Condition category
Mental and Behavioural Disorders
Date applied
21/08/2014
Date assigned
21/08/2014
Last edited
26/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
This study looks at whether giving personal feedback to people being treated for depression can help them get better more quickly. This is done through the use of patient-reported outcome measures (PROMs) which involve patients assessing their own symptoms, daily functioning, and quality of life and feeding back to the professionals involved in their care. This approach has not been researched in UK general practice yet. We want to find out whether patients, general practitioners, and practice nurses are willing to take part in such a study. It will test out whether PROMs, including questionnaires for symptoms of depression, daily functioning, quality of life, and problems particular to the individual patient, are acceptable to patients and to their general practitioners and practice nurses. If using PROMs is beneficial then their use is likely to be very cost-effective, and the benefits at a population level would be considerable given how common, disabling and long-lasting depression can be.

Who can participate?
Patients undergoing treatment for depression in each of eight participating general practices.

What does the study involve?
For patients:
Patients would be asked to see a researcher on three occasions over six months while they are having treatment for depression. Their treatment will be given by their doctor and/or nurse as usual, but they would be asked to fill out questionnaires and answer questions about their symptoms of depression, daily activities, quality of life, and any particular problems which they think may have caused their depression. Half the patients taking part will be chosen at random to be given the results of some of the questionnaires they complete (the PROMs), as will the doctors and nurses involved in their care. The other half of the patients taking part will not be asked to complete the PROMs for their doctor or nurse, but will still be asked to complete questionnaires and answer questions about their symptoms, activities, problems and quality of life, but these will be for the purpose of assessing differences between them and the patients completing the PROMs, and will be kept by the research team. In both patient groups all treatments within the patients’ general practices will be given by the doctors and nurses as usual but in one group the results of the results of the PROMS may be taken into account when deciding whether to continue or change treatments. It is possible that patients may be asked to take part in a one-off half-hour interview about their experience in taking part in the study and using the PROMS.

For professionals:
Healthcare professionals would use PROMs with either all of their patients with depression, or with half of them, or with none of them (depending on their group allocation). Professionals will treat patients with depression as usual, but will be asked to encourage those patients randomly allocated to use PROMs to complete the measures within the first 10 days of diagnosis, and again 10 to 35 days later. Healthcare professionals will be encouraged to take the results of the PROMs into account in their management of the patient, as appropriate, using clinical judgement. It is possible that health professionals would also be asked to participate in a one-off half-hour interview about their experience in taking part in the study and in using the PROMs with some or all of their patients, if they are allocated at random to use them.

What are the possible benefits and risks of participating?
For patients:
It is not known whether a patient’s treatment may be improved through more adjustments, if they are in the group chosen at random to have the results of the PROMs fed back to them and their doctor or nurse. The effect will only be known after a larger study to test out this approach. The main disadvantage is that patients would need to give their time to being interviewed on three occasions over a six-month period with a study researcher, each interview taking around an hour to an hour and a half. Patients would be asked questions about their education, employment, past history of depression, symptoms of depression and anxiety, quality of life, personal life problems, work and home life, some of which patients might find sensitive or difficult to answer. However, patients would not be put under any pressure to answer questions they do not want to answer.

For professionals:
If professionals are in the group chosen to have some or all patients complete the PROMs then it is possible that the treatment of those patients may be improved due to making more adjustments to their treatment, but this cannot be guaranteed. The main disadvantage is that professionals would need to spend around 10 minutes longer in the consultations they have with participating patients if they are randomly allocated to filling out PROMs, but the cost of the extra time spent would be reimbursed.

Where is the study run from?
The study is run from the University of Southampton (UK).

When is the study starting and how long is it expected to run for?
October 2014 to November 2015.

Who is funding the study?
National Institute for Health Research (NIHR) (UK).

Who is the main contact?
Miss Rachel Ryves
r.ryves@soton.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Miss Rachel Ryves

ORCID ID

Contact details

Primary Medical Group
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
r.ryves@soton.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

17281

Study information

Scientific title

Patient-reported outcome measures (PROMs) in the assessment and follow-up monitoring of patients with depression in primary care: a feasibility study

Acronym

PROMDEP

Study hypothesis

Is systematic assessment and follow-up monitoring of patients treated for depression using PROMs effective in terms of improved patient outcomes, and is it cost-effective?

The hypothesis is that more systematic assessment of patients using PROMs at diagnosis and follow-up will result in significantly better outcomes for patients, and be cost-effective at the level usually adopted for recommendation by NICE for use in the NHS.

The objectives of the feasibility study are to determine key elements of the best design for the main study, including whether to randomise individual patients to intervention or control arms within practices, or to allocate whole practices to intervention or control arms in a cluster randomisation design. We will select four practices at random to try out individual patient randomisation, and four to be cluster randomised.

Ethics approval

14/SC/1067; First MREC approval date 04/07/2014

Study design

Randomised; Interventional; Design type: Treatment

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

GP practices

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Topic: Mental Health, Primary Care; Subtopic: Depression, Mental Health, Primary care; Disease: Depression, All Diseases

Intervention

Eight practices will be randomised: four cluster-randomised practices and four practices with individually randomised patients. Two practices within the cluster-randomised arm will be intervention practices, and two will be control practices. The four cluster-randomised practices will recruit a total of 24 patients. The other four practices will individually randomise 24 patients.

All patients will be assessed at baseline, and have two follow-ups at 12 weeks and 26 weeks. Severity of symptoms, demographic details, self-reported duration of symptoms and anxiety symptoms will be collected at baseline. Depressive symptoms, social functioning and health-related quality of life will be measured in all patients at baseline, and at the 12-week and 26-week follow up. In addition, use of services, sickness absence, and patient satisfaction will be assessed at the 26-week follow-up.

Intervention: Three PROMs will be assessed:
PHQ-9; PSYCHLOPS; Distress Thermometer

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Beck Depression Inventory (BDI)-II; Timepoint(s): 12 weeks and 26 weeks

Secondary outcome measures

1. EQ-5D; Timepoint(s): 12 weeks and 26 weeks
2. Short Form (SF)-12; Timepoint(s): 12 weeks and 26 weeks
3. Work and Social Adjustment Scale (WSAS); Timepoint(s): 12 weeks and 26 weeks

Overall trial start date

01/10/2014

Overall trial end date

30/11/2015

Reason abandoned

Eligibility

Participant inclusion criteria

Adults who are diagnosed with depression by their GPs

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 48; UK Sample Size: 48; Description: 24 in monitoring arm and 24 receiving usual care.

Participant exclusion criteria

1. Patients with comorbid dementia, psychosis, or significant substance misuse, of a level that makes depression a secondary rather than primary diagnosis
2. Patients who are seriously suicidal and need urgent referral to secondary care

Recruitment start date

01/10/2014

Recruitment end date

30/11/2015

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Primary Medical Group
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

University of Southampton (UK)

Sponsor details

Southampton Primary Care Academic Unit
School of Medicine
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-0613-31004

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes