Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000246684
Ethics application status
Approved
Date submitted
22/02/2023
Date registered
8/03/2023
Date last updated
23/05/2024
Date data sharing statement initially provided
8/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of Arts on Prescription in subacute hospitals: Reported impact on psychological well-being
Scientific title
An evaluation of Arts on Prescription in subacute hospitals: Reported impact on psychological well-being
Secondary ID [1] 309061 0
Nil known
Universal Trial Number (UTN)
U1111-1288-7658
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological well-being 329120 0
Condition category
Condition code
Mental Health 326092 326092 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This is an evaluation study of the Arts on Prescription (AoP) in hospitals program, which is an ongoing service part of routine care in the participating hospitals. It was first implemented into routine care April 2022. For the purpose of this study, data will be collected from participants that attend at least one AoP in hospital session during the 16-month data collection period (April 2023 to July 2024).

The AoP in hospitals program is a service offered to people admitted on the palliative care, rehabilitation, and older persons’ mental health wards (service users) of the three participating hospitals. Service users are prescribed AoP by a member of their subacute healthcare team (staff) to address health and well-being needs identified during their admission.

An experienced artist attends the site weekly to facilitate art sessions face to face with referred service users either on a one-to-one basis or in a group setting (often determined by the capabilities and preferences of the service users). Group sessions involve up to eight service users with one artist. Each ward has a set environment for the AoP in Hospitals program to take place (group and one-to-one sessions), or one-to-one sessions can also take place in the service user’s room. The location of one-to-one sessions are determined by the service user’s preferences and ability. Artist provide multiple sessions on the one day a week they attend, providing service users with the opportunity to attend up to two sessions a day/week, dependent on their preferences, other commitments (e.g. medical review, off-ward appointments/investigations, allied health sessions), and own capabilities.

During the AoP in hospitals sessions different forms of art are offered and practised, such as portraiture, card making, clay work, drawing, and water colour painting. The type of art selected is negotiated between the artist and service users based on their preferences. The duration and level of participation in the sessions varies based on individual service user’s capabilities (e.g. medical needs, functional ability, fatigue) but on average the sessions run between 30 and 60 minutes. Nursing staff are available on the wards to assist artists during the sessions (e.g. with medical needs that may arise, transporting service users to the program location).

Basic service user demographic details (age range, gender, ward type, hospital location) and reason for referral are collected by the member of the subacute healthcare team as part of the AoP in hospitals program referral form (paper-based). Basic program details (date, session number, session type [group or individual], session duration, art form) are also routinely collected for the AoP in hospitals program by the artist (electronic). The research team will extract these routinely collected data, which will be de-identified, directly from medical records of service users who provide written, informed consent to participate in this study.

In addition to the routinely collected data, service users who participate in this stiudy will complete two paper-based psychological well-being outcome measures (Positive Well-being Umbrella - Generic [PWU-G] and the Negative Well-being Umbrella - Generic [NWU-G]) before and after each AoP session they attend (at least one). After each AoP session artists will complete the Pittsburgh Rehabilitation Participation Scale to measure level of engagement of service users (paper-based). Each of the outcome measures collected for the purpose of this study take approximately five minutes to complete.

Service users who attend at least two AoP sessions, as well as staff and artists from the participating wards will be invited to participate in the study's qualitative evaluation. This will be in the form of a 30 minute semi-structed interviews for service users (conducted face-to-face), and one hour focus groups for artists and staff (conducted online using Microsoft Teams). Participants will only have to attend one semi-structured interview/focus group, which will be conducted by a member of the research team at a location and time suitable for participants. The qualitative analysis will explore the impact of AoP in the subacute setting from the perspective of service users, artists, and staff. It will also explore the perceived usability of the PWU-G and NWU-G as an evaluation tool of the AoP in hospitals program.
Intervention code [1] 325503 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 333958 0
Change in psychological well-being as assessed by the Positive Well-being Umbrella - Generic (PWU-G).
Timepoint [1] 333958 0
Immediately before attending an AoP in hospitals session, immediately after attending an AoP in hospitals session.
Primary outcome [2] 333959 0
Change in psychological well-being as assessed by the Negative Well-being Umbrella - Generic (NWU-G).
Timepoint [2] 333959 0
Immediately before attending an AoP in hospitals session, immediately after attending an AoP in hospitals session.
Secondary outcome [1] 418844 0
Level of participation in the AoP in hospitals session as assessed by the Pittsburgh Rehabilitation Participation Scale (PRPS).
Timepoint [1] 418844 0
Immediately after attending a AoP in hospitals session.
Secondary outcome [2] 418847 0
Perceived impact of the AoP in hospitals program in a subacute hospital setting from the perspectives of service users using semi-structured interviews.

Semi-structured interviews with service users will be conducted one-to-one, face-to-face in a location and at a time suitable for the service user. They will be conducted by a member of the research team experienced in conducting interviews.
Timepoint [2] 418847 0
After attending two AoP in hospitals sessions.
Secondary outcome [3] 418848 0
Perceived impact of the AoP in hospitals program in a subacute hospital setting from the perspectives of artists and hospital staff using focus groups.

Focus groups with artists and hospital staff will be conducted online via Microsoft Teams to support the different locations of participants. By using this application it will allow for audio-recording and automatic transcription of the focus groups. Multiple sessions at different times and days will be offered to support participants to select a time suitable for them. Between six and eight participants and a single member of the research team (to facilitate the focus group discussions) will attend each focus group. However, final numbers will be dependent on how many participants are recruited, and individuals' time preferences. The member of the research team facilitated the focus groups is experienced in conducting focus groups.
Timepoint [3] 418848 0
At 15 to 16 months after the data collection period commenced.
Secondary outcome [4] 418849 0
Explore the perceived usability of the Positive Well-being Umbrella - Generic (PWU-G) and the Negative Well-being Umbrella - Generic (NWU-G) as evaluation tools for the AoP in hospitals program from the perspectives of service users using semi-structured interviews.

Semi-structured interviews with service users will be conducted one-to-one, face-to-face in a location and at a time suitable for the service user. They will be conducted by a member of the research team experienced in conducting interviews.
Timepoint [4] 418849 0
After attending two AoP in hospitals sessions.
Secondary outcome [5] 418850 0
Explore the perceived usability of the Positive Well-being Umbrella - Generic (PWU-G) and the Negative Well-being Umbrella - Generic (NWU-G) as evaluation tools for the AoP in hospitals program from the perspectives of artists and hospital staff using focus groups.

Focus groups with artists and hospital staff will be conducted online via Microsoft Teams to support the different locations of participants. By using this application it will allow for audio-recording and automatic transcription of the focus groups. Multiple sessions at different times and days will be offered to support participants to select a time suitable for them. Between six and eight participants and a single member of the research team (to facilitate the focus group discussions) will attend each focus group. However, final numbers will be dependent on how many participants are recruited, and individuals' time preferences. The member of the research team facilitated the focus groups is experienced in conducting focus groups.
Timepoint [5] 418850 0
At 15 to 16 months after the data collection period commenced.

Eligibility
Key inclusion criteria
(i) Pretest-posttest quantitative evaluation (of well-being using PWU-G and NWU-G)
Service users:
- Receiving care on one of the palliative care, rehabilitation, or older persons’ mental health wards at the participating subacute hospitals
- AoP prescribed by a member of the service user’s subacute healthcare team to address health and well-being needs
- Willingness to participate in at least one AoP session
- Willingness to provide written, informed consent (with the aid of supported decision making if needed)
- Willingness to participate in and comply with this study

(ii) Qualitative evaluation (semi-structured interviews and focus groups on impact of intervention and useability of primary outcome measures)
Service users:
- Participated in the pretest-posttest quantitative evaluation of this study
- Attended at least two sessions of the AoP in hospitals program
- Able to communicate in English at a level that allows them to participate in a semi-structured interview
- Willingness to provide written, informed consent (with the aid of supported decision making if needed)
- Willingness to participate in and comply with this study

Artists and staff:
- Artist or staff working on one of the palliative care, rehabilitation, or older persons’ mental health wards at the participating subacute hospitals
- Involved in, or regular observation of the AoP in hospitals program
- Able to communicate in English at a level that allows them to participate in a focus group
- Willingness to provide written, informed consent
- Willingness to participate in and comply with this study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) Pretest-posttest quantitative evaluation (of well-being using PWU-G and NWU-G)
Service users:
- Has a cognitive impairment of a degree that does not allow them to consent with the aid of supported decision making

(ii) Qualitative evaluation (semi-structured interviews and focus groups on impact of intervention and useability of primary outcome measures)
Service users:
- Unable to communicate in English at a level that allows them to participate in a semi-structured interview
- Has a cognitive impairment of a degree that does not allow them to consent with the aid of supported decision making

Artists and staff:
- Unable to communicate in English at a level that allows them to participate in a focus group

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
Sample size:
(i) Pretest-posttest quantitative evaluation (of well-being using PWU-G and NWU-G)
The target sample size for the pretest-posttest quantitative evaluation with service users (n=187) was determined based on participation rate of the AoP in hospitals program at the participating hospitals in the previous nine months (April 2022 to December 2022 inclusive). The previous participation rate was 353. This figure was then adjusted to reflect an 8-month period (n=312) and an anticipated 60% recruitment rate (n=187).

(ii) Qualitative evaluation (semi-structured interviews and focus groups on impact of intervention and useability of primary outcome measures)
Based on current literature, the target sample size for the qualitative evaluation is 12 per the two participant group type (service users, and artists and staff). However, the final sample size for this component of this study will be dependent on how many participants consent to being involved, and when data saturation is achieved.

Statisitcal analysis plan:
(i) Pretest-posttest quantitative evaluation (of well-being using PWU-G and NWU-G)
Descriptive statistics will be used to analyse quantitative data collected using the PWU-G and NWU-G, as well as demographic and program data. Inferential analysis of the psychological well-being data (PWU-G and NWU-G) will also be conducted to provide preliminary evidence on the self-reported impact of AoP on psychological well-being in the subacute setting. The Wilcoxon test will be used to compare changes in the total study population over time. The ANOVA will be used to consider changes over time based on ward type (palliative care, rehabilitation, older persons’ mental health) and age category (younger adults [<65], older adults [>65]).

(ii) Qualitative evaluation (semi-structured interviews and focus groups on impact of intervention and useability of primary outcome measures)
Data collected in the semi-structured interviews and focus groups will be recorded and transcribed using Microsoft Teams (which Hammondcare holds a licence for). The written transcripts will be de-identified and thematically analysed by three members of the research team to identify relevant themes related to the impact of the AoP in hospitals program in the subacute hospital setting.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/05/2023
Actual
7/06/2023
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
16/08/2024
Actual
Sample size
Target
199
Accrual to date
38
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 24101 0
Braeside Hospital - Prairiewood
Recruitment hospital [2] 24102 0
Neringah Hospital - Wahroonga
Recruitment hospital [3] 24103 0
Greenwich Hospital - Greenwich
Recruitment postcode(s) [1] 39609 0
2176 - Prairiewood
Recruitment postcode(s) [2] 39610 0
2076 - Wahroonga
Recruitment postcode(s) [3] 39611 0
2065 - Greenwich

Funding & Sponsors
Funding source category [1] 313266 0
Charities/Societies/Foundations
Name [1] 313266 0
HammondCare Foundation
Country [1] 313266 0
Australia
Primary sponsor type
Individual
Name
Lindsey Brett
Address
Centre for Positive Ageing
HammondCare
4 Spicer Avenue
Hammondville
NSW 2170
Country
Australia
Secondary sponsor category [1] 315001 0
Individual
Name [1] 315001 0
Christopher Poulos
Address [1] 315001 0
Centre for Positive Ageing
HammondCare
4 Spicer Avenue
Hammondville
NSW 2170
Country [1] 315001 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312496 0
St Vincent’s Hospital Human Research Ethics Committee
Ethics committee address [1] 312496 0
Ethics committee country [1] 312496 0
Australia
Date submitted for ethics approval [1] 312496 0
26/02/2023
Approval date [1] 312496 0
12/04/2023
Ethics approval number [1] 312496 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124870 0
Dr Lindsey Brett
Address 124870 0
Centre for Positive Ageing
HammondCare
4 Spicer Avenue
Hammondville
NSW 2170
Country 124870 0
Australia
Phone 124870 0
+61287883900
Fax 124870 0
Email 124870 0
[email protected]
Contact person for public queries
Name 124871 0
Lindsey Brett
Address 124871 0
Centre for Positive Ageing
HammondCare
4 Spicer Avenue
Hammondville
NSW 2170
Country 124871 0
Australia
Phone 124871 0
+61287883900
Fax 124871 0
Email 124871 0
[email protected]
Contact person for scientific queries
Name 124872 0
Lindsey Brett
Address 124872 0
Centre for Positive Ageing
HammondCare
4 Spicer Avenue
Hammondville
NSW 2170
Country 124872 0
Australia
Phone 124872 0
+61287883900
Fax 124872 0
Email 124872 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
As per the protocol and consent forms, no individual participant data will be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18416Study protocol  [email protected]
18417Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.