Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer study).

BACKGROUND: Depression and debt are common in the UK. Debt Counselling for Depression in Primary Care: an adaptive randomised controlled pilot trial (DeCoDer) aimed to assess the clinical effectiveness and cost-effectiveness of the addition of a primary care debt counselling advice service to usual care for patients with depression and debt. However, the study was terminated early during the internal pilot trial phase because of recruitment delays. This report describes the rationale, methods and findings of the pilot study, and implications for future research. OBJECTIVES: The overarching aim of the internal pilot was to identify and resolve problems, thereby assessing the feasibility of the main trial. The specific objectives were to confirm methods for practice recruitment and the ability to recruit patients via the proposed approaches; to determine the acceptability of the study interventions and outcome measures; to assess contamination; to confirm the randomisation method for main trial and the level of participant attrition; and to check the robustness of data collection systems. DESIGN: An adaptive, parallel, two-group multicentre randomised controlled pilot trial with a nested mixed-methods process and economic evaluation. Both individual- and cluster (general practice)-level were was used in the pilot phase to assign participants to intervention or control groups. SETTING: General practices in England and Wales. PARTICIPANTS: Individuals were included who were aged ≥ 18 years, scored ≥ 14 on the Beck Depression Inventory II and self-identified as having debt worries. The main exclusion criteria were being actively suicidal or psychotic and/or severely depressed and unresponsive to treatment; having a severe addiction to alcohol/illicit drugs; being unable/unwilling to give written informed consent; currently participating in other research including follow-up phases; having received Citizens Advice Bureau (CAB) debt advice in the past year; and not wanting debt advice via a general practice. INTERVENTIONS: The participants in the intervention group were given debt advice provided by the CAB and shared biopsychosocial assessment, in addition to treatment as usual (TAU) and two debt advice leaflets. The participants in the control group were given advice leaflets provided by the general practitioner and TAU only. MAIN OUTCOME MEASURES: (1) Outcomes of the pilot trial - the proportion of eligible patients who consented, the number of participants recruited compared with target, assessment of contamination, and assessment of patient satisfaction with intervention and outcome measures. (2) Participant outcomes - primary - Beck Depression Inventory II; secondary - psychological well-being, health and social care utilisation, service satisfaction, substance misuse, record of priority/non-priority debts, life events and difficulties, and explanatory measures. Outcomes were assessed at baseline (pre-randomisation) and at 4 months post randomisation. Other data sources - qualitative interviews were conducted with participants, clinicians and CAB advisors. RESULTS: Of the 238 expressions of interest screened, 61 participants (26%) were recruited and randomised (32 in the intervention group and 29 in the control group). All participants provided baseline outcomes and 52 provided the primary outcome at 4 months' follow-up (14.7% dropout). Seventeen participants allocated to the intervention saw a CAB advisor. Descriptive statistics are reported for participants with complete outcomes at baseline and 4 months' follow-up. Our qualitative findings suggest that the relationship between debt and depression is complex, and the impact of each on the other is compounded by other psychological, social and contextual influences. CONCLUSIONS: As a result of low recruitment, this trial was terminated at the internal pilot phase and was too small for inferential statistical analysis. We recommend ways to reduce this risk when conducting complex trials among vulnerable populations recruited in community settings. These cover trial design, the design and delivery of interventions, recruitment strategies and support for sites. TRIAL REGISTRATION: Current Controlled Trials ISRCTN79705874. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 35. See the NIHR Journals Library website for further project information. Mark Gabbay and Adele Ring are part-funded by NIHR Collaborations for Leadership in Applied Health Research and Care (CLAHRC) North West Coast and Richard Byng and Rod S Taylor, Vashti Berry and Elizabeth Shaw part-funded by NIHR CLAHRC South West Peninsula.

Change in diagnosis on fit notes within an episode of certified sickness absence.

BACKGROUND: Little consideration has previously been given to the implications of a change in diagnosis during a sickness certification episode. OBJECTIVE: To report the extent and patterns of change in diagnosis and to identify factors associated with likelihood of change. METHODS: Sixty-eight general practices in the UK recorded details of sickness certificates (fit notes) issued to patients in a 12-month data collection period. Diagnoses on fit notes were assigned to modified READ categories. RESULTS: Over 23% (3841/16400) of episodes consisting of more than one sickness certificate had a change in diagnosis during the course of the episode. Over 4% (438/10398) of initial physical health episodes had a later mental health diagnosis. Lowest rate of change was found within episodes with an initial mental health diagnosis, the highest when an unspecified physical symptom was entered on the first fit note in the episode. A change in diagnosis was more likely when the total duration of the episode was longer, the episode included more fit notes and the patient was living in a socially deprived neighbourhood. Episodes where the patient had been issued fit notes by more than one GP were more likely to have a change in diagnosis. CONCLUSION: Change in diagnosis on fit notes is much less common when the patient has a psychological health problem.

Modelling condom use: Does the theory of planned behaviour explain condom use in a low risk, community sample?

To date, most condom research has focused on young or high-risk groups, with little evidence about influences on condom use amongst lower-risk community samples. These groups are not risk free and may still wish to negotiate safer sex; yet the considerations involved could be different from those in higher-risk groups. Our research addresses this gap: We report a cross-sectional questionnaire study enquiring about recent condom use and future use intentions in community settings. Our sample (n = 311) purposively included couples in established relationships, known to be condom users. Items included demographics, sexual history and social-cognitive variables taken from the theory of planned behaviour. The strongest association with condom use/use intentions amongst our respondents was sexual partner's perceived willingness to use them. This applied across both univariate and multivariate analyses. Whilst most social-cognitive variables (attitudes; self-efficacy and peer social norms) were significant in univariate analyses, this was not supported in multivariate regression. Of the social-cognitive variables, only "condom-related attitudes" were retained in the model explaining recent condom use, whilst none of them entered the model explaining future use intentions. Further analysis showed that attitudes concerning pleasure, identity stigma and condom effectiveness were most salient for this cohort. Our results suggest that, in community samples, the decision to use a condom involves different considerations from those highlighted in previous research. Explanatory models for established couples should embrace interpersonal perspectives, emphasising couple-factors rather than individual beliefs. Messages to this cohort could usefully focus on negotiation skills, condom advantages (other than disease prevention) and reducing the stigma associated with use.

Increasing heart-health lifestyles in deprived communities: economic evaluation of lay health trainers.

RATIONALE, AIMS AND OBJECTIVES: Cardiovascular disease (CVD) often arises from modifiable lifestyle factors. Health care professionals may lack the skills and resources to sustain behaviour change, lay 'health trainers' (LHT) offer a potential alternative. We sought to assess the cost-effectiveness of using a LHT to improve heart-health lifestyles in deprived communities. METHODS: Participants in this randomized trial were aged ≥18 years with at least one risk factor for CVD (hypertension, raised cholesterol, diabetes, BMI>30 or current smoker). Both groups received health promotion literature. LHT were also able to provide intervention participants with information, advice and support aimed at changing beliefs and behaviour. Costs and quality-adjusted life year (QALY) changes were estimated over 6 months. The cost-utility [incremental cost-effectiveness ratio (ICER)] of LHT was calculated and assessed in relation to the cost-effectiveness threshold of £20 000-30 000 per QALY. The probability of LHT being cost-effective was also calculated. RESULTS: Seventy-two participants were randomized to a LHT, with 38 controls. The mean cost of the LHT intervention was £151. On average, other health and social service costs fell by £21 for controls and £75 for intervention participants giving a LHT mean overall incremental cost of £98. The mean QALY gains were 0.022 and 0.028, respectively. The ICER for LHT was £14 480, yet there was a 61% chance of making the wrong decision at a £20 000/QALY threshold. CONCLUSION: LHT provision was estimated to be cost-effective for people at risk of CVD. However, a large level of uncertainty was associated with that decision.

A randomized crossover trial of the impact of additional spermicide on condom failure rates.

OBJECTIVE: Opinions remain divided concerning the potential for additional water-based lubricant to reduce condom breaks and slips. We sought to explore impact of externally applied additional lubrication on condom failure rates among regular users in stable heterosexual relationships. GOAL: To compare condom failure rates with and without additional spermicide. STUDY DESIGN: Couples randomized to use up to 70 condoms alone (control) or with additional spermicide (intervention), with midpoint crossover. Couple demographic and failure risk data collected at baseline. Follow ups at three and six months recorded condom failure events, spermicide acceptability, side-effects and adverse events. Condom failure rates were compared using an intention to treat analysis. RESULTS: Altogether 12,530 condoms were used by 145 couples completing the trial, There were 45/6,463:0.70% (95% CI 0.51%-0.93%) clinical and nonclinical failures in the additional spermicide arm, compared to 111/6,067:1.83% (95% CI 1.51%-2.20%) during the control arm. The clinical condom failure rate was 0.53% (95% CI 0.41%-0.66%), with 19 (0.31%: 95% CI 0.18%-0.43%) during the additional spermicide arm, compared to 46 (0.77%: 95% CI 0.56%-0.99%) during the control arm. Couples experienced significantly lower total (P = 0.017) and clinical (P = 0.042) condom failure rates during the additional spermicide arm. Furthermore additional spermicide significantly reduced clinical failures among the 101 couples who'd experienced a previous condom failure (P = 0.002). There were 22 urinary tract infections, equally divided between the control and additional spermicide arms, however 10 of the 12 genital irritation episodes occurred with additional spermicide (P = 0.021). CONCLUSIONS: Additional water-based external lubricant significantly reduced condom failures despite low failure rates among this stable, experienced group of condom users. Our results suggest that this may be a useful supplement to condom use, particularly among couples who experienced condom failures previously.

Patient, clinician, and general practice factors in long-term certified sickness.

AIMS: To investigate the association of patient, clinician, and general practice factors with long-term certified sickness absence. METHODS: Analysis of a sickness certification database constructed via the use of carbonized sick notes by clinicians at nine general practices in the north-west of England. A total of 3,385 patient sickness episodes certified by 44 general practitioners (GPs) were included in the analysis. Three logistic regression models were constructed in order to estimate independent effects of the patient, GP, and the general practice on risk of long-term (>28 weeks) incapacity. RESULTS: The logistic regression models explained a maximum of 27% of the variation in long-term certified sickness. The diagnostic reason for the sickness episode explained over 18% of variance, while clinician and general practice effects explained only 3.4% and 2.3% respectively. In all models, older patient age and an episode within the mild mental disorder (MMD) diagnostic category significantly increased the risk of long-term work incapacity. CONCLUSIONS: The study results imply that, rather than basing 'return to work' interventions on identification of individual patient/claimant characteristics or on GP training initiatives, it may be more productive to focus upon a more diagnosis-based approach within primary care itself. Interventions aiming to reduce mild mental disorder-related work incapacity should be given priority.

The role of primary care in the prevention of suicide and accidental deaths among young men: an epidemiological study.

BACKGROUND: Despite generally falling mortality and suicide rates, among young men the rates of violent death from accidents and suicide continue to rise. Most research has focused upon suicide, and the potential for effective interventions, particularly in primary care, remains controversial. AIMS: To compare health service contacts prior to suicidal and accidental deaths among young men. DESIGN OF STUDY: Examination of inquest data, postmortem and toxicology reports, and general practitioner (GP) and hospital records. SETTING: All sudden, unexpected, violent or unnatural deaths involving young men aged between 15 and 39 years and reported to the four coroner's offices of Merseyside and Cheshire during 1995. METHOD: We compared data on the timing and nature of final GP contacts before death among young men with a verdict of accident or misadventure and suicide or undetermined death. RESULTS: Out of a total of 268 violent deaths, 130 received verdicts of accident/misadventure and 97 received verdicts of suicide/undetermined death. Information on the final contact with a GP was available for 172 deaths. Although there was a significant difference between the proportion of suicide cases (56%) and that of cases of accidental death (41%) who had seen their GP during the 3 months before death, this was not significant at 1 month (38% versus 30%, respectively). Suicide cases were more likely to have seen a mental health professional at some time (27% for suicides versus 13% for accidental deaths). CONCLUSION: These findings confirm that relatively few young men consult their GP during the period before death from suicide or accidents. Prevention strategies must extend beyond suicide risk assessment, and consider ways to encourage young men to consult GPs when they are experiencing emotional distress or problems related to mental health or substance misuse.

Patient factors associated with duration of certified sickness absence and transition to long-term incapacity.

BACKGROUND: Despite a considerable increase in claims for long-term sickness benefits, and the impact of certifying sickness upon general practitioner (GP) workload, little is known about transition to long-term incapacity for work. AIM: To explore the relationship between patient factors and the transition from short-term to long-term work incapacity, in particular focusing on mild mental health and musculoskeletal problems. SETTING: Nine practices comprising the Mersey Primary Care R&D Consortium. DESIGN: Prospective data collection and audit of sickness certificate details. METHOD: GPs issued carbonised sickness certificates for a period of 12 months. The resulting baseline dataset included claimant diagnosis, age, sex, postcode-derived deprivation score, and sickness episode duration. Associations of patient factors with sickness duration outcomes were tested. RESULTS: Mild mental disorder accounted for nearly 40% of certified sickness. Relatively few claimants had their diagnosis changed during a sickness episode. Risk factors for longer-term incapacity included increasing age, social deprivation, mild and severe mental disorder, neoplasm, and congenital illness. For mild mental disorder claimants, age, addiction, and deprivation were risk factors for relatively longer incapacity. For musculoskeletal problems, the development of chronic incapacity was significantly related to the nature of the problem. Back pain claimants were likely to return to work sooner than those with other musculoskeletal problems. CONCLUSIONS: In addition to the presenting diagnosis, a range of factors is associated with the development of chronic incapacity for work, including age and social deprivation. GPs should consider these when negotiating sickness certification with patients.