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Phase 2 Randomised Controlled Trial and Feasibility Study of Future Care Planning in Patients with Advanced Heart Disease.

Denvir MA, Cudmore S, Highet G, Robertson S, Donald L, Stephen J, Haga K, Hogg K, Weir CJ, Murray SA, Boyd K - Sci Rep (2016)

Bottom Line: Future Care Planning (FCP) rarely occurs in patients with heart disease until close to death by which time the potential benefits are lost.FCP did not increase anxiety/distress (Kessler score -E 16.7 (7.0) vs D 16.8 (7.3), p = 0.94).Qualitative interviews indicated that FCP was highly valued by patients, carers and family physicians.

View Article: PubMed Central - PubMed

Affiliation: Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.

ABSTRACT
Future Care Planning (FCP) rarely occurs in patients with heart disease until close to death by which time the potential benefits are lost. We assessed the feasibility, acceptability and tested a design of a randomised trial evaluating the impact of FCP in patients and carers. 50 patients hospitalised with acute heart failure or acute coronary syndrome and with predicted 12 month mortality risk of >20% were randomly allocated to FCP or usual care for 12 weeks upon discharge and then crossed-over for the next 12 weeks. Quality of life, symptoms and anxiety/distress were assessed by questionnaire. Hospitalisation and mortality events were documented for 6 months post-discharge. FCP increased implementation and documentation of key decisions linked to end-of-life care. FCP did not increase anxiety/distress (Kessler score -E 16.7 (7.0) vs D 16.8 (7.3), p = 0.94). Quality of life was unchanged (EQ5D: E 0.54(0.29) vs D 0.56(0.24), p = 0.86) while unadjusted hospitalised nights was lower (E 8.6 (15.3) vs D 11.8 (17.1), p = 0.01). Qualitative interviews indicated that FCP was highly valued by patients, carers and family physicians. FCP is feasible in a randomised clinical trial in patients with acute high risk cardiac conditions. A Phase 3 trial is needed urgently.

No MeSH data available.


Related in: MedlinePlus

Flow chart of patients screened, excluded and recruited.Patients over the age of 70 were routinely screened on cardiology and general medical wards using the GRACE and EFFECT scores; an estimated risk of death within 12 months of at least 20% was the threshold level for trial inclusion the reasons for failing to recruit eligible patients are also listed in the flow chart.
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f1: Flow chart of patients screened, excluded and recruited.Patients over the age of 70 were routinely screened on cardiology and general medical wards using the GRACE and EFFECT scores; an estimated risk of death within 12 months of at least 20% was the threshold level for trial inclusion the reasons for failing to recruit eligible patients are also listed in the flow chart.

Mentions: Over a 12 month period between 1st October 2013 and 31st September 2014, 408 patients were screened, 137 met eligibility criteria of which fifty were randomised to an early or delayed intervention. Reasons for not enrolling eligible patients are outlined in Fig. 1. The characteristics of enrolled patients are summarised in Table 1. For comparison, similar data for the screened population is provided in supplementary Table 1. Study patients were elderly with increased care needs as defined by a high Charleson Comorbidity Index, low mean Karnofsky Performance Scale and more than 50% of the cohort was considered frail according to the Canadian Frailty Scale. There was a low attrition rate for a palliative care study in such a frail population.


Phase 2 Randomised Controlled Trial and Feasibility Study of Future Care Planning in Patients with Advanced Heart Disease.

Denvir MA, Cudmore S, Highet G, Robertson S, Donald L, Stephen J, Haga K, Hogg K, Weir CJ, Murray SA, Boyd K - Sci Rep (2016)

Flow chart of patients screened, excluded and recruited.Patients over the age of 70 were routinely screened on cardiology and general medical wards using the GRACE and EFFECT scores; an estimated risk of death within 12 months of at least 20% was the threshold level for trial inclusion the reasons for failing to recruit eligible patients are also listed in the flow chart.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4836296&req=5

f1: Flow chart of patients screened, excluded and recruited.Patients over the age of 70 were routinely screened on cardiology and general medical wards using the GRACE and EFFECT scores; an estimated risk of death within 12 months of at least 20% was the threshold level for trial inclusion the reasons for failing to recruit eligible patients are also listed in the flow chart.
Mentions: Over a 12 month period between 1st October 2013 and 31st September 2014, 408 patients were screened, 137 met eligibility criteria of which fifty were randomised to an early or delayed intervention. Reasons for not enrolling eligible patients are outlined in Fig. 1. The characteristics of enrolled patients are summarised in Table 1. For comparison, similar data for the screened population is provided in supplementary Table 1. Study patients were elderly with increased care needs as defined by a high Charleson Comorbidity Index, low mean Karnofsky Performance Scale and more than 50% of the cohort was considered frail according to the Canadian Frailty Scale. There was a low attrition rate for a palliative care study in such a frail population.

Bottom Line: Future Care Planning (FCP) rarely occurs in patients with heart disease until close to death by which time the potential benefits are lost.FCP did not increase anxiety/distress (Kessler score -E 16.7 (7.0) vs D 16.8 (7.3), p = 0.94).Qualitative interviews indicated that FCP was highly valued by patients, carers and family physicians.

View Article: PubMed Central - PubMed

Affiliation: Cardiology, Edinburgh Heart Centre, Royal Infirmary of Edinburgh, Little France Crescent, Edinburgh, EH16 4SA, UK.

ABSTRACT
Future Care Planning (FCP) rarely occurs in patients with heart disease until close to death by which time the potential benefits are lost. We assessed the feasibility, acceptability and tested a design of a randomised trial evaluating the impact of FCP in patients and carers. 50 patients hospitalised with acute heart failure or acute coronary syndrome and with predicted 12 month mortality risk of >20% were randomly allocated to FCP or usual care for 12 weeks upon discharge and then crossed-over for the next 12 weeks. Quality of life, symptoms and anxiety/distress were assessed by questionnaire. Hospitalisation and mortality events were documented for 6 months post-discharge. FCP increased implementation and documentation of key decisions linked to end-of-life care. FCP did not increase anxiety/distress (Kessler score -E 16.7 (7.0) vs D 16.8 (7.3), p = 0.94). Quality of life was unchanged (EQ5D: E 0.54(0.29) vs D 0.56(0.24), p = 0.86) while unadjusted hospitalised nights was lower (E 8.6 (15.3) vs D 11.8 (17.1), p = 0.01). Qualitative interviews indicated that FCP was highly valued by patients, carers and family physicians. FCP is feasible in a randomised clinical trial in patients with acute high risk cardiac conditions. A Phase 3 trial is needed urgently.

No MeSH data available.


Related in: MedlinePlus