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A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of dignity therapy for older people in care homes: study protocol.

Hall S, Chochinov H, Harding R, Murray S, Richardson A, Higginson IJ - BMC Geriatr (2009)

Bottom Line: The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory.Secondary outcomes for residents include depression, hopefulness and quality of life.This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Palliative Care, Policy & Rehabilitation, King's College London, Weston Education Centre, London, UK. sue.hall@kcl.ac.uk

ABSTRACT

Background: Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT.

Methods/design: A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method.

Discussion: Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable.

Trial registration: Current Controlled Clinical Trials: ISRCTN37589515.

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Related in: MedlinePlus

Recruitment and follow-up procedure.
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Figure 1: Recruitment and follow-up procedure.

Mentions: The recruitment and follow-up procedure is shown in Figure 1. Care home managers are asked to distribute patient information sheets and reply slips (indicating whether or not they are interested in taking part in the study) to all residents eligible for the study. At least one week is given for full consideration and discussion of participation in the study with family and friends. Residents are asked to give their reply slips to the care home manager who gives them to the research assistant. The research assistant organises a convenient time to meet with the resident. At this meeting the research assistant: (i) explains the study to the resident, (ii) answers any questions they may have about their participation in the study, (iii) checks that they have fully understood the remit and implications of the study before obtaining written consent and proceeding with the Time 1 (baseline) interview. As a final check residents are screened with the Blessed Orientation Memory Concentration Test [10] to assess cognitive functioning. It has been suggested by Chochinov (personal communication) that Dignity Therapy is not suitable for residents with a score equal to or greater than 15. In such cases residents are excluded. This is done sensitively: the research assistant spends some time chatting with them about neutral topics. This approach has worked successfully in a previous study involving residents of care homes [7]. The proportion of residents excluded at this stage will be reported.


A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of dignity therapy for older people in care homes: study protocol.

Hall S, Chochinov H, Harding R, Murray S, Richardson A, Higginson IJ - BMC Geriatr (2009)

Recruitment and follow-up procedure.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2666739&req=5

Figure 1: Recruitment and follow-up procedure.
Mentions: The recruitment and follow-up procedure is shown in Figure 1. Care home managers are asked to distribute patient information sheets and reply slips (indicating whether or not they are interested in taking part in the study) to all residents eligible for the study. At least one week is given for full consideration and discussion of participation in the study with family and friends. Residents are asked to give their reply slips to the care home manager who gives them to the research assistant. The research assistant organises a convenient time to meet with the resident. At this meeting the research assistant: (i) explains the study to the resident, (ii) answers any questions they may have about their participation in the study, (iii) checks that they have fully understood the remit and implications of the study before obtaining written consent and proceeding with the Time 1 (baseline) interview. As a final check residents are screened with the Blessed Orientation Memory Concentration Test [10] to assess cognitive functioning. It has been suggested by Chochinov (personal communication) that Dignity Therapy is not suitable for residents with a score equal to or greater than 15. In such cases residents are excluded. This is done sensitively: the research assistant spends some time chatting with them about neutral topics. This approach has worked successfully in a previous study involving residents of care homes [7]. The proportion of residents excluded at this stage will be reported.

Bottom Line: The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory.Secondary outcomes for residents include depression, hopefulness and quality of life.This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable.

View Article: PubMed Central - HTML - PubMed

Affiliation: Department of Palliative Care, Policy & Rehabilitation, King's College London, Weston Education Centre, London, UK. sue.hall@kcl.ac.uk

ABSTRACT

Background: Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT.

Methods/design: A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method.

Discussion: Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable.

Trial registration: Current Controlled Clinical Trials: ISRCTN37589515.

Show MeSH
Related in: MedlinePlus