Evaluation of a lengthened and multi-disciplinary consultation model in a socially deprived community
| ISRCTN | ISRCTN70578736 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70578736 |
| Secondary identifying numbers | N/A |
- Submission date
- 19/04/2007
- Registration date
- 09/05/2007
- Last edited
- 27/01/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Whitford
Scientific
Scientific
RCSI-MUB
PO Box 15503
Adliya
Manamsa
15503
Bahrain
| Phone | +973 17 58 35 00 |
|---|---|
| dwhitford@rcsi-mub.com |
Study information
| Study design | This is a randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Quality of life |
| Scientific title | |
| Study objectives | The null hypothesis is that implementation of a lengthened and multidisciplinary primary care consultation will have no impact upon the psychological health of mothers in terms of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS). |
| Ethics approval(s) | Approval received from the Research Ethics Committee of the Royal College of Surgeons in Ireland (RCSI REC) on the 13th December 2004 (ref: REC115). |
| Health condition(s) or problem(s) studied | Depression of mothers in socially deprived area |
| Intervention | Families (with at least one child under the age of 16 years) with a history of social problems, substance misuse or depression will be identified by the general practices. Mothers of the families will be approached on behalf of the families and invited to participate in the research by letter and telephone follow up. Families agreeing to participate will be randomised into two equal sized non-stratified groups. Intervention group: A multidisciplinary lengthened primary care consultation will be given to the intervention families. The mothers and their families in the intervention group will be offered the multidisciplinary consultation with the Primary Health Care Team (PHCT) to assess their health and social needs. The General Practitioner (GP) will hold an initial discussion with the mother to discuss what her needs are, and this will guide the GP as to which members of the PHCT to invite to the trial consultation. The GP will invite up to other three members of the PHCT, who he or she feels will be able to give significant input, to help address the familys health and social problems. The health care professionals in attendance will actively participate in the consultation and offer advice and input where appropriate. The GP will be in charge of running the consultation, and will have the whole PHCT from the Ballymun primary care project available to him or her. The GP will try to bring out all the health and social problems of the family so solutions may be worked out. Further lengthened consultations with the members of the primary care team may be required. The GP will arrange the appointments of the trial consultation for the families to attend. An allowance of up to an hour will be given for each case so that three consultations may be arranged per clinical session. Control group: The mothers and families in the control group will receive normal care from their GP and the PHCT. |
| Intervention type | Other |
| Primary outcome measure | The primary outcome of this study is the psychological health of mothers in terms of anxiety and depression as measured by the Hospital Anxiety and Depression Scale (HADS), measured at 0, 6 months and 12 months. |
| Secondary outcome measures | 1. Service delivery: 1.1. Frequency of GP and PHCT visits 1.2. Time spent with GP and PHCT 1.3. Referrals to secondary care and other agencies 2. Medical measures: 2.1. Health status (36-item Short Form health survey [SF-36]) 2.2. Smoking status 2.3. Alcohol consumption 2.4. Substance misuse 3. Social measures: 3.1. School truanting 3.2. Unemployment 3.3. Family income 4. Psychological measures (psychotropic prescribing) 5. Satisfaction with management It is not possible at the outset to determine whether an increase or decrease of service measures is beneficial. An assessment of the trend in referrals and time spent with primary care professionals will be made as the study comes to completion. All secondary outcomes will be measured at time 0, 6 months and 12 months. |
| Overall study start date | 07/02/2004 |
| Completion date | 31/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 92 families |
| Key inclusion criteria | Inclusion - must be mothers who: 1. Have at least one child under 16 years old 2. Have multiple physical or mental health and/or social and/or alcohol and/or drug problems |
| Key exclusion criteria | 1. Mothers of the families who are under 18 years of age 2. English is not the first language 3. Mothers who have a learning disability or dementia 4. Have high financial income, i.e., non-General Medical Services (GMS) (means tested access to medical services in Ireland) |
| Date of first enrolment | 07/02/2004 |
| Date of final enrolment | 31/01/2007 |
Locations
Countries of recruitment
- Bahrain
- Ireland
Study participating centre
RCSI-MUB
Manamsa
15503
Bahrain
15503
Bahrain
Sponsor information
Royal College of Surgeons in Ireland (RCSI) (Ireland)
University/education
University/education
123 St Stephens Green
Dublin
2
Ireland
| Website | http://www.rcsi.ie |
|---|---|
"ROR" |
https://ror.org/01hxy9878 |
Funders
Funder type
Government
Health Research Board (Ireland) (ref: PC/2003/11)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- HRB
- Location
- Ireland
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | Protocol: | 28/06/2007 | Yes | No | |
| Results article | Results: | 24/01/2011 | Yes | No |
