Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Pragmatic Cluster Randomised Trial of a Tailored Intervention for Implementing Recommendations for Managing Depressed Elderly Patients in Primary Care: Protocol
Brief Summary: Background The prevalence of depression is high and the elderly have an increased risk of developing a chronic course. International data suggest that depression in the elderly is under-recognised, the latency before clinicians provide a treatment plan is longer, and elderly patients with depression are not offered psychotherapy to the same degree as younger patients. Although recommendations for the treatment of elderly patients with depression exist, health care professionals adhere to these recommendations to a limited degree only. Investigators conducted a systematic review to identify recommendations for managing depression in the elderly and prioritised six recommendations. Investigators identified and prioritised determinants of practice related to implementation of these recommendations in primary care, and subsequently discussed and prioritised interventions to address the identified determinants. The objective of this study is to evaluate the effectiveness of these tailored implementation interventions to implement six recommendations for the management of elderly patients with depression in primary care.

Methods/design Investigators will conduct a pragmatic cluster randomised trial comparing implementation of the six recommendations using tailored interventions with usual care. Investigators will randomize 80 municipalities into one of two groups: an intervention group, to which investigators will deliver tailored interventions to implement the six recommendations, and a control group, to which investigators will not deliver any intervention. Investigators will randomise municipalities rather than patients, individual clinicians or practices because we will deliver the intervention for the first three recommendations at the municipal level and investigators want to minimise the risk of contamination across practices for the other three recommendations. The primary outcome is the proportion of general practitioners' behaviours which are consistent with the recommendations.

Discussion This trial will investigate whether a tailored implementation approach is an effective strategy to improve collaborative care in the municipalities and health care professionals' practice towards elderly patients with depression in primary care. The effectiveness evaluation described in this protocol will be accompanied with a process evaluation exploring why and how the interventions were effective or ineffective.


Options:
A: Inclusion Criteria:

Home-dwelling patients aged 65 or higher, who have a diagnosis of depression, according to International Statistical Classification of Diseases and Related Health Problems, Tenth Revision

Exclusion Criteria:

Patients will be excluded if they have a diagnosis of dementia, bipolar disorder or reside in nursing homes or is assessed by their practitioner to have low life expectancy.
B: Inclusion Criteria

* Patient must be ≥ 18 years of age.
* Patient must have been seen by a rheumatology health care provider at least two times within the last 18 months at Mayo Clinic Rochester.
* Patient must have rheumatoid arthritis (RA) according to the 2010 ACR/EULAR classification criteria.
* Patient must have the ability to understand and the willingness to sign a written informed consent document.
* Patient must be willing to return to Mayo Clinic Rochester for follow-up appointments and fill out questionnaires as outlined in the study.
C: Inclusion Criteria:

* General hospital inpatients with risky drinking (AUDIT-C \>= 4/5 (women/men) and AUDIT \< 20)

Exclusion Criteria:

* Patients already recruited during an earlier hospital stay
* Patients physically and mentally not capable of participating in the study
* Patients with a hospital stay of less than 24 hours
* Patients with insufficient language/ reading skills
* Patients employed at one of the departments participating in the study or conducting the study
* Patients with more severe alcohol problems (AUDIT \>= 20)
D: Inclusion Criteria:

* Eligible primary clinicians will include all clinicians who provide ongoing primary or specialty care to eligible patient populations. This will include primary care physicians (family medicine and internal medicine), oncologists, pulmonologists, cardiologists, gastroenterologists, nephrologists, neurologists, hepatologists, and geriatricians. Primary clinicians may also include nurse practitioners and physician assistants playing a "primary role" with eligible patients. A "primary role" denotes any clinician for whom having a discussion about end-of-life care with eligible patients would be indicated
* Eligible interprofessional team members will include nurses, social workers and other clinicians who are part of an enrolled primary clinician's clinic team.
* Eligible patients will be those under the care of a participating clinician who are 18 years of age or older, have had 2 or more visits with the primary clinician in the last 18 months, and meet diagnostic criteria. Diagnostic criteria include: 1) metastatic cancer or inoperable lung cancer; 2) chronic obstructive pulmonary disease with FEV1 values \<35% predicted or oxygen dependence or restrictive lung disease with a TLC \< 50% predicted; 3) New York Heart Association Class III or IV heart failure; 4) Child's Class C cirrhosis or MELD score of \>17; 5) dialysis-dependent renal failure and either diabetes or a serum albumin of \< 2.5; or, 6) older than 75 years with at least one life-limiting chronic illness or older than 90 years. Additional criteria include: PAH w. 6MWD \<250m, restrictive lung disease (IPF, ILD) w/ TLC \<50%, and cystic fibrosis with FEV1 \< 30%. Eligible patients will also be English-speaking and have no significant dementia or cognitive impairment that would limit his/her ability to complete questionnaires.
* Eligible family members will be identified by the patient, with the criterion that the patient would want the family member involved in medical decision-making for the patient if he/she was not able. For the purpose of this study, "family member" is not confined to legal next-of-kin or immediate family member. Any family member, friend, or caregiver is eligible who is English-speaking and has no dementia or delirium limiting his/her ability to complete questionnaires.

Exclusion Criteria:

* Reasons for exclusion for all subject groups include: legal or risk management concerns; and physical or mental limitations preventing ability to complete research activities.

Answer: A