.

    PubMed 22895999

  • Echevarria C, Steer J, Heslop-Marshall K, Stenton SC, Hickey PM, Hughes R, Wijesinghe M, Harrison RN, Steen N, Simpson AJ, Gibson GJ, Bourke SC. Validation of the DECAF score to predict hospital mortality in acute exacerbations of COPD. Thorax. 2016 Feb;71(2):133-40. doi: 10.1136/thoraxjnl-2015-207775.

    PubMed 26769015

  • Knaus WA, Wagner DP, Draper EA, Zimmerman JE, Bergner M, Bastos PG, Sirio CA, Murphy DJ, Lotring T, Damiano A, et al. The APACHE III prognostic system. Risk prediction of hospital mortality for critically ill hospitalized adults. Chest. 1991 Dec;100(6):1619-36. doi: 10.1378/chest.100.6.1619.

    PubMed 1959406

  • Meguro M, Barley EA, Spencer S, Jones PW. Development and Validation of an Improved, COPD-Specific Version of the St. George Respiratory Questionnaire. Chest. 2007 Aug;132(2):456-63. doi: 10.1378/chest.06-0702. Epub 2007 Jul 23.

    PubMed 17646240

  • Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

    PubMed 6880820

  • Abernethy AP, Shelby-James T, Fazekas BS, Woods D, Currow DC. The Australia-modified Karnofsky Performance Status (AKPS) scale: a revised scale for contemporary palliative care clinical practice [ISRCTN81117481]. BMC Palliat Care. 2005 Nov 12;4:7. doi: 10.1186/1472-684X-4-7.

    PubMed 16283937

  • Steer J, Norman EM, Afolabi OA, Gibson GJ, Bourke SC. Dyspnoea severity and pneumonia as predictors of in-hospital mortality and early readmission in acute exacerbations of COPD. Thorax. 2012 Feb;67(2):117-21. doi: 10.1136/thoraxjnl-2011-200332. Epub 2011 Sep 6.

    PubMed 21896712

  • Kendrick KR, Baxi SC, Smith RM. Usefulness of the modified 0-10 Borg scale in assessing the degree of dyspnea in patients with COPD and asthma. J Emerg Nurs. 2000 Jun;26(3):216-22. doi: 10.1016/s0099-1767(00)90093-x.

    PubMed 10839848

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Disease, Chronic Obstructive and Pulmonary Disease, Obstructive, run by Northumbria Healthcare NHS Foundation Trust at 2 sites 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 5 inclusion and 3 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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?

Positive predictive value of the prognostic tools listed for prediction of one year mortality. (time frame: 12 months). 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 NCT03657121, which also lists 15 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 3 Mar 2021; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in